Drug Register (September 2018)

This list is updated regularly when available data on such products are evaluated and relevant sites are inspected by National Drug Authority. Please enter the criteria below to display products from the Drug Register database.


S/n NDA Registration No License Holder Local Technical Representative Name of Drug Manufacturer Country of Manufacture Dosage Form Pack Size
NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLET CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (A) LTD - WILSON LANELIVOMYN SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE
NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDALKA 5 SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/8509CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDEVANOVA CAPSULE CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011INDIAORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER
NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY POWDERS 1.0X10.0X765.0 MG SACHET
NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICAJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABADINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HHP/5498AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFIGURINAJANTA PHARMA LTD 31-0-AJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREACHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X6.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5560AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSTAMINAAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAPDYL-H, HERBAL COUGH SYRUPAJANTA PHARMA, AURANGABAD & SAVERA PHARMACEUTICAL PVT. LIMITED-,H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA,SAVERA PHARMACEUTICALS PVT LTD --H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA.INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HHP/8551AMRUTANJAN HEALTHCARE LIMITEABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN RELIEF COUGH AND COLD SYRUPAMRUTANJAN HEALTH CARE LIMITED -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA PLOT NO.:37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK, KANCHEEPURAM, DIST. ? 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY UNIT DOSE LIQUIDS 1.0X8.0 ML SACHET
NDA/MAL/HHP/8552AMRUTANJAN HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BALM AMRUTANJAN HEALTH CARE LIMITED -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA PLOT NO.:37, 38 & 39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TK, KANCHEEPURAM, DIST. ? 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X10.0 G TUBE
NDA/MAL/HHP/5571ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDRAGON LIQUID BALMAMRUTANJAN HEALTH CARE LIMITED-PLOT NO 37,38&39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TALUK, KANCHEEPURAM DISTRICT 603110, INDIAINDIATOPICAL EXTERNAL OTHER OINTMENTS 1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER
NDA/MAL/HHP/8215AMRUTANJAN HEALTH CARE LTD ABACUS PHARMA (A) LTD - WILSON LANEAMRUTANJAN DRAGON BACK PAIN ROLL-ONAMRUTANJAN HEALTH CARE LTD -103 COLD NO (42-45),LUZ CHURCH ROAD, MYLAPORE, CHENNAI INDIA -600004INDIATOPICAL EXTERNAL LOTIONS 1.0X50.0 ML CONTAINER
NDA/MAL/HHP/5508ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BALM AMRUTANJAN HEALTHCARE LTD, CHENNAI-(42-45),LUZ CHURCH ROAD, MYLAPORE, CHENNAI INDIA -600004INDIATOPICAL EXTERNAL OTHER OINTMENTS 1.0X9.0 G CONTAINER
NDA/MAL/HHP/8548ARTURA PHARMACEUTICALS PVT LTDMEDVIN PHARMA LIMITEDPEPSOLARTURA PHARMACEUTICALS PVT LTD-PLOT NO. 1505 PORTIA ROAD SIRI CITY SEZ SATYAVEDU MANDAL CHITTOOR DISTRICT ANDHRA PRADESHI - 517 588 INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDPLANET PHARMACEUTICALS UGANDA LTDKIDFLAMEBHARGAVA PHYTOLAB PVT LTD-B-92, SECTOR ? 2 , NOIDA ? 201301, U.P. ( INDIA)INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0 TABLET BLISTER
NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDPOSTORALBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HHP/8457BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDGASTICA SYRUPBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE
NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDTHUNDER-MBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HHP/8512BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDINFAB SYRUPBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDMENIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X20.0 TABLET BLISTER
NDA/MAL/HHP/8841DEWYX INTERNATIONAL LTDDEWYX PHARMACEUTICALS LIMITEDM-ENERGEX CAPSULESBIO GALLERY-SDN BHDMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X50.0X1.0 CAPSULE BLISTER,1.0X25.0X1.0 CAPSULE BLISTER
NDA/MAL/HHP/8842DEWYX INTERNATIONAL LTDDEWYX PHARMACEUTICALS LIMITEDM-ENERGEX COFFEEBIO GALLERY-SDN BHDMALAYSIAORAL SOLID ORDINARY POWDERS 1.0X10.0X20.0 G SACHET
NDA/MAL/HHP/8510 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDFRICKS COUGH SYRUPBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5597CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDTOOCHE DROPSCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAORAL TOPICAL DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HHP/7931DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDKIMSY MEDS LTDLIBLAB SYRUPDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD,-NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN.JORDANORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5580MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA SYRUPDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY VIETNAMORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HHP/7942MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA FORTDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY THAILANDORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5613ANDYCO PHARMACYANDYCO PHARMACY (UGANDA) LTDSMOOTH COUGH DROPSDR KIM AYURVEDIC PHARMACY-INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X100.0X2.0 LOZENGE STRIP
NDA/MAL/HHP/5536ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMENTHO PLUS PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIANASAL TOPICAL OINTMENTS 1.0X24.0X3.5 ML VIAL,1.0X1.2 G JAR,1.0X4.0 G JAR,1.0X9.0 G JAR,1.0X30.0 G JAR,1.0X1.2 ML VIAL,1.0X4.0 ML VIAL,1.0X9.0 ML VIAL,1.0X30.0 ML BOTTLE
NDA/MAL/HHP/5548EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FAST HERBAL PAIN RELIEF OINTMENTEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL OINTMENTS 1.0X4.0 ML BOTTLE,1.0X25.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X12.0 ML BOTTLE
NDA/MAL/HHP/5551EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FAST HERBAL PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL OINTMENTS 1.0X25.0 ML BOTTLE
NDA/MAL/HHP/5554EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FIRST HERBAL PAIN RELIF SPRAYEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL PRESSURISED AEROSOLS 1.0X150.0 ML CANNISTER
NDA/MAL/HHP/5558EMAMI LTDJEET PHARMACEUTICALS LIMITEDHIMANI FIRST HERBAL VAPOUR RUBEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL OTHER OINTMENTS 1.0X25.0 ML JAR
NDA/MAL/HHP/5567ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW EMAMI MENTHOPLUS RELAXING BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIINDIATOPICAL EXTERNAL LIQUIDS 1.0X8.0 ML JAR
NDA/MAL/HHP/8071EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOOVE MASSAGE CREAMEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTTOPICAL EXTERNAL LOTIONS 1.0X1.0X40.0 G TUBE
NDA/MAL/HHP/7945STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDKOFKICH LOR HERBAL FAGRIS MEDICA PVT LTD-255,SATYAM MALL SATELLITE,AHMEDABAD 380015INDIAORAL SOLID ORDINARY LOZENGES 1.0X20.0 LOZENGE CARTON,1.0X50.0 LOZENGE CARTON,1.0X150.0 LOZENGE CARTON
NDA/MAL/HHP/7948STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDKOFKICH LOR (LEMON FLAVOUR)FAGRIS MEDICA PVT LTD-255,SATYAM MALL SATELLITE,AHMEDABAD 380015INDIAORAL SOLID ORDINARY LOZENGES 1.0X20.0 LOZENGE CARTON,1.0X50.0 LOZENGE CARTON,1.0X150.0 LOZENGE CARTON
NDA/MAL/HHP/7967STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDKOFKICH MIX HERBALFAGRIS MEDICA PVT LTD-255,SATYAM MALL SATELLITE,AHMEDABAD 380015INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORIINDIATOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HHP/7937GLENMARK PHARMACEUTICAL LTD STAR PHARMACEUTICALS LTDSENSUR OILGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORIINDIATOPICAL EXTERNAL LIQUIDS 1.0X10.0 ML VIAL
NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR LOTIONGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORIINDIATOPICAL EXTERNAL OTHER CREAMS 1.0X50.0 ML BOTTLE
NDA/MAL/HHP/8385GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDMEBOSCAR OINTMENTGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HHP/5502HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDGASEXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE)
NDA/MAL/HHP/5515HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDMENTATHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5517HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDMENTATHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X50.0 TABLET CONTAINER
NDA/MAL/HHP/5520HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDPILEXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE),1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5522HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMCOLINHIMALAYA DRUG COMPANY-27256287 INDIAINDIATOPICAL EXTERNAL EMULSION GELS 1.0X30.0 G TUBE
NDA/MAL/HHP/5524HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHERBOLAXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5527HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDKOFLETHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5529HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDLIV.52HIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE (PHYSICIAN'S SAMPLE)
NDA/MAL/HHP/5530HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDLIV.52 TABLETSHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE
NDA/MAL/HHP/5531HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HHP/5533HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN SAMPLE)
NDA/MAL/HHP/5538HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDSEPTILINHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5540HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDSEPTILINHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5549HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDBONISAN LIQUIDHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HHP/5563HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDCYSTONEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5569HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDDIAREXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5583HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDEVECAREHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER
NDA/MAL/HHP/5595HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDTENTEX ROYALHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5616HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDV-GELHIMALAYA DRUG COMPANY-27256287 INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HHP/8288HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDDIABECONHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HHP/8289HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDGERIFORTEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/8290HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDOPTHCAREHIMALAYA DRUG COMPANY-27256287 INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HHP/8291HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDTENETEX FORTEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HHP/7926HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDHOVID GINKO HOVID BERHAD-121, JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HHP/8554OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDDIGLOCISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8672OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDHYARTHO CAPSULESISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X60.0 CAPSULE BOTTLE
NDA/MAL/HHP/8673OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDCALMLA CAPSULEISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X60.0 CAPSULE BOTTLE
NDA/MAL/HHP/8674OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDPYLKER TABLETSISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8675OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDDIBCARE TABLETSISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8676OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDSUTRIM TABLETSISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/6863KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES (HONEY & LEMON FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER
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NDA/MAL/HHP/7963KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(LEMON FLAVOUR)KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE BLISTER
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NDA/MAL/HHP/8899LEXINE TECHNOCHEM PVT LTD MUKWANO PHARMACEUTICALS LIMITEDLEXICOF HERBAL COUGH SYRUPLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373, OPP. RAMAKAKA DERI CHHANI, VADODARA ? 391704 GUJARAT, INDIA INDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
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NDA/MAL/HHP/8549 UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDUNOSOYMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL HARIDWAR-249403 UTTARAKHANDINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X60.0 CAPSULE BOTTLE
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NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER
NDA/MAL/HHP/5518MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER
NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X12.0 G TUBE
NDA/MAL/HHP/5532MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATIINDIANASAL TOPICAL OINTMENTS 1.0X12.0 G CONTAINER
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NDA/MAL/HHP/8553RAZA INTERNATIONALWIDE SPECTRUM ENTERPRISES (U) LIMITEDHONEY CUREOZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANY?-SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET. OZONE INDUSTRIAL COMPLEX. P.O. BOX : 1764. AMMAN 11953, JORDANJORDANTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
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NDA/MAL/HHP/5505VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDAMPUCARE HERBAL OILPLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIAINDIATOPICAL EXTERNAL LIQUIDS 1.0X50.0 ML BOTTLE
NDA/MAL/HHP/5503ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAMODEX OINTMENTPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL OINTMENTS 1.0X25.0 G JAR
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NDA/MAL/HHP/8507SYDLER REMEDIES PVT LTD M-190ROYAL PHARMA 2011 LIMITEDCUFSOL LOZENGES ORANGESYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X50.0 LOZENGE BLISTER
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NDA/MAL/HHP/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDMANIX HERBAL CAPSULES TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
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NDA/MAL/HHP/5629UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(ORANGE FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP
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NDA/MAL/HHP/7954UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(PINEAPPLE)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP
NDA/MAL/HHP/7956UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF COLD RUBUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER
NDA/MAL/HHP/8900UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMIGROSTOPUNOSOURCE PHARMA LTD -503/504, HUBTOWN SOLARIS, N.S PHADKE MARG, ANDHERRI EAST, MUMAI 400069 INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X60.0 CAPSULE CONTAINER
NDA/MAL/HHP/5516MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDANCARE CAPSULESVITAL CARE PVT LTD-361-362 GIDC POR RAMAGANDI VADODARAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVYBRANTVITAL CARE-INDIAINDIAORAL SOLID ORDINARY CAPSULES 5.0X10.0 CAPSULE BLISTER

S/n Manufacturer Drug Name Strength Product Name Number Pack Sizes Dosage Form Applicant Country of Origin ltr Reason
AQUATAIN PRODUCTS PTY LTD, AUSTRALIAAQUATAIN AMF78% W/VPOLYDIMETHYLSILOXANEPHA029LIQUID1*500ML & 1*5LMCP-MOHAUSTRALIAMOH
ARYSTA LIFE SCIENCES LIMITED 12 DENYS ROAD, RIVER CLUB, 2191,PRIMIHOSMETHYL833ML/LACTELLIC 300 CS (PRIMIHOSMETHYL)PHA043LIQUID1L HDPE BOTTLEARYSTA LIFE SCIENCES LIMITEDSOUTH AFRICAORIENTAL BUSINESS GROUP LTD
ASTRAZENECA PHARMACEUTICALS [PTY] LTDTETMOSOL SOAP5% W/WMONOSULFIRAMPHA065SOAP100GASTRAZENECA PHARMACEUTICALSMCNAUGHTONSOUTH AFRICA
AVIMAR PTY LTD, 18 ASCHENBERG STREET CHAMDOR KRUGEAVI-DDT75%W/VDDT WETTABLE POWDERPHA014POWDER1* 540GAVIMAR PTY LTDSOUTH AFRICACOOPER (U) LTD
BASF,BODIPALAYAM INDIA & STI SOLFOTECNICA ITALIANAFENDONA 5WPFENDONA 5WPALPHA-CYPERMETHRINPHA017WETTABLE POWDER1X150 G SACHETSBASF,GERMANYITALYCOOPER (U) LTD
BAYER ENVIROMENTAL SCIENCE P. O BOX 143 ,ISANDO 16K-OTHRINE WG 250250DELTAMETHRINPHA018WETTABLE POWDER1X25 G SACHETSQUALITY CHEMICALS LTDSOUTH AFRICAQUALITY CHEMICALS LTD
BCS/BES QUART DE POBLET & BAYER (PTY) LTD,A-3FICAM VC800G/KGBENDIOCARBPHA023POWDER1*125G ,1*100GBAYER ENVIRONMENT SCIENCE,BAYER EAST AFRICA LTDSPAINQUALITY CHEMICALS
BEIJING BIOSEEN CROP SCIENCES CO. LTD NO.8, XHENGOTNE ROAD LIANGXIANG TOWN FANGSHAN DISTRICT, PC: 102488, CHINAFIPRONIL50GBUIDOR 5 TCPHA056LIQUID1*50GDUDU EAST AFRICACHINAAGROMART UGANDA LTD
DAINIHON JOCHUGIKU Co., Ltd, 1-4-11, Tosabori, Nishi-Ku, Osaka, 550-0001 JapanKAGAINAKUNARU-SPRAY15.8%W/V(Metofluthrin)PHA070AEROSOL SPRAY55mlDAINIHON JOCHUGIKU Co., Ltd, 1-4-11, Tosabori, Nishi-Ku, Osaka, 550-0001 JapanJAPANSARAYA EAST AFRICA LTD
ECOLAB USAVALIANT EXPRESS 3 (EXPRESS 3 + EXPRESS BLUE)3.65% (W/V) & 8.9% (V/V)SODIUM CHLORITE AND LACTI ACIDPHA027LIQUID1L +1LECOLAB USAUSAABS TCM (U) LTD
FMC CORPORATION, 1735 MARKET STREET, PHILADELPH IABISTAR 10WP () WETTABLE POWDER10%BIFENTRIN 10%PHA012WETTABLE POWDER62.5G SACHETARYSTA LIFESCIENCES SASUSABALTON (U) LTD
GREAT INDIA INDUSTRIAL AND PHARMACEUTICAL LABORATORIES 19 SUN MILLS COMPD MUMBAI 400013AQUA-SHEILD-2010% V/VHYDROGEN PEROXIDEPHA035LIQUID1*20 MLGREAT INDIA INDUSTRIAL AND PHARMACEUTICAL LABORATORIEINDIAAARON PHARMACEUTICALS LTD
INNOVATIVE RESEARCH & DEVELOPMENT (INRAD) 4 SAUDI COMPANY BLD, HELIOPOLIS, CAIROSUN ACTIVATED FORMULATED EXTRACT (SAFE) POWDERMULTI INGRIDIENTSUN ACTIVATED FORMULATED EXTRACT (SAFE)PHA 032POWDERZINNOVATIVE RESEARCH & DEVELOPMENTEGYPTPINE PHARMACY
LARCHIFARMA SRL - SS 16 ZONA INDUSTRIALE-73010 ZOLLACHI CYM P-EC ()71.4,14.3% &,4.3%PIPERONYL BUTOXIDE- 71.4%, TETRAMETHRIN 14.3% & PERMETHRIN14.3%PHA011LIQUID1*1L &1*5LLARCHIFARMA SRL - ITALYITALYNEC HEALTH WORLD
MEDENTECH LTD WHITE MILL IND. ESTATE CLONARD ROADWATERGUARD AQUATABS69.3MGSODIUM DICHLORO ISOCYANURATE TABLETSPHA001TABLET1 * 10'SMEDENTECH LTDIRELANDPACE
MITSUI CHEMICALS AGRO INCVECTRON 20WP20% W/WETOFENPROXPHA030WETTABLE POWDER FOR IRS1* 100G SACHETMITSUI CHEMICALS AGRO INCJAPANTWIGA CHEMICALS
MOSAIC CAPITAL VENTURES(UGANDA) LTD MCV PUBLIC HEALTH SOLUTIONSBORAKILL COCKROACH BAIT30%W/WBORIC ACIDPHA028PASTE1*50GMOSAIC CAPITAL VENTURES(UGANDA) LTD MCV PUBLIC HEALTH SOLUTIONSUGANDAMOSAIC CAPITAL VENTURES
NEXGEN HEALTHCARE PVT LTD, S-25, D-6 T-BLOCK M.I.DMOSUT BODY SPRAY5.06GMDIETHLYTOLUAMIDEPHA 020SPRAY1*40MLINEXGEN HEALTHCARE PVT LTDINDIAWORLD HEALTH WORKS
RENE INDUSTRIES (E.A) LTD PLOT 680, KAMULI KIREKAAQUASAFE TABLETS70MGSODIUM DICHLORO ISOCYANURATE TABLETSPHA003TABLET1*8*10 STRIPHYDRACHEM LIMITED ENGLANDUGANDAAFFORD / UHMG
SARAYA CO. LTD 2-2-8 YUZATO HIGASHISUMIYOSHI-KU OSAKA 546-0013 JAPANSARAYAN GEL SH10.1% W/VCHLORHEXIDINE GLUCONATEPHA037GEL (TOPICAL)40MLSARAYA EAST AFRICAJAPANSARAYA EAST AFRICA
SARAYA CO. LTD 2-2-8 YUZATO HIGASHISUMIYOSHI-KU OSAKA 546-0013 JAPANALSOFT SH0.1G/ 100ML (0.1W/V)CHLORHEXIDINE GLUCONATEPHA036SOLUTION (TOPICAL)1LSARAYA EAST AFRICAJAPANSARAYA EAST AFRICA
SUMITOMO CHEMICALS, KHUSUS , MALAYSIASUREDUZ MOSQUITO CANDLEMULTI INGRIDIENTSUREDUZ MOSQUITO CANDLEPHA 044CANDLEZE AND N GLOBAL NTINDAMALAYSIAE AND N GLOBAL NTINDA
SYNGENTA HUDDERSFIELD MANUFACTURING CENTER LEEDSICON 10CS10GM/100MLLAMBDA-CYHALOTHRINPHA 013LIQUID1*62,5MLSYNGENTA EAST AFRICA LTDUKTWIGA CHEMICAL INDUSTRIES (U) LIMITED
TAGROS CHEMICALS INDIA PVT LIMITE AND VESTERGAARD FRANDSEN GROUP SAPERMANETN/ADELTAMETHRIN IMPREGNATED MOSQUITO NETPHA 053ITN NETN/AVESTDERGAAD FRANDSEN GROUP S.ANETTSHOPPEINDIA
TAGROS CHEMICALS INDIA LIMITED PLOT A4/1 & 2, SIPCOT INDUSTRIAL COMPLEX, PACHAYANKUPPAN, CUDDALORE-607 005, TAMILNADU, INDIATEPHRA 500EC500ECTEMEPHOSPHA 052SOLUTION1*1 LITREQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROADINDIAQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROAD
TAGROS CHEMICALS INDIA LIMITED PLOT A4/1 & 2, SIPCOT INDUSTRIAL COMPLEX, PACHAYANKUPPAN, CUDDALORE-607 005, TAMILNADU, INDIAFINITTO GEL0.05%FIPRONILPHA 053GEL1*10GQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROADINDIAQUALITY CHEMICALS
TAGROS CHEMICALS INDIA LIMITED PLOT A4/1 & 2, SIPCOT INDUSTRIAL COMPLEX, PACHAYANKUPPAN, CUDDALORE-607 005, TAMILNADU, INDIAD-FENCE 25 EC2.5% W/VDELTAMETHRINPHA 050SOLUTION1*250 MLQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROADINDIAQUALITY CHEMICALS
TAGROS CHEMICALS INDIA LIMITED PLOT A4/1 & 2, SIPCOT INDUSTRIAL COMPLEX, PACHAYANKUPPAN, CUDDALORE-607 005, TAMILNADU, INDIAREVITAL 100CS250WGLABDACYHALOTHRIN 10%PHA 047POWDER1*160*62.5ML SACHETQUALITY CHEMICALS LIMITED PLOT 64/65 KATWE ROADINDIAQUALITY CHEMICALS

S/n NDA Registration No License Holder Local Technical Representative Name of Drug Manufacturer Name Country of Manufacture Dosage Form Pack Size
NDA/MAL/VHP/8117COOPER K-BRANDS LTDCEE K-BRANDS LIMITEDSOOTHING OILCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY, NAIROBI KENYAUNKNOWN OILS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE

S/n NDA Registration No License Holder Local Technical Representative Name of Drug Generic Name of Drug Strength of Drug Manufacturer Country of Manufacture Dosage Form Pack Size
NDA/MAL/HDP/6348ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDCOMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BPSODIUM LACTATE SOLUTION +SODIUM CHLORIDE + CALCIUM CHLORIDE + POTASSIUM CHLORIDE 0.533 GM +0.600 GM + 0.027G+ 0.040 GM/100ML ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/6389ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDMETRONIDAZOLE BPMETRONIDAZOLE0.5%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6426ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDSODIUM CHLORIDE INTRAVENOUS INFUSION BPSODIUM CHLORIDE0.9%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/6441ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDOFLOXACIN INTRAVENOUS INFUSIONOFLOXACIN0.2%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6456ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDGLUCOSE INTRAVENOUS INFUSION BP (5% W/V) GLUCOSE ANHYDROUS 5%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/6059RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDNEUROZONEMECOBALAMIN + PREGABALIN750MCG + 75MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7362RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDTRAM-DOL-50TRAMADOL HYDROCHLORIDE50MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7575ACME FORMULATION PVT. LTD.MARIE STOPES UGANDA LIMITEDMEDIPRISTMIFEPRISTONE200MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8249RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDPANZOL-DPANTOPRAZOLE+DOMPERIDONE20MG + 10MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8330RESONANT PHARMACEUTICALSSHREEJI PHARMACEUTICALS LIMITEDCOARTLUMEFANTRINE + ARTEMETHER 480 MG + 80 MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/8396MARIE STOPES INTERNATIONALMARIE STOPES UGANDA LIMITEDBACK-UPLEVONORGESTREL1.5MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/8469UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMETHICOWEL INJECTIONMETHYLCOBALAMIN500MCG/ML AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT III, PLOT NO 2,3,4 &5, SECTOR 6-B, IIE, SIDCUL RANIPUR HARIDWAR-249403 UTTARAKHAND INDIAINDIAPARENTERAL ORDINARY I M AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/3011ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDGYNESTCLOTRIMAZOLE 100MG ASTRA LIFE CARE (INDIA) PVT-PLOT 57 ROJADA382220, BAVLA AHMEDABAD INDIAINDIAVAGINAL TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/4682AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINELAMIVUDINE10MG/ML AUROBINDO PHARMA LIMITED-UNIT ? III-SURVEY NO.:313 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA.INDIAORAL LIQUID ORDINARY SYRUPS 1.0X240.0 ML BOTTLE
NDA/MAL/HDP/7243BAL PHARMA LIMITEDHEALTHCARE LTD.EMTRIMTRIMETHOPRIM + SULPHAMETHOXAZOLE80MG+ 400MG BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8135BAL PHARMA LIMITEDSHREEJI PHARMACEUTICALS LIMITEDREGAMOLPARACETAMOL500MG BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8487BAL PHARMA LIMITEDHEALTHCARE LTD.EMTRIM FORTESULFAMETHOXAZOLE + TRIMETHOPRIM 800MG + 160MG BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6239 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATEARTESUNATE60MG BLISS GVS PHARMA LTD- PLOT 73 -76 SILVER INDUSTRIAL ESTATE BHIMPORE DAMAN 396 210 (UT)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 1*5 ML AMPOULE OF 0.9%W/V NACL + 1*1 ML OF 5%W/V SODIUM BICARBONATE
NDA/MAL/HDP/2679CIPLA LTD.QUALITY CHEMICALS LTD - HUMANALERID SYRUPCETIRIZINE HYDROCHLORIDE5MG/5ML CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA.INDIAORAL LIQUID ORDINARY SYRUPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/7071 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFORACORT-200 FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE6MCG + 200MCG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA.INDIALUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/7074 CIPLA LTDQUALITY CHEMICALS LTD - HUMANFORACORT-100FORMETEROL FUMARATE DIHYDRATE + BUDESONIDE 6 MCG+100 MCG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA.INDIALUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/7077 CIPLA LTDQUALITY CHEMICALS LTD - HUMANFORACORT-400FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE6MCG + 400MCG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA.INDIALUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/7157 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLINEZOLID TABLETS 600MGLINEZOLID600MG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BOTTLE,1.0X20.0 TABLET CONTAINER
NDA/MAL/HDP/6468 CIRON DRUGS & PHARMACEUTICAL PVT LTDROYAL PHARMA 2011 LIMITEDCIROLAZINE HYDRALAZINE HYDROCHLORIDE20MG/ML CIRON DRUGS & PHARMACEUTICAL PVT LTD -1, PRABHAT NAGAR, GROUND FLOOR, JOGESHWARI (W), MUMBAI -400 102. INDIA INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2 GLIMEPIRIDE 2MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3 GLIMEPIRIDE 3MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6179DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDON.SETRON-DENK 4MG ODTONDANSENTRON4MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6185DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDDOLOFORTE DENKTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6811DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDCOVALSAR- DENK 160/12.5VALSARTAN + HYDROCHLOROTHIAZIDE160MG +12.5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6813DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDCOVALSAR- DENK 320/12.5VALSARTAN + HYDROCHLOROTHIAZIDE320MG +12.5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6814DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDCOVALSAR- DENK 80/12.5VALSARTAN + HYDROCHLOROTHIAZIDE80MG +12.5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6833DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDON.SENTRON-DENK 8MG ODTONDANSETRON8MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/8145DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR 10MONTELUKAST SODIUM10MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8146DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR JUNIOR 4MONTELUKAST SODIUM4MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8147DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR JUNIOR 5MONTELUKAST SODIUM 5 MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/3589DENK PHARMA GMBH & COBENLE CONSULT LIMITEDSIMVA-DENK 20SIMVASTATIN20MG DENK PHARMA GMBH & CO-.GK GOII STR.1 84529 TIHMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1447EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITONA PLUSVITAMINS + MINERALSMULTI-INGREDIENT EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES 1.0X2.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/2144EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICOTILTENOXICAM20MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 1.0X3.0 VIAL CARTON + 1*3*2ML WFI AMPOULE
NDA/MAL/HDP/2322EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTREFLUCAN FLUCONAZOLE150MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES 1.0X2.0X1.0 CAPSULE STRIP
NDA/MAL/HDP/3245EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDNYSTATIN ORAL DROPSNYSTATIN 100,000 I.U/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL TOPICAL DROPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/3379EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIFASIHUMAN CHORIONIC GONADOTROPIN5000I.U EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY AMPOULES 1.0X2.0 AMPOULE CARTON
NDA/MAL/HDP/3502EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDHYDROCORTISONE SODIUM SUCCINATE HYDROCORTISONE SODIUM SUCCINATE100MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL + 1*2ML AMPOULE OF WFI
NDA/MAL/HDP/3781EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDALZENTELALBENDAZOLE20MG/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL LIQUID ORDINARY SUSPENSIONS 1.0X20.0 ML BOTTLE
NDA/MAL/HDP/3932EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIRAX TABLETSCLIDINIUM BROMIDE + CHLORDIAZEPOXIDE2.5MG + 5MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/4401EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE DISODIUM2G EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X2.0 G VIAL + 2*5 ML OF WFI GLASS AMPOULES
NDA/MAL/HDP/4413EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE1G EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 2 PLASTIC AMPOULES OF WFI
NDA/MAL/HDP/4417EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE SODIUM500MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X0.5 G VIAL + 1*5 ML OF WFI GLASS AMPOULES
NDA/MAL/HDP/4419EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIGONAL 75HUMAN MENOPAUSAL GONADOTROPHIN75IU/5ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL + 1 ML AMPOULE 0.9%W/V NACL
NDA/MAL/HDP/4774EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFERROFOL VIT-ZFERROUS SULPHATE+FOLIC ACID+ASCORBIC ACID+THIAMINE MONONITRATE+RIBOTLAVINE+PYRIDOXINE HCL+NICOTINAMIDE+ZINC150MG+0.5MG+50MG+2MG+2MG+1MG+10MG+25MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES 1.0X5.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/5279EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDDOSINDOXAZOCIN2MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6075EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOLOHISTINEOLOPATADINE HYDROCHLORIDE1MG/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6078EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIMOLOL MALEATETIMOLOL MALEATE5MG/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/7686EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTGENTGENTAMICIN SULPHATE0.3W/V EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/8197EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAMIKACINAMIKACIN SULPHATE500MG/2ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 1.0X2.0 ML VIAL
NDA/MAL/HDP/4141SANOFI WINTHROP A.M.OLABOREX UGANDA LIMITEDEPILIM 200SODIUM VALPROATE200MG FISONS LTD (ALSO KNOWN AS SANOFI-AVENTIS)-RIELL, SPAINSPAINORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6236MOONLINK PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL ADVANCEPARACETAMOL + IBUPROFEN + CAFFEINE325 MG + 400 MG + 40 MG FREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404INDIAORAL SOLID ORDINARY CAPSULES 1.0X40.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8314ZIFAM PINNACLE PTY. LTD. BOOTS PHARMACEUTICALS LIMITEDCIPROZIF ? 500CIPROFLOXACIN HYDROCHLORIDE500MG FREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4407FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDSUXAMETHONIUM CHLORIDE- FRESENIUSSUXAMETHONIUM CHLORIDE100MG/2ML FRESENIUS KABI MANUFACTURING S.A (PTY) LTD ?-6 GIBAUD?ROAD KORSTEN, PORT ELIZABETH, SOUTH AFRICA.SOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/2884NOVARTIS PHARMA SERVICES INCERIS LTDHYCAMTINTOPOTECAN HYDROCHLORIDE4MG GLAXOSMITHKLINE MANUFACTURING S.P.A-STRADA PROVINCIALE ASOLANA, 9043056 SAN POLO DI TORRILE,PARMA ITALY ITALYPARENTERAL ORDINARY VIALS 1.0X5.0X17.0 ML VIAL
NDA/MAL/HDP/2826GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON SYRUPCHLORPHENIRAMINE MALEATE4MG/10ML GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X2.0 L BOTTLE
NDA/MAL/HDP/6192GLAXOSMITHKLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDENO FRUIT SALT ORANGESODIUM BICARBONATE + CITRIC ACID 55.80%W/W + 43.20 %W/W GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBIKENYAORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES 1.0X10.0X5.0 G SACHET,1.0X48.0X5.0 G SACHET
NDA/MAL/HDP/6116DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDZOLEDRO-DENK 4MG/5MLZOLEDRONIC ACID4MG/5ML HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELNGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X5.0 ML VIAL
NDA/MAL/HDP/6117DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDGRAN-DENKGRANISETRON HYDROCHLORIDE1MG/ML HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELNGERMANYPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE
NDA/MAL/HDP/7078 ICPA HEALTH PRODUCTS LTDMETRO PHARMACEUTICALS LIMITEDHEXIDINE?CHLORHEXIDINE GLUCONATE0.2 %W/V ICPA HEALTH PRODUCTS LIMITED-286/287, GIDC, ANKLESHWAR-393002. GUJARAT, INDIA. INDIATOPICAL EXTERNAL LIQUIDS 1.0X160.0 ML BOTTLE
NDA/MAL/HDP/0248EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE40 MG IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0929IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDDUOQUINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG +320MG IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. INDIAORAL SOLID ORDINARY TABLETS 10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER
NDA/MAL/HDP/1747IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDPRESARTAN H 50LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE 50MG + 12.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2130IPCA LABORATORIES MEDVIN PHARMA LIMITEDZERODOL-LAACECLOFENAC200MG IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2271EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDARTEMETHER 20MG/LUMEFANTRINE 120MGARTEMETHER + LUMEFANTRINE20MG + 120MG IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0X6.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER,1.0X10.0X2.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X4.0X6.0 TABLET BLISTER,1.0X30.0X3.0X6.0 TABLET BLISTER,1.0X30.0
NDA/MAL/HDP/3202IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDPRESARTAN-50 LOSARTAN50MG IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6507 IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDZITRAM PACETAMINOPHEN + TRAMADOL HYDROCHLORIDE325MG + 37.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0526LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDAMILEB- 25 AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X20.0 TABLET BLISTER
NDA/MAL/HDP/4057LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDLAMPYAMPICILLIN250MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4379LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDSINURHONMULTI-INGREDIENT5MG/ 2MG/ 500MG / 30MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY TABLETS 1.0X12.0X40.0 TABLET BLISTER,1.0X1.0X6.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/5381LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDADIFLAM GELDICLOFENAC DIETHYLAMINE1.16%W/W LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/5454LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDMOXILEBAMOXICILLIN125MG/5ML LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY POWDERS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6118LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDL-TRIM DSSULPHAMETHOXAZOLE + TRIMETHOPRIM800MG + 160MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6374LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDPREDLEB-5 DTPREDNISOLONE5MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X20.0 TABLET BLISTER
NDA/MAL/HDP/7708LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDLAMPYKLOX CAPSULESAMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM250MG+250MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7531LINCOLN PHARMACEUTICALS LTDABACUS PARENTERAL DRUGS LIMITEDFRUSO FUROSEMIDE 10MG/ML LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/8359ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDASUNATE 120ARTESUNATE120MG LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 1.0X120.0 MG VIAL + 1*10 ML SODIUM CHLORIDE IN GLASS AMPOULE + 1*2 ML SODIUM BICARBONATE IN GLASS AMPOULE
NDA/MAL/HDP/8822ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDALIDOLIDOCAINE HYDROCHLORIDE2%W/V LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. INDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X30.0 ML VIAL
NDA/MAL/HDP/8825LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLAXALINKLACTULOSE3.35G/5ML LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X170.0 ML BOTTLE
NDA/MAL/HDP/3175M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDSPACOVINDROTAVERINE40MG M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208 NAVI MUMBAI, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5066M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDDEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE4MG/ML M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208 NAVI MUMBAI, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X100.0X1.0 ML AMPOULE
NDA/MAL/HDP/7422CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAV 625MGAMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM500MG+125MG MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7597CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAVAMOXICILLIN SODIUM + CLAVULANIC ACID1000MG + 200MG MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSPARENTERAL ORDINARY DRY VIALS 1.0X10.0X1.2 G VIAL
NDA/MAL/HDP/8472CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAV 375MGAMOXICILLIN + CLAVULANIC ACID250MG + 125MG MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8928CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAVAMOXICILLIN TRIHYDRATE + CLAVULANIC ACID125MG+31.25MG / 5ML MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0741MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMEDOCIPRINCIPROFLOXACIN500MG MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8686CODAL-SYNTO LTD RENE PHARMACY LTDCODANOLATENOLOL 100 MG MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1739MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMELOX MELOXICAM15MG MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8113MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMOXICLAV FORTEAMOXICILLIN + CLAVULANIC ACID312.5MG/5ML MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY POWDERS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1853MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAERIUS ORAL SOLUTIONDESLORATADINE0.5MG/ML MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA,SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERGBELGIUMORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE,1.0X150.0 ML BOTTLE
NDA/MAL/HDP/5256MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROFOS INJECTIONBETAMETHASONE DISODIUM PHOSPHATE + BETAMETHASONE DIPROPIONATE2MG + 5MG/ML MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA,SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERGBELGIUMPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/7012MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDMYHEP DVIRDACLATASVIR + SOFOSBUVIR 60MG + 400MG MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON, SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X28.0 TABLET BOTTLE
NDA/MAL/HDP/8504MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLEDVIRLEDIPASVIR + SOFOSBUVIR90MG + 400MG MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON, SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X28.0 TABLET BOTTLE
NDA/MAL/HDP/6119 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDSUPER CVAMOXICILLIN SODIUM + POTASSIUM CLAVULANATE1 G + 0.2 G NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY VIALS 1.0X10.0X1.2 G VIAL
NDA/MAL/HDP/6144 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDNIKOPARACETAMOL500MG NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALORAL SOLID ORDINARY TABLETS 1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6166 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDGMICINGENTAMICIN SULPHATE0.3%W/V NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/7231 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDLIGNAT 2%LIDOCAINE HYDROCHLORIDE 2% W/V NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY VIALS 1.0X30.0 ML VIAL
NDA/MAL/HDP/8221 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDNEMADOLTRAMADOL HYDROCHLORIDE50MG/ML NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/6037GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAVITVITAMIN A200,000 IU OLIVE HEALTHCARE-197/2, ATHIYAWAD DABHEL VILLAGE DAMAN 396210 (U.T)INDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 TABLET JAR
NDA/MAL/HDP/6595RAVIAN LIFE SCIENCE PVT. LTDROYAL PHARMA 2011 LIMITEDMOLURAVLEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MG RAVIAN LIFE SCIENCE PVT LTD-PLOT NO.34,SECTOR-8A,IIE,HARIDWAR-249403, UTTARKHANDINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2558 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMYCOREN SUSPENSIONNYSTATIN 100000 I.U/ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL TOPICAL SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/2576 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEQUINE TABLETSCHLOROQUINE PHOSPHATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2680RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIREN CAPSULESAMPICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/2681RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/2683 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN CASCORBIC ACID100MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2685 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEDOL(SUSPENSION)PARACETAMOL120MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3474RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMCLOREN DRY SYRUPAMPICILLIN + CLOXACILLIN125MG+125MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3478RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDDICLORENDICLOFENAC SODIUM BP50MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3582RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDSULPHADIMIDINESULPHADIMIDINE500MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3677 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDIBURENIBUPROFEN200MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2069SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSK DERMBETAMETHASONE + CLOTRIMAZOLE + GENTAMYCIN0.05%W/W + 1%W/W + 0.1%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/6207S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDGO!GELDICLOFENAC DIETHYLAMINE+METHYL SALICYLATE1.16%W/W + 10%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/8217S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDMETFOKANTMETFORMIN HYDROCHLORIDE850MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1666SANOFI AVENTIS LABOREX UGANDA LIMITEDAMARYL 1GLIMEPIRIDE1MG SANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6788SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDROYAL VIT GMULTI-INGREDIENTSMULTI-INGREDIENTS SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, S" OF OCTOBER CITY, EGYPT. PO. BOX 43, OCTOBER CITY. POSTAL CODE NO.12566 EGYPTORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6108SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDTREVOX 750LEVOFLOXACIN HEMIHYDRATE750MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6109SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDMEXLOLOMEFLOXACIN HYDROCHLORIDE0.3%W/V SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6111SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDMOTIFASTDOMPERIDONE10MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY OTHER TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6112SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSULTOLINSALBUTAMOL SULPHATE2.5MG/2.5ML SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHLUNG ADMINISTRATION LIQUID FOR INHALATION 1.0X10.0X2.5 ML AMPOULE
NDA/MAL/HDP/6139SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSERVIN CAPSULEFERROUS SULPHATE+FOLIC ACID+THIAMINE MONONITRATE+RIBOFLAVIN+PYRIDOXINE HYDROCHLORIDE+NICOTINAMIDE+ASCORBIC ACID150MG+0.5MG+2MG+2MG+1MG+10MG+50MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6182SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALARIDKETOTIFEN FUMARATE0.025%W/V SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6623SQUARE PHARMACEUTICALS LTD.PABNA UNITGAMA PHARMACEUTICALS (U) LIMITEDREFINAC SRDICLOFENAC SODIUM100MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID RETARD ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6624SQUARE PHARMACEUTICALS LTD.PABNA UNITGAMA PHARMACEUTICALS (U) LIMITEDCIPROKENCIPROFLOXACIN HYDROCHLORIDE0.3%W/V SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6360 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDETOCOXX 90MGETORICOXIB90MG SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6368 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDETOCOXX 120MGETORICOXIB120MG SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/0725TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDSPASMOTROY 40DROTAVERINE HYDROCHLORIDE 40MG TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X5.0X4.0 ML VIAL
NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/4958TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBENZOSEDMIDAZOLAM1MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/5316TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPARDICLOFENAC SODIUM + PARACETAMOL50MG + 500MG TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5318TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR AQ (1ML)DICLOFENAC SODIUM75MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/5319TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR SRDICLOFENAC SODIUM100MG TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAORAL SOLID RETARD ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8343 TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDXYKAA EXTEND 1000PARACETAMOL BP(IMMEDIATE RELEASE)+ PARACETAMOL BP(EXTENDED RELEASE)325MG+675MG TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE 50MG TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/0755TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDT- DOL TRAMADOL HYDROCHLORIDE50MG/ML TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/6122 TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDROCUTROYROCURONIUM BROMIDE10MG TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL
NDA/MAL/HDP/1102MATRIX UGANDA LTDROYAL PHARMA 2011 LIMITEDOVUREXCLOMIPHENE50MG Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSANMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1683Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDVOREN PLUSDICLOFENAC10MG/ML Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSANMALAYSIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE,1.0X45.0 G TUBE
NDA/MAL/HDP/8205Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDANLODINAMLODIPINE BESYLATE10MG Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSANMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0127DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0128DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0152DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 150IRBESARTAN150MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA,DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUSCHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0153DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 300IRBESARTAN300MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA,DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUSCHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2394MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRIN EFAVIRENZ600MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA,MERCK SHARP & DOHME B.V-WAARDENWEG 392031 BN, HAARLEMCHINAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/1869MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRIN 200EFAVIRENZ200MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA,MERCK SHARP & DOHME.-WAADERWAG 39, POSTBUS 581. 2003 PC HAARLEMNETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X90.0 TABLET BOTTLE
NDA/MAL/HDP/2037MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSTOCRIN 50EFAVIRENZ50MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA,MERCK SHARP & DOHME.-WAADERWAG 39, POSTBUS 581. 2003 PC HAARLEMNETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8488 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCEFRAZ 200CEFIXIME TRIHYDRATE200MG ZIM LABORATORIES LIMITED-B-21122, MIDC AREA, KALMESHWAR -441 501, DIST. NAGPUR,INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6405 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLOPRAZ CLOPIDOGREL BISULFATE 75MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6407 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDZIMCOX 200 CELECOXIB 200 MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6442 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDAZITO SUSPENSIONAZITHROMYCIN DIHYDRATE200 MG/5ML ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/6444 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCEFRAZ 100CEFIXIME TRIHYDRATE100MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7029 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDLIPIZAR 20ATORVASTATIN CALCIUM (TRIHYDRATE)20MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8653PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD)ROYAL PHARMA 2011 LIMITEDLEFLOXIN 500LEVOFLOXACIN HEMIHYDRATE500MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8815 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDZIMAGRA ? ODS 50SLIDENAFIL CITRATE50 MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAOTHER SYSTEMIC SPECIAL SOLIDS 1.0X1.0X10.0 SACHET CARTON
NDA/MAL/HDP/8316AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDOLUTEGRAVIR 50 MG/ LAMIVUDINE 300 MG/ TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETSDOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50MG + 300MG + 300MG"AUROBINDO PHARMA LIMITED-UNIT ?VII, SEZ, TSIIC, PLOT NO. SI,S. NO.?S 411/P, 425/P, 434/P, 435/P & 458/P,GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT -509 302 TELANGANA STATE, INDIA" INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8821AUROBINDO PHARMA LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDROFAST 10ROSUVASTATIN CALCIUM10MG"AUROBINDO PHARMA LIMITED-UNIT ?VII, SEZ, TSIIC, PLOT NO. SI,S. NO.?S 411/P, 425/P, 434/P, 435/P & 458/P,GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT -509 302 TELANGANA STATE, INDIA" INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6366BEXIMCO PHARMACEUTICALS LIMITED.ABACUS PHARMA (AFRICA) LIMITEDODYCIN EYE DROPSMOXIFLOXACIN HYDROCHLORIDE5MG/ML"BEXIMCO PHARMACEUTICALS LTD-126 KATHALDIA, AUCHPARA, TONGI-1711, GAZIPUR." BANGLADESHOPHTHALMIC DROPS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/6629MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET PLUS 5/25NEBIVOLOL+HYDROCHLOROTHIAZIDE5MG+25MG) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION-TEMPELHOFER WEG 83 D-12347 BERLIN GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0747MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE ORANGE CO-PACKGLUCOSE ANHYDROUS + SODIUM CHLORIDE + TRISSODIUM CITRATE DEHYDRATE + POTASSIUM CHLORIDE / ZINC SULPHATE13.5G + 2.6G + 2.9G + 1.5G/ SACHET + 27.43MG/5ML: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE POSTAL ADDRESS : P.O.BOX 5917, KAMPALA. UGANDAORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS 1.0X20.8 G SACHET + 60 ML BOTTLE
NDA/MAL/HDP/8108MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDORSGLUCOSE ANHYDROUS+TRISODIUM CITRATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE6.75G + 1.45G + 1.3G + 0.75G: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE POSTAL ADDRESS : P.O.BOX 5917, KAMPALA. UGANDAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0X25.0 G SACHET
NDA/MAL/HDP/4358A.MENARINI INDUSTRIE FARMACEUTICHE S.R.IPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLIOTONHEPARIN SODIUM1000I.U/GA. MENARINI MANUFACTURING LOGICTICS AND SERVICES-VIA 3 SETTE SANTI FLORENCE 50131 ITALYITALYTOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/2395A.MENARINI INDUSTRIE FARMACEUTICHE S.R.ISTAR PHARMACEUTICALS LTDFASTUM GELKETOPROFEN 2.5%W/WA. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA SETTE SANTI 3, 50131 FIRENZE-ITALYITALYTOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE
NDA/MAL/HDP/3504MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBIFRILZOFENOPRIL30MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILAITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7288MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKETESSE FILM COATED TABLETSDEXKETOPROFEN TROMETAMOL25MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILAITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7656A.MENARINI INDUSTRIE FARMACEUTICHE RIUNITEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSPASMOMENOTILONIUM BROMIDE40MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA CAMPO DI PILE, L?AQUILA (AQ), ITALYITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HDP/0348ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDXBETABETAMETHASONE SODIUM PHOSPHATE0.1%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/0558ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGENTA EYE DROPS GENTAMICIN SULPHATE 0.3% W/V ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/0889ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDNSSODIUM CHLORIDE + GLUCOSE0.9%W/V + 5% W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/HDP/1122ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EAR DROPSCHLORAMPHENICOL5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOTIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL
NDA/MAL/HDP/1368ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD5GLUCOSE5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/1370ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSTERILIZED WATER FOR INJECTIONWATER FOR INJECTIONNEUTRALABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE
NDA/MAL/HDP/4784ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD50GLUCOSE INTRAVENOUS INFUSION50%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4910ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDFLUZOLFLUCONAZOLE200MGABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6820ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABBORI EAR DROPSBORIC ACID1.83%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOTIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/7674ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABLEVOXLEVOFLOXACIN HEMIHYDRATE5G/LABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8816ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABPARAPARACETAMOL1%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION BAGS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8934ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCYCLO P EYE DROPSCYCLOPENTOLATE HYDROCHLORIDE1.0%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/6812ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDNOFLOXNORFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191UGANDAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/0002ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDX-SONE-NDEXAMETHASONE+NEOMYCIN0.1W/V+ 0.35W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/0077ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDX-SONE DEXAMETHASONE SODIUM PHOSPHATE0.1 % W/V ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/0080ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABWATERSTERILE WATER FOR IRRIGATIONN/AABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY OTHER INFUSIONS 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/3411ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABNAL NASAL DROPSSODIUM CHLORIDE0.9%W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDANASAL SYSTEMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/3866ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDRLCOMPOUND SODIUM LACTATE 0.6/ 0.25 /0.04 / 0.027 % W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/HDP/4702ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABTOL 20%W/VMANNITOL200MG/MLABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4703ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGYLMETRONIDAZOLE500MGABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6815ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCROM EYE DROPSSODIUM CROMOGLYCATE2%W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/0491ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EYE DROPSCHLORAMPHENICOL0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAOPHTHALMIC DROPS 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL
NDA/MAL/HDP/0619ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD10 GLUCOSE10%W/V ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/0638ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/1849ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIFINCIPROFLOXACIN0.2%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4030ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDXBETA- NBETAMETHASONE + NEOMYCIN0.1%W/V +0.5%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/4394ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDNSSODIUM CHLORIDE0.9% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/4796ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDARROWS SOLUTION (HALF STRENGTH)POTASSIUM CHLORIDE+SODIUM CHLORIDE+SODIUM LACTATE0.13%+0.20%+0.30%ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/7154ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDCIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDE2MG/MLABARIS HEALTHCARE PVT LTD - -SURVEY NO. 1407-11, VILLAGE RAJPUR, TALUKA KADI DIST. MEHSANA, GUJARAT-382740INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5311ABBOTT HEALTHCARE PRODUCTS B.V.STAR PHARMACEUTICALS LTDDUPHASTON TABLETSDYDROGESTERONE10MGABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLSTNETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0 TABLET BLISTER
NDA/MAL/HDP/8234ABBOT LABORATORIES S.A. (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDINFUVAC 2015INACTIVATED INFLUEZA VACCINE-SURFACE ANTIGEN [A/CALIFORNIA/7/2009(H1N1) PDM09 + A/SWITZERLAND/9715293/2013(H3N2) + B/PHUKET/3073/2013-LIKE STRAINS]15?G + 15?G +15?GABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLSTNETHERLANDSPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)
NDA/MAL/HDP/8491MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCETROTIDE 0.25MGCETRORELIX0.25MGABBOTT BIOLOGICALS B.V VEERWEG -12,NL-8121 AA OLST THE NETHERLANDS,PIERRE FABRE MEDICAMENT -AQUITAINE PHARM INTERNATIONAL SITE 1FRANCEPARENTERAL ORDINARY COMBINATION PACK VIALS 1.0X1.0 VIAL CARTON,1.0X1.0 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/1569ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDKALETRALOPINAVIR+RITONAVIR80MG + 20MGABBOTT LABORATORIES LTD-QUEENSBOROUGH, KENT ME11 SELUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X160.0 ML BOTTLE
NDA/MAL/HDP/1661ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIA 100/25LOPINAVIR/ RITONAVIR100MG/25MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY.GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/2087ABBVIE LOGISTICS BVMEDICAL ACCESS (UGANDA) LIMITEDNORVIRRITONAVIR100MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY.GERMANYORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/3831ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIALOPINAVIR+RITONAVIR200MG+50MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY.GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X120.0 TABLET CONTAINER
NDA/MAL/HDP/6243ABBVIE (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDSURVANTABERACTANT100MG/4MLABBVIE NORTH CHICAGO FACILITY-1401 SHERDAN ROAD NORTH CHICAGO FACILITY ILLINOIS 60064 -4000UNITED STATESTOPICAL EXTERNAL INSTILLATION VIALS 1.0X4.0 ML VIAL,1.0X8.0 ML VIAL
NDA/MAL/HDP/3005ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN-100 SR DEPOCAPSDICLOFENAC SODIUM100MGACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BLSWITZERLANDORAL SOLID RETARD CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3686ACINO PHARMA AGGOODMAN INTERNATIONAL LTDNEURORUBINEMULTIVITAMINMULTINGREDIENTACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BLSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4736ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMEPHAQUIN LACTABMEFLOQUINE250MGACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BLSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8241ACINO PHARMA AGGOODMAN INTERNATIONAL LTDCLOPACINCLOPIDOGREL BESILATE75MGACINO PHARMA AG .-BIRSWEG 2 4253 LIESBERG BASEL LANDSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/3492ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN-50DICLOFENAC SODIUM50MGACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLANDSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3804ACINO PHARMA AGGOODMAN INTERNATIONAL LTDNEURORUBINEVITAMIN B1+VITAMIN B6+VITAMIN B12100MG+100MG+1MGACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY I M AMPOULES 1.0X1.0 ML AMPOULE,1.0X3.0 ML AMPOULE
NDA/MAL/HDP/4626ACINO PHARMA AGGOODMAN INTERNATIONAL LTDGASEC-20OMEPRAZOLE20MGACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLANDSWITZERLANDORAL SOLID ORDINARY CAPSULES 1.0X1.0X14.0 CAPSULE BOTTLE
NDA/MAL/HDP/2774ACINO PHARMA AGGOODMAN INTERNATIONAL LTDBACTIFLOX NEO 500CIPROFLOXACIN500MGACINO PHARMA AG.-DORNACHERSTRASSE 114, CH-4147 AESCH, SWITZERLANDSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3532ACINO PHARMA AGGOODMAN INTERNATIONAL LTDSIMEPAR CAPSULESMULTINGREDIENTMULTINGREDIENTACINO PHARMA AG-DORNACHERSTRASSE 114 P.O.BOX 445 CH4147 AESCH/BL SWITZERLANDSWITZERLANDORAL SOLID ORDINARY CAPSULES 1.0X40.0 CAPSULE CONTAINER
NDA/MAL/HDP/0005STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDALPRAZEC 0.25ALPRAZOLAM0.25MGACME FORMULATION PVT LTD -ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X4.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0009STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDDINASOD-100DICLOFENAC100MGACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4875PHARM ACCESS AFRICA LTDMARIE STOPES UGANDA LIMITEDMISOCLEARMISOPROSTOL200MCGACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/0010STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITED02-LON OFLOXACIN + ORNIDAZOLE200MG + 500MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/8328RESONANT PHARMACEUTICALSSHREEJI PHARMACEUTICALS LIMITEDAZITHROCINAZITHROMYCIN500MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/8835RESONANT PHARMACEUTICALSSHREEJI PHARMACEUTICALS LIMITEDTRIO-FAS(KIT)AZITHROMYCIN DIHYDRATE + FLUCONAZOLE + SECNIDAZOLE1000MG + 150MG + 2GACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8930RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDGASTRISAFE-(KIT)CLARTHROMYCIN + ESOMEPRAZOLE MAGNESIUM DIHYDRATE + TINIDAZOLE5000MG + 40MG + 500MGACME PHARMACEUTICAL PVT. LTD.-ROPAR ROAD NALAGARH, DIST. SOLAN, HIMACHAL PRADESH ? 174101 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X6.0 TABLET STRIP (2 TABLETS + 2 TABLETS + 2 CAPSULES)
NDA/MAL/HDP/3102PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDEPANUTIN READY MIXEDPHENYTOIN SODIUM50MG/MLACTAVIS ITALY S.P.A-VIALE PASTEUR, 10 20014 NERVIANO(MILAN) - ITALYITALYPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE
NDA/MAL/HDP/7344ACULIFE HEALTHCARE SUPER MEDIC LTDHEPANIR HEPARIN SODIUM 1000IU/ML ACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL
NDA/MAL/HDP/0058 NIRMA LIMITED.SUPER MEDIC LTDWATER FOR INJECTION B.P.WATER FOR INJECTIONN/AACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE
NDA/MAL/HDP/3208 NIRMA LIMITED.SUPER MEDIC LTDNIRFOL 1%PROPOFOL1%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X10.0X1.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL
NDA/MAL/HDP/4398 NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARESUPER MEDIC LTDSODIUM CHLORIDESODIUM CHLORIDE0.9 % W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/4955 NIRMA LIMITED.SUPER MEDIC LTDCOMPOUND SODIUM LACTATE INFU.COMPOUND SODIUM LACTATEMULTI INGREDIENTACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/5110 NIRMA LIMITED.SUPER MEDIC LTDGLUCOSE INFUSION BPDEXTROSE5%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/HDP/5214 NIRMA LIMITED.SUPER MEDIC LTDNIRMETMETRONIDAZOLE500MG/100MLACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5427 NIRMA LIMITED.SUPER MEDIC LTDNIRCIPCIPROFLOXACIN200MG/100MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
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NDA/MAL/HDP/7255ACULIFE HEALTHCARE SUPER MEDIC LTDNIRIXONECEFTRIAXONE SODIUM 1000MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*1 10ML WFI AMPOULE
NDA/MAL/HDP/8317ACULIFE HEALTHCARE SUPER MEDIC LTDMERONIR 500MEROPENEM 500MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL + 1*10ML AMPOULE OF WFI
NDA/MAL/HDP/8318ACULIFE HEALTHCARE SUPER MEDIC LTDB-CANE HEAVYBUPIVACAINE HYDROCHLORIDE BP5 MG/MLACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X4.0 ML AMPOULE
NDA/MAL/HDP/0496ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDMYPRODOLPARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE 250MG + 200MG + 10MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA INDIAORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER
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NDA/MAL/HDP/6758ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDADCO-NAPAMOLPARACETAMOL500MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLINGERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
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NDA/MAL/HDP/4532DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIRUCID 400ACICLOVIR400 MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY OTHER TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4535DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 250CLARITHROMYCIN250MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/4540DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIPROLOX500CIPROFLOXACIN500MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4542DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 500CLARITHROMYCIN500MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4887DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE200MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4889DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE50MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/4890DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE100MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
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NDA/MAL/HDP/1805MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 1000MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X14.0 TABLET BLISTER
NDA/MAL/HDP/1873MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 850MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER
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NDA/MAL/HDP/4928AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, ROYAL PHARMA 2011 LIMITEDFOLIC ACID TABLETSFOLIC ACID5MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4971AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, ROYAL PHARMA 2011 LIMITEDFRUSEMIDE TABLETSFUROSEMIDE40MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER
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NDA/MAL/HDP/3021 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDGLIBENCLAMIDE TABLETSGLIBENCLAMIDE5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3035 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFORTE TONICFERRIC AMMONIUM + FOLIC ACID + PYRIDOXINE + THIAMINE50 MG + 0.55 MG + 2.4 MG + 1.2 MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3037AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT SYRUPMULTI-INGREDIENTN/AAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3040 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODOX DOXYCYCLINE 100MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
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NDA/MAL/HDP/3057AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOLD-A-GO CAPSULESPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + DIPHENHYDRAMINE + CAFFEINE400MG + 5MG + 12.5MG + 30MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3060AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDKETOS TABLETKETOCONAZOLE USP200 MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3067AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMAGO SYRUPPROMETHAZINE5MG/5MLAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3072AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL TABLETS(THANE)PARACETAMOL500 MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3085AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCOLD TABLETSPARACETAMOL+PHENYLEPHRINE HCL+CAFFEINE+CHLORPHENIRAMINE HYDROCHLORIDE500.MG+5.0MG+30.0MG+2.0MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER
NDA/MAL/HDP/3031 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMETHASONE DEXAMETHASONE0.5MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3063AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC-50DICLOFENAC SODIUM 50MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1087AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/1247 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1369MEDIPHARM (EA) LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE CO-PACK ORANGE FLAVOURDT ZINC-20 + ORAL REHYDRATION SALTS (ORS)20GAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X2.0X20.8 G SACHET + 1.0 *10.0 TABLET BLISTER
NDA/MAL/HDP/3023 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOTRAXLEVAMISOLE HYDROCHLORIDE40MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET STRIP,1.0X10.0X1.0X3.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/0463 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTOPHEN PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0670 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER
NDA/MAL/HDP/0677 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0694AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON
NDA/MAL/HDP/1049AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/1056AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE-N OINTMENT BETAMETHASONE + NEOMYCIN0.1%W/W + 0.5% W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE
NDA/MAL/HDP/1123AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPAR PARACETAMOL500 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/1136AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL EMULSIONS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1139AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1140AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1242 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1474 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODICDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/1476 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDSEPTOLSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE1%W/W + 0.20W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/1598 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1660AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP
NDA/MAL/HDP/1786 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2075 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPREDPREDNISOLONE5MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2076 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMIDE FUROSEMIDE40MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2098 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO QUININEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2320 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDERO-125ERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2995 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDGALLOP LOPERAMIDE HYDROCHLORIDE USP2MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER
NDA/MAL/HDP/3367AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL SUSPENSIONPARACETAMOL125 MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3378 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCHLOZINE TABLETSCHLORPROMAZINE100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3383 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZEPINCARBAMAZEPINE200 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3634 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPLUSPARACETAMOL/ DEXTROMETHORPHAN HCL/ CHLORPHENIRAMINE500MG/ 15MG/ 2MG /10MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0007 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROCIP SYRUPCYPROHEPTADINE HYDROCHLORIDE2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0022 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/0045 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0088 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKANHYDROUS GLUCOSE/SODIUM CHLORIDE/TRISODIUM CITRATE/POTASSIUM CHLORIDE(2.7G/0.52G/0.58G/0.3G)/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY COMBINATION PACK POWDERS/GRANULES 4.0X500.0 ML SACHET + 1*10 BLISTERS,10.0X200.0 ML SACHET + 1*10 BLISTERS,2.0X1000.0 ML SACHET + 1*10 BLISTERS
NDA/MAL/HDP/0101AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULES (THANE)TETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0105AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPRIN TABLETSACETYL SALICYLIC ACID300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/0422 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL100MG + 162.5MG /5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0423AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0635AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0672AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONOR TABLETSNORFLOXACIN400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0674 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0679AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDMEFENA-250 CAPSULESMEFENAMIC ACID250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0688 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0689 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0835AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/0902 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SR NIFEDIPINE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1052 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDMICLOGEN MICONAZOLE NITRATE+NEOMYCIN SULPHATE+CLOBETASOL PROPIONATE2.0%W/W+0.5%W/W+0.05%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1054AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/1079AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUINE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1100 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOVIR SKIN CREAMACICLOVIR5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/1103 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1124 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO SCRUBCHLORHEXIDINE GLUCONATE4%W/VAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL LIQUIDS 1.0X1.0X500.0 ML BOTTLE
NDA/MAL/HDP/1138 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO-CALAMINECALAMINE15%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL LOTIONS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1142 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCANDIZOL CLOTRIMAZOLE 1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/1265 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCOMBIPLEXVITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B61.0 MG + 1.0 MG + 15 MG + 0.5 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1427AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDTENA-50ATENOLOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1544 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINE HYDROCHLORIDE B.PPROMETHAZINE HCL25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1566AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDVITAVITMULTI-INGREDIENTMULTI-INGREDIENTAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1616AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZINCETIRIZINE5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/1748AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0 CAPSULE BLISTER
NDA/MAL/HDP/1782 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINEPER 5ML: 15MG + 90MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE
NDA/MAL/HDP/1809AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1810AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRITRIFLUOPERAZINE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1895 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO (PAEDIATRIC)CO-TRIMOXAZOLE100MG/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1900 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOM 20OMEPRAZOLE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/1997AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTENA-100ATENOLOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/2007AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDB-COX TABLETSVITAMIN B COMPLEXBCP FORMULAAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2019AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOHALHALOPERIDOL10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2031AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOZID TABLETSISONIAZID 100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2095AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2282 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPROPANPROPRANOLOL40MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2335AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOBEN TABLETS(THANE)MEBENDAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2349 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD-LYTEANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + POTASSIUM CHLORIDE2.7G + 0.52G/ 200ML + 0.58G/ 200ML + 0.30G/ 200MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X200.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X500.0 ML SACHET
NDA/MAL/HDP/2571 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINE180 MG + 1080 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE
NDA/MAL/HDP/2594 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFEFFERROUS SULPHATE + FOLIC ACID200MG + 0.4MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2946 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO ORAL SUSPENSION(THANE)CO-TRIMOXAZOLE240MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/2947AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO TABLETSCO-TRIMOXAZOLE480MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X250.0 BLISTER CARTON
NDA/MAL/HDP/3003 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOVIR ACICLOVIR 200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3013 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOZOLE ALBENDAZOLE 400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/3029AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZOLE SUSPENSIONALBENDAZOLE USP200 MG/ 5 MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/3064 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTIN-TIN TABLETSTINIDAZOLE500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/3069 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMOVE CAPSULESPIROXICAM 20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER
NDA/MAL/HDP/3219AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPHENOL ORAL SUSPENSIONCHLORAMPHENICOL125MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3246 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCOMPOUND MAGNESIUM TRISILICATEMAGNESIUM TRISILICATE370MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3255AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDSATISFIL-50SILDENAFIL CITRATE50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/3315 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDERO-250 TABLETSERYTHROMYCIN STEARATE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3377 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAMILINE AMITRIPTYLINE25 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3382 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFEN SUSPENSIONIBUPROFEN100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3391 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCEZIN TABLETCETIRIZINE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3451AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPHENOL CAPSULES (THANE0CHLORAMPHENICOL250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER
NDA/MAL/HDP/3647 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNYSTAGO ORAL SUSPENSIONNYSTATIN100000 IUAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL TOPICAL SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/3746AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENDROBENDROFLUMETHIAZIDE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3748AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPIRINACETYL SALICYLIC ACID100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3773 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOBUTOL-4SALBUTAMOL SULPHATE4 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3794 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMET-200 (THANE)METRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3860AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOLACLACTULOSE3.35MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/3991AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFULVINGRISEOFULVIN TABLETS500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3996AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTOIN TABLETSNITROFURANTOIN BP100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3998AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOKOFF SYRUPTERBUTALINE SULPHATE +GUAIFENESIN+BROMHEXINE HYDROCHLORIDE +LEVOMENTHOL1.25MG/5ML+50MG//5ML+4MG/5ML+2.5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4001AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCOLD PLUS SYRUPPARACETAMOL+PHENYLEPHRINE+CHLORPHENIRAMINE+SODIUM CITRATE125MG/5ML+2.5MG/5ML+1MG/5ML+60MG /5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4002AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIDALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE250MG/5ML+ 250MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X170.0 ML BOTTLE
NDA/MAL/HDP/4064AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDTERAFINETERBINAFINE 250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4188AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPRAZPRAZIQUANTEL600MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X4.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4329AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CPMCHLORPHENIRAMINE MALEATE2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4406AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDSATISFIL -100SILDENAFIL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4526AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/4598 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/4605AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODRYL SYRUPBROMHEXINE HCL+DEXTROMETHORPHAN HBR+AMMONIUM CHLORIDE+MENTHOL4MG/5ML+5MG/5ML+50MG/5ML+2.5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4751 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFEROLFERROUS SULPHATE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4766GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBEN SUSPENSIONMEBENDAZOLE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/4769 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOBEXMEBENDAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4805 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFENIBUPROFEN200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4806 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFERFERROUS SULPHATE+FOLIC ACID200MG + 0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4807 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFORMINMETFORMIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4809 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCORTHYDROCORTISONE0.1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4811 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOGYLMETRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4812 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMETROL SUSPENSIONMETRONIDAZOLE BENZOATE125MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4813 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMETROL TABLETS (THANE)METRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4836AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETRONMETRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4903AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDCMT-TABLETSMAGNESIUM TRISILICATE+DRIED ALUMINIUM HYDROXIDE+PEPPERMINT OIL250MG+120MG+0.003MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4924AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMULTIVIT TABLETMULTIVITAMINMULTI-INGREDIENTAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4940 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFOLONFOLIC ACID5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5115AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDINDOS-25(THANE)INDOMETHACIN25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1000.0 CAPSULE CONTAINER,20.0X5.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5188AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDITRAZ CAPSULESITRACONAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X5.0 CAPSULE BLISTER,1.0X6.0X10.0 CAPSULE BLISTER
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NDA/MAL/HDP/5302 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDIBUGO-COMBIIBUPROFEN + PARACETAMOL + CAFFEINE200MG + 325MG + 30MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
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NDA/MAL/HDP/5419AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CPMCHLORPHENIRAMINE4MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5429AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCIPRO-500CIPROFLOXACIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON
NDA/MAL/HDP/5434MEDIPHARM (EA) LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE CO-PACK DT ZINC-20 + ORAL REHYDRATION SALTS (ORS)20G AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY OTHER SPECIAL FORMS 1.0X2.0X20.5 G SACHET + 1.0*10.0 TABLET BLISTER
NDA/MAL/HDP/5435 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPICPARACETAMOL+IBUPROFEN+CAFFEINE500MG+200MG+30MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET STRIP
NDA/MAL/HDP/5464AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINE20MG + 120MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X4.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,2.0X6.0 TABLET BLISTER,4.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER
NDA/MAL/HDP/5482 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOLINSALBUTAMOL2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5495 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCAL TABLETSCALCIUM LACTATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6041 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAVAGINAL TABLETS 1.0X6.0 PESSARY STRIP
NDA/MAL/HDP/6142AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCARBACTIVATED CHARCOAL0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6190 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD-LYTEANHYDROUS GLUCOSE,SODIUM CHLORIDE,TRISODIUM CITRATE DIHYDRATE,POTASSIUM CHLORIDE2.7G + 0.52G + 0.58G + 0.30G/ 200MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X500.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X200.0 ML SACHET
NDA/MAL/HDP/6213 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOXIN 250 DTAMOXICILLIN TRIHYDRATE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6631 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOBURNSILVER SULFADIAZINE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/8151 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO-C (THANE)VITAMIN C100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/8154 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOGCORTHYDROCORTISONE ACETATE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/8157 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD LYTE- PLAINANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE + POTASSIUM CHLORIDE13.50G + 2.60G + 2.90G +1.50G/ 1LAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X20.5 G SACHET
NDA/MAL/HDP/8178 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNYSTAGO TABLETSNYSTATIN500,000I.UAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3790AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDAGOFLOX-PPEFLOXACIN400MGAGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3985 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMYCIN SUSPENSIONERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7241EXPHAR SA.SURGIPHARM (U) LIMITEDGENTASOLGENTAMICIN SULFATE0.3%W/VAHLCON PARENTERAL (I) LTD.--SP-918,BHLWADI (RAJ) INDIA M.LIC.: RAJ 2002INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4995ROYAL GROUPHARLEYS UGANDA LIMITEDGENTABACT EYE/EAR DROPSGENTAMYCIN SULPHATE0.3%W/VAHLCON PARENTERALS (I) LIMITED-SP-918,INDUSTRIAL AREA,PHASE III BHIWADI DIST, ALWAR (RAJASTHAN) INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/0575MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOXMOXIFLOXACIN400MG/100MLAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIAPARENTERAL ORDINARY INFUSION BAGS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1078MICRO LABS LTD LABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5073CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA EYE/EAR DROPDEXAMATHASONE SODIUM PHOSPHATE+NEOMYCIN SULPHATE0.35%W/V+0.1%W/VAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE,1.0X2.5 ML BOTTLE
NDA/MAL/HDP/6082EXPHAR SASURGIPHARM (U) LIMITEDCROMSOLSODIUM CROMOGLYCATE2%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6354EXPHAR SA.SURGIPHARM (U) LIMITEDTIMOSOL ?TIMOLOL MALEATEO.5%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6537EXPHAR SASURGIPHARM (U) LIMITEDCARBOSOL CARMELLOSE SODIUM0.5%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 INDIAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/6202MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSALPRAZ 20PANTOPRAZOLE SODIUM20MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/7707MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDZOLIGLIT 15PIOGLITAZONE15MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BLISTER
NDA/MAL/HDP/8128MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDATOREG 10ATORVASTATIN CALCIUM10MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8132MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDZOLIGLIT 30PIOGLITAZONE HYDROCHLORIDE30MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8134MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSALPRAZ 40PANTOPRAZOLE40MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/8129MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDATOREG 20ATORVASTATIN CALCIUM20MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD.-SY. N0. 172 & 173,PARK ROAD, DULAPALLY VILLAGEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7355AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDARTEFAN SUSPENSIONARTEMETHER+LUMEFANTRINE180MG+1080MGAJANTA PHARMA LIMITED.-B-41516, MIDC INDUSTRIAL AREA, PAITHAN, AURANGABAD-431 148 DIST: AURANGABAD MAHARASHTRA,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/1901AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDIBUMOLIBUPROFEN + PARACETAMOL100MG + 162.5 MG /5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3899AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFEDATE SYRUPSODIUM FEREDETATE + PYRIDOXINE + CYANOCOBALAMIN + FOLIC ACID216.87MG + 1.5MG + 7.5MCG + 1.5MGAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/4713AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMEFLAMMEFENAMIC ACID50MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6617AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPFLUCHLOROPHENERAMINE + PARACETAMOL + VITAMIN C0.5MG + 120MG + 50MGAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8353AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDNURIFER CAPSULESCARBONYL IRON + FOLIC ACID + VITAMIN B12 + VITAMIN C + ZINC SULFATE MONOHYDRATE100MG+1.5 MG + 15 MCG + 75 MG + 61.8 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4365AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDACTINAC PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGAJANTA PHARMA LIMITED-B-4/5/6,MIDC AREA, PAITHAN,431 148 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2552AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCAROFITVITAMIN C/ VITAMIN A/ ZINC SULPHATE150MG/10MG/75MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7339AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDADERAN 16 CANDESARTAN CILEXETIL16 MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8346AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDADERAN 8CANDESARTAN CILEXETIL 8MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7149AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDOLOPAT ODOLOPATADINE HYDROCHLORIDE0.2% W/VAJANTA PHARMA LIMITED-N-118, 119, MIDC, TARAPUR BOISAR, DIST. THANE 401506, MAHARASHTRA STATE, INDIA INDIAOPHTHALMIC DROPS 1.0X1.0X3.0 ML VIAL
NDA/MAL/HDP/7151AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAPDROPS DXMOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE SODIUM PHOSPHATE5MG+1MG/MLAJANTA PHARMA LIMITED-N-118, 119, MIDC, TARAPUR BOISAR, DIST. THANE 401506, MAHARASHTRA STATE, INDIA INDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/0959AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DISPERSIBLE 20/120ARTEMETHER + LUMEFANTRINE20MG + 120MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X2.0 TABLET BLISTER
NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/2005AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA-100SILDENAFIL CITRATE100MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/2040AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MG AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0X12.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER
NDA/MAL/HDP/2272AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLARANTA -500CLARITHROMYCIN500MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3515AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 40/240ARTEMETHER + LUMEFANTRINE40 MG + 40 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3551AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA-500MGAZITHROMYCIN500MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/3653AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDARTEFANARTEMETHER + LUMEFANTRINE80 MG + 480 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO)
NDA/MAL/HDP/3827AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDATORFIT-10ATORVASTATIN10MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3874AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDRIDMAL 40/320DIHYDROARTEMISININ + PIPERAQUINE40MG + 320MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X8.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6392AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDMET XL 50METOPROLOL SUCCINATE50 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8078AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 100/270ARTESUNATE + AMODIAQUINE100 MG + 270 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X6.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6612AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAPRAZOLE PLUS-20OMEPRAZOLE + SODIUM BICARBONATE20MG/6G + 1680MG/6GAJANTA PHARMA LTD.-B-4-5-6, MIDC PAITHAN, AURANGABADINDIAORAL SOLID ORDINARY POWDERS 1.0X20.0X6.0 G SACHET
NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/0963AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD ARTESUNATE+AMODIAQUINE50MG+135MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/0964AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 25 / 67.5ARTESUNATE + AMODIAQUINE25 MG + 67.5 MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/3702AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDATORFIT-20ATORVASTATIN20MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4801AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDAZEL KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/5379AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZOLANAS-30LANSOPRAZOLE30MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7735AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDIBUMOL 400PARACETAMOL + IBUPROFEN 325MG + 400MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6090 UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDPROSTAR 200PROGESTERONE100MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403INDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/8321UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDPROSTER- 200 CAPSULESPROGESTERONE200 MGAKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6209 UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDRESPIWEL 4RISPERIDONE4MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6440UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCEFIWEL 400CEFIXIME TRIHYDRATE400MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7912UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDGLIMEWEL M-1GLIMEPIRIDE + METFORMIN HYDROCHLORIDE1MG + 500MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8107UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDWELRAB 20RABEPRAZOLE SODIUM20MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8640UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCORTUM 250CEFUROXIME AXETIL250MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6681UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDWELQUINE LEVOFLOXACIN0.5%W/VAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR, HARIDWAR, UTTARAKHAND INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0030UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRADMINTRAMADOL HYDROCHLORIDE 50MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/6165UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDCEFTRISONE - 1000CEFTRIAXONE SODIUM1G/VIALAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/6167UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDAKUROSEIRON SUCROSE20MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 INDIAPARENTERAL ORDINARY INFUSION AMPOULES 1.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/6675UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNOSEMIDE -10FUROSEMIDE10MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403 INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/7692UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDCEFECTRON-S 1.5 GCEFOPERAZONE SODIUM+SULBACTAM SODIUM1000MG + 500MG AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.5 G VIAL + 1*10 ML LDPE AMPOULE OF SWFI
NDA/MAL/HDP/7740UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMETHICOWEL 1500METHYLCOBALAMIN1500 MCG/MLAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/7745UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDTAZOGARDPIPERACILLIN +TAZOBACTAM 4G + 0.5GAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X4.5 G VIAL ,2X10ML LDPE AMPOULES OF WFI
NDA/MAL/HDP/7747UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDTHERMODOLPARACETAMOL1.0%W/VAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7695UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDCORTUM 500CEFUROXIME AXETIL500MGAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8106UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDPLENMOXIMOXIFLOXACIN HYDROCHLORIDE0.4%W/VAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4318UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDAKUGABALIN PREGABALIN75 MGAKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6086 UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDACEWEL-PACECLOFENAC+PARACETAMOL100MG+500MGAKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6141UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDACEWELACECLOFENAC100MGAKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8356UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLORFACT-DDESLORATIDINE5MG,AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6181UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDAZINOWEL-500AZITHROMYCIN500MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6622UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCEFIWEL-100 DTCEFIXIME TRIHYDRATE100MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY OTHER TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6647UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDJOYCLAV -625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG + 125MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6656UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDPLENMOXIMOXIFLOXACIN HYDROCHLORIDE400MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6669UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDSUPER WELGRA -100SILDENAFIL CITRATE + DAPOXETINE HYDROCHLORIDE100MG + 60MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/7098UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDACEFORCE SPACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG+325MG+15MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7123UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMARTINEZ 10MONTELUKAST SODIUM10MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8105UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDXERINLEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2416IDA KIMSY MEDS LTDSODIUM STIBOGLUCONATE INJECTIONSODIUM STIBOGLUCONATE 100MG/MLALBERT DAVID LTD .-15-CHITTARANJAN AVE. KOLKATAINDIAPARENTERAL ORDINARY VIALS 1.0X30.0 ML VIAL
NDA/MAL/HDP/2768ALCON PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ECONOPRED PLUSPREDNISOLONE ACETATE1%W/WALCON (PUETRO RICO) LABORATORIES-INC USAUNITED STATESOPHTHALMIC SUSPENSIONS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4738NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCILOXANCIPROFLOXACIN0.3%W/VALCON -ALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML VIAL
NDA/MAL/HDP/1738ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TEARS NATURALE IINATURAL TEARS15MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/1864NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDPATANOLOLOPATADINE HYDROCHLORIDE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML VIAL
NDA/MAL/HDP/2050NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDISOPTO CARPINE 2%PILOCARPINE2%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/2545NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBREXTOBRAMYCIN0.3%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/2974NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTRAVATANTRAVOPROST4?G/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X2.5 ML VIAL
NDA/MAL/HDP/3331NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDBETOPTICBETAXOLOLO.5%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML VIAL
NDA/MAL/HDP/3718ALCON PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ISOPTO ATROPINE 1%ATROPINE SULPHATE1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4060NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBRADEXTOBRAMYCIN/DEXAMETHASONE0.3%W/V+ 0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4650NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDDUOTRAVTRAVOPROST + TIMOLOL MALEATE40MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X1.0X2.5 ML VIAL
NDA/MAL/HDP/4927NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZOPTBRINZOLAMIDE10MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC SUSPENSIONS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5041NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXITROLDEXAMETHASONE/NEOMYCIN/POLYMYXIN B0.1%W/W +0.1%W/W+6000 I.UALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC OINTMENTS 1.0X3.5 G TUBE
NDA/MAL/HDP/5043NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXITROLDEXAMETHASONE/NEOMYCIN/POLYMYXIN B0.1%W/W+3500I.U/ML+6000I.U/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5050NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXIDEXDEXAMETHASONE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4321NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCUSIMOLOL 0.5%TIMOLOL MALEATE0.5% W/VALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAINSPAINOPHTHALMIC DROPS 1.0X5.0 ML VIAL
NDA/MAL/HDP/4326NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCUSICROM 4% EYE DROPSSODIUM CROMOGLYCATE4 %W/VALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAINSPAINOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/2961NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDOFTALMOLOSA CUSI ERYTHROMYCIN 0.5%ERYTHROMYCIN0.5%W/WALCON CUSI SA-CAMIL FABRA 58 08320 EL MASNOUR BARCELONASPAINOPHTHALMIC OINTMENTS 1.0X3.5 G TUBE
NDA/MAL/HDP/8935AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.FECLO GELDICLOFENAC DIETHYLAMMONIUM SALT1%W/WAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTANPAKISTANTOPICAL EXTERNAL EMULSION GELS 1.0X1.0X20.0 G TUBE
NDA/MAL/HDP/8936AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.ESOFOLEESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTANPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/8937AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.ESOFOLEESOMEPRAZOLE MAGNESIUM TRIHYDRATE20MGAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTANPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/8938AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.SULPHASILSILVER SULPHADIAZINE1%W/WAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE
NDA/MAL/HDP/7706CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDCACEF 200CEFPODOXIME PROXETIL200MGALKEM LABORATORIES LIMITED -VILLAGE- THANA BADDI, YEH NALAGAR, DISTRICT SOLAN, HIMACHAL PRADESH INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/1080ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDZOCEF 250 TABLETSCEFUROXIME AXETIL250MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2640CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDBENZYL BENZOATE APPLICATIONBENZYL BENZOATE25%W/WALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIATOPICAL EXTERNAL LOTIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3616: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZAXTERMEROPENEM1GALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/3685GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDODICEFCEFTRIAXONE1GALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/3948: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME50MG/5MLALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4361: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME200MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4577ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDMAGTAMCEFOPERAZONE + SULBACTAM500 MG + 500 MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/4677: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEFCEFUROXIME125MG/5MLALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X30.0 ML BOTTLE,1.0X70.0 ML BOTTLE
NDA/MAL/HDP/4678: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEF-500CEFUROXIME AXETIL500MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0521ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDPAN 40 PANTOPRAZOLE SODIUM 40MGALKEM LABORATORIES LTD .- VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1954: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDRAPEED-20RABEPRAZOLE20MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/8485CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDTRIAXONCEFIXIME400MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2120ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDMEGAPIMECEFEPIME1GALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL
NDA/MAL/HDP/8495CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCACEF 50CEFPODOXIME PROXETIL USP50MG / 5MLALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA.INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/4556ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 375AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM250MG + 125MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/4568ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 625AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM500MG + 125MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/4573ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM DT 228.5MGAMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM200MG + 28.5MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/4581ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1000AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM875MG + 125MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/6496ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEUROKEM 150PREGABALIN150MGALKEM LABORATORIES LTD--167/2, MAHATMA GANDHI UDYOG NAGAR DABHEL, AMALIYA, DAMAN(UT) 396 210 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1568: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAMAMOXICILLIN AND CLAVULANATE POTASSIUM156.25MGALKEM LABORATORIES LTD-PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8334PRIDE INTERNATIONALROYAL PHARMA 2011 LIMITEDS-AUGPROAMOXICILLIN TRIHYDRATE+CLAVULANIC ACID200MG+ 28.5MGALKEM LABORATORIES LTD-PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2602: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM BIDAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MG/ 5 MLALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3310ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDGEMFOSRISEDRONATE SODIUM35MGALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4745ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDPIPZOPIPERACILLIN + TAZOBACTAM4.5GALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X4.5 G VIAL
NDA/MAL/HDP/6228CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDACINETAMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6322CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDCLAVACE 1000 MG AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM875MG + 125MGALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8248CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDCLAVACE SUSPENSIONAMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM457MG/5MLALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8344CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCELZA DRY SYRUPCEFUROXIME AXETIL USP125 MG/5 MLALKEM LABORATORIES LTD--PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESHINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/8345CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCELZA 500CEFUROXIME AXETIL USP 500 MGALKEM LABORATORIES LTD--PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0117ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDZOCEF 1.5GCEFUROXIME SODIUM1.5GALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.5 G VIAL
NDA/MAL/HDP/0118ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDZOCEF 750MGCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X750.0 MG VIAL
NDA/MAL/HDP/1088GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDRESTUM CEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X750.0 MG VIAL
NDA/MAL/HDP/1187GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDKEFTAZ-1000CEFTAZIDIME1 GALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION
NDA/MAL/HDP/1345ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDSWICH-200CEFPODOXIME200MGALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8087ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDONDEM INJECTION 4MG/2MLONDANSETRON4MG/2MLALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/8088ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDONDEM INJECTION 8MG/4MLONDANSETRON8MG/4MLALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X4.0 ML AMPOULE
NDA/MAL/HDP/1632: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1.2GAMOXICILLIN SODIUM + CLAVULANATE POTASSIUM1000MG +200MGALKEMS LABORATORIES LIMITED-PLOT 167/1 MAHATMA GHANDHI, UDYOG NAGAR, DABHEL, AMALIYA DAMAN- 396 210 UTTARANCHAL, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/7491DENK PHARMA GMBH & COBENLE CONSULT LIMITEDCIPRO-DENK 750CIPROFLOXACIN HYDROCHLORIDE750MGALLPHAMED PHARBIL ARZNEIMITTEL GMBH. -HILDEBRANDSTRABE 12 37081 GOTTINGENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8490ALTHEA PHARMA PVT LTD.JOINT MEDICAL STORE (UPMB - UCMB)SODIUM CHLORIDESODIUM CHLORIDE0.9% W/VALTHEA PHARMA PVT LTD --PLOT NO. 374 SHED NO. E,.ALPHA INDUSTRIAL PARK , ATHIYAWAD DABHEL ,NANI DAMAN (U.T) 396210, INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID LINEZOLID2MG/MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4099GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEVO I.VLEVOFLOXACIN500MG/100MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7212PHARMACO DISTRIBUTION (PTY) LTDECHO PHARMACY (U) LIMITEDPHARMALGANPARACETAMOL10MG/MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1741AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEOPRED-PPREDNISOLONE ACETATE + NEOMYCIN SULPHATE+ POLYMYXIN-B5MG/ML +5MG/ML + 1M I.U/MLAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/1751AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIFUCINFUSIDIC ACID1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 1.0X5.0 ML AMPOULE
NDA/MAL/HDP/1754AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIMOLTIMOLOL MALEATE0.5%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/1756AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPRICROMSODIUM CROMOGLYCATE2%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/1758AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICORTPREDNISOLONE ACETATE0.12%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/1762AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPITROPINATROPINE1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/1745AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIGENGENTAMYCIN SULPHATE0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/1750AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIFLOXNORFLOXACIN0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/1760AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEODEXNEOMYCIN +DEXAMETHASONE0.5%W/V + 0.1%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDANJORDANOTIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/3798AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEUROTON TABLETMULTI-INGREDIENTN/AAMOUN PHARMACETICAL COMPANY-1ST INDUSTRIAL ZONE, EL OBOUR CITY, CAIRO, EGYPTEGYPTORAL SOLID ORDINARY COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1176AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDFUNGISAFETERBINAFINE HYDROCHLORIDE1%W/WAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT EGYPTTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1225AMOUN PHARMACEUTICAL COMPANYBOOTS PHARMACEUTICALS LIMITEDMOSEDIN PLUS SRPSEUDOEPHEDRINE HYDROCHLORIDE + LORATADINE120MG + 5MGAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT EGYPTORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1227AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDFUNGISAFETERBINAFINE HCL250MGAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET STRIP
NDA/MAL/HDP/6191AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON AMPOULE TRANEXAMIC ACID500MG/5MLAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT EGYPTPARENTERAL ORDINARY AMPOULES 1.0X6.0X5.0 ML AMPOULE
NDA/MAL/HDP/0186WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBBC SPRAYBENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE1.5%W/V+0.15%W/V+0.0413%W/VAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL TOPICAL SPRAYS WITHOUT GAS 1.0X25.0 ML BOTTLE
NDA/MAL/HDP/0187AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON TABLET TRANEXAMIC ACID500 MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0192AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDAMOCOMB CREAMNEOMYCIN + TRIAMCINOLONE ACETONIDE + GRAMICIDIN0.25GM + 0.1G + 100000IU + 0.025G/100GAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1863AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDORACURE GELLIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE2 GM+0.1 GMAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL TOPICAL GELS AND SOLS 1.0X15.0 G TUBE
NDA/MAL/HDP/3098AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOSEDINLORATADINE5MG/5MLAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/0227AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDCYRINOL SYRUP PHOLCODINE+EPHEDRINE HCL +CARBINOXAMINE MALEATE4MG+7MG+2MG /5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3459AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDENEMAXHYPERTONIC SOLUTION OF SODIUM PHOSPHATES6GM AND 16GM/100MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTRECTAL SYSTEMIC ENEMA LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/3609AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDANTINALNIFUROXAZIDE200MGAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X2.0X12.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/3650AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDANTINALNIFUROXAZIDE220MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3770AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDXITHRONEAZITHROMYCIN500 MGAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPTEGYPTORAL SOLID ORDINARY COATED TABLETS 1.0X1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/3778AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDXITHRONEAZITHROMYCIN200MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/4000AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIDONE SYRUPCHLORPHENIRAMINE MALEATE/DEXAMETHASONE2MG/5ML + 0.5MG/5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE,EL OBOUR CITY, CAIRO, EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X125.0 ML BOTTLE
NDA/MAL/HDP/0773HEBEI NOVASCON TRADING CO. LTDRENE PHARMACY LTDARTEMETHER INJECTIONARTEMETHER80MG/MLANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINACHINAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE
NDA/MAL/HDP/1448HEBEI NOVASCON TRADING CO. LTDRENE PHARMACY LTDVITAMIN B INJECTIONVIT B1 + VIT B2 + VIT B6 + NICOTINAMIDE + CALCIUM DEXTROPANTOTHENATE20MG + 2MG + 2MG + 30MG + 1MG /2MLANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE
NDA/MAL/HDP/5382HEBEI NOVASCON TRADING CO. LTDRENE PHARMACY LTDDICLOFENAC SODIUMDICLOFENAC75MG/3MLANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X3.0 ML AMPOULE
NDA/MAL/HDP/0081ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXAPEN-625 AMOXICILLIN + CLAVULANATE500 MG + 125 MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST. SOLAN (HP) ? 174 101(INDIA) INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0082ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)CEPOVEX-50CEFPODOXIME PROXETIL 50MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST. SOLAN (HP) ? 174 101(INDIA) INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/0084ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXIME CP-625CEFUROXIME AXETIL + POTASSIUM CLAVULANATE500MG + 125MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST. SOLAN (HP) ? 174 101(INDIA) INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0086ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXAPEN -228.5 AMOXICILLIN + CLAVULANATE200 MG + 28.5 MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST. SOLAN (HP) ? 174 101(INDIA) INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0087ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXAPEN CP-457 AMOXICILLIN + CLAVULANATE400 MG + 57 MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST. SOLAN (HP) ? 174 101(INDIA) INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0089ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)CEPOVEX-200CEFPODOXIME PROXETIL 200MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST. SOLAN (HP) ? 174 101(INDIA) INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/5470ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VERIUN CP-325CEFIXIME + CLAVULANATE POTASSIUM200 MG + 125 MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST. SOLAN (HP) ? 174 101(INDIA) INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1513ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXACEFCEFTRIAXONE1GANKUR DRUGS AND PHARMA LTD-WHITE TO OFF WHITE VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NELAGARH DIST.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/2307THE ARAB P'CAL MANUFACTIRING CO.GOODMAN INTERNATIONAL LTDZOCIN SUSPENSIONAZITHROMYCIN200MG/5MLARAB PHARMACEUTICAL MANUFACTURING INDUSTRIES --KING ABDULAH 2ND STREET / INDUSTRIAL AREA BUILDING NO. 1 AL-BUHAIRAH / SULT-JORDANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X15.0 ML BOTTLE,1.0X22.5 ML BOTTLE
NDA/MAL/HDP/4017THE ARAB P'CAL MANUFACTIRING CO.GOODMAN INTERNATIONAL LTDZOCIN CAPSULESAZITHROMYCIN250MGARAB PHARMACEUTICAL MANUFACTURING INDUSTRIES --KING ABDULAH 2ND STREET / INDUSTRIAL AREA BUILDING NO. 1 AL-BUHAIRAH / SULT-JORDANJORDANORAL SOLID ORDINARY CAPSULES 1.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/3076ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 40TELMISARTAN40MGARISTO PHAMACUTLAB PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE 5MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1208ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDVISCO LIQUIDALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE100 MG + 250 MG + 125 MG + 50 MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESHINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X200.0 ML BOTTLE
NDA/MAL/HDP/0326ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDOSTEBONCALCIUM + COLECALCIFEROL250MG + 125 IUARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/0430ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO ACECLO PLUSACECLOFENAC+PARACETAMOL100MG+500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X15.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2956ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRANLOK 500MG TABLETSTRANEXAMIC ACID500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3147ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 40/12.5TELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/4528ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPIOSAFE MF 15/500PIOGLITAZONE + METFORMIN15 MG + 500 MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0593ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPANTOP-DPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES20MG+10MGARISTO PHARMACEUTICALS PVT LTD .-MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP
NDA/MAL/HDP/6772ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDPIOSAFE 30PIOGLITAZONE HCL30MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6773ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITED ACECLOACECLOFENAC100MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3580ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDFEXOFEN-120FEXOFENADINE HYDROCHLORIDE120MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3588ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDFEXOFEN-180FEXOFENADINE180MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3815ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDQURE 500LEVOFLOXACIN HEMIHYDRATE500MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/4519ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDS-AMLOSAFE 5AMLODIPINE BESILATE5MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4522ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDS-AMLOSAFE 2.5AMLODIPINE BESILATE 2.5 MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEPINDIAORAL SOLID ORDINARY OTHER TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0584ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 1GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE1MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0589ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 2GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE2MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0582ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDACECLO SERAACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG + 500MG + 15MGARISTO PHARMACEUTICALS PVT LTD-VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0429ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDFLEXON MRIBUPROFEN + PARACETAMOL + CHLORZOXAZONE400MG + 325MG + 250MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1042ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 80/12.5 TELMISARTAN +HYDROCHLOROTHIAZIDE80MG +12.5 MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/1463ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDARISTOZYME LIQUIDDIASTASE+PEPSIN50MG+10MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/1464ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNIDAORNIDAZOLE500MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDALSARTAN-AMLOSARTAN + AMLODIPINE50MG + 5MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/2077ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3070ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3083ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 80TELMISARTAN80MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/4523ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDBIGOMET SR 500METFORMIN HYDROCHLORIDE500MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2593E DENK OHGBENLE CONSULT LIMITEDATENOLOL DENK 50ATENOLOL50MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1481ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTROGYLMETRONIDAZOLE200MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA 382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1614ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRA-50SILDENAFIL50MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA 382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1808ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTACIDMAGNESIUM TRISILICATE370MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA 382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2115ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRIMCO-TRIMOXAZOLE480MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA 382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2962ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTIDINCIMETIDINE200MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA 382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2936ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFEMIN-PNYSTATIN100,000IUASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAVAGINAL TABLETS 1.0X15.0 PESSARY BLISTER
NDA/MAL/HDP/3493ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASVIRACICLOVIR200MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3505ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFLICFOLIC ACID5MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3518ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFLOXCIPROFLOXACIN500MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3660ASTRA PHARMA (U) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRASILDENAFIL CITRATE100MGASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0508ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTARGANPROMETHAZINE HYDROCHLORIDE25MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1645ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTAZOLEMEBENDAZOLE100MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3652ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDBENDAS-400ALBENDAZOLE400MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/0025ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-5 AMLODIPINE5MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220,TALUKA BAVLA DIST AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0026ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-10 AMLODIPINE10MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0289ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDTETRASTETRACYCLINE HYDROCHLORIDE250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0332ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 20ROSUVASTATIN CALCIUM20MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HDP/0385ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFORMINMETFORMIN HYDROCHLORIDE500MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0792ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAS-VPHENOXYMETHYL PENICILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/1346ASTRA PHARMA LTD ASTRA PHARMA (U) LIMITEDASIXFUROSEMIDE40MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2549ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAZY-250AZITHROMYCIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/2991ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLIPORATORVASTATIN20MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HDP/3161ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASCILLINAMPICILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3345ASTRA PHARMACY (U) PVT LTDASTRA PHARMA (U) LIMITEDPAINOL-PPARACETAMOL + CAFFEINE650MG + 50MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET STRIP
NDA/MAL/HDP/3401ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASCODYLBISACODYL5MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3570ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRIM-960TRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3675ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASCOPAN - SCHYOSCINE BUTYLBROMIDE10MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3878ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDASTIDIN 400CIMETIDINE TABLETS400 MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4021ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAZY-500AZITHROMYCIN500MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/4295ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTRAFLAM TABLETSPARACETAMOL + IBUPROFEN500MG + 400MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4571ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASPICLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE STRIP,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/4662ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOLTRAMADOL50MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4870ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFLUCASFLUCONAZOLE150MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0 CAPSULE BLISTER
NDA/MAL/HDP/4873ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFLUCASFLUCONAZOLE200MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE BLISTER
NDA/MAL/HDP/4883ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASFEN-FCIBUPROFEN200MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4884ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASFULVIN-500GRISEOFULVIN500MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4888ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASOMYCINERYTHROMYCIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5494ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASMOXAMOXYCILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/0093ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLORASLORATADINE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0096ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLIPORATORVASTATIN20MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HDP/0099ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDCARBASCARBAMAZEPINE200MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/0169ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 10ROSUVASTATIN 10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HDP/0982ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMETO-10METOCLOPRAMIDE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1833ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMOXAMOXICILLIN500MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2934ASTRA LIFE CARE PVT LTDASTRA PHARMA (U) LIMITEDASTOLONPREDNISOLONE5MGASTRA LIFE CARE PVT LTD-57/P RAJODA-382220 BAVIA AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1832ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDDICLOASDICLOFENAC SODIUM50MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X5.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2317ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASMOLPARACETAMOL500MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3366ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDDIASGLIBENCLAMIDE5MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3895ASTRA PHARMA UGANDA LIMITEDASTRA PHARMA (U) LIMITEDASNORNORFLOXACIN400MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3900ASTRA PHARMA UGANDA LTDASTRA PHARMA (U) LIMITEDASTIBA-500TINIDAZOLE500MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4022ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASPI-MCHLORPHENIRAMINE4MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4656ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASCETCETIRIZINE10MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4881ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOXINDOXYCYCLINE100MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2086ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDBENDASALBENDAZOLE200MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, SARKEJ BAVLA HIGHWAY RAJODA AHMEDABAD 382220, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X2.0 TABLET STRIP
NDA/MAL/HDP/3056ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASCAFCHLORAMPHENICOL250MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, SARKEJ BAVLA HIGHWAY RAJODA AHMEDABAD 382220, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/3560ASTRA PHARMA UGANDA LIMITEDASTRA PHARMA (U) LIMITEDDERMIZOLKETOCONAZOLE200MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3923ASTRA PHARMA UGANDA LIMITEDASTRA PHARMA (U) LIMITEDAXASONEDEXAMETHASONE0.5MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6505 ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDCO-ARLUMETHER FORTEARTEMETHER + LUMEFANTRINE80MG + 480MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6509 ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDASPYROX PIROXICAM20MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6881 ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDASTRALEVOFLOXALEVOFLOXACIN500MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8283ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDQUINASQUININE SULPHATE BP300MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3921ASTRA PHARMA (U) PVT LTDASTRA PHARMA (U) LIMITEDAS-BPYRIDINE-3-CARBOXAMIDE/ RIBOFLAVIN/ THIAMINE NITRATE17.25MG/ 1.3MG/ 1.3MGASTRA LIFECARE (INDIA) PVT. LTD. -PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/0028ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-50ATENOLOL50MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0029ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-100ATENOLOL100MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0330ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASBUTOL-4 SALBUTAMOL4MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0336ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAS-DP TABLETSDICYCLOMINE HCL + PARACETAMOL20MG+500MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/0900ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLAPSONEDAPSONE100MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1010ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOPA TABLETSMETHYLDOPA250MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1228 ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDLUMETHERARTEMETHER + LUMEFANTRINE20 MG + 120 MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X6.0 TABLET BLISTER
NDA/MAL/HDP/2939ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTODIUMLOPERAMIDE HYDROCHLORIDE2MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3911ASTRA PHARMA UGANDA LTDASTRA PHARMA (U) LIMITEDASIDOMEPRAZOLE20 MGASTRA LIFECARE PVT LTD-57/P RAJODA 382220 BAVLA AHMEDABADINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4367ASTRA ZENECA MACNAUGHTON LIMITEDATACAND 8MGCANDESARTAN8MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJESWEDENORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4411ASTRA ZENECA MACNAUGHTON LIMITEDATACAND PLUSCANDESARTAN + HYDROCHLOROTHIAZIDE16 MG + 12.5 MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJEUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/5143ASTRA ZENECA MACNAUGHTON LIMITEDBETALOC ZOK - 25MGMETOPROLOL25MGASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDENSWEDENORAL SOLID ORDINARY TABLETS 1.0X1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/5147ASTRA ZENECAMACNAUGHTON LIMITEDBETALOC ZOK - 50MGMETOPROLOL50MGASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDENSWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/1211ASTRA ZENECA MACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)UNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER
NDA/MAL/HDP/2353ASTRA ZENECA MACNAUGHTON LIMITEDNEXIUMESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE)10MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)SWEDENORAL SOLID ORDINARY GRANULES 1.0X28.0 SACHET CARTON
NDA/MAL/HDP/5146ASTRA ZENECAMACNAUGHTON LIMITEDBETALOC ZOK - 100MGMETOPROLOL100MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)SWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5496ASTRA ZENECA MACNAUGHTON LIMITEDATACAND 16MGCANDESARTAN CILEXETIL16MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)SWEDENORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/2233ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.25MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDENSWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION 1.0X4.0X5.0X2.0 ML VIAL
NDA/MAL/HDP/2705ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.5MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDENSWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION 1.0X4.0X5.0X2.0 ML VIAL
NDA/MAL/HDP/1415ASTRA ZENECA MACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE SWEDENORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/1392ASTRA ZENECA MACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/1931ASTRAZENECAMACNAUGHTON LIMITEDZOLADEX LAGOSERELIN ACETATE10.8MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMPARENTERAL RETARD PRE-FILLED SYRINGES 1.0X10.8 MG IMPLANT
NDA/MAL/HDP/5363ASTRA ZENECAMACNAUGHTON LIMITEDCASODEX 50MGBICALUTAMIDE50MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,,BULK CORDEN PHARMA GMBH-OTT HAHN STRASSE ,68723 GERMANYUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/0946ASTRAZENECAMACNAUGHTON LIMITEDTENORETICATENOLOL + CHLORTHALIDONE100 MG + 25 MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/1828ASTRAZENECAMACNAUGHTON LIMITEDTENORETATENOLOL + CHLORTHALIDONE50 MG + 12.5 MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/2772ASTRAZENECAMACNAUGHTON LIMITEDTENORMINATENOLOL100MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/3376ASTRAZENECAMACNAUGHTON LIMITEDTENORMINATENOLOL50MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJESWEDENPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL
NDA/MAL/HDP/0858ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/1397ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/1793MACNAUNGHTON LIMITEDMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL80MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENLUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X60.0 DOSE CANNISTER
NDA/MAL/HDP/2350ASTRA ZENECA ABMACNAUGHTON LIMITEDPULMICORT TURBUHALERBUDESONIDE200MCGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENLUNG ADMINISTRATION METERED-DOSE INHALER 1.0X100.0 DOSE CANNISTER
NDA/MAL/HDP/2615ASTRA ZENECA ABMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL160MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENLUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X60.0 DOSE CANNISTER
NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON
NDA/MAL/HDP/1803ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MGESOMEPRAZOLE40MGASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON
NDA/MAL/HDP/1452ASTRA ZENECA MACNAUGHTON LIMITEDZESTORETICLISINOPRIL/HYDROCHLOROTHIAZIDE20MG/12.5MGASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/5362ASTRA ZENECA MACNAUGHTON LIMITEDCASODEX 150MGBICALUTAMIDE150MGASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY TABLETS 2.0X14.0 TABLET STRIP
NDA/MAL/HDP/1575ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL20MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/1576ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL10MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4360ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL5MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/0418ASTRA ZENECA MACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWAREUNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4190ASTRAZENECAMACNAUGHTON LIMITEDNOLVADEXTAMOXIFEN10MGASTRAZENECA UK LIMITED -ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4943ASTRAZENECAMACNAUGHTON LIMITEDNOLVADEXTAMOXIFEN20MGASTRAZENECA UK LIMITED -ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1331ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N OINTMENTBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTANPAKISTANTOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/2502ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDPROBETA N EYE DROPBETAMETHASONE + NEOMYCIN0.1%W/V+0.5%W/VATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTANPAKISTANOPHTHALMIC DROPS 1.0X7.5 ML VIAL
NDA/MAL/HDP/2979ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N CREAMBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/3177ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM CREAMBETAMETHASONE VALERATE0.1%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/3867ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM OINTMENTBETAMETHASONE VALERATE0.1%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/1125AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXONE 1000CEFTRIAXONE1000MGA-UNIT VI, SY. NO 329/39, 329/INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/2337AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXETIL-500CEFUROXIME AXETIL500MGA-UNIT VI, SY. NO 329/39, 329/INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5287AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATEEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE600MG + 300MG + 300MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/6299AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLANGEM 5OLANZAPINE5MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6301AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLANGEM 10OLANZAPINE 10MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6363AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMF-DAY 850METFORMIN HYDROCHLORIDE850MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X14.0 TABLET BLISTER
NDA/MAL/HDP/6382AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMF-DAY 500METFORMIN TABLETS BP 500MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X14.0 TABLET BLISTER
NDA/MAL/HDP/6457AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMOXIWAR 400MOXIFLOXACIN HYDROCHLORIDE400MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X5.0 TABLET BLISTER
NDA/MAL/HDP/6470AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMF-DAY 1000METFORMIN HYDROCHLORIDE1000MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6630AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTOPRAZ 20PANTOPRAZOLE 20MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8189AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULPHATE TABLETSABACAVIR SULPHATE 300MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/0071AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSUMAFIX 100SUMATRIPTAN SUCCINATE100MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1937AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ600MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/3731AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ 50MGEFAVIRENZ50MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER
NDA/MAL/HDP/5275AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ200MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X90.0 CAPSULE CONTAINER,1.0X30.0 CAPSULE CONTAINER
NDA/MAL/HDP/8159AUROBINDO PHARMA LIMITED (UNIT III)GITTOES PHARMACEUTICALS LIMITEDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR100MG + 25MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/2938AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOXIL-250 CAPSULESCLOXACILLIN250MGAUROBINDO PHARMA LIMITED UNIT -SURVEY NO. 314, BACHUPALLY, QUTHUBULLAPUR (MANDAL), R.R - DISTRICT, HYDERABAD ? 500 072, AP ? INDIA INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6367AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFINAGEN1FINASTERIDE1 MGAUROBINDO PHARMA LIMITED, UNIT ? III-SURVEY NO.:113 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/7828 AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIZTROL 24BETAHISTINE DIHYDROCHLORIDE24MGAUROBINDO PHARMA LIMITED, UNIT ? III-SURVEY NO.:113 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0213AUROBINDO PHARMA LTD (UNIT VI)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROPODOX 200 CEFPODOXIME200MGAUROBINDO PHARMA LTD (UNIT VI) ,.,.,-SURVEY NOS. 329/39 & 329/47, CHITKUL VILLAGE, PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2582AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXETIL-250CEFUROXIME AXETIL250MGAUROBINDO PHARMA LTD (UNIT VI) ,-SURVEY NOS. 329/39 & 329/47,CHITKUL VILLAGE,PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3543AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDROX 250CEFADROXIL250 MGAUROBINDO PHARMA LTD (UNIT VI) ,-SURVEY NOS. 329/39 & 329/47,CHITKUL VILLAGE,PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESHINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3593AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDROX 500CEFADROXIL 500MGAUROBINDO PHARMA LTD (UNIT VI) ,-SURVEY NOS. 329/39 & 329/47,CHITKUL VILLAGE,PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1112AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINE CAPSULESZIDOVUDINE100MGAUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHUINDIAORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CONTAINER
NDA/MAL/HDP/4686AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINE ORAL SOLUTION USPZIDOVUDINE50MG/5MLAUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHUINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X240.0 ML BOTTLE
NDA/MAL/HDP/4397AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBISODAC-HF 2.5BISOPROLOL FUMARATE 2.5MGAUROBINDO PHARMA LTD UNIT III.-SURVEY NO.313 BACHUPALL VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4446AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDHI-ALFA 2.5ALFUZOSIN HYDROCHLORIDE2.5MGAUROBINDO PHARMA LTD UNIT III.-SURVEY NO.313 BACHUPALL VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5224AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATEEMTRICITABINE/TENOFOVIR DISOPROXIL FUMERATE200MG/300MGAUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/8190AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE TABLETSLAMIVUDINE 150 MGAUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/0331AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEVOKILZ 500LEVOFLOXACIN 500MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4410AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDM-KAST 4MONTELUKAST CHEWABLE TABLETS 4 MG4MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4412AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDM-KAST 5MONTELUKAST SODIUM5MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8661AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDOLUTEGRAVIR TABLETS 50MGDOLUTEGRAVIR SODIUM50MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/3908AUROBINDO PHARMAGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINEZIDOVUDINE100MGAUROBINDO PHARMA LTD --UNIT VII PLOT NO. S1 GREEN INDUSTRIAL PARK POLLEPALLY VILLAGE ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X100.0 CAPSULE CONTAINER
NDA/MAL/HDP/3912AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE/ZIDOVUDINE/NEVIRAPINELAMIVUDINE+ZIDOVUDINE+NEVIRAPINE150MG+300MG+200MGAUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/5281AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXILEFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE600MG +200MG + 300MGAUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/8188AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE + ZIDOVUDINE + NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGAUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/4039AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ50MGAUROBINDO PHARMA LTD UNIT VII---UNIT VII PLOT NO. S1 GREEN INDUSTRIAL PARK POLLEPALLY VILLAGE ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER
NDA/MAL/HDP/2339AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-375AMOXICILLIN + CLAVULANATE POTASSIUM250 MG + 125 MGAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER
NDA/MAL/HDP/2342AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X5.0 TABLET BLISTER
NDA/MAL/HDP/2703AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT 312.50 CO-AMOXICLAV (AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVULANATE)250+62.50MG/ 5MLAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESHINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4175AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT 156.25AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNALATE156.25MG/5MLAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESHINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1631AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2346AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULFATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLAUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X240.0 ML BOTTLE
NDA/MAL/HDP/3322AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE NEVIRAPINE50MGAUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/3397AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGAUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/2132AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLOPINAVIR/ RITONAVIRLOPINAVIR/ RITONAVIR200MG/ 50MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER
NDA/MAL/HDP/2327AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/3127AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDIDANOSINE DELAYED - RELEASDIDANOSINE DELAYED RELEASE250MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID RETARD CAPSULES 1.0X30.0 CAPSULE CONTAINER
NDA/MAL/HDP/4068AUROBINDO PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE/ZIDOVUDINE/EFAVIRENZLAMIVUDINE+ZIDOVUDINE + EFAVIRENZ150MG + 300MG + 600MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0X15.0 TABLET BLISTER
NDA/MAL/HDP/4570AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINENEVIRAPINE200MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/5369AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINELAMIVUDINE150MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/5431AUROBINDO PHARMA LTD GITTOES PHARMACEUTICALS LIMITEDZIDOVUDINEZIDOVUDINE300MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8191AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDIDANOSINE DELAYED-RELEASEDIDANOSINE DELAYED-RELEASE400MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID RETARD CAPSULES 1.0X30.0 CAPSULE BOTTLE
NDA/MAL/HDP/3941AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROZIL 500CEFPROZIL500MGAUROBINDO PHARMA LTD-UNIT VI SY.NO.329/39 & 329/47 CHITKUL VILLAG,PATARICHEM,MANDAT MEDAK DISTRICT,ANDRA PRADESH,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3942AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROZIL 250CEFPROZIL250 MGAUROBINDO PHARMA LTD-UNIT VI SY.NO.329/39 & 329/47 CHITKUL VILLAG,PATARICHEM,MANDAT MEDAK DISTRICT,ANDRA PRADESH,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0004AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDINRAB 20RABEPRAZOLE SODIUM20 MGAUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK, POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR INDIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1037AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE + TENOFOVIRLAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE300MG+300MGAUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK, POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/1868AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINEZIDOVUDINE300MGAUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK, POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8355AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDONECLAPZ 75CLOPIDOGREL75MGAUROBINDO PHARMA LTD--UNIT VII SEZ PLOT S1 SPECIAL ECONOMIC ZONEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8476 AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAURODANZ 8ONDANSETRON HYDROCHLORIDE DIHYDRATE8MGAUROBINDO PHARMA LTD--UNIT-III SURVEY NO. 313 & 314, BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT TELANGANA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5376AUROBINDO PHARMA LTD GITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE & ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG+300MGAUROBINDOPHARMA LIMITED,-SURVEY NO. 313 & 314, BACHUPALLY VILLAGE, QUTHUBULLAPUR MANDAL, HYDERABAD, RANGA REDDY (DT), ANDHRA PRADESH - 500090 INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/4468AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTOPRAZ 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGAUROBINDOPHARMA LIMITED,-UNIT VII, SEZ APIIC, PLOT NO.SI SURVEY NO?S 425, 434,435 & 458 GREEN INDUSTRIAL PARK, POLEPALLY VILLAGEJEDCHERTA MANDAL, MAHABOOBNAGAR DISTTRICT, ANDRA PRADESH, INDIA.INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8243AUROCHEM LABORATORIES(INDIA) PVT LTDSUPER MEDIC LTDTRANEXAMIC ACID + MEFENAMIC ACIDTRANEXAMIC ACID + MEFENAMIC ACID500MG + 250MGAUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0594AUROLABSWASTIK PHARMACEUTICAL LTDAUROVISC-2ML PFSHYPROMELLOSE OPHTHALMIC SOLUTION USP2%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIAINDIAOPHTHALMIC VIALS 1.0X2.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/6062AUROLABSWASTIK PHARMACEUTICAL LTDOFPREDOFLOXACIN + PREDNISOLONE SODIUM PHOSPHATE0.3W/V + 0.5%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIAINDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6223AUROLABSWASTIK PHARMACEUTICAL LTDAUROPROST- RTLATANOPROST0.005%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIAINDIAOPHTHALMIC DROPS 1.0X2.5 ML BOTTLE
NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDNISOLONE ACETATE1%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC SUSPENSIONS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC LIQUIDS 1.0X10.0 ML CONTAINER
NDA/MAL/HDP/1341AUROLABSWASTIK PHARMACEUTICAL LTDG-FLOXGATIFLOXACIN SESQUIHYDRATE0.3%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC LIQUIDS 1.0X5.0 ML VIAL
NDA/MAL/HDP/4390AUROLABSWASTIK PHARMACEUTICAL LTDAUROCOLCHLORAMPHENICOL0.5%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/4279AUROLABSWASTIK PHARMACEUTICAL LTDAUROTIMTIMOLOL MALEATE0.5% W/VAUROLAB-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAIINDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/0753AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 500MEROPENEM500MGAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/7378AURONEXT PHARMA PRIVATE LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDERTAPIK ERTAPENEM SODIUM1 GAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/8500AURONEXT PHARMA PRIVATE LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDINEMPLUS 500 IMIPENEM+CILASTATIN 500MG +500MGAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 G VIAL
NDA/MAL/HDP/0749AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 1000MEROPENEM1000MGAURONEXT PHARMA PVT LTD.-A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/1669SANOFI AVENTIS LABOREX UGANDA LIMITEDAMARYL 2GLIMEPIRIDE2MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1670SANOFI AVENTIS LABOREX UGANDA LIMITEDAMARYL 4GLIMIPIRIDE4MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2118AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDRIFAFOURE E-275RIFAMPICIN+ISONIAZID+PYRAZINAMIDE+ETHAMBUTOL150MG+75MG+400MG+275MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X20.0 TABLET BLISTER
NDA/MAL/HDP/4121AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDRIFINAH 300RIFAMPICIN + ISONIAZID300MG + 150MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER
NDA/MAL/HDP/2114AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDAXA-LEVOLEVOFLOXACIN HEMIHYDRATE500MG/100MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML VIAL
NDA/MAL/HDP/4909AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDAXAGYLMETRONIDAZOLE0.5%W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6512AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDAXACIPCIPROFLOXACIN200MG/100MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7446AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDCIPLUMECIPROFLOXACIN HYDROCHLORIDE 0.3% W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/7906AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDIVMOLPARACETAMOL10MG/MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8245AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDMOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDE0.5%W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/0745MIRACLE CENTRE KAWEMPEKARURI PHARMACEUTICALS LTD.TELI 80TELMISARTAN80MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0514MANKIND PHARM LTDTATA UGANDA LIMITEDCEFAKIND-500CEFUROXIME AXETIL500MGBAROQUE PHARMACEUTICALS PVT LTD -192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0519MANKIND PHARM LTDTATA UGANDA LIMITEDCEFAKIND-250CEFUROXIME AXETIL250MGBAROQUE PHARMACEUTICALS PVT LTD -192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5176BAYER AGSURGIPHARM (U) LIMITEDCANESTENCLOTRIMAZOLE100MGBAYER AG -D-51368 LEVERKUSEN GERMANYGERMANYVAGINAL TABLETS TABLET STRIP, KG AMPOULE
NDA/MAL/HDP/5174BAYER AGSURGIPHARM (U) LIMITEDCANESTEN CREAMCLOTRIMAZOLE1%W/VBAYER AG-D-51368 LEVERKUSEN GERMANYGERMANYTOPICAL EXTERNAL CREAMS G TUBE, G AMPOULE
NDA/MAL/HDP/3148BAYER AGSURGIPHARM (U) LIMITEDALKA-SELTZERACETYL SALICYLIC ACID + SODIUM HYDROGEN CARBONATE + CITRIC ACID342 MG + 1625 MG + 965 MGBAYER BITTERFIELD GMBH- -ORTSEIL GREPPIN SALEGASTER CHAUSSEE 1,06803, BITTERFIELD WOLFEN, GERMANYGERMANYORAL SOLID ORDINARY EFFERVESCENT TABLETS 1.0X72.0 TABLET STRIP,1.0X10.0 TABLET STRIP,1.0X20.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER
NDA/MAL/HDP/1487BAYER PHARMA AGSURGIPHARM (U) LIMITEDSCHERIPROCT SUPPOSITORIESPREDNISOLONE CAPROATE/ CINCHOCAINE HYDROCHLORIDE1.3MG/ 1MGBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYRECTAL SYSTEMIC SUPPOSITORIES 1.0X12.0 SUPPOSITORY STRIP
NDA/MAL/HDP/2943SCHERING N.V.SA...SURGIPHARM (U) LIMITEDSCHERIPROCT OINTMENTPREDNISOLONE CAPROATE + CINCHOCAINE HYDROCHLORIDE1.9MG/G + 5MG/GBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYRECTAL SYSTEMIC UNIT DOSE OINTMENTS AND PASTES 1.0X10.0 G TUBE
NDA/MAL/HDP/2993SCHERING N.V.SA...SURGIPHARM (U) LIMITEDTRAVOCORTDIFLUCORTOLONE VALERATE + ISOCONAZOLE NITRATE0.1% + 1% W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4755BAYER SCHERING AGSURGIPHARM (U) LIMITEDADVANTAN CREAMMETHYL PREDNISOLONE ACEPONATE0.1%W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/6690SCHERING N.V.SA...SURGIPHARM (U) LIMITEDADVANTAN OINTMENTMETHYLPREDNISOLONE ACEPONATE0.1%W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/6740SCHERING N.V.SA...SURGIPHARM (U) LIMITEDTRAVOGEN CREAMISOCONAZOLE NITRATE1%W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS 1.0X3.0X1.0 IMPLANT STRIP
NDA/MAL/HDP/2070BAYER PHARMA AGSURGIPHARM (U) LIMITEDMIRENALEVONORGESTREL52MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS 1.0X1.0 IMPLANT CARTON
NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL
NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL. 0.15MG / 0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X2.0X28.0 TABLET BLISTER
NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X35.0 TABLET BLISTER
NDA/MAL/HDP/4035BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDYASMINDROSPIRENONE + ETHINYLESTRADIOL3MG+0.3MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X21.0 TABLET BLISTER
NDA/MAL/HDP/4187BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORIGYNON ESTRADIOL VALERATE +NORETHINDRONE ENANTHATE 5 MG+50 MG / MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/1491BAYER PHARMA AGSURGIPHARM (U) LIMITEDBILTRICIDE TABLETSPRAZIQUANTEL600MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER,1.0X10.0 TABLET BOTTLE
NDA/MAL/HDP/3568BAYER PHARMA AGSURGIPHARM (U) LIMITEDMYCOSPOR CREAMBIFONAZOLE1%W/WBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYTOPICAL EXTERNAL CREAMS 1.0X50.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/3730BAYER PHARMA AGSURGIPHARM (U) LIMITEDAVELOXMOXIFLOXACIN HYDROCHLORIDE400MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 2.0X5.0 TABLET BLISTER,1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/3768BAYER PHARMA AGSURGIPHARM (U) LIMITEDNIMOTOP 30MGNIMODIPINE30MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3789BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRAVARDENAFIL HCL5MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/3802BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRA 10MGVARDENAFIL MONOHYDROCHLORIDE TRIHYDRATE10 MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/3846BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRAVARDENAFIL HCL20 MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4750BAYER AGSURGIPHARM (U) LIMITEDCIPROBAY I.VCIPROFLOXACIN2MG/MLBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4753BAYER AGSURGIPHARM (U) LIMITEDCIPROBAY 750CIPROFLOXACIN750MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4754BAYER PHARMASURGIPHARM (U) LIMITEDCIPROBAY XRCIPROFLOXACIN500MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID RETARD TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/4901BAYER PHARMA AGSURGIPHARM (U) LIMITEDAVELOX IVMOXIFLOXACIN HCL400MG/250MLBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE
NDA/MAL/HDP/5469BAYER PHARMA AGSURGIPHARM (U) LIMITEDNIMOTOPNIMODIPINE0.2MG/MLBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY I V VIALS 1.0X50.0 ML VIAL
NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/5634BAYER AGSURGIPHARM (U) LIMITEDCIPROBAYCIPROFLOXACIN500MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8142BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDXARELTORIVAROXABAN2.5MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/2167BAYER AGSURGIPHARM (U) LIMITEDMYCOSPOR SOLUTIONBIFONAZOLE10MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANYGERMANYTOPICAL EXTERNAL LIQUIDS 1.0X15.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/HDP/3714BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDADALAT LA NIFEDIPINE30MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANYGERMANYORAL SOLID RETARD FILM-COATED TABLETS 2.0X14.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4055BAYER PHARMA AGSURGIPHARM (U) LIMITEDBAYER ASPIRIN CARDIOACETYLSALICYLIC ACID100MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANYGERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/8007BAYER AGSURGIPHARM (U) LIMITEDADALAT RETARDNIFEDIPINE20MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANYGERMANYORAL SOLID RETARD OTHER COATED TABLETS 6.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0484KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPILPLAN PLUSETHINYL ESTRADIOL + LEVONORGESTREL / FERROUS FUMARATE0.03MG+0.15MG/75MGBAYER SCHERING PHARMA AG.-13342, BERLINGERMANYORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0X28.0 TABLET BLISTER
NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300 IOPROMIDE300MG/MLBAYER SCHERING PHARMA AG-1334231, BERLINGERMANYPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL, 1.0X100.0 ML VIAL
NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER SCHERING PHARMA AG-1334231, BERLINGERMANYPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/3901BAYER SCHERING PHARMA FRANCESURGIPHARM (U) LIMITEDMICROGYNON ED FELEVONORGESTREL + ETHINYLESTRADIOL0.15MG + 0.03MGBAYER WEIMER GMBH- DOBEREINERSTRASSE 20, D-99427 WEIMER 2.BAYER PHARMA AG 13342, BERLIN,BAYER PHARMA AG -51368 LEVERKUSEN GERMANYFRANCEORAL SOLID ORDINARY TABLETS 1.0X3.0X28.0 TABLET BLISTER
NDA/MAL/HDP/3495BELL SONS & CO.(DRUGGISTS) LTDECHO PHARMACY (U) LIMITEDMENTHODEX COUGH MIXTUREMULTIINGREDIENTN/ABELL SONS & CO (DRUGGISTS) LTD-SLAIDBURN CRES CHESHIRE HOUSE/GORSEY LAUNITED KINGDOMORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/5342BELL SONS & CO.(DRUGGISTS) LTDECHO PHARMACY (U) LIMITEDBELL'S MUSCLE RUBMULTI-INGREDIENTN/ABELL SONS & CO (DRUGGISTS) LTD-SLAIDBURN CRES CHESHIRE HOUSE/GORSEY LAUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X40.0 G TUBE
NDA/MAL/HDP/6625MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET PLUS 5/12.5NEBIVOLOL HYDROCHLORIDE + HYDROCHLOROTHIAZIDE5MG + 12.5MGBERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, -) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, BATCH CONTROL) TEMPELHOFER WEG 83 D-12347 BERLIN GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/6620MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET 5MG NEBIVOLOL HYDROCHLORIDE5MGBERLIN-CHEMIE AG-BERLIN-CHEMIE AG GLIENICKER WEG 125 D-12489 BERLINGERMANYORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/3036BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGBETA HEALTH CARE INTERNATIONAL LTD-INDUSTRIAL AREA BONDO RD PLOT NO.7261/207 NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X200.0 TABLET CONTAINER, 1.0X500.0 TABLET CONTAINER, 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1413BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDPODINE MOUTH WASHPOVIDONE IODINE0.1%W/VBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL TOPICAL LIQUIDS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/1646BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETROZOLE TABLETSMETRONIDAZOLE+DILOXANIDE200MG+250MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BLISTER
NDA/MAL/HDP/1785BETA HEALTHCARE BETA HEALTHCARE UGANDA LIMITEDACTION TABLETSACETYL SALICYLATE + CAFFEINE + PARACETAMOL600 MG + 50 MG + 400 MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER
NDA/MAL/HDP/1839BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDFEVEREXPARACETAMOL500MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2509BETA HEALTHCARE BETA HEALTHCARE UGANDA LIMITEDOPELE LOTIONBENZYL BENZOATE25%W/VBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYATOPICAL EXTERNAL LOTIONS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/3051BETA HEALTHCARE BETA HEALTHCARE UGANDA LIMITEDBETROZOLEDILOXANIDE FUROATE/METRONIDAZOLE25MG/ML + 20MG/MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3266BETA HEALTHCARE BETA HEALTHCARE UGANDA LIMITEDSALIMIA LINIMENTMETHYL SALICYLATE+TURPENTINE OIL5ML+25MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYATOPICAL EXTERNAL LIQUIDS 1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/HDP/3542BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDMARA MOJAASPIRIN + PARACETAMOL + CAFFEINE400MG + 200MG + 50MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X50.0X2.0 TABLET STRIP,1.0X110.0X2.0 TABLET STRIP
NDA/MAL/HDP/3829BETA HEALTHCARE BETA HEALTHCARE UGANDA LIMITEDBETACOOLDRIED ALUMINUM HYDROXIDE/MAGNESIUM HYDROXIDE /MAGNESIUM ALUMINUM SILICATE/SIMETHICANE 300MG / 25MG / 50MG / 25MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X2.0X50.0 TABLET STRIP
NDA/MAL/HDP/4965BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETAFEN SYRUPIBUPROFEN100MG/5MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5134BETA HEALTHCARE BETA HEALTHCARE UGANDA LIMITEDGOODMORNING COUGH TABLETSMULTIINGREDIENTN/ABETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CARTON
NDA/MAL/HDP/5136BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDGOODMORNING LUNG TONICMULTIINGREDIENTN/ABETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/HDP/5154BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETASIL PAEDIATRIC SYRUPIPECACUANHA TINCTURE0.5MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/6756BETA HEALTHCARE BETA HEALTHCARE UGANDA LIMITEDFEVERIX TOTO SUSPENSIONPARACETAMOL120MG/5MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/8211SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCO-ASTHALIN SYRUPSALBUTAMOL + BROMHEXINE2MG/5ML + 4MG/5MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1715SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN SYRUPAMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMHEXINE50MG+2MG+5MG+4MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA,SHELYS PHARMACEUTICALS LTD,-NEW BAGAMOYO ROAD, MWENGE, PLOT NO 696,BLOCK NO 32, P.O.BOX 3016, DAR ES SALAAMTANZANIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1509BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDFEVEREXPARACETAMOL120MG/5MLBETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100,KENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/0461BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDBEXITROL-F HFA 25/125 SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG+125MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/0462BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDDECOMIT 50 HFA BECLOMETHASONE50MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/0465BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDDECOMIT 100 HFA BECLOMETHASONE DIPROPIONATE200MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/0466BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDALPHIN DS ALBENDAZOLE400MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBANGLADESHORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X50.0 TABLET BLISTER,1.0X50.0X1.0 TABLET BLISTER
NDA/MAL/HDP/0492BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDZOLFINACECLOFENAC100MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X15.0X20.0 TABLET BLISTER
NDA/MAL/HDP/0494BEXIMCO PHARMACEUTICALS LIMITEDKIMSY MEDS LTDINFORMET 500METFORMIN HYDROCHLORIDE500MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0498BEXIMCO PHARMACEUTICALS LTDKIMSY MEDS LTDEVO 500 LEVOFLOXACIN500MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5485BEXIMCO PHARMACEUTICALS LIMITEDKIMSY MEDS LTDAZMASOL HFASALBUTAMOL100MCG/ACTUATIONBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/1532BF BIOSCIENCES LTDTOP UNIVERSAL MEDICARE LIMITEDNOVAPRESSINTERLIPRESSIN1MG/VIALBF BIOSCIENCES LTD. -RAIWIND,PAKISTANPAKISTANPARENTERAL ORDINARY VIALS 1.0X1.0 MG VIAL
NDA/MAL/HDP/4092SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLORANORMSACCHAROMYCES BOULARDII250MGBHARAT BIOTECH INTERNATIONAL LTD-TURKPALLY SHAMEX 500 078 MYDERAHAD INDIAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X2.0X250.0 MG SACHET,1.0X10.0X250.0 MG SACHET
NDA/MAL/HDP/7907BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDHUCOG 5000 HPCHORIONIC GONADOTROPHIN5000 I.U/ VIALBHARAT SERUMS & VACCINES LIMITED -PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (E) MAHARASHTRA STATE 421501 INDIAPARENTERAL ORDINARY DRY VIALS 1.0X5000.0 I.U VIAL + 1*1ML 0.9%W/V NACL AMBER GLASS AMPOULE
NDA/MAL/HDP/7090BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDENDOPROSTCARBOPROST TROMETHAMINE 125MCG/0.5MLBHARAT SERUMS & VACCINES LTD.-PLOT NO. K?27, JAMBIVILI VILLAGE, ANAND NAGAR, ADDITIONAL M.I.D.C., AMBERNATH (EAST)-INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL (5 DOSE VIAL)
NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN 250IUBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY I M VIALS 1.0X1.0X2.0 ML VIAL (1 DOSE VIAL)
NDA/MAL/HDP/0590BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDASNA ANTIVENOM C B.GABONICA/B.ARIENTANS/ B.NASICORNIS/ DENDROASPIS/ POLYEPIS/D.ANGUSTICEPS/ N.NIVEA /N.NLGRCOLLIS/N.HAJE25/25/20/25/25/25/25/25/20/25/20/25 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY VIALS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDRHOCLONEMONOCLONAL ANTI-D IMMUNOGLOBULIN300MCGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY DRY VIALS 1.0X2.0 ML VIAL (1 DOSE VIAL)
NDA/MAL/HDP/3711BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDPOLY-MXBPOLYMYXIN B500,000 UNITSBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY DRY VIALS 1.0X5.0 ML VIAL
NDA/MAL/HDP/4404BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDFOLIGRAFRECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE75I.U/ VIALBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL RETARD OTHER VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/6040BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDU-TRYPULINASTATIN100,000 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/6137BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDLUPRODEX LEUPROLIDE ACETATE3.75MGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY S C VIALS 1.0X1.0 ML VIAL + 1*2ML GLASS AMPOULE OF DILUENT (EACH ML CONTAINS 50MG OF D-MANNITOL AND WFI TO Q.S) + 1 DISPOSABLE SYRINGE, 2 NEEDLES AND 2 ALCOHOL SWABS
NDA/MAL/HDP/2696BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDAMPHOTRETAMPHOTERICIN B50MGBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501INDIAPARENTERAL ORDINARY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/8162BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDHUMOG 75 HPHIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] /150 I.U75 IU + 75 IU/ 150 I.U VIALBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON + 1*1 ML AMPOULE OF 0.9%W/V NACL
NDA/MAL/HDP/1160DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + CLAVULANIC ACID875MG+125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAGTURKEYORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0 TABLET BLISTER
NDA/MAL/HDP/1704DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAGTURKEYORAL SOLID ORDINARY TABLETS 1.0X3.0X5.0 TABLET BLISTER
NDA/MAL/HDP/2388DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE400MG + 57MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAGTURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/8043DAFRA PHARMA GMBHLABOREX UGANDA LIMITEDRABEZOLRABEPRAZOLE SODIUM20MGB?L?M PHARMACEUTICALS-GOSB 41480 GEBZE-KOCAEL?/TURKETURKEYORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4611DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE200MG + 28MGBILIM PHARMACEUTICALS-ISLETMESI 59501 CERKEZKOY TEKIRDAGTURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/4820IDAKIMSY MEDS LTDFERROUS SULPHATE+FOLIC ACIDFERROUS SULPHATE+FOLIC ACID200MG+0.4MGBIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLIINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4824MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)FERROUS SULPHATE+FOLIC ACIDFERROUS SULPHATE+FOLIC ACID200MG+0.25MGBIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLIINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1026BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN R (REGULAR)INSULIN HUMAN100 IU/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/1027BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN-N (NPH)INSULIN HUMAN100 IU/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/1028BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDINSUGEN -30/70 (BIPHASIC)INSULIN HUMAN30/70I.U/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROADINDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/0481BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDERYPRO SAFE 4000RECOMBINANT HUMAN ERYTHROPOIETIN ALPHA4,000 IU/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA INDIAPARENTERAL ORDINARY CARTRIDGES 1.0X1.0 ML CARTRIDGE
NDA/MAL/HDP/0487BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDBASALOGINSULIN GLARGINE100IU/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA INDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X3.0 ML PRE- FILLED SYRINGE,1.0X3.0 ML VIAL
NDA/MAL/HDP/6145MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDENDULIN SELECTINSULIN GLARGINE(R-DNA ORGIN)100I.U/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA INDIAPARENTERAL ORDINARY PRE-FILLED PENS 1.0X3.0 ML PREFILLED PEN
NDA/MAL/HDP/6147MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDENDULIN VAILINSULIN GLARGINE (R-DNA ORIGIN)100I.U/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA INDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/6047MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDHERTRAZ 150TRASTUZUMAB (R-DNA ORIGIN)150MGBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X150.0 MG VIAL ,1X10ML VIAL OF WFI
NDA/MAL/HDP/8244MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDHERTRAZ 440TRASTUZUMAB (R-DNA ORIGIN)440MGBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIAPARENTERAL ORDINARY DRY VIALS 1.0X440.0 MG VIAL ,1X2X10ML VIALS OF WFI
NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBETTTETANUS VACCNE ADSORBED40 I.UBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIAPARENTERAL ORDINARY AMPOULES 1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)
NDA/MAL/HDP/2083BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBEVACPURIFIED HEPATITIS B SURFACE ANTIGEN20MCGBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIAPARENTERAL ORDINARY VIALS 1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL)
NDA/MAL/HDP/6245BIOLOGICAL E. LTDABACUS PHARMA (AFRICA) LIMITEDCOSCOPIN LINCTUSNOSCAPINE + CHLORPHENIRAMINE MALEATE + SODIUM CITRATE + AMMONIUM CHLORIDE7MG+2 MG+ 3.25 MG+28 MG/5 ML.BIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8156TATA UGANDA LIMITEDGITTOES PHARMACEUTICALS LIMITEDDIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINEDIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE25 LF (? 30 IU)+5.5 LF (? 40 IU)+16 IOU (? 4.0 IU)+12.5MCG+11MCGBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIAPARENTERAL ORDINARY I M VIALS 1.0X48.0X0.5 ML VIAL (1 DOSE VIAL),1.0X24.0X5.0 ML VIAL (10 DOSE VIAL)
NDA/MAL/HDP/8927BIOLOGICAL E. LTDPILLAR LOGISTICS LIMITEDDIPHTHERIA AND TETANUS VACCINE (ADSORBED REDUCED ANTIGEN(S) CONTENT)DIPHTHERIA TOXOID + TETANUS TOXOID 2 LF ( NOT LESS THAN 2 IU) + 8.8 LF (NOT LESS THAN 20 IU)/ 0.5MLBIOLOGICAL E. LIMITED--PLOT NO.1 SHAPOORJI PALLONJI BIOTECH PARK PHASE II, KOLTHUR VILLAGE, SHAMEERPET, MANDAL, R.R. DISTRICT, ANDRA PRADESH 500078, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X24.0X1.0X10.0 DOSE VIAL,1.0X48.0X1.0 DOSE VIAL
NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCIN 500 AZITHROMYCIN500MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/0367 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDBG-ZOLE -400 ALBENDAZOLE400MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/0663BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGLYCERINGLYCERIN1GBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN500MG+65,000I.U+100,000I.UBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAVAGINAL SUPPOSITORIES 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1220BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART ARTEMETHER + LUMEFANTRINE180 MG + 1080 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BLISTER
NDA/MAL/HDP/1260BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDDIABETAGLIBENCLAMIDE 5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1312 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM- 2.5DIAZEPAM2.5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/2907BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART DSARTEMETHER + LUMEFANTRINE80 MG + 480 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/2951 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART FORTE TABLETSARTEMETHER + LUMEFANTRINE40 MG + 240 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X2.0X6.0 TABLET BLISTER
NDA/MAL/HDP/2980BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART TABLETSARTEMETHER + LUMEFANTRINE20 MG + 120 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0X8.0 TABLET BLISTER
NDA/MAL/HDP/3528 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART-DISPERSABLEARTEMETHER + LUMEFANTRINE20 MG + 120 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3982BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART SUPPOSITORYARTEMETHER + LUMEFANTRINE20 MG + 120 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X6.0 SUPPOSITORY STRIP
NDA/MAL/HDP/3123BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDRECTOL 250 SUPPOSITORYPARACETAMOL BP250 MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11 SURVEY NO.39/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 1.0X1.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/3736PHARMAVET LTDDELMAW ENTERPRISES LIMITEDRECTOL 125 SUPPOSITORYPARACETAMOL125MGBLISS GVS PHARMA LIMITED-PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGEINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X1.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/0662PHARMAVET LTDDELMAW ENTERPRISES LIMITEDRECTIN 100INDOMETHACIN100MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/1925 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDG - ALFENAC- PACECLOFENAC + PARACETAMOL100MG + 500MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2390BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXINDIHYDROARTEMISININ/ PIPERAQUINE PHOSPHATE80MG /640MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X80.0 ML BOTTLE
NDA/MAL/HDP/2450BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDTODAY PESSARYNONOXYNOL-95%W/VBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAVAGINAL TABLETS 1.0X5.0 PESSARY BLISTER
NDA/MAL/HDP/2809BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDMAITRIPEG 150OBP/ PEG 1000BP1280MG/ 320MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAVAGINAL TABLETS 1.0X5.0 PESSARY STRIP
NDA/MAL/HDP/3340BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDPOVEDPOVIDONE IODINE200MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAVAGINAL TABLETS 1.0X2.0X7.0 PESSARY STRIP
NDA/MAL/HDP/3600BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXIN TABLETSDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X9.0 TABLET BLISTER
NDA/MAL/HDP/3803BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDDICLODYNE SUPPOSITORYDICLOFENAC SODIUM100MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/4839PHARMAVET LTDDELMAW ENTERPRISES LIMITEDANOMEXZINC OXIDE+LIDOCAINE+HYDROCORTISONE+ALLANTOIN5%W/W+3%W/W+0.25%W/W+0.5%W/WBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X1.0X5.0 SUPPOSITORY BLISTER,1.0X2.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/5169BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGVGYL SUPPOSITORYMETRONIDAZOLE BP500MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/5274 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDECOZOLEECONAZOLE150MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAVAGINAL TABLETS 1.0X3.0 PESSARY STRIP
NDA/MAL/HDP/6176BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDG-GLUTAMIN PLUSVITAMIN B1 +B6+B12 WITH L-GLUTAMIC ACID100MG+50MG+100MCG+50MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8637 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCINAZITHROMYCIN DIHYDRATE40MG/MLBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X15.0 ML BOTTLE
NDA/MAL/HDP/1218BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATE-50ARTESUNATE50MGBLISS INDASI LIFESCINCES PRIVATE LIMITED - -PLOT 73-76 SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN 396 210, INDIA INDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X6.0 SUPPOSITORY STRIP
NDA/MAL/HDP/1552BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUDROX TABLETS, DISPERSIBLECEFADROXIL125MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET STRIP
NDA/MAL/HDP/1806BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUMOX PAMOXYCILLIN125MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0X2.0 TABLET STRIP
NDA/MAL/HDP/2617BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUDROX TABLETS DISPERSABLECEFADROXIL250MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET STRIP
NDA/MAL/HDP/6679BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDWOMIBAN TABLETSALBENDAZOLE400MGBLUE CROSS LABORATORIES LTD-A-12, M.I.D.C AMBAD NASHIK-422010,BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET STRIP
NDA/MAL/HDP/1821BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL 500 TABLETSMEFENAMIC ACID500MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/2653BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDSONADERM-GMCLOBETASOL + MICONAZOLE + GENTAMICIN0.05%W/W + 2% W/W+ 0.1%W/WBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/3385BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL-P-SUSPENSIONMEFENAMIC ACID100MG/5MLBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4715BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDMEFTAL FORTEMEFENAMIC ACID + PARACETAMOL500MG + 450MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4717BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDMEFTAL-SPASMEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE250MG + 10MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X20.0 TABLET BLISTER
NDA/MAL/HDP/8443BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDEKON-D TABLETSCETIRIZINE10 MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X10.0X12.0 TABLET STRIP
NDA/MAL/HDP/6678BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDTUSQ-DXCHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN HBR + PHENYLEPHRINE2MG/5ML + 15MG/5ML + 5MG/5MLBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010INDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6753BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDTUSQ X SYRUPTERBUTALINE+BROMHEXINE+GUAIFENESIN1.25MG+4MG+50MG/5MLBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2852BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDLEK-500LEVOFLOXACIN HEMIHYDRATE500MGBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK MAHARASHTRA 422010INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6431BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDBRUMOX 125AMOXICILLIN TRIHYDRATE125MG/5MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6433BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDFICYC CREAMACICLOVIR5%W/WBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/6435BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDFIMABUTE 200CEFIXIME TRIHYDRATE200MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6447BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDAZIBRU 500AZITHROMYCIN DIHYDRATE500MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6455BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDFICYC TABLETSACYCLOVIR200MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6857BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDBRUCIPRO TABLETS CIPROFLOXACIN500MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6862BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDDITS GELDICLOFENAC DIETHYLAMINE1%W/WBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE,1.0X10.0 G TUBE
NDA/MAL/HDP/6865BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDDITS INJECTIONDICLOFENAC SODIUM25MG/MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X3.0 ML AMPOULE
NDA/MAL/HDP/6870BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDHYDROSONE 100MGHYDROCORTISONE SODIUM SUCCINATE100MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X5.0 ML VIAL
NDA/MAL/HDP/6872BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDNETRACORTIL EYE/EAR SUSPENSIONOXYTETRACYCLINE HYDROCHLORIDE +HYDROCORTISONE ACETATE+POLYMYXIN B SULPHATE 10MG+5MG+10000I.UBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAOPHTHALMIC SUSPENSIONS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6874BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDCEZIN TABLETSCETIRIZINE HYDROCHLORIDE10MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6875BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDBRUMOX-250 CAPSULESAMOXICILLIN TRIHYDRATE250MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8206BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDBRULEXINCEFALEXIN MONOHYDRATE125MG/5MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0892ASTRA ZENECA MACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN2.5MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/6218ASTRA ZENECA MACNAUGHTON LIMITEDFORXIGADAPAGLIFLOZIN10MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/0904ASTRA ZENECA MACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN5MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA,ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/7469BROOKES PHARMA (PRIVATE) LIMITEDABACUS PHARMA (AFRICA) LIMITEDECZEMUS 0.03% OINTMENTTACROLIMUS MONOHYDRATE0.03%W/WBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900PAKISTANTOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE
NDA/MAL/HDP/1779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SOLUTION POVIDONE IODINE10.0G/100MLBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTANPAKISTANTOPICAL EXTERNAL LIQUIDS 1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE
NDA/MAL/HDP/2026BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 10MGAMLODIPINE BESYLATE10MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SURGICAL SCRUBPOVIDONE IODINE7.5%W/VBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTANPAKISTANTOPICAL EXTERNAL LIQUIDS 1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE
NDA/MAL/HDP/6057BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 5MGAMLODIPINE BESYLATE5MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6897BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE GARGLE & MOUTH WASHPOVIDONE IODINE1G/100MLBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTANPAKISTANORAL TOPICAL LIQUIDS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/8324CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDLOOBID TABLETSOFLOXACIN + ORNIDAZOLE 200MG + 500 MG CACHET PHARMACEUTICAL PVT LTD. HIMACHAL-THANA, BADDI, HIMACHAL PRADESH-173 205, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6230CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDEMITINOONDANSENTRON4MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6700CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDARTIMEDDICLOFENAC SODIUM50MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6703 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHCOLD PLUSPARACETAMOL/ CAFFEINE/ PHENYLEPHRINE/ CHLORPHENIRAMINE500MG/ 30MG/ 5MG/ 2MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X50.0X4.0 TABLET STRIP
NDA/MAL/HDP/6704 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHETCETIRIZINE HCL10MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6705 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHEWORMMEBENDAZOLE100MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6706 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACH-E-WORMMEBENDAZOLE100MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/6707 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHFERIRON + FOLIC ACID + VITAMIN B1232MG/15ML + 0.5MG/15ML + 7.5MCG/15MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/6711 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHPARPARACETAMOL125MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6712 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACID-OOMEPRAZOLE20MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/6713 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAMETMETOCLOPRAMIDE HYDROCHLORIDE10MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6715 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAZITHROAZITHROMYCIN200MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X15.0 ML BOTTLE
NDA/MAL/HDP/6717 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAZITHROAZITHROMYCIN500MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6718 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCETPROCYPROHEPTADINE HYDROCHLORIDE2MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6734 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDEASCOFBROMHEXIDINE HCL + SALBUTAMOL SULPHATE + GUAIPHENESIN24MG/100ML + 42MG/100ML + 1G/MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6765 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDIBUCACH 200IBUPROFEN200MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6793 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDNESTAMINOPHYLLINE100MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/7357 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDPAMAGIN-C SYRUPCETIRIZINE HYDROCHLORIDE+DEXTROMETHORPHAN HYDROBROMIDE+ACETAMINOPHEN+PHENYLEPHRINE HYDROCHLORIDE+ZINC GLUCONATE+MENTHOL2.5MG+7.5MG+125MG+5MG+7.5MG+2.5MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/8264CACHET PHARMA PVT LTDASTRA PHARMA (U) LIMITEDEMITINO ORAL SOLUTIONONDANSETRON2MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/4545CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDCACH-ART 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X8.0 TABLET BLISTER
NDA/MAL/HDP/6244CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDCABALINPREGABALIN75MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/6701 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACH-ART DSARTEMETHER / LUMEFANTRINE80MG/ 480MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6709 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHPARPARACETAMOL500MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/7105CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDTRAMACETAL TABLETSACETAMINOPHEN +TRAMADOL HYDROCHLORIDE 325MG+37.5MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8644 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDLOOBID SUSPENSIONOFLOXACIN + ORNIDAZOLE50MG + 125MG / 5MLCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X30.0 ML BOTTLE
NDA/MAL/HDP/8665 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDPAMAGIN-CCETIRIZINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + ACETAMINOPHEN + PHENYLEPHRINE HYDROCHLORIDE + ZINC GLUCONATE5.0 MG +15 MG + 500 MG + 5 MG + 7.5 MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6737 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDESENVITGLYCERIN/ ZINC SULPHATE/ SODIUM MOLYBDATE/ MANGANESE CHLORIDE/ LYSINE HCL5.0G/ 263.83MG/ 0.4035MG/ 57.66MG/ 612MGCACHET PHARMACEUTICALSPVT.LTD.--415,SHAH NAHAR,WORLI MUMBAIINDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0774MIRACLE CENTRE KAWEMPEKARURI PHARMACEUTICALS LTD.NODONNEBIVOLOL10MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0937CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDVALAZYD H 92.5VALSARTAN/HYDROCHLOROTHIAZIDE80MG/12.5MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONTMONTELUKAST10MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1908CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLMY 20OLMESARTAN20MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1929CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3569CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCARBADAC-200CARBAMAZEPINE200MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4067CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-50 TABLETSATENOLOL50MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4594CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTINIBA-500 TABLETSTINIDAZOLE500MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0X4.0 TABLET BLISTER,1.0X25.0X4.0 TABLET BLISTER
NDA/MAL/HDP/5405CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLANDUS 10OLANZAPINE10MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1681CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 25LOSARTAN POTASSIUM25MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2868CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 50LOSARTAN POTASSIUM50MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X7.0 TABLET BLISTER
NDA/MAL/HDP/2941CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 20ATORVASTATIN20MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X7.0 TABLET BLISTER
NDA/MAL/HDP/4049CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDLEVODAY 500LEVOFLOXACIN HEMIHYDRATE500MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER,1.0X6.0X2.0X5.0 TABLET BLISTER
NDA/MAL/HDP/4169CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZYD-200FLUCONAZOLE200MGCADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X4.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/5074CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA INJECTIONDEXAMETHASONE DISODIUM PHOSPHATE4MG/MLCADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X2.0 ML VIAL
NDA/MAL/HDP/5075CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA TABLETSDEXAMETHASONE0.5MGCADILA HEALTHCARE LIMITED SARKHEJ-SARKHEJ-BAVLA N.H NO.8A, N.H NO.8A,INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/0400CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDIBSOL 1.2 MESALAMINE DELAYED RELEASE 1.2GMCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0780CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA TABLETSATORVASTATIN10MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X1.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1147CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVALAZYDVALSARTAN80MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2220CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 5AMLODIPINE BESYLATE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2699CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 12.5CARVEDILOL 12.5 MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2702CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 2GLIMEPIRIDE2MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/2816CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-100 TABLETSATENOLOL100MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2879CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOFLIN-200OFLOXACIN200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X20.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3044CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPIRICAM-20 CAPSULESPIROXICAM20MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3105CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEPIN-E RETARDNIFEDIPINE20MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/3249CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3356CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYCEL-100 CAPSULESCELECOXIB100MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3743CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 3.125 CARVEDILOL3.125 MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4132CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDZYCEL 200CELECOXIB200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4170CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTRAMAZACTRAMADOL HYDROCHLORIDE50MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4364CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVOMIZ OD 8ONDANSETRON HYDROCHLORIDE DIHYDRATE8MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDBETANASE TABLETSGLIBENCLAMIDE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER
NDA/MAL/HDP/2567CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCIPROBID-500CIPROFLOXACIN500MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA,S.KANT HEALTHCARE LIMITED--PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0245CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 4GLIMEPIRIDE4MGCADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1297CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLMY 40OLMESARTAN40MGCADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2377CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDR-LOC TABLETSRANITIDINE150MGCADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8697CADILA HEALTHCARE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDZYPIRON 20IRON SUCROSE 20MG/MLCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210INDIAPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/8233CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCOLSTIMFILGRASTIM300?G/MLCADILA HEALTHCARE LTD.--PLOT SURVEY NO. 23, 25/P, 37, 40/P, 42 TO 47 SARKHEJ BAVLA N.H NO.8A OPP.RAMDEV MASALA CHANGODAR TAL. SANAND DIST AHMEDABAD 382213INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/0733CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDZYNACACECLOFENAC100MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3739CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDALDRENALENDRONATE70MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0630CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEO LORIDINDESLORATADINE5MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0823CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDTRAP TABLETSTRAMADOL HCL + PARACETAMOL 37.5MG+325MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2467CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDNOKLOT CLOPIDOGREL 75MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3015CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPENEGRA-50 TABLETSSILDENAFIL50MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/3663CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 10AMLODIPINE BESYLATE10MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3694CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLORIDIN RAPITABLORATADINE10MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3704CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPENEGRA 100SILDENAFIL100MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0756CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDTOLFREE 100TOLPERISONE100MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0757CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDTOLFREE 150TOLPERISONE150MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2183CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID I.V.OMEPRAZOLE40MG/VIALCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/4621CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDCARVIL 6.25CARVEDILOL6.25MGCADILA HEALTHCARE LTD--PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA 403401INDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID CAPSULESOMEPRAZOLE20MGCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA, S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.INDIAORAL SOLID RETARD CAPSULES 1.0X10.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/0700CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVAXIRAB NINACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN)>2.5 I.UCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIAPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)
NDA/MAL/HDP/1519CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 400BUDESONIDE + FORMOTEROL FUMARATE120 METERED DOSES (400MCG/6MCG)CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X1.0 CANNISTER CARTON
NDA/MAL/HDP/2187CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVOMIZONDANSETRON4MG/2MLCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE
NDA/MAL/HDP/2431CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 200BUDESONIDE + FORMOTEROL FUMARATE200MCG/ 6MCGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X1.0 CANNISTER CARTON
NDA/MAL/HDP/2432CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 100BUDESONIDE + FORMOTEROL FUMARATE100MCG+6MCGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/2565CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTRAMAZAC INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE,1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/2919CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 5MONTELUKAST5MGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5051CADILA HEALTHCARE LIMITED SARKHEJABACUS PHARMA (AFRICA) LIMITEDDERIHALERSALBUTAMOL100CMG/DOSECADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/8743CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ISONIAZIDISONIAZID300 MGCADILA PHARMACEUTICALS LIMITED.-1389, DHOLKA-387810, INDIA OPP.RAJVANSH APARTMENT, SATYA MARG, BODAKDEV, AHMEDABAD ? 380054, GUJARAT, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X24.0X28.0 TABLET BLISTER
NDA/MAL/HDP/0984CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.JOVAN T20TADALAFIL20MGCADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0988CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2071CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR DRY SYRUPCEFALEXIN125MG/5MLCADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2751CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.FLUDAC CAPSULESFLUOXETINE HCL20MGCADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER
NDA/MAL/HDP/7342CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ZEALARGY RUPATADINE FUMERATE10 MG CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4987CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.PYRAZINAMIDEPYRAZINAMIDE400 MGCADILA PHARMACEUTICALS LIMITED-1389,TRASAD ROAD, DHOLKA-382 225, AHMEDABAD GUJARAT STATE,INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X24.0X28.0 TABLET BLISTER
NDA/MAL/HDP/2093CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TRIGAN-D TABLETPARACETAMOL + DICYCLOMINE500MG + 20MGCADILA PHARMACEUTICALS LTD ...-1389 DHOKA GUIJARAT STATE, INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET STRIP
NDA/MAL/HDP/5233CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ENVAS 10 MG TABLETSENALAPRIL10MGCADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA ? 387 810, AHMEDABAD, GUJARAT STATE INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5234CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ENVAS 5MG TABLETSENALAPRIL MALEATE5MGCADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA ? 387 810, AHMEDABAD, GUJARAT STATE INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8312CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TRICORT 40 TRIAMCINOLONE ACETONIDE 40MG/MLCADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA ? 387 810, AHMEDABAD, GUJARAT STATE INDIA INDIAPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL
NDA/MAL/HDP/0585CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DOMPERONDOMPERIDONE1MG/MLCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/0668CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL
NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL
NDA/MAL/HDP/2765CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HAEM FFOLICACID+ VITAMIN B12+IRON AMMONIUM CITRATE1MG+5MCG+200MG/15MLCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/3571CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.CADIPHEN EXPECTORANTCHLORPHENIRAMINE/GUAIFENESIN/AMMONIUM CHLORIDE2MG//80MG/100MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3779CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LOSIUM 50LOSARTAN POTASSIUM50MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4015CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TAMBAC 50CEFPODOXIME PROXETIL50MG/5MLCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5300CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DOLACKETOROLAC TROMETHAMINE30MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/5619CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.RABELOC 20RABEPRAZOLE SODIUM20MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/6843CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.FYTOBACTCEFOPERAZONE + SULBACTAM0.5 G + 0.5 GCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/8641CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TELI HTELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0130CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TRIGAN -DDICYCLOMINE HYDROCHLORIDE10MG/MLCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/0586CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETTONDANSETRON2MG/MLCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE
NDA/MAL/HDP/0587CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0676CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETT 4ONDANSETRON4MGCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3902CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.NODONNEBIVOLOL5MGCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6845CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.FYTOBACT 2GSULBACTAM SODIUM + CEFOPERAZONE SODIUM1G + 1GCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X2.0 G VIAL
NDA/MAL/HDP/8123CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.MYCIDAC- CMYCOBACTERIUM W (HEAT KILLED) + SODIUM CHLORIDE0.5 *10 TO POWER 9 BACILLI + 0.9%W/VCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAPARENTERAL RETARD I M PRE-FILLED SYRINGES 1.0X0.2 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/6716NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCATAFLAM 50DICLOFENAC POTASSIUM50MGCATALENT GERMANY EBERBACH GMBH..-GAMMELS BACHERSTRASSE2 GERMANYORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0 CAPSULE BLISTER,1.0X20.0 CAPSULE BLISTER
NDA/MAL/HDP/0576GLAXO SMITH KLINE LTDERIS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANYGERMANYORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER
NDA/MAL/HDP/2717CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUMYCIN EYE OINTMENTCHLORAMPHENICOL1%W/WCENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIAINDIAOPHTHALMIC OINTMENTS 1.0X3.5 G TUBE
NDA/MAL/HDP/3574CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOZ 2.5 TABLETMETOLAZONE TABLETS USP2.5MGCENTAUR PHARMA PVT.LIMITED-PLANT I-PLOT3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3581CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOZ 5METOLAZONE5MGCENTAUR PHARMA PVT.LTD-PLANT I-PLOT 3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2940CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENZOX 5 GELBENZOYL PEROXIDE5%W/WCENTAUR PHARMACEUTICALS LTD- PLOT NO. 39 TIVIN IN INDIATOPICAL EXTERNAL OTHER GELS/SOLS 1.0X2.0 G TUBE
NDA/MAL/HDP/2018CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDORAXIN SYRUPCYPROHEPTADINE+TRICHOLINE CITRATE2MG+275MGCENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2415CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSOLINA TABLETSDIAZEPAM5MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2982CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDNEURO-FORTE TABLETSVITAMIN B1 + VITAMIN B6 + VITAMIN B12200MG + 50MG + 1MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3754CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDSINAREST PD NASAL DROPSOXYMETAZOLINE HYDROCHLORIDE0.025%W/VCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIANASAL TOPICAL DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/4182CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSINAREST- FORTEMULTI INGREDIENTMULTI INGREDIENTCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET STRIP
NDA/MAL/HDP/5122CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDKOFAREST SYRUPSALBUTAMOL SULPHATE/AMBROXOL SULPHATE/GUAFENESIN/MENTHOL2MG+30MG+100MG+5MG/10MLCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4118CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDOCUREST-AHPHENYLEPHRINE HYDROCHLORIDE+NAPHAZOLINE HYDROCHLORIDE+CHLORPHRENIRAMINE MALEATE+MENTHOL+CAMPHOR0.12%+0.05%+0.1%+0.005%+0.01%CENTAUR PHARMACEUTICALS PRIVATE LIMITED-PLOT NO.3,TIVIM INDUSTRIAL ESTATE KARASWADA MUPUSA-GOA 403 526 INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/3357CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDESOREST 20ESOMEPRAZOLE20MGCENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEARINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3364CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDESOREST 40ESOMEPRAZOLE40MGCENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEARINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1264CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUCYCLINE EYE OINTMENTTETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAOPHTHALMIC OINTMENTS 1.0X5.0 G TUBE,1.0X3.5 G TUBE
NDA/MAL/HDP/1976CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDOROGELCHOLINE SALICYLATE+LIGNOCAINE HCL+BENZALKONIUM CHL8.7%W/W+2%W/W+0.01%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAORAL TOPICAL GELS AND SOLS 1.0X10.0 G TUBE
NDA/MAL/HDP/2141CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDINFLAZONEMULTIINGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HDP/2802CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDTASOLCLOBETASOL0.05%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/2920CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDTRANSLIPO -C CREAMCLOTRIMAZOLE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X20.0 G TUBE,1.0X10.0 G TUBE
NDA/MAL/HDP/2942CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDARGISSEPT CREAMCHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE0.2%W/W / 1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE,1.0X10.0 G TUBE
NDA/MAL/HDP/4867CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDMICONA ORAL GELMICONAZOLE20MGCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAORAL TOPICAL GELS AND SOLS 1.0X40.0 G TUBE,1.0X20.0 G TUBE
NDA/MAL/HDP/8242IDA FOUNDATIONKIMSY MEDS LTDTETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAOPHTHALMIC OINTMENTS 1.0X50.0X5.0 G TUBE
NDA/MAL/HDP/3800CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOLDARESTPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE + CAFFEINE500MG+5MG+2MG+30MGCENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X50.0X4.0 TABLET STRIP
NDA/MAL/HDP/5228CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOGENTADICLOFENAC SODIUM+GENTAMICIN SULPHATE1MG/ML+3MG/MLCENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5415CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDSINARESTOXYMETAZOLINE0.05%W/VCENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIANASAL TOPICAL DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/1589CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDCENTACID SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE40MG+200MG+250MG/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE
NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/4023CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSINAREST LINCTUSCHLORPHENIRAMINE+DEXTROMETHORPHAN+METHANOL2MG+10MG+1.5MGCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4101CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDAMLOTRUST 5AMLODIPINE5MGCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5185CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDHB FORTEMULTI INGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/4082SANOFI AVENTIS LABOREX UGANDA LIMITEDNO-SPA FORTEDROTAVERINE HCL80MGCHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY.HUNGARYORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2569SANOFI AVENTIS LABOREX UGANDA LIMITEDNO-SPA DROTAVERINE HYDROCHLORIDE40MG/2MLCHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO. LTD CSANYIKVOLGY SITE-CSANYIKVOLGY, P.O.BOX 565.3510, MISKOLC, HUGARYHUNGARYPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/3977CHINOIN PHARMACEUTICALS AND CHEMICAL WORKS, CO. LTDLABOREX UGANDA LIMITEDNO-SPA 40MGDROTAVERINE HYDROCHLORIDE40MGCHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO.LTD-H-2112, VERESEGYHAZ, LEVAI U.5.HUNGARYHUNGARYORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8826CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATE AND LAMIVUDINE TABLETS FOR ORAL SUSPENSION 120/60 MGABACAVIR SULFATE + LAMIVUDINE120MG + 60MGCIPLA LIMITED -PLOT NO A ? 33, A ? 2 (UNIT ? I), MIDC PATALGANGA, DISTRICT RAIGAD, 410 220 MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/3191CIPLA LTDQUALITY CHEMICALS LTD - HUMANERECTO -100SILDENAFIL CITRATE100 MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/3193CIPLA LTDQUALITY CHEMICALS LTD - HUMANERECTO- 50SILDENAFIL CITRATE50MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/3220CIPLA LTDQUALITY CHEMICALS LTD - HUMANPYLO KITLANSOPRAZOLE+TINIDAZOLE+CLARITHROMYCIN30MG+500MG+250 MGCIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)
NDA/MAL/HDP/8933CIPLA LTDQUALITY CHEMICALS LTD - HUMANQ-TIBSULFAMETHOXAZOLE + TRIMETHOPRIM + ISONIAZID + PYRIDOXINE HYDROCHLORIDE800MG + 160MG + 300MG +25MGCIPLA LIMITED>-A-33, A-37/2/2 & A-2, M.I.D.C, PATALANGA 410 220, DISTRICT RAIGAD, M.S, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8466CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANLUMARTEM HS 80ARTEMETHER + LUMEFANTRINE80MG + 480MGCIPLA LIMITED--UNIT 1,VILLAGE UPPER MALPUR, P.O. BHUD, TEHSIL NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 173205, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6183CIPLA LTD..QUALITY CHEMICALS LTD - HUMANPRAZIQUANTEL TABLETSPRAZIQUANTEL600MGCIPLA LTD .-352 KUNDAIM INDL. ESTATE KUNDAIM GOA 403 115INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0 TABLET BOTTLE,1.0X500.0 TABLET BOTTLE
NDA/MAL/HDP/4880CIPLA LTDQUALITY CHEMICALS LTD - HUMANMISOPROST 200MISOPROSTOL200MCGCIPLA LTD .-CIPLA GOA UNIT 8 L-147 TO L-147/1 L-147-3 TO L-138 VERNA INDUSTRIAL ESTATE VERNA GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER,1.0X7.0X4.0 TABLET BLISTER,1.0X15.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1399CIPLA LTD.QUALITY CHEMICALS LTD - HUMANASTHALIN SALBUTAMOL100MCG/DOSECIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE ?II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESHINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/2175CIPLA LTDQUALITY CHEMICALS LTD - HUMANPARAFIZZPARACETAMOL500MGCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE ?II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESHINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP
NDA/MAL/HDP/3062CIPLAQUALITY CHEMICALS LTD - HUMANLAMIVUDINE,ZIDOVUDINE, NEVIRAPINELAMIVUDINE/ZIDOVUDINE/NEVIRAPINE150MG + 300MG + 200MGCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE ?II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH,CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/5374CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANLAMIVIR ORAL SOLUTIONLAMIVUDINE50MG/5MLCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE ?II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH,CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X240.0 ML BOTTLE
NDA/MAL/HDP/2188CIPLA LTDQUALITY CHEMICALS LTD - HUMANPREDNISOLONEPREDNISOLONE5MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2262CIPLA LTD QUALITY CHEMICALS LTD - HUMANTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/2603CIPLA LTDQUALITY CHEMICALS LTD - HUMANVIRADAYTENOFOVIR + EMTRICITABINE + EFAVIRENZ300 MG + 200 MG + 600 MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/4899CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANCLOSERINECYCLOSERINE250MGCIPLA LTD -CIPLA LTD VERNA IND BT GOA 403722INDIAORAL SOLID ORDINARY CAPSULES 1.0X40.0 CAPSULE CONTAINER
NDA/MAL/HDP/2507CIPLA LTDQUALITY CHEMICALS LTD - HUMANEXERMET 1000METFORMIN HCL1000MGCIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5389CIPLA LTDQUALITY CHEMICALS LTD - HUMANLUMARTEMARTEMETHER + LUMEFANTRINE20MG + 120 MGCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER
NDA/MAL/HDP/6061CIPLA LTD..QUALITY CHEMICALS LTD - HUMANNASEHALERMOMETASONE FUROATE50MCG /SPRAYCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIANASAL TOPICAL SPRAYS WITHOUT GAS 1.0X140.0 METERED DOSE BOTTLE
NDA/MAL/HDP/8250CIPLA LTDQUALITY CHEMICALS LTD - HUMANLUMARTEM DTARTEMETHER+LUMEFANTRINE20MG+120MGCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER
NDA/MAL/HDP/1156CIPLA LTDQUALITY CHEMICALS LTD - HUMANFUNGICIPCLOTRIMAZOLE1%W/WCIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/6173CIPLA LTD..QUALITY CHEMICALS LTD - HUMANMONTAIR 5MONTELUKAST SODIUM5MGCIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0608CIPLA LTDQUALITY CHEMICALS LTD - HUMANLOPINAVIR AND RITONAVIR TABLETS 200MG/50MGLOPINAVIR + RITONAVIR200MG + 50MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X120.0 TABLET BOTTLE
NDA/MAL/HDP/3480CIPLA LTDQUALITY CHEMICALS LTD - HUMANHYOSPANHYOSCINE BUTYL BROMIDE10MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845 INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4376CIPLA LTD.QUALITY CHEMICALS LTD - HUMANEFAVIRENZ+LAMIVUDINE & TENOFOVIR TABLETSEFAVIRENZ + LAMIVUDINE + TENOFOVIR600MG +300MG + 300MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5360CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANMOXICIP 400MOXIFLOXACIN400MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845 INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/6652 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLAMIVUDINE +TENOFOVIR DISOPROXIL FUMARATELAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/6655 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANATORLIP-20ATORVASTATIN CALCIUM20MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845 INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2497CIPLA LTDQUALITY CHEMICALS LTD - HUMANNEVIMUNE NEVIRAPINE50MG/5MLCIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II, SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3286CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANLOMAC-20OMEPRAZOLE 20 MGCIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II, SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1777CIPLA LTDQUALITY CHEMICALS LTD - HUMANNUZAC 20FLUOXETINE20MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2983CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFORCAN-200FLUCONAZOLE200MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X5.0X1.0X4.0 CAPSULE BLISTER
NDA/MAL/HDP/8093CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIR-NZIDOVUDINE + LAMIVUDINE + NEVIRAPINE 300MG + 150MG + 200MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/2402IDA FOUNDATIONKIMSY MEDS LTDPRAZIQUANTELPRAZIQUANTEL600MGCIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/3553CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFALCIMON 25/67.5 B/LARTESUNATE+AMODIAQUINE25MG+67.5MGCIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/5457CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANFALCIMON 100/270 B/LARTESUNATE+AMODIAQUINE100MG+270MGCIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/5458CIPLA LTDQUALITY CHEMICALS LTD - HUMANFALCIMON 50/135 B/LARTESUNATE+AMODIAQUINE50MG+135MGCIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/7266 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANATAZANAVIR SULFATE AND RITONAVIR TABLETS ATAZANAVIR SULFATE + RITONAVIR USP 300 MG + 100 MGCIPLA LTD(PATALGANGA)-CIPLA LIMITED, PLOT NO. A-42 (UNIT II),MIDC,PATALGANGADISTRICT - RAIGAD, MAHARASHTRA,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/1381CIPLA LTDQUALITY CHEMICALS LTD - HUMANLAMIVUDINE,/ ZIDOVUDINE TABLETSLAMIVUDINE,+ ZIDOVUDINE150MG+300MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/1384CIPLA LTDQUALITY CHEMICALS LTD - HUMANLAMIVUDINE AND ZIDOVUDINE TABLETS LAMIVUDINE + ZIDOVUDINE30MG + 60MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/2092CIPLA LTDQUALITY CHEMICALS LTD - HUMANDUOVIR-NLAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE,1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/2671CIPLA LTD..QUALITY CHEMICALS LTD - HUMANDUOLIN RESPULESIPRATROPIUM BROMIDE & SALBUTAMOL500MG + 2.5 MG /2.5MLCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIALUNG ADMINISTRATION LIQUID FOR INHALATION 4.0X5.0X2.5 ML VIAL
NDA/MAL/HDP/2910CIPLA LTDQUALITY CHEMICALS LTD - HUMANTENVIR EMTENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE300MG+200MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/3041CIPLA LTDQUALITY CHEMICALS LTD - HUMANLEVOFLOXACINLEVOFLOXACIN250MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3049CIPLA LTD..QUALITY CHEMICALS LTD - HUMANEFAVIRENZEFAVIRENZ600MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/3088CIPLA LTDQUALITY CHEMICALS LTD - HUMANPILL 72LEVONORGESTREL0.75MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/3228CIPLA LTDQUALITY CHEMICALS LTD - HUMANENTOSECSECNIDAZOLE1000MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET STRIP
NDA/MAL/HDP/3441CIPLA LTDQUALITY CHEMICALS LTD - HUMANLEVOFLOXACINLEVOFLOXACIN500MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3548CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE 200BECLOMETASONE200MCG/DOSECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/3558CIPLA LTDQUALITY CHEMICALS LTD - HUMANSEROFLO-250SALMETEROL+ FLUTICASONE PROPIONATE25MCG + 250MCGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/3684CIPLA LTDQUALITY CHEMICALS LTD - HUMANI-PILLLEVONORGESTREL1.5MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/4647CIPLA LTD..QUALITY CHEMICALS LTD - HUMANLEVOLIN LEVOSALBUTAMOL50MCGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIANASAL SYSTEMIC METERED-DOSE LIQUIDS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5202CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANHYDROCORT INJECTIONHYDROCORTISONE SODIUM SUCCINATE100MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL
NDA/MAL/HDP/5371CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANLAMIVUDINELAMIVUDINE10MG/MLCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5478CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE-50BECLOMETHASONE DIPROPIONATE50MCG/ACTUATIONCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5480CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE NASAL SPRAYBECLOMETHASONE DIPROPIONATE50MCGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIANASAL TOPICAL METERED DOSE AEROSOLS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/8021CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANLAMIVIR-150 TABLETSLAMIVUDINE150MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8022CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG +50MG + 60MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/1698CIPLA LTDQUALITY CHEMICALS LTD - HUMANAZEE-500AZITHROMYCIN500MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/2966CIPLA LTDQUALITY CHEMICALS LTD - HUMANTENVIRTENOFOVIR DISOPROXIL FUMARATE300MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/5252CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANENCLEX-40ENOXAPARIN SODIUM40MG/0.4MLCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0X0.4 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/8032CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATE/LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE600 MG + 300 MG CIPLA LTD-A-33 & A-37/2/2 MIDC PATALGANGA 410220INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8229CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATE + LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE60MG + 30MGCIPLA LTD-A-33 & A-37/2/2 MIDC PATALGANGA 410220INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/3141CIPLA LTD.QUALITY CHEMICALS LTD - HUMANAMLOPRESS-5AMLODIPINE BESYLATE5MGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3182CIPLA LTDQUALITY CHEMICALS LTD - HUMANTADACIP 20TADALAFIL20MGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/3215CIPLA LTDQUALITY CHEMICALS LTD - HUMANSEROFLO-125MGSALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 125MCGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/3920CIPLA LTDQUALITY CHEMICALS LTD - HUMANPHOTERICIN BAMPHOTERICIN B50MGCIPLA LTD-M-61, M-62 & M-63, VERNA INDUSTRIAL ESTATE VERNA GOA,INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X50.0 MG VIAL
NDA/MAL/HDP/3326CIPLA LTDQUALITY CHEMICALS LTD - HUMANAMICIPAMIKACIN500MG/2MLCIPLA LTD-M-61, M-62 &M-63 UNIT IX VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE GOA 403 722INDIAPARENTERAL ORDINARY DRY VIALS 5.0X2.0 ML VIAL
NDA/MAL/HDP/1255CIPLA LTDQUALITY CHEMICALS LTD - HUMANNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3055CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATEABACAVIR SULPHATE300MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/6657 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANMETFORMINMETFORMIN HYDROCHLORIDE500MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4351CIPLA LTDQUALITY CHEMICALS LTD - HUMANABACAVIR SULFATEABACAVIR SULPHATE60MGCIPLA LTD-PATALGANGA UNIT II PLOT MO A-33 A42 MIDC RAIGADINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/0189CIPLA LTDQUALITY CHEMICALS LTD - HUMANNEVIMUNE TABLETSNEVIRAPINE200MGCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/3084CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANNEVIRAPINENEVIRAPINE200MGCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/3212CIPLA LTD.QUALITY CHEMICALS LTD - HUMANCLOPIVAS 75MGCLOPIDOGREL BISULPHATE75MGCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4869CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANMICOGEL CREAMMICONAZOLE NITRATE2%W/WCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1811CIPLA LTDQUALITY CHEMICALS LTD - HUMANDUOVIR TABLETSZIDOVUDINE+ LAMIVUDINE300MG + 150MGCIPLA LTD---PLOT NO. 143 AND L-144A VERNA IND. ESTATE SALCETTE GOA 403 722,CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/1360CIPLA LTDQUALITY CHEMICALS LTD - HUMANABAMUNE-L BABYABACAVIR SULPHATE + LAMIVUDINE60MG + 30MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/3491CIPLA LTD.QUALITY CHEMICALS LTD - HUMANBENDEX-400ALBENDAZOLE400MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10.0X1.0 TABLET BLISTER
NDA/MAL/HDP/5236CIPLA LTD.QUALITY CHEMICALS LTD - HUMANETHIONAMIDE TABLETS USPETHIONAMIDE250MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/1907CIPLA LTDQUALITY CHEMICALS LTD - HUMANABACAVIR ABACAVIR 300MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220, DIST- RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/3968CIPLA LTDQUALITY CHEMICALS LTD - HUMANNORLUT-N NORETHISTERONE ACETATE5MGCIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3972CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFERTOMID-50CLOMIPHENE50MGCIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1525CIPLA LTDQUALITY CHEMICALS LTD - HUMANBENDEXALBENDAZOLE20MG/5MLCIPLA LTD-VERNA INDUSTRIAL ESTATE, GOAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/2527CIPLA LTD.QUALITY CHEMICALS LTD - HUMANACIVIR CREAMACICLOVIR 5%W/WCIPLA LTD-VERNA INDUSTRIAL ESTATE, GOAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/0196CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIRLAMIVUDINE/ZIDOVUDINE150MG/300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALAUGANDAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/0198CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIRAPINE TABLETS 200 MGNEVIRAPINE200MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/0480CIPLA LTDQUALITY CHEMICALS LTD - HUMANEFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMERATE 600/300/300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG+300MG+300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA,CIPLA L.T.D -MIDC PATALGANGA MAHARASHTRA 410 220,CIPLA LTD UNIT VII PD II-S-103 TO S-105, S-107 TO S-112, L-138, L-147/1 TO L-147/3, L-147A, VERNA INDUSTRIAL ESTATE, VERNINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5372CIPLA LTD QUALITY CHEMICALS LTD - HUMANDUOMUNELAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA,CIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/0197CIPLA LTDQUALITY CHEMICALS LTD - HUMANEFAVIR-600EFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA,CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/1906ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ TABLETS 600MGEFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/7162ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDTEXAVIRTENOFOVIR DISOPROXIL FUMARATE 300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7274CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDZENTAIR 0.5MGENTECAVIR0.5MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7663CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDZENTAIRENTECAVIR MONOHYDRATE1.0MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7449CIPLAQCILCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE/ TENOFOVIR DF 300/300MG LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7617CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG/300 MG /300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600 MG + 300 MG + 300 MGCIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/1167CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDMETOCLOPRAMIDE INJECTIONMETOCLOPRAMIDE5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/1172CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE 20MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL,1.0X30.0 ML VIAL
NDA/MAL/HDP/5067CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLUFENACDICLOFENAC 25MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X3.0 ML AMPOULE
NDA/MAL/HDP/5380CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIROZEPDIAZEPAM5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/1171CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDBETNEW EYE / EAR DROPBETAMETHASONE+NEOMYCIN0.1%W/W+0.5%W/WCIRON DRUGS & PHARMACEUTICALS PVT LTD.-N-118 MIDC TARAPUR BOISAR DIST THANE 401 506 MAHARASTHTRAINDIAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/2923CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCOLD PLUS SYRUPPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE125MG + 2.5MG + 2.5MG/ 5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6548 CIRON DRUGS & PHARMACEUTICAL PVT LTDROYAL PHARMA 2011 LIMITEDCIROPAIN GEL DICLOFENAC DIETHYLAMINE BP1%W/WCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/8201CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCENTROZINECETIRIZINE HYDROCHLORIDE5MG/5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/8210CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDHYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BPHYDROCORTISONE100MGCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506INDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X100.0 MG VIAL
NDA/MAL/HDP/1069CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDK-ONE INJECTIONPHYTOMENADIONE10MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/3635CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIROGANPROMETHAZINE HYDROCHLORIDE25MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/3873CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORPROMAZINE INJECTION B.PCHLORPROMAZINE25MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/3938CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDADRENALINE INJECTIONADRENALINE1MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X100.0X1.0 ML AMPOULE
NDA/MAL/HDP/4737CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCICOL DROPSDICYCLOMINE HYDROCHLORIDE + SIMETICONE10MG + 40MG/ 5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/4783CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCYPOTINCYPROHEPTADINE HYDROCHLORIDE2MG/5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7147AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBIMATBIMATOPROST0.03% W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAOPHTHALMIC DROPS 1.0X1.0X3.0 ML VIAL
NDA/MAL/HDP/8209 CIRON DRUGS & PHARMACEUTICAL PVT LTDRENE PHARMACY LTDTHIOPENTAL SODIUM INJECTIONTHIOPENTAL SODIUM 1GM / VIALCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X50.0X1.0 G VIAL
NDA/MAL/HDP/8818AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLEVOTOP-PFLEVOFLOXACIN HEMIHYDRATE1.5%W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/8824AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEPAFLAMNEPAFENAC0.1% W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAOPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/3485CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDERGOMETRINEERGOMETRINE MALEATE0.5MG/MLCIRON DRUGS AND PHARMACEUTICALS PRIVATE LTD-N-118 MIDC TARAPUM BOISAR DIST THANE 401506 MAHARASHTRA, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X100.0X1.0 ML AMPOULE
NDA/MAL/HDP/3594CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDSTERILE QUININE DIHYDROCHLORIDEQUININE DIHYDROCHLORIDE300MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LIMITED-N-118, N119, N113, MIDC TARAPUR BOISAR DIST THANE 401506, INIDAINDIAPARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE
NDA/MAL/HDP/1432CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL EAR DROPSCHLORAMPHENICOL5%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAOTIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/3584CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL EYE DROPSCHLORAMPHENICOL0.5%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/4587CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIRATROATROPINE1MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/4979CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDFUROSEMIDEFUROSEMIDE10MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/5013CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDGENTAMYCIN EYE/EAR DROPSGENTAMYCIN0.3%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/8208 CIRON DRUGS & PHARMACEUTICAL PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL SODIUM SUCCINATECHLORAMPHENICOL SODIUM SUCCINATE1GCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X25.0X1.0 G VIAL
NDA/MAL/HDP/6246CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLUTHERARTEMETHER80MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT. LTD-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIAINDIAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE
NDA/MAL/HDP/2670ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDSENSINILLIDOCAINE2%W/VCLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL,1.0X20.0 ML VIAL,1.0X30.0 ML VIAL
NDA/MAL/HDP/6660ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDKETAJEXKETAMINE50MG/MLCLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/1520CLARIS INJECTABLES LTDREDDYS PHARMA LIMITEDFLUCANOLFLUCONAZOLE2MG/MLCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML VIAL
NDA/MAL/HDP/2045ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICANBUPIVACAINE0.5% W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/3396ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICAN HEAVYBUPIVACAINE HYDROCHLORIDE IN DEXTROSE 0.5%W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X25.0X4.0 ML AMPOULE
NDA/MAL/HDP/5438ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDTAMINPARACETAMOL10MG/MLCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE,1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML VIAL
NDA/MAL/HDP/3797ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDPROVIVE 1%PROPOFOL10MG/MLCLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL
NDA/MAL/HDP/6124CLARIS LIFE SCIENCES LTDREDDYS PHARMA LIMITEDSPIVAPROPOFOL1%W/VCLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/6063CLARIS LIFESCIENCE LTDREDDYS PHARMA LIMITEDANSEDFLUMAZENIL0.1MG/MLCLARIS LIFE SCIENCES LTD-CHACHARWADI-VASANA,SANAND, AHMEDABAD GUJARAT-382213 INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/6140CLARIS OTSUKA LIMITEDREDDYS PHARMA LIMITEDKIDROLYTESODIUM ACETATE + DIBASIC POTASSIUM PHOSPHATE + MAGNESSIUM CHLORIDE + DEXTROSE MONONOHYDRATE + POTASSIUM CHLORIDE(0.32G + 0.026G + 0.031G + 5.50G + 0.13G)/100MLCLARIS OTSUKA LIMITED .-VILLAGE VASANA CHACHARWADI TAL:SANAD DIST -AHMEDABAD 382 213INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/0945CLARIS LIFE SCIENCES LIMITEDREDDYS PHARMA LIMITEDZOFEXOFLOXACIN2 MG/MLCLARIS OTSUKA LIMITED-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2749CLARIS LIFESCIENCE LTDREDDYS PHARMA LIMITEDHESTAR-200 PENTASTARCHHYDROXYETHYLSTARCH6%W/VCLARIS OTSUKA PRIVATE LIMITED-N3INDIAPARENTERAL ORDINARY INFUSION BAGS 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/6914I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDPANZOLE TABLETSPANTOPRAZOLE40MGCORONA REMEDIES PVT LIMITED-VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH ? 173223. INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6924I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDNAC MRDICLOFENAC POTASSIUM+PARACETAMOL+CHLORZOXAZONE50MG+325MG+250MGCORONA REMEDIES PVT LIMITED-VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH ? 173223. INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6422INTERNATIONAL ORGANIZATION FOR MIGRATIONAIVEEN (U) LIMITEDEMADONONDANSETRON4MGCORONA REMEDIES PVT LTD--VILLAGE JATOLI,POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. OLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1911COSMOS LTDASTRA PHARMA (U) LIMITEDCODIENE PHOSPHATE TABLETS BP 30CODEINE PHOSPHATE 30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8180COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOL TABLETS 500MGPARACETAMOL500MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X50.0X2.0 TABLET STRIP,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/0746COSMOS LTDASTRA PHARMA (U) LIMITEDDTS-Z KIT TABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSETABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75GCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0784COSMOS LTDASTRA PHARMA (U) LIMITEDHEMOSANFERROUS FUMERATE300MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0879COSMOS LTD.ASTRA PHARMA (U) LIMITEDTRIBEES FORTE FILM COATED TABLETSTHIAMINE + PYRIDOXINE + CYANOCOBALAMIN200MG + 50MG +1000MCGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1007COSMOS LTDASTRA PHARMA (U) LIMITEDZINCOS DISPERSIBLE TABLETS 20MGZINC SULPHATE20MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1011COSMOS LTDASTRA PHARMA (U) LIMITEDDABORAL SYRUP AMINOSIDINE125MG/5MLCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA KENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4710COSMOS LTDASTRA PHARMA (U) LIMITEDMEDOPRESS TABLETS 250MGMETHYLDOPA250MGCOSMOS LIMITED..-RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/0141COSMOS LTDASTRA PHARMA (U) LIMITEDNYCOSTAT SUSPENSIONNYSTATIN100,000 I.U/MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0948COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINA SYRUP 5MG/5ML LORATADINE5MG/5MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY LIQUIDS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/1565COSMOS LTDASTRA PHARMA (U) LIMITEDSALBUT SYRUP 2MG/5MLSALBUTAMOL2MG/5MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
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NDA/MAL/HDP/2385COSMOS LIMITEDASTRA PHARMA (U) LIMITEDCOZEPAM 5MGDIAZEPAM 5MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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NDA/MAL/HDP/3516COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS BP 5MGTRIHEXYPHENIDYL HYDROCHLORIDE5MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET BLISTER
NDA/MAL/HDP/3752COSMOS LTDASTRA PHARMA (U) LIMITEDPAINOTAB 200PARACETAMOL/CAFFEINE500MG+65MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3837COSMOS LTDASTRA PHARMA (U) LIMITEDNITROFURANTOINNITROFURANTOIN100MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3904COSMOS LTDASTRA PHARMA (U) LIMITEDNYCOSTAT PESSARIESNYSTATIN100,000 I.UCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAVAGINAL TABLETS 1.0X50.0X14.0 PESSARY STRIP,1.0X14.0 PESSARY STRIP
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NDA/MAL/HDP/4400COSMOS LTDASTRA PHARMA (U) LIMITEDORAL REHYDRATION SALT (DTS)ORAL REHYDRATION SALT N/ACOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0X20.6 G SACHET,1.0X100.0X10.3 G SACHET
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NDA/MAL/HDP/4974COSMOS LTDASTRA PHARMA (U) LIMITEDFRUSEMIDE TABLETS BP 40MGFUROSEMIDE40MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5042COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM DS TABLETSCO-TRIMOXAZOLE960MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
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NDA/MAL/HDP/8297COSMOS LTDASTRA PHARMA (U) LIMITEDISONIAZIDE TABLETSISONIAZID100MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1000.0 TABLET CONTAINER
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NDA/MAL/HDP/2319COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOLPARACETAMOL120MG/5MLCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/0278COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 100MGCHLORPROMAZINE HYDROCHLORIDE100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/2009COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN200MG/5MLCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE
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NDA/MAL/HDP/2046COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINALORATADINE10MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/3178COSMOS LTDASTRA PHARMA (U) LIMITEDBENDURIC TABLETSBENDROFLUMETHIAZIDE5MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3374COSMOS LIMITEDASTRA PHARMA (U) LIMITEDZITHROX 250MGAZITHROMYCIN 250MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3610COSMOS LTDASTRA PHARMA (U) LIMITEDPROMETHAZINE TABLETS BP 25MGPROMETHAZINE HYDROCHLORIDE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
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NDA/MAL/HDP/5164COSMOS LTDASTRA PHARMA (U) LIMITEDBROMSAL EXPECTORANTSALBUTAMOL SULPHATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL1MG+2MG+50MG+0.5MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5259COSMOS LTDASTRA PHARMA (U) LIMITEDCARDINOL TABLETATENOLOL100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X14.0 TABLET STRIP
NDA/MAL/HDP/5334COSMOS LTDASTRA PHARMA (U) LIMITEDETHAM-400ETHAMBUTOL400MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6728COSMOS LTDASTRA PHARMA (U) LIMITEDCIPROCOS-500 TABLETSCIPROFLOXACIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6729COSMOS LTDASTRA PHARMA (U) LIMITEDCOSCOF 'C' LINCTUSMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
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NDA/MAL/HDP/6762COSMOS LTDASTRA PHARMA (U) LIMITEDFLUCOLD CAPSULESMULTIINGREDIENTNACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8009COSMOS LTD.ASTRA PHARMA (U) LIMITEDGRISO-500GRISEOFULVIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/1746MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)PRAZIQUANTELPRAZIQUANTEL USP600MGCSPC OUYI PHARMACEUTICAL CO.LTD. LIMITED-NO. 276, WEST ZHONGSTAN ROAD, SHIJIAZHUANG, CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
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NDA/MAL/HDP/3328GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN1 MUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 MU VIAL,1.0X10.0X1.0 MU VIAL
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NDA/MAL/HDP/2806RENE INDUSTRIES LIMITEDRENE PHARMACY LTDPHENOBARBITONE TABLETSPHENOBARBITONE 30MGCYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8124RENE PHARMACY(R) LTD..RENE PHARMACY LTDCODEINE PHOSPHATE CODEINE PHOSPHATE30 MGCYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE
NDA/MAL/HDP/1055DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDROZITTA 40ROSUVASTATIN CALCIUM40MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/1466DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDMATADORLEVOFLOXACIN500MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/2295DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDROZITTA 10ROSUVASTATIN CALCIUM10MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/2299DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDROZITTA 20ROSUVASTATIN CALCIUM20MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/2437DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDRISDONERISPERIDONE1MG/MLDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3139DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDOMEDAROMEPRAZOLE20MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/3500DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDGIZLAN 300IRBESARTAN300MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4078DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDEPIGABPREGABALIN75MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY CAPSULES 1.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/4945DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDFORMITMETFORMIN850MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5046DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDGIZLAN PLUS 150/12.5IRBESARTAN+HYDROCHLOROTHIAZIDE150MG+12.5MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/5049DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDGIZLAN PLUS 300/12.5IRBESARTAN/HYDROCHLOROTHIAZIDE300MG/12.5MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/5093DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDLIPODAR 10ATORVASTATIN10MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5350DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCEPHADAR FORTECEPHALEXIN250MG/5MLDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5351DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCEPHADAR CEPHALEXIN MONOHYDRATE125MG/5MLDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6188DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDGIZLAN 150IRBESARTAN150MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8125DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDKIMSY MEDS LTDMATADORLEVOFLOXACIN500MGDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD, -NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/4657DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDVOLAR 300MGGABAPENTIN300MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4660DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDRISDONE 2MG RISPERIDONE2MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4663DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDLORATANLORATIDINE5MG/5MLDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4669DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDDICLOGESIC 100MG SUPPOSITORIESDICLOFENAC SODIUM. 100MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANTOPICAL EXTERNAL ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/4675DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDDICLOGESIC RETARD 100DICLOFENAC SODIUM100MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY CAPSULES 1.0X2.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/4704DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDDICLOGESIC 12.5DICLOFENAC SODIUM12.5MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANRECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/4705DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDDICLOGESIC-50DICLOFENAC 50MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANRECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/4759DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCIPRODARCIPROFLOXACIN500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4795DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDDAROXIMECEFUROXIME500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BOTTLE
NDA/MAL/HDP/4895DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCLOMIFERTCLOMIPHENE50MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4948DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDFORMIT 1000METFORMIN HYDROCHLORIDE1000MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4950DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDFORMIT 500METFORMIN500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1618DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDAMOXYDARAMOXYCILLIN TRIHYDRATE125MG/5MLDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1792DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDLIPODARATORVASTATIN20MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2129DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCLAVODARAMOXICILLIN/CLAVULANIC ACID500MG/125MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/2686DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDAMOXYDAR FORTEAMOXICILLIN TRIHYDRATE250MG/5MLDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2734DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDAMLODAR-10AMLODIPINE BESILATE10MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/2960DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCLAVODARAMOXICILLIN/CLAVULANIC ACID400MG/57MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY GRANULES 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/3125DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDAMLODAR 5AMLODIPINE BESILATE5MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/3724DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDEPIGABPREGABALIN150MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY CAPSULES 1.0X4.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/3897DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCLAVODARAMOXICILLIN/CLAVULANIC ACID875MG/125MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/4666DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDANTIPLEX CLOPIDOGREL BISULFATE30MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4804DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCLAVODARAMOXICILLIN + CLAVULANIC200MG + 28MG /5MLDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/5321DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDIBUGESIC COLD & SINUSIBUPROFEN/PSEUDOEPHEDRINE200MG/30MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY GELATIN-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0692DAWA LIMITED SUPER MEDIC LTDDAWACLOX -250 CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/1105DAWA LIMITED SUPER MEDIC LTDDERMAZINE PLUS SILVER SULPHADIAZINE AND CHLORHEXIDINE GLUCONATE1%W/W / 10.0%W/WDAWA LIMITED -BABA DOGO RWARAKAKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/2297DAWA LIMITEDSUPER MEDIC LTDSABULIN SYRUPSALBUTAMOL SULPHATE2MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2387DAWA LIMITEDSUPER MEDIC LTDVERMOUTMEBENDAZOLE100MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0125DAWA LIMITED SUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE
NDA/MAL/HDP/0126DAWA LIMITED SUPER MEDIC LTDWHITFIELD'SBENZOIC ACID + SALICYLIC ACID6.0%W/W +3.0%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE
NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULIN SALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/W DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 50.0X2.0 TABLET STRIP
NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1015DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN250MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1186DAWA LIMITEDSUPER MEDIC LTDDACOF EXPECTORANT DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL14.0MG + 135.0MG + 57.0MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3466DAWA LIMITEDSUPER MEDIC LTDDAWASEC SECNIDAZOLE1GDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/3657DAWA LIMITEDSUPER MEDIC LTDDAWASTINNYSTATIN100000IU/MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/3687DAWA LIMITEDSUPER MEDIC LTDDAWA-PROMPROMETHAZINE HCL5MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3966DAWA LIMITEDSUPER MEDIC LTDASCORBIC ACID TABLETSASCORBIC ACID100 MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4800DAWA LIMITEDSUPER MEDIC LTDDAWAVITE SYRUPMULTI-INGREDIENTMULTI-INGREDIENTDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4872DAWA LIMITEDSUPER MEDIC LTDMICLOCIN CREAMMICONAZOLE NITRATE + CLOBETASOL PROPRIONATE + GENTAMICN2%W/W+0.5%W/W+0.1W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/6686DAWA LIMITEDSUPER MEDIC LTDDAWASOLONEPREDNISOLONE5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6761ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDDAWANOL TABLETSPARACETAMOL+ACETYLSALICYLIC ACID+CAFFEINE200MG+300MG+30MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CARTON
NDA/MAL/HDP/7329DAWA LIMITEDSUPER MEDIC LTDACEPAR- MR PARACETAMOL +ACECLOFENAC+CHLORZOXAZONE 500 MG+100 MG +375 MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0542DAWA LIMITED SUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1084DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE4MGDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPAR ACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3101DAWA LIMITEDSUPER MEDIC LTDDACOLD SYRUPPARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE120MG/5ML+10MG/5ML+2MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4104DAWA LIMITEDSUPER MEDIC LTDDAWA-PROMPROMETHAZINE HCL25MGDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4335DAWA LIMITEDSUPER MEDIC LTDCURAMOL SUSPENSIONPARACETAMOL120MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4629DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN MONOHYDRATE125MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8235DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + SERRATIOPEPTIDASE + PARACETAMOL100MG + 15MG + 500MGDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8434DAWA LIMITEDSUPER MEDIC LTDDACINAZOLEMICONAZOLE NITRATE2%W/WDAWA LTD-BABA DOGO ROAD RUARAKA KENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/0139ANGLIAN NUTRITION PRODUCTS COMPANYSUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
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NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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NDA/MAL/HDP/1111DAWA LIMITEDSUPER MEDIC LTDFAST-ACT GEL DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS1.16%W/W + 10%W/W + 3%W/W + 5%W/WDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
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NDA/MAL/HDP/2905EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDBRONCHOPHANE SYRUPGUAIPHENESIN+EPHEDRINE HYDROCHLORIDE+DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN50MG+7.5MG+5MG+4.58MGEGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. EIPICO-10TH STREET RAMADAN CITY, FIST INDUSTRIES AREEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X1.0X125.0 ML BOTTLE
NDA/MAL/HDP/5019EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDCOLOSPASMIN FORTEMEBEVERINE135MGEGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)-EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)EGYPTORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER
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NDA/MAL/HDP/6476EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIZOLONE-DEPOTMETHYLPREDNISOLONE80MG/2MLEGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY ? INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPTEGYPTPARENTERAL RETARD VIALS 1.0X1.0X2.0 ML VIAL
NDA/MAL/HDP/7136EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAMIKACIN 100 MG / 2MLAMIKACIN SULPHATE100MG/2MLEGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY ? INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPTEGYPTPARENTERAL ORDINARY VIALS 1.0X1.0X2.0 ML VIAL
NDA/MAL/HDP/6342EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIFENAC EYE DROPSDICLOFENAC SODIUM SALT1MG/MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT EGYPTOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE
NDA/MAL/HDP/7104EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPISOPT DOROZOLAMIDE + TIMOLOL 20MG/1ML + 5MG/1ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT EGYPTOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/7286EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTOBRIN OPHTHALMIC OINTMENTTOBRAMYCIN3MG/GEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT EGYPTOPHTHALMIC OINTMENTS 1.0X5.0 G TUBE
NDA/MAL/HDP/8224EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIGENTGENTAMICIN SULFATE0.3%W/WEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT EGYPTOPHTHALMIC OINTMENTS 1.0X5.0 G TUBE
NDA/MAL/HDP/6448EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIZOLONE-DEPOT 40 MG/ 1 ML VIALMETHYLPREDNISOLONE ACETATE 40 MG/ MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPTEGYPTPARENTERAL ORDINARY VIALS 1.0X1.0X1.0 ML VIAL
NDA/MAL/HDP/7287EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPISTIGMIN 0.05% NEOSTIGMINE METHYLSULPHATE0.05%W/VEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPTEGYPTPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/8949EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDCETAL SUPOSITORIESPARACETAMOL120MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPTEGYPTRECTAL SYSTEMIC SUPPOSITORIES 1.0X1.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/1030LABORATORIOS SALVAT SALABOREX UGANDA LIMITEDMALACURDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG+320MGELDER PHARMACEUTICALS LTD -PLOT NO. C-11/1, INDUSTRIAL AREA, SELAQUI, DEHRADUN-248197, UTTRAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X12.0 TABLET BLISTER
NDA/MAL/HDP/2036ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN REGULARHUMAN INSULIN100IUELI LILLY & COMPANY-LILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221,LILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/4821EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDMETPURE-XL 50METOPROLOL50MGEMCURE PHARMACEUTICALS LIMITED -LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4911EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDMOFILET-500MYCOPHENOLATE MOFETIL500MGEMCURE PHARMACEUTICALS LIMITED -LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5486EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDFOSEAL 400SEVELAMER HCL400MGEMCURE PHARMACEUTICALS LTD .-C-10(12) MIDC BHOSAN PUNEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0681GENNOVA BIOPHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI
NDA/MAL/HDP/1761EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDATAZOR-RATAZANAVIR + RITONAVIR300 MG + 100 MGEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/0969EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-2.5AMLODIPINE BESILATE2.5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2053EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-5AMLODIPINE BESILATE5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3965EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDOROFER SYRUPIRON(II) HYDROXIDE POLYMALTOSE COMPLEX50MG/5MLEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/0386EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-80ENOXAPARIN SODIUM80MG/ 0.8MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5070EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-60ENOXAPARIN SODIUM60MG/0.6MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5071EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-40ENOXAPARIN SODIUM40MG/0.4MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5249EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDENCIFERIRON SUCROSE100MG/5MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY INFUSION AMPOULES 1.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/0376EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-DAMLODIPINE + HYDROCHLOROTHIAZIDE2.5 MG + 12.5 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0397EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-LTAMLODIPINE + LOSARTAN POTASSIUM2.5 MG + 50 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1551EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCALOSHELL-500CALCIUM CARBONATE + VITAMIN D31250MG + 250IUEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1553EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDVIFEXSALBUTAMOL + BROMHEXINE + GUAIFENESIN1MG/5ML+2MG/5ML+50MG/5MLEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2160EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDACEM-500CLARITHROMYCIN500MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2326EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDSYLATE-500ETAMSYLATE50MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X6.0 TABLET STRIP
NDA/MAL/HDP/4946ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICAL COMPANY LTDMOVATECLOBETASOL0.05%W/WESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY ITALYTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/5106ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICAL COMPANY LTDLEMONVATE CREAMCLOBETASOL PROPIONATE0.05%W/WESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY ITALYTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/6619ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICAL COMPANY LTDORANVATECLOBETASOL PROPIONATE0.05G/100GESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY ITALYTOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/5445ESKAYEF BANGLADESH LTDMEDVIN PHARMA LIMITEDAZITHRAX 500AZITHROMYCIN DIHYDRATE500 MGESKAYEF BANGLADESH LTD--400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X6.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/7130LIFEPHARM FZEAIVEEN (U) LTD - WILSON ROADHEMOVIT CAPSULESDRIED FERROUS SULPHATE + FOLIC ACID150MG +500MCGESKAYEF BANGLADESH LTD--400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH BANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3563EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDLEVOLIFELEVOFLOXACIN500MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4814EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDMETLIFEMETRONIDAZOLE500MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4878EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDFLUCOLIFEFLUCONAZOLE200MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5062EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDMANNILIFEMANNITOL20MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5097EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDGLUCOLIFEGLUCOSE5%W/VEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5237EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDEUROCIPCIPROFLOXACIN200MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0986EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0990EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDFUSIDERM CREAMFUSIDIC ACID2%W/WEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/0997EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDGENUPHILGLUCOSAMINE SULPHATE SODIUM CHLORIDE+METHYLSULPHONYLMETHANE+CHONDROITIN SULPHATE375MG+375MG+300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0999EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID600MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1001EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOTACID ACIDTHIOTIC ACID300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1003EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDZEFICAMLORNOXICAM8MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1022EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1031EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOXIFLOXMOXIFLOXACIN400MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY TABLETS 1.0X1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/1032EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDARTHFREE 20LEFLUNOMIDE20MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1063EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDVIRECTA SILDENAFIL CITRATE100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X3.0 TABLET BLISTER
NDA/MAL/HDP/1106EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1767EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDPROSTEROLALFUZOSIN HYDROCHLORIDE10MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6073EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMILGABENFOTIAMINE + PYRIDOXINE + CYANOCOBALAMIN40MG + 60MG + 20MCGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6449 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESGAMA PHARMACEUTICALS (U) LIMITEDDESLORAT SYRUPDESLORATIDINE0.5MG/MLEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7246 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESGAMA PHARMACEUTICALS (U) LIMITEDDESLORATDESLORATIDINE5MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X10.0 TABLET STRIP
NDA/MAL/HDP/7248 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESGAMA PHARMACEUTICALS (U) LIMITEDESOMELODAN 20ESOMEPRAZOLE20MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7249 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESGAMA PHARMACEUTICALS (U) LIMITEDESOMELODAN 40ESOMEPRAZOLE MAGNESIUM40MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6068EXIR PHARMACEUTICAL COMPANYUNEED GLOBAL GROUP LIMITEDZIMEXIR 250AZITHROMYCIN DIHYDRATE250MGEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANIRANORAL SOLID ORDINARY CAPSULES 1.0X5.0 CAPSULE BLISTER
NDA/MAL/HDP/6069EXIR PHARMACEUTICAL COMPANYUNEED GLOBAL GROUP LIMITEDZIMEXIR 200MGAZITHROMYCIN DIHYDRATE200MG/5MLEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANIRANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/7153EXIR PHARMACEUTICAL COMPANY.UNEED GLOBAL GROUP LIMITEDTYLOPHEN? ACETAMINOPHEN 120MG/5MLEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANIRANORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/8223IRAN MEDICAL GROUP COMPANY UNEED GLOBAL GROUP LIMITEDLORAXIMECEFOTAXIME1000MG/MLEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANIRANPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL
NDA/MAL/HDP/1620IRAN MEDICAL GROUP COMPANY UNEED GLOBAL GROUP LIMITEDLORAXONECEFTRIAXONE1000MGEXIR PHARMACEUTICAL FACTORY-2ND KM, BORUJERD, RUIRANPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL
NDA/MAL/HDP/5276F.HOFFMANN-LA ROCHE LTD LABOREX UGANDA LIMITEDDORMICUM INJECTIONMIDAZOLAM5MG/5MLF. HOFFMAN LA ROCHE LTD-CH-4070 BASEL GRENZACHERSTRASSE 124, 4058 BASELSWITZERLANDPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE
NDA/MAL/HDP/5278ROCHELABOREX UGANDA LIMITEDDORMICUMMIDAZOLAM7.5MGF. HOFFMAN LA ROCHE LTD-CH-4070 BASEL GRENZACHERSTRASSE 124, 4058 BASELSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4275F. HOFFMANN LA-ROCHELABOREX UGANDA LIMITEDAVASTIN 100MG/4MLBEVACIZUMAB100 MG/ 4MLF. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGST,F.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL,ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANYSWITZERLANDPARENTERAL ORDINARY VIALS 1.0X4.0 ML VIAL
NDA/MAL/HDP/4284F. HOFFMANN LA-ROCHELABOREX UGANDA LIMITEDAVASTIN 400MG/4MLBEVACIZUMAB400MG/4MLF. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGST,F.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL,ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANYSWITZERLANDPARENTERAL ORDINARY VIALS 1.0X16.0 ML VIAL
NDA/MAL/HDP/5101F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDLEXOTANILBROMAZEPAM1.5MGF. HOFFMANNLA ROCHE LTD BASEL, SWITZERLAND-GRENZACHERSTRASSE 124 4070, BASELSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4562F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDPEGASYSPEGINTERFERON ALPHA 2A180MCG/2MLF.HOFFMANN- LA ROCHE LTD-CH-4070 BASEL SWITZERLANDSWITZERLANDPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X2.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/1033FAES FARMA S.ALABOREX UGANDA LIMITEDDYNAMOGENGLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE3MG +1GFAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYASPAINORAL LIQUID ORDINARY LIQUIDS 1.0X20.0X10.0 ML SACHET
NDA/MAL/HDP/3771FAES FARMA S.ALABOREX UGANDA LIMITEDBRONQUIDIAZINA C.RTRIMETHOPRIM/SULFAMETHOXAZOLE/BROMHEXINE/SODIUM BENZOATE/TOLU BALSAM80MG/400MG/4MG/250MG/325MGFAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYASPAINORAL LIQUID ORDINARY LIQUIDS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/2652AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDFLAGENTYL TABLETSSECNIDAZOLE500MGFAMAR LYON-29 AVENUE CHARLES DE GAULLE SAINTFRANCEORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4789PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN HYDROCHLORIDE300MGFAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CARTON,1.0X2.0X8.0 CAPSULE STRIP
NDA/MAL/HDP/4790PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN HYDROCHLORIDE150MGFAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCEBELGIUMORAL SOLID ORDINARY CAPSULES 1.0X2.0X8.0 CAPSULE STRIP,1.0X100.0 CAPSULE CARTON
NDA/MAL/HDP/5140PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDDIFLUCANFLUCONAZOLE200MGFAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 1.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDZENTELALBENDAZOLE100MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS 1.0X20.0 ML BOTTLE
NDA/MAL/HDP/3405GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL BABY AND INFANT 120MG/5MLPARACETAMOL 120MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0722FDC LTDAIVEEN (U) LIMITEDIOTIM 0.5%TIMOLOL MALEATE0.5% W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/0768FDC LTDAIVEEN (U) LIMITEDPYRIMON EYE DROPDEXAMETHASONE/CHLORAMPHENICOL1%W/V + 0.1%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/1865FDC LTDAIVEEN (U) LIMITEDMYCODERM-C POWDERCLOTRIMAZOLE1%W/WFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIATOPICAL EXTERNAL POWDERS 1.0X75.0 G CONTAINER
NDA/MAL/HDP/2912FDC LTDAIVEEN (U) LIMITEDMYCODERMSALICYLIC ACID + BENZOIC ACID3%W/W + 6%W/WFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIATOPICAL EXTERNAL POWDERS 1.0X100.0 G CONTAINER
NDA/MAL/HDP/4575FDC LTDAIVEEN (U) LIMITEDPYRICORT EYE/EAR DROPSDEXAMETHASONE+GENTAMICIN 0.1%+0.3%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4819FDC LTDAIVEEN (U) LIMITEDORAL REHYDRATION SALTORAL REHYDRATION SALT27.9GMFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X27.9 G SACHET
NDA/MAL/HDP/6114FDC LTDAIVEEN (U) LIMITEDZOXANCIPROFLOXACIN0.3% W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE
NDA/MAL/HDP/8212FDC LTDAIVEEN (U) LIMITEDBACTIGEN EYE/EAR DROPSGENTAMICIN0.3%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC VIALS 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL
NDA/MAL/HDP/8213FDC LTDAIVEEN (U) LIMITEDZOCON 200FLUCONAZOLE200MGFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X2.0 TABLET BLISTER
NDA/MAL/HDP/2754FDC LTDAIVEEN (U) LIMITEDZATHRIN 500AZITHROMYCIN DIHYDRATE500MGFDC LIMITED -PLOT NO. L121 B VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0X3.0 TABLET BLISTER,1.0X50.0X1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/0938FEROZSONS LABORATORIES LTDTOP UNIVERSAL MEDICARE LIMITEDESOMEGA 20MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS20MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/0940FEROZSONS LABORATORIES LTDTOP UNIVERSAL MEDICARE LIMITEDESOMEGA 40MG ESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS40MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/1127FEROZSONS LABORATORIES LTDTOP UNIVERSAL MEDICARE LIMITEDCLARION TABLETS 500MGCLARITHROMYCIN500MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4589FEROZSONS LABORATORIES LTDTOP UNIVERSAL MEDICARE LIMITEDLEFOXCIN-500LEVOFLOXACIN HEMIHYDRATE500MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1526FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B675MG + 75MG + 37MG + 37MGFERRER INTERNACIONAL S.A --FOR LABORATORIOS NOVAG S.A GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3494LABORATORIOS NOVAG SALABOREX UGANDA LIMITEDGAMALATE B6 SOLUTIONMAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B62G + 2G + 1G +1GFERRER INTERNACIONAL S.A --FOR LABORATORIOS NOVAG S.A GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL LIQUID ORDINARY LIQUIDS 1.0X80.0 ML BOTTLE
NDA/MAL/HDP/0685FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONASPAINPARENTERAL RETARD I M AMPOULES 1.0X5.0X4.0 ML AMPOULE
NDA/MAL/HDP/0687FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONASPAINORAL LIQUID ORDINARY LIQUIDS 1.0X6.0X10.0 ML SACHET
NDA/MAL/HDP/0752FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDNUCLEO C.M.P FORTECYTIDINE + URIDINE10MG + 6MGFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONASPAINPARENTERAL ORDINARY DRY PRE-FILLED PENS 1.0X3.0 ML AMPOULE + 1 *2ML CLEAR GLASS AMPOULES FOR SOLVENT
NDA/MAL/HDP/1214FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDNUCLEO C.M.P FORTECYTIDINE+URIDINE5MG+3MGFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAINSPAINORAL SOLID ORDINARY CAPSULES 1.0X2.0X15.0 CAPSULE BLISTER
NDA/MAL/HDP/1494FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDPEITEL 0.25%PREDNICARBATE0.25%W/WFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAINSPAINTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/1989FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDDERMOFIXSERTACONAZOLE NITRATE2%W/WFERRER INTERNACIONAL,S.A.-GRAN VIA CARLOS III 94 BARCELONA (ESPANA /SPAIN)SPAINTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/7724FERRING GMBHMACNAUGHTON LIMITEDMENOPURHIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU]75 IU + 75 IU/ 4ML VIALFERRING (PTY) LTD-WITTLAND II 24146 KIELGERMANYPARENTERAL ORDINARY DRY VIALS 10.0X4.0 ML VIAL 10*1ML CLEAR COLOURLESS GLASS AMPOULES CONTAINING 9.0MG/ML OF NACL
NDA/MAL/HDP/7611FERRING GMBHMACNAUGHTON LIMITEDPABALCARBETOCIN100MCG/MLFERRING GMBH.-11, WITTLANDGERMANYPARENTERAL ORDINARY VIALS 1.0X5.0X1.0 ML VIAL
NDA/MAL/HDP/0401FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDL MONTUSLEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGFOURRTS (INDIA) LABORATORIES (PVT) LTD-FOURRTS AVENUE, VANDALUR ROADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP
NDA/MAL/HDP/3678FOURRTS LABORATORIES LTDDELMAW ENTERPRISES LIMITEDREDINPLUSIRON PENTACARBONYL + ZINC SULPHATE MONOHYDRATE + FOLIC ACID + SODIUM SELENITE + LYSINE HYDROCHLORIDE + HISTIDINE HYDROCHLORIDE + CHOLINE BITARTRATE100MG + 30MG + 7.5MG + 0.11MG + 26MG + 4.4MG + 52MGFOURRTS (INDIA) LABS PVT LTD .-VANDALUR ROAD. KELAMBAKK AM-603103 TAMIL, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X30.0 CAPSULE BLISTER
NDA/MAL/HDP/0432FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDK MAC ORAL SOLUTIONPOTASSIUM CITRATE + MAGNESIUM CITRATE22MG + 7.5MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/1337FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFOURTS BTHIAMINE +RIBOFLAVIN + PYRIDOXINE + NICOTINAMIDE + FOLIC ACID + ASCORBIC ACID + COLECALCIFEROL + ACETYL CYSTEINE + GLYCINE + GLUTAMIC ACID + CHROMIUM + VANADIUM + ZINC + SELENIUM10MG + 10MG + 3MG + 50MG + 1MG + 75MG + 400IU + 25MG +25MG +MG +200MCG + 100MCG + 55MG +100MCGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1456FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDSUCRAFIL O GELSUCRALFATE + OXETACAINE10MG + 0.2MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/2143FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDGRISEOFILGRISEOFULVIN 500MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2145FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDMETFIL 500METFORMIN500MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/2147FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDDICLOFEN -50DICLOFENAC50MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5119FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDKONTRAC 200MISOPROSTOL200MCGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X2.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0507FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDFILDILOL 12.5CARVEDILOL12.5 MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0509FOURRTS (INDIA) LABORATORIES (PVT) LTDDELMAW ENTERPRISES LIMITEDFILDILOL 25CARVEDILOL25MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0512FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 10ATORVASTATIN CALCIUM10MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0515FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 20ATORVASTATIN20MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0520FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 40ATORVASTATIN CALCIUM40MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1987FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFOMYCETINCHLORAMPHENICOL250MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3476FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDPARAFILPARACETAMOL500MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER, 1.0X1000.0 TABLET CONTAINER, 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3592FOURRTS (INDIA) LABORATORIES PUT LTDDELMAW ENTERPRISES LIMITEDMEGATRIM DSCO-TRIMOXAZOLE BP960MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3655FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDQUADRAJEL GELCHLORHEXIDINE+METRONIDAZOLE+LIDOCAINE5%W/W+1.61%W/W+2.13%W/WFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL TOPICAL GELS AND SOLS 1.0X15.0 G TUBE
NDA/MAL/HDP/5033FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDMEBFIL TABLETSMEBENDAZOLE100MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5086FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDGLIFIL M FORTGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG+500MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5324FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDIBUFIL 400IBUPROFEN400MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5327FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDIBUFIL 200IBUPROFEN200MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2492FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDPROFIL 25PROMETHAZINE HYDROCHLORIDE25MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2695FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDIDUMSTRAPARACETAMOL + IBUPROFEN + CAFFEINE325MG + 200MG + 40MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY CAPSULES 1.0X20.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2837FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDGRAMOFIL TABLETSNALIDIXIC ACID500MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3683FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDCOLD TABS FORTINSAPARACETAMOL + PHENYLEPHRINE +CHLORPHENIRAMINE + CAFFEINE500MG + 5MG + 2MG + 30MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X25.0 TABLET BLISTER
NDA/MAL/HDP/2151USV LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 850METFORMIN850MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2154ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYNASEGLIPIZIDE5MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2970ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 500METFORMIN500MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5307ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDDUOTROLGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG + 500MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8925ZIFAM PINNACLE PTY. LTD. BOOTS PHARMACEUTICALS LIMITEDZIFAMET 250METRONIDAZOLE250 MGFREDUN PHARMACEUTICALS LTD --14, 15, 16, ZORABIAN INDUSTRIAL COMPLEX, VILLAGE, VEOOR, PALGHAR (EAST) DIST: THANE ? 401 404 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8939FREDUN PHARMACEUTICALS LTDMEDICIVE PHARMACEUTICALS LTDFREMOL PLUSPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE + CAFFEINE (ANHYDROUS)500MG + 10MG + 2MG + 30MMGFREDUN PHARMACEUTICALS LTD --14, 15, 16, ZORABIAN INDUSTRIAL COMPLEX, VILLAGE, VEOOR, PALGHAR (EAST) DIST: THANE ? 401 404 - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X50.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0776FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL TABLETSPARACETAMOL TABLETS500MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2643FREDUN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDNEOPHIL -100 TABLETSAMINOPHYLLINE 100MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4975FREDUN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFRUSINA TABLETSFUROSEMIDE40MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8357FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDFRESENIUS PROPOVEN 1%PROPOFOL1% W/VFRESENIUS KABI AUSTRIA GMBH PLANT GRAZ-HAFNERSTRASSE 36 A-8055 GRAZ AUSTRIA,FRESENIUS KABI AB PLANT UPPSALA-RAPSGATAN 7S-75174 UPPSALA SWEDENAUSTRIAPARENTERAL ORDINARY OTHER INFUSIONS 1.0X10.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL,1.0X10.0X100.0 ML VIAL
NDA/MAL/HDP/8252FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDPARACETAMOL FRESENIUSPARACETAMOL10MG/MLFRESENIUS KABI AUSTRIA GMBH-AUSTRIA GMBH HAFNERSTRASSEM 36 8055 GRAZAUSTRIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X10.0X50.0 ML VIAL
NDA/MAL/HDP/0382FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDKETAMINE FRESENIUSKETAMINE HYDROCHLORIDE50MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY VIALS 1.0X10.0X10.0 ML VIAL
NDA/MAL/HDP/0383FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMANNITOL FRESENIUSMANNITOL20%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY INFUSION BAGS 1.0X500.0 ML BAG
NDA/MAL/HDP/0384FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDPANCURONIUM BROMIDE FRESENIUSPANCURONIUM BROMIDE4MG/2MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/0435FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDLIGNOCAINE HCL FRESENIUSLIGNOCAINE HYDROCHLORIDE2%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY VIALS 1.0X10.0X20.0 ML VIAL
NDA/MAL/HDP/0437FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDNALOXONE HCL NEONATAL FRESENIUSNALOXONE HYDROCHLORIDE0.02MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/0439FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDNALOXONE HCL FRESENIUS 0.4MG/1MLNALOXONE HYDROCHLORIDE0.4MG/1MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/0444FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDNEOSTIGMINE METHYLSUIPHATE FRESENIUSNEOSTIGMINE METHYLSULPHATE2.5MG\MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/6058FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDFENTANYL FRESENIUSFENTANYL100MCG/2MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/6194FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDFENTANYL FRESENIUSFENTANYL CITRATE500MCG/10MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X5.0X10.0 ML AMPOULE
NDA/MAL/HDP/6195FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMORPHINE SULPHATE FRESENIUSMORPHINE SULPHATE10MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/6196FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMORPHINE SULPHATE FRESENIUSMORPHINE SULPHATE15MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/8204FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDDOPAMINE HCL FRESENIUSDOPAMINE HYDROCHLORIDE200MG/5MLFRESNIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD KORSTEN PORT ELIZABETH 6020SOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0 ML AMPOULE
NDA/MAL/HDP/4706WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL GELDICLOFENAC DIETHYLAMINE1.16%W/WG,S PHARMBUTOR PVT LTD -B-172 INDUSTRIAL AREA BEHROR 301701 RAJASTHANINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G CONTAINER
NDA/MAL/HDP/7312MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDBETADINE OINTMENT 5%W/WPOVIDONE IODINE5%W/WG.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X125.0 G TUBE,1.0X250.0 G JAR
NDA/MAL/HDP/7335MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDBETADINE 5%POVIDONE IODINE5%W/VG.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIATOPICAL EXTERNAL LIQUIDS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/HDP/7381MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDBETADINE ANTISEPTIC CREAM 5%POVIDONE-IODINE5%W/WG.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/4180WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDOSMOWINLACTULOSE10G/15MLG.S PHAMBUTOR PVT LTD-G.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/7336MODI NUNDIPHARMA PVT LTDSURGIPHARM (U) LIMITEDBETADINE GERMICIDE GARGLE 2% MINTPOVIDONE IODINE2%W/VG.S PHAMBUTOR PVT LTD-G.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIAORAL TOPICAL LIQUIDS 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2481GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDNETRACORTHYDROCORTISONE1%W/WGALENTIC PHARMA PVT LIMITED-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X20.0 G TUBE
NDA/MAL/HDP/1550GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDRUBIGELMULTI-INGREDIENTMULTI-INGREDIENTGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIA INDIAORAL TOPICAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/1555GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIA INDIATOPICAL EXTERNAL LIQUIDS 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/2250GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCANDIGENCLOTRIMAZOLE1%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIA INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/2362GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDCANDISTATIN OINTMENTNYSTATIN100,000I.UGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701 INDIA INDIATOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HDP/2080GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDBETAMETHASONE VALERATEBETAMETHASONE VALERATE0.1%W/VGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701 INDIA INDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/2206GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDNETRA CORT HYDROCORTISONE ACETATE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701 INDIA INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/2211GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBENZYL BENZOATEBENZYL BENZOATE 25%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701 INDIA INDIATOPICAL EXTERNAL EMULSIONS 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/HDP/2079GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDNETRAVIRACICLOVIR5%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE
NDA/MAL/HDP/2248GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDTETRACYCLINE OPHTHALMICTETRACYCLINE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIAINDIAOPHTHALMIC OINTMENTS 1.0X3.5 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/1923GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBETAMETHASONEBETAMETHASONE0.1%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/3252GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDPYLOOCAINBETAMETHASONE + PHENYLEPHRINE + LIDOCAINEO.5 MG/G + 1 MG/G + 25 MG/GGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL OINTMENTS 1.0X1.0X30.0 G TUBE
NDA/MAL/HDP/3810GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDTRIOSPORINE OINTMENTNEOMYCIN+ POLYMYXIN B +BACITRACIN3.4%W/W + 5%W/W + 0.4%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIAOPHTHALMIC OINTMENTS 1.0X5.0 G TUBE
NDA/MAL/HDP/4614GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCOMPOUND BENZOIC ACID OINTMENTBENZOIC ACID + SALICYLIC ACID6 %W/W + 3 %W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE,1.0X500.0 G TUBE
NDA/MAL/HDP/5507GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCALADIN LOTIONCALAMINE15 %W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL LOTIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/6844IDA FOUNDATIONJOINT MEDICAL STORE (UPMB - UCMB)BENZOIC ACID + SALICYLIC ACIDBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL OINTMENTS 1.0X40.0 G TUBE,1.0X800.0 G CONTAINER
NDA/MAL/HDP/0611GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDGALCIPRO 500CIPROFLOXACIN HYDROCHLORIDE500MGGALPHA LABORATORIES LIMITED-VILLAGE ? THANA BADDI, TEHSIL BADDI SOLAN HIMACHAL PRADESH-173 205 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1083GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCHOCOFER SYRUPIRON + FOLIC ACID50MG + 0.5MG /5MLGALPHA LABORATORIES LIMITED-VILLAGE ? THANA BADDI, TEHSIL BADDI SOLAN HIMACHAL PRADESH-173 205 INDIA INDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/0827GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCLANOXY 1.2 AMOXICILLIN + CLAVULANATE1000 MG + 200 MGGALPHA LABORATORIES LTD-AT: ALKEM LABORATORIES LTD PLOT 167/2 MAHATMA UDYOG NAGAR AMALIYA DAMAN 396210INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 ML VIAL 1*20ML VIAL OF WFI
NDA/MAL/HDP/3206HEALTHCARE LTD.HEALTHCARE LTD.POSTINOR 2LEVONORGESTREL0.75MGGEDEON RICHTER PLC-1103 BUDAPEST GYOMROI UT 19-21HUNGARYORAL SOLID ORDINARY TABLETS 1.0X1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/4014GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDFUSIGENSODIUM FUSIDATE20MG/GGENO PHARMACEUTICALS LIMITED-KARASWADA,MAPUSAINDIATOPICAL EXTERNAL OINTMENTS 1.0X10.0 G TUBE
NDA/MAL/HDP/4347GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDVERTIGONCINNARIZINE25MGGENO PHARMACEUTICALS LTD. -TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA, GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5080GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDLOBAKDICLOFENAC/PARACETAMOL/CHLORZOXAZONE50MG/325MG/250MGGENO PHARMACEUTICALS LTD--PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5448GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDFLUNER-5FLUNARIZINE5MGGENO PHARMACEUTICALS LTD--PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3235IDA FOUNDATIONKIMSY MEDS LTDCHLORPROMAZINE INJECTIONCHLORPROMAZINE HYDROCHLORIDE25MG/MLGLAND PHARMA LIMITED-D. P PALLY NARSAPUR ROAD, HYDERABAD ? 500 043, INDIA INDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/8137IDA FOUNDATIONKIMSY MEDS LTDDIAZEPAMDIAZEPAM10MGGLAND PHARMA LIMITED-D. P PALLY NARSAPUR ROAD, HYDERABAD ? 500 043, INDIA INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/2041IDA KIMSY MEDS LTDOXYTOCINOXYTOCIN10IUGLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/4003TATA UGANDA LIMITEDTATA UGANDA LIMITEDOXYTOCIN INJOXYTOCIN10IU/MLGLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0 ML AMPOULE
NDA/MAL/HDP/8354MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDZORUXAZOLEDRONIC ACID5MG/100MLGLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5061TATA UGANDA LIMITEDTATA UGANDA LIMITEDMAGNESIUM SULPHATEMAGNESIUM SULPHATE50MG/MLGLAND PHARMA LIMITTED 143-148-SURVEY NOS. 143-148, 150&151, NEAR GANDIMAISAMMA CROSS ROADS. RANGA REDDY DISTRICT HYDERABAD 500043INDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/4563TATA UGANDA LIMITEDTATA UGANDA LIMITEDQUININE DIHYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLGLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/4566TATA UGANDA LIMITEDTATA UGANDA LIMITEDFUROSEMIDE INJECTION BPFUROSEMIDE10MG/MLGLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/5206TATA UGANDA LIMITEDTATA UGANDA LIMITEDDIGOXIN INJECTION BPDIGOXIN0.25MG/MLGLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/2325IDA FOUNDATIONKIMSY MEDS LTDPARAMOMYCINPAROMOMYCIN375MG/MLGLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/2882TATA UGANDA LIMITEDTATA UGANDA LIMITEDHYOSCINE BROMIDEHYOSCINE BROMIDE2OMG/MLGLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/5016IDA FOUNDATIONKIMSY MEDS LTDGENTAMYCIN INJECTIONGENTAMYCIN SULPHATE40MG/MLGLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043INDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/1455IDA KIMSY MEDS LTDLIDOCAINE HCL 5% & DEXTROSE 7.5% INJECTIONLIDOCAINE HCL 5%+DEXTROSE 7.5%50MG +75MG/MLGLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESHINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/2264TATA UGANDA LIMITEDTATA UGANDA LIMITEDARTEMETHER INJECTION ARTEMETHER80MG/MLGLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESHINDIAPARENTERAL ORDINARY I M AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/4773IDA FOUNDATIONKIMSY MEDS LTDMETHYLERGOMETRINEMETHYLERGOMETRINE0.2MG/MLGLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESHINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/4810TATA UGANDA LIMITEDTATA UGANDA LIMITEDMETHYLERGONOVINEMETHYLERGONOVINE MALEATE0.2MG/MLGLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESHINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/3230GLAND PHARMA LIMITEDTATA UGANDA LIMITEDMETOCLOPRAMIDE INJECTIONMETOCLOPRAMIDE HYDROCHLORIDE5MG/MLGLAND PHARMA LTD -DOMMARA POCHAMPALLY SURVEY NO. 5INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/3239GLAND PHARMA LIMITEDTATA UGANDA LIMITEDTRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE50MG/MLGLAND PHARMA LTD -DOMMARA POCHAMPALLY SURVEY NO. 5INDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/2736IDAKIMSY MEDS LTDFUROSEMIDEFUROSEMIDE20MG/2MLGLAND PHARMA LTD -GLAND PHARMA LTD D.P PALLY DUNDIGAL HYDERABADINDIAPARENTERAL ORDINARY AMPOULES 1.0X100.0 AMPOULE CARTON
NDA/MAL/HDP/4153TATA UGANDA LIMITEDTATA UGANDA LIMITEDDIAZEPAM INJECTIONDIAZEPAM5MG/MLGLAND PHARMA LTD.-GLAND PHARMA LTD, D.P. PALLY, SURVEY NO. 143,150 &INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/6129GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDTRIUMEQDOLUTEGRAVIR + ABACAVIR + LAMIVUDINE50MG + 600MG + 300MGGLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)-PRIORY STREET, WARE HERTFORDSHIRE SG12 0DJ, UK UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/4935GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDBACTROBAN OINTMENTMUPIROCIN2%W/WGLAXO OPERATIONS UK LTD -PRIORY STREET, WARE HERTFORDSHIRE SG12 0DJ, UK UNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X3.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/4938GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDBACTROBAN CREAMMUPIROCIN2%W/WGLAXO OPERATIONS UK LTD -PRIORY STREET, WARE HERTFORDSHIRE SG12 0DJ, UK UNITED KINGDOMTOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE
NDA/MAL/HDP/1724GLAXOSMITHKLINE LTDERIS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UKUNITED KINGDOMNASAL TOPICAL SPRAYS WITHOUT GAS 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/6834GLAXO SMITH KLINE LTDERIS LTDRELVAR ELLIPTA 100/25FLUTICASONE FUROATE + VILANTEROL100MCG + 25MCGGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UKUNITED KINGDOMLUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X1.0 CANNISTER CARTON
NDA/MAL/HDP/6836GLAXO SMITH KLINE LTDERIS LTDRELVAR ELLIPTA 200/25FLUTICASONE FUROATE + VILANTEROL200MCG + 25MCGGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UKUNITED KINGDOMLUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X30.0 DOSE CANNISTER
NDA/MAL/HDP/8239GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDUMBIPRO GELCHLORHEXIDINE 4%W/WGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UKUNITED KINGDOMTOPICAL EXTERNAL GELS AND SOLS 1.0X7.0 SACHET CARTON
NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5255GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDENO LEMONFRUIT SALTMULTI-INGREDIENTMULTI-INGREDIENTGLAXO SMITH KLINE LTD-LIKONI RD, INDUSTRIAL AREA,NAIROBI KENYA,GLAXOSMITHLINE-CAPE TOWN, S.ASOUTH AFRICAORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES 1.0X8.0X4.5 G SACHET,1.0X10.0X4.5 G SACHET,1.0X48.0X4.5 G SACHET
NDA/MAL/HDP/2869GLAXO SMITHKLINE LTDERIS LTDPRIORIX VACCINEMEASLES + MUMPS + RUBELLA103.0CCID50 + 103.7CCID50 + 103.0CCID50GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY DRY VIALS 1.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/4103GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPOLIO SABIN - ONE AND THREE [ORAL]LIVE ATTENUATED POLIOMYELITIS VIRUS VACCINE OF THE SABIN STRAINS TYPE 1 +TYPE 210?CCID??+10?.?CCID??GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY I M VIALS 1.0X100.0X2.0 ML VIAL (20 DOSES)
NDA/MAL/HDP/0903GLAXO WELLCOME(KENYA) LTDERIS LTDZANTACRANITIDINE50MG/2MLGLAXO SMITHKLINE MANUFACTURING S.P.A .-STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA)ITALYPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/4149GLAXOSMITH KLINE LTDERIS LTDTRACRIUM INJECTIONATRACURIUM BESYLATE10MG/MLGLAXO SMITHKLINE MANUFACTURING S.P.A .-STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA),GLAXOSMITHKLINE SPA FLEMING -2, 37135 PARMAITALYPARENTERAL ORDINARY AMPOULES 1.0X2.5 ML AMPOULE,1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE
NDA/MAL/HDP/1936GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON EXPECTORANTCHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDEMULTINGREDIENTGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2051GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON TABLETSCHLORPHENIRAMINE MALEATE4MGGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4779GLAXO WELLCOME (KENYA) LTDERIS LTDCUTIVATEFLUTICASONE PROPIONATE 0.05%W/WGLAXO WELLCOME (UK)-UKUNITED KINGDOMTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/4780GLAXO WELLCOME (KENYA) LTDERIS LTDCUTIVATEFLUTICASONE PROPIONATE 0.005%W/WGLAXO WELLCOME (UK)-UKUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HDP/3166PHARMACARE LTDBETA HEALTHCARE UGANDA LIMITEDSEPTRINTRIMETHOPRIM + SULPHAMETHOXAZOLE40MG/5ML + 200MG/5MLGLAXO WELLCOME EGYPT CO. S.A.E-CAIROEGYPTORAL LIQUID ORDINARY SUSPENSIONS 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3434PHARMACARE LIMITEDBETA HEALTHCARE UGANDA LIMITEDSEPTRINCO-TRIMOXAZOLE480MGGLAXO WELLCOME EGYPT CO. S.A.E-CAIROEGYPTORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET CARTON,1.0X50.0 TABLET CARTON
NDA/MAL/HDP/0404GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED WET COUGH & COLDTRIPLORIDINE HCL/PSEUDOEPHEDRINE/GUAIPHENESIN1.25MG/30MG/100MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN
NDA/MAL/HDP/1258GLAXO WELLCOME(KENYA),LTDERIS LTDMYOGLIN CAPSULESCHLORZOXAZONE/PARACETAMOL250MG/300MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROEGYPTORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2986GLAXO WELLCOME(KENYA) LTDERIS LTDOXYBRAL SRVINCAMINE 30MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROEGYPTORAL SOLID RETARD CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4310GLAXOSMITHLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED SYRUPTRIPLORIDINE HCL/PSEUDOEPHEDRINE1.25MG/30MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN
NDA/MAL/HDP/5020GLAXO WELLCOME (KENYA) LTDERIS LTDVENTOLINSALBUTAMOL2MG/MLGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROKENYAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3762GLAXO WELLCOME (KENYA) LTDERIS LTDLAMICTAL 2MGLAMOTRIGINE2MGGLAXO WELLCOME INC-ZI DE LA PEYENNIERE, 53100, MAYENNEUNITED STATESORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/1673GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN250MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4541GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN500MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4722GLAXO SMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED COLD TABLETSTRIPROLIDINE HYDROCHLORIDE+PSEUDOPHEDRINE HYDROCHLORIDE2.5MG+60MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X96.0 TABLET BLISTER,1.0X480.0 TABLET BLISTER
NDA/MAL/HDP/4724GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED DRY COUGH & COLDTRIPROLIDINE HYDROCHLORIDE+PSEUDOEPHEDRINE HYDROCHLORIDE+DEXTROMETHORPHAN1.25MG+30MG+10MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X2.0 L BOTTLE
NDA/MAL/HDP/6807GLAXOSMITHKLINE LTDERIS LTDAUGMENTIN ESAMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE600MG + 42.9MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8474GLAXOSMITH KLINE LTDERIS LTDAUGMENTIN SACHETS 1G/125MGAMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE1000MG + 125MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X12.0 SACHET CARTON
NDA/MAL/HDP/1563GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN125MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCEFRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3285GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN250MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCEFRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5018GLAXO WELLCOME (KENYA) LTDERIS LTDVENTOLINSALBUTAMOL100MCGGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE NO.2 23, RUE LAVOISIER 27000 EVREUX,FRANCE.FRANCERECTAL SYSTEMIC METERED-DOSE PRESSURISED AEROSOLS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/1505GLAXOSMITHKLINEERIS LTDSERETIDE EVOHALERSALMETEROL/ FLUTICASONE PROPIONATE25/50 MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X1.0 CANNISTER CARTON
NDA/MAL/HDP/3530GLAXO SMITH KLINE LTDERIS LTDFLIXOTIDE ACCUHALERFLUTICASONE PROPIONATE100MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCELUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X60.0 ML CANNISTER
NDA/MAL/HDP/4294GLAXO SMITHLINE LIMITEDERIS LTDFLIXOTIDE ACCUHALER 250FLUTICASONE PROPIONATE250MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCELUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X60.0 METERED DOSE CANNISTER
NDA/MAL/HDP/4302GLAXO SMITH KLINE LTDERIS LTDFLIXOTIDE ACCUHALER 500FLUTICASONE PROPIONATE500MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCELUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X60.0 METERED DOSE CANNISTER
NDA/MAL/HDP/4339GLAXOSMITHKLINE LIMITEDERIS LTDSERETIDE 125 EVOHALERSALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG/125MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/1356GLAXO SMITH KLINE LTDERIS LTDREQUIP PD 24 HOUR 2 MGROPINIROLE2MGGLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BLISTER
NDA/MAL/HDP/1357GLAXO SMITH KLINE LTDERIS LTDREQUIP PD 24 HOUR 4 MGROPINIROLE4MGGLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BLISTER
NDA/MAL/HDP/3460GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDMALANIL ADULT TABLETSATOVAQUONE + PROGUANIL HCL250MG + 100MGGLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X12.0 TABLET BLISTER
NDA/MAL/HDP/4620GLAXO SMITH KLINE LTDERIS LTDMALANIL PAEDIATRIC TABLETATOVAQUONE + PROGUANIL62.5 MG + 25.0 MGGLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOSSPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X12.0 TABLET BLISTER
NDA/MAL/HDP/0174GLAXO SMITHKLINE LTDERIS LTDFLIXOTIDE 50FLUTICASONE PROPIONATE50MCGGLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3 09400 ARANDA DE DUERO BURGOS SPAIN SPAINLUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/0201GLAXO SMITH KLINE LTDERIS LTDFLIXOTIDE 125FLUTICASONE PROPIONATE125MCGGLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3 09400 ARANDA DE DUERO BURGOS SPAIN SPAINLUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/4062GLAXO SMITH KLEINE LIMITED ERIS LTDKIVEXAABACAVIR SULFATE + LAMIVUDINE600 MG + 300 MGGLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3 09400 ARANDA DE DUERO BURGOS SPAIN SPAINORAL SOLID ORDINARY TABLETS 1.0X1.0X30.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4640GLAXOSMITHLINE LTDERIS LTDREQUIP PD 24 HOUR 8 MGROPINIROLE8MGGLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3 09400 ARANDA DE DUERO BURGOS SPAIN SPAINORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BLISTER
NDA/MAL/HDP/4085GLAXO WELLCOME (KENYA) LTDERIS LTDZINACEFCEFUROXIME SODIUM750MGGLAXO WELLCOME -VERONA ITALYITALYPARENTERAL ORDINARY DRY VIALS 1.0X750.0 MG VIAL
NDA/MAL/HDP/0203GLAXOSMITHLINE LTDERIS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUXFRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/1328GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN20MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS 1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE)
NDA/MAL/HDP/1557GLAXOSMITHKLINEERIS LTDSYNFLORIX VACCINEPNEUMOCOCCAL POLYSACCHARIDE SEROTYPES (1,5,6B,7F,9V,14,23F) + (4,18C,19F) + PROTEIN D+TETANUS TOXOID+DIPTHERIA TOXOID CARRIER PROTEINS AND ALUMINIUM PHOSPHATE1MCG+3MCG+13MCG+8MCG+5MCG+0.5MGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/1769GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN10MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS 1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/2185GLAXOSMITHKLINE LTDERIS LTDROTARIXLIVE ATTENUATED RIX4414 STRAIN OF HUMAN ROTAVIRUS OF THE G1P[8] TYPENOT LESS THAN 10? CCID?? OF THE RIX4414 STRAINGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMORAL LIQUID ORDINARY LIQUIDS 1.0X1.5 ML TUBE (1 DOSE)
NDA/MAL/HDP/4289GLAXOSMITHKLINE LTDERIS LTDTWINRIX ADULTINACTIVATED HEPATITIS A ANTIGEN + HEPATITIS B SURFACE ANTIGEN720 ELISA UNITS + 20MCGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL (1 DOSE)
NDA/MAL/HDP/5124GLAXOSMITHKLINE LTD BELGIUMERIS LTDINFANRIX-HEXADIPHTHERIA + PERTUSSIS + BORDETELLA/PERTUSSIS + PERTUSSIS + HAEMAGGLUTININ + PERTACTIN + (HEPATITIS B/POLIOVIRUS TYPE 1 +2 +3)NLT 30 IU + NLT 40IU + 25MCG + 25MCG + 8MCG + 10MCG + (TYPE I 40D +TYPE 2 + TYPE 3)GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY COMBINATION PACK VIALS 1.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/6810GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCERVARIXHUMAN PAPILLOMA VIRUS VACCINE (RDNA)TYPE 16 L1 PROTEIN + TYPE 18 L1 PROTEIN + 3-0-DESACYL-4'MONOPHOSPHORYL LIPID A(MPL)GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X10.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE) + A 25 GAUGE NEEDLE
NDA/MAL/HDP/1694GLAXO WELLCOME(KENYA),LTDERIS LTDBETNOVATE CREAMBETAMETHASONE VALERATE0.1%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/2505GLAXO WELLCOME(KENYA),LTDERIS LTDBETNOVATE OINTMENTBETAMETHASONE VALERATE0.1%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/4097GLAXOSMITHKLINE LTD UKERIS LTDDERMOVATECLOBETASOL PROPIONATE0.05%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL CREAMS 1.0X25.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/5055GLAXOSMITHKLINE LTD UKERIS LTDDERMOVATECLOBETASOL PROPIONATE0.05%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE,1.0X25.0 G TUBE
NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRAPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON
NDA/MAL/HDP/3111GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDCALPOLPARACETAMOL120MG/5MLGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3639GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL ADVANCEPARACETAMOL500MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X11.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3885GLAXO WELLCOME(KENYA) LTDERIS LTDZANTACRANITIDINE150MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5004GLAXOSMITHKLINE LIMITED LIKONIBETA HEALTHCARE UGANDA LIMITEDCOFTA TABLETSMULTI-INGREDIENTN/AGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA,BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY LOZENGES 1.0X100.0 TABLET CARTON,1.0X50.0 TABLET CARTON,1.0X150.0 TABLET CARTON
NDA/MAL/HDP/1472GLAXO WELLCOME (KENYA) LTDERIS LTDFORTUM INJECTIONCEFTAZIDIME1GMGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/1768GLAXO SMITHKLINE LTD(ITALY)ERIS LTDULTIVA INJECTION 2MGREMIFENTANIL2MGGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/2003GLAXO SMITHKLINE LTD(ITALY)ERIS LTDPROTEDEX 1GCEFTRIAXONE1GGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/2511GLAXO SMITHKLINE LTD(ITALY)ERIS LTDULTIVA INJECTION 3MGREMIFENTANIL3MGGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/3140GLAXO SMITHKLINE LTDERIS LTDULTIVA INJECTION 1MGREMIFENTANIL1MLGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/8149GLAXO SMITHKLINE LTDERIS LTDAVODARTDUTASTERIDE0.5MGGLAXOSMITHKLINE PHARMACEUTICALS SA .-GRUNWALDZKA 189 STREET, 60-322 POZNANA POLANDORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1962GLAXO SMITHKLINE LTD(ITALY)ERIS LTDNIMBEXCISATRACURIUM BESYLATE2MG/MLGLAXOSMITHKLINE S.P.A -STRADA PROVINCIALE ASOLANA 9ITALYPARENTERAL ORDINARY VIALS 2.5 ML VIAL,1.0X10.0 ML VIAL
NDA/MAL/HDP/0275GLAXO SMITHLINE LIMITEDERIS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD-39 HAWKINS AVENUE, EPPING INDUSTRIAL, CAPE TOWN, 7460, SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/1985GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPROXIMEXA ORAL SUSPENSION 250MG/5MLCEFUROXIME AXETIL250MG/5MLGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITEDUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X50.0 ML BOTTLE
NDA/MAL/HDP/2287GLAXO WELLCOME (KENYA) LTDERIS LTDZINNATCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITEDUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON
NDA/MAL/HDP/2568GLAXO WELLCOME (KENYA) LTDERIS LTDZINNATCEFUROXIME AXETIL500MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITEDUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON
NDA/MAL/HDP/3384GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPROXIMEXA 250MGCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITEDUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3387GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPROXIMEXA 500MGCEFUROXIME AXETIL500MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITEDUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3622GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPROXIMEXACEFUROXIME AXETIL 125MG/5MLGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITEDUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X50.0 ML BOTTLE
NDA/MAL/HDP/4380GLAXO WELLCOME (KENYA) LTDERIS LTDZINNAT SUSPENSIONCEFUROXIME AXETIL-125MG/5MLGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITEDUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/HDP/6490GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSORVATE OINTMENT CALCITRIOL0.0003% W/WGLENMARK PHARMACEUTICALS LIMITED, AT: (UNIT II)-VILLAGE BHATTANWALA, P.O. RAJPURA, NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH, 174 101, INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X10.0 G TUBE
NDA/MAL/HDP/6039GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCOMBIWAVE SF 250SALMETEROL XINAFOATE/FLUTICASONE PROPIONATE25MCG+250MCG/ACTUATIONGLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/6042GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDCOMBIWAVE SF 125SALMETEROL XINAFOATE/ FLUTICASONE PROPIONATE25MCG+125MCG/ACTUATIONGLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/6044GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDCOMBIWAVE SF 50SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG+50MCG/ACTUATIONGLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/8322 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEMONT LMONTELUKAST SODIUM+LEVOCETIRIZINE DIHYDROCHLORIDE10 MG + 5 MGGLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BOTTLE
NDA/MAL/HDP/0327GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR 8LORNOXICAM8MGGLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0328GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR PLORNOXICAM + PARACETAMOL4MG + 500MGGLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1244GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR SRLORNOXICAM16MGGLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1245GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR P8LORNOXICAM + PARACETAMOL8MG + 500MGGLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0854GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-50BECLOMETASONE50MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA INDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/0862GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR- 200BECLOMETASONE200MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA INDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/1073GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-250BECLOMETASONE250MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA INDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5397 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-100BECLOMETHASONE100MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA INDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5487 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-SSALBUTAMOL + BECLOMETASONE100MCG/ACTUATION + 50MCG/ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/3527AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLEVOTOP-500LEVOFLOXACIN500MGGLENMARK PHARMACEUTICALS LTD (UNIT III)-B-4/5/6 MIDC INDUSTRIAL AREA,CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4325AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDACTINAC 100ACECLOFENAC100MGGLENMARK PHARMACEUTICALS LTD (UNIT III)-B-4/5/6 MIDC INDUSTRIAL AREA,CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4957GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDMUMFERIRON (111) POLYMALTOSE COMPLEX + FOLIC ACID100MG + 500MCGGLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRAINDIAORAL SOLID ORDINARY CHEWABLE COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5352GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDMUMFERIRON(111) POLYMALTOSE COMPLEX50MG/5MLGLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X4.0 TABLET STRIP
NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAVAGINAL TABLETS 1.0X6.0 PESSARY STRIP
NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAVAGINAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL OTHER OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/1919GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDIDERM CREAMBECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN0.025%W/W+1%W/W+0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/2008GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- CREAMCLOTRIMAZOLE + BECLOMETASONE DIPROPIONATE 1%W/W + 0.025%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/2012GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- LOTIONCLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE1% + 0.025%GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL LOTIONS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/2016GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID CREAMCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/2173 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVO-500LEVOFLOXACIN500MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X5.0 TABLET BLISTER
NDA/MAL/HDP/2476GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDDERIVA AQUEOUS GELADAPALENE0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE
NDA/MAL/HDP/2553GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZ-20ESOMEPRAZOLE20MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP
NDA/MAL/HDP/2554GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZESOMEPRAZOLE 40MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/3204GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDRELCER GELALUMINIUM HYDROXIDE/MAGNESIUM HYDROXIDE/DIMETHICONE/LIQUORICE6G+80MG+100MG+400MG/5MLGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X180.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3289GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID DUSTING POWDERCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL DUSTING POWDERS 1.0X30.0 G BOTTLE,1.0X100.0 G BOTTLE
NDA/MAL/HDP/3291 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDFINTOPBUTENAFINE HCL1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/3295 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVATECLOBETASOL0.05%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/3415GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID V-1CLOTRIMAZOLE500MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAVAGINAL TABLETS 1.0X1.0 PESSARY STRIP
NDA/MAL/HDP/3545GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID MOUTH PAINTCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL TOPICAL LIQUIDS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/4855GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDASCORIL EXPECTORANTBROMHEXINE+MENTHOL+TERBUTALINE+GUAIFENESIN2MG+0.5MG+1.25MG+50MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5150GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDKETO PLUS SHAMPOOKETOCONAZOLE/ZINC PYRITHIONE1%W/V+2%W/VGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL LIQUID SOAPS/WASHES 60.0 ML BOTTLE
NDA/MAL/HDP/5170GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDITRAL CAPSULEITRACONAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE STRIP
NDA/MAL/HDP/6489GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDASCORIL-SFSALBUTAMOL+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN2MG+4MG+100MG/10MLGLENMARK PHARMACEUTICALS LTD-VILLAGE, KISHANPURA, BADDI, NALAGARH ROAD, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1246GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEMONT CT 4MONTELUKAST4MGGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5079GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEMONT CT 5MONTELUKAST5MGGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6048GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE AZMOMETASONE FUROATE / AZELASTINE HYDROCHLORIDE50MCG/140MCGGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIAINDIANASAL TOPICAL METERED DOSE AEROSOLS 1.0X150.0 METERED DOSE BOTTLE
NDA/MAL/HDP/8232GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDMOMATEMOMETASONE FUROATE MONOHYDRATE50MCG/ SPRAYGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA,GLENMARK PHARMACEUTICALS LTD-VILLAGE, KISHANPURA, BADDI, NALAGARH ROAD, INDIAINDIANASAL SYSTEMIC METERED-DOSE LIQUIDS 1.0X120.0 METERED DOSE BOTTLE
NDA/MAL/HDP/1419GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOPRIL 10LISINOPRIL10MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2293GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIOCONTIOCONAZOLE1%W/WGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/3699GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOPRIL 5MG TABLETSLISINOPRIL5MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3705GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDSORAL 20MG CAPSULESTENOXICAM20MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7453GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDANTIDIAZOXNITAZOXANIDE 100MG/5MLGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/7683GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDDELAREXDESLORATADINE5MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3903PFIZER LABS LTDERIS LTDCELSENTRI 300MGMARAVIROC300MGGODECKE GMBH -MOOSWALDALLEE 179090, FREIBERG GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6080EXPHAR SASURGIPHARM (U) LIMITEDFEBRILEX JUNIORPARACETAMOL+CHLORPHENIRAMINE MALEATE125MG+1MG/5MLGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/6081EXPHAR SASURGIPHARM (U) LIMITEDANTALGEX TPARACETAMOL/TRAMADOL HYDROCHLORIDE325MG/37.5MGGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6523EXPHAR SA.SURGIPHARM (U) LIMITEDFLEXDOLIBUPROFEN+METHOCARBAMOL200MG+500MGGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7023EXPHAR SA.SURGIPHARM (U) LIMITEDVERZOL ORAL SUSPENSIONALBENDAZOLE200 MG / 5 MLGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X10.0 ML BOTTLE
NDA/MAL/HDP/7024EXPHAR SA.SURGIPHARM (U) LIMITEDMICOZALKETOCONAZOLE2%W/WGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/7269EXPHAR SA.SURGIPHARM (U) LIMITEDFEBRILEX SYRUPPARACETAMOL+DEXTROMETORPHAN HYDROBROMIDE+CHLORPHENAMINE MALEATE125MG+5MG+1MG/5 MLGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/6383EXPHAR SA.SURGIPHARM (U) LIMITEDEXXIBCELECOXIB200MGGRACURE PHARMACEUTICALS LIMITED -E- 1105, RIICO INDUSTRIAL AREA, PHASE-III BHIWADI, PIN-301019 DIST. ALWAR, RAJASTHAN, INDIINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3566GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE60 MGGUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 1*5% NAHCO3 + 5 ML NACL INJECTION
NDA/MAL/HDP/6921 GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDUFENAC DICLOFENAC SODIUM75MGGUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1278GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY TABLETS 1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER
NDA/MAL/HDP/2529GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDG-CEFTRIACEFTRIAXONE1GGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 10 ML AMPOULE WFI
NDA/MAL/HDP/6231GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPP DISPERSIBLEDIHYDROARTEMISININ/PIPERAQUINE20MG/160MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6242GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ/PIPERAQUINE PHOSPHATE80MG/640MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6436GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDMOXAFMOXIFLOXACIN HYDROCHLORIDE 400 MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/6488GUILIN PHARMACEUTICAL CO.LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPARACETAMOL INJECTIONPARACETAMOL300MG/2MLGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/1212GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDGLINTHERARTEMETHER80MG/MLGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXICHINAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE
NDA/MAL/HDP/2055GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE120MGGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXICHINAPARENTERAL ORDINARY DRY VIALS 1.0X120.0 MG VIAL + 1 *2 ML AMPOULE OF 5% SODIUM BICARBONATE SOLUTION + 1*10 ML AMPOULE OF 0.9% SODIUM CHLORIDE
NDA/MAL/HDP/4553GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUN ARTESUNATE30MGGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXICHINAPARENTERAL ORDINARY DRY VIALS 1.0X30.0 MG VIAL + 1*0.5 ML SODIUM BICARBONATE
NDA/MAL/HDP/6234GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPP DIHYDROARTEMESININE/ PIPERAQUINE PHOSPHATE40MG/320MGGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXICHINAORAL SOLID ORDINARY OTHER TABLETS 1.0X2.0X3.0 TABLET BLISTER
NDA/MAL/HDP/1035GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDG-CIPROXCIPROFLOXACIN500MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM400MG /80MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2807GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDASAQ GPSCARTESUNATE + AMODIAQUINE100 MG + 270 MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER
NDA/MAL/HDP/5460GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDASAQ GPSCARTESUNATE+AMODIAQUINE50MG+135MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0X20.0 TABLET BLISTER
NDA/MAL/HDP/5483GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDASAQ GPSCARTESUNATE + AMODIAQUINE25 MG + 67.5 MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0X20.0 TABLET BLISTER
NDA/MAL/HDP/8948GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDJULMENTIN ESAMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM600 MG / 5 ML + 42.9 MG / 5 MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR) --DIGDAGA, AIRPORT STREET RAS AL KHAIMAH UNITED ARAB EMIRATESINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8955GULF PHARMACEUTICAL INDUSTRIES(JULPHAR)GOODMAN INTERNATIONAL LTDCEFUZIMECEFUROXIME AXETIL125MG/5MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR) --DIGDAGA, AIRPORT STREET RAS AL KHAIMAH UNITED ARAB EMIRATESINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/1272GULF PHARMACEUTICAL INDUSTRIES(JULPHAR)GAMA PHARMACEUTICALS (U) LIMITEDMEBO HERBAL OINTMENTB-SITOSTEROL0.25%W/WGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA, P.O.BOX: 997, RAS AL KHAIMAH, U.A.E. UNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/5639GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDFEROMAXIRON SUCROSE20MG/MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA, P.O.BOX: 997, RAS AL KHAIMAH, U.A.E. UNITED ARAB EMIRATESPARENTERAL ORDINARY INFUSION AMPOULES 1.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/6485GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDCEFUZIME 750CEFUROXIME SODIUM 750MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA, P.O.BOX: 997, RAS AL KHAIMAH, U.A.E. UNITED ARAB EMIRATESPARENTERAL ORDINARY DRY VIALS 1.0X750.0 MG VIAL
NDA/MAL/HDP/6469GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDJUSPRIN 81 E/C TABLETSASPIRIN81MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X20.0 TABLET BLISTER
NDA/MAL/HDP/6475GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDMOXAL SUSPENSIONALUMINIUM HYDROXIDE +MAGNESIUM HYDROXIDE405 MG+100 MG/ 5MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/6478GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDRANTAG INJECTIONRANITIDINE HYDROCHLORIDE50MG/2MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/6481GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDMOXAL PLUS CHEWABLE TABLETSDRIED ALUMINIUM HYDROXIDE GEL+MAGNESIUM HYDROXIDE+SIMETHICONE 200MG+200MG+25MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6483GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDMOXAL II SUSPENSIONALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE 215MG+80MG/5MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6547GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDAMYDRAMINE PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL7MG+28.5MG+0.55 MG/5 MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/6561GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDRISEKOMEPRAZOLE20MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY CAPSULES 1.0X14.0 CAPSULE BOTTLE
NDA/MAL/HDP/7030GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDADOL EXTRAPARACETAMOL+CAFFEINE500MG+65MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY TABLETS 1.0X2.0X12.0 TABLET BLISTER
NDA/MAL/HDP/7046GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDXEMADERM 0.1% CREAMMOMETASONE FUROATE0.1%W/WGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/7047GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDXEMADERM0.1% OINTMENTMOMETASONE FUROATE0.1%W/WGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HDP/7050GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDPANDERM SKIN OINTMENTNYSTATIN+NEOMYCIN SULFATE+GRAMICIDIN+TRIAMCINOLONE10,000,000I.U+2.5MG+0.25MG+1MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/7051GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDDEXIPAN CREAMDEXPANTHENOL0.05%W/WGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/8237GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDBCOOLCETYLPYRIDINIUM CHLORIDE + LIDOCAINE HYDROCHLORIDE1MG +1MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY LOZENGES 1.0X2.0X9.0 LOZENGE BLISTER
NDA/MAL/HDP/6471GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDCEFUZIME 500CEFUROXIME AXETIL500MGGULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.EUNITED ARAB EMIRATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6540GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDVANCOLONVANCOMYCIN HYDROCHLORIDE1GGULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.EUNITED ARAB EMIRATESPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/6541GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDDIALON 1000 MG METFORMIN HYDROCHLORIDE1000MGGULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.EUNITED ARAB EMIRATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/2011HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDSIFE 50SILDENAFIL CITRATE50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8227HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDALZER 5DONEPEZIL HYDROCHLORIDE5MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8339SPECPHARM (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDEFTENEMEFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXIL FUMARATE600MG+200MG+300MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/2111HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR200MG /50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.,HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER
NDA/MAL/HDP/0063HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDABACAVIR SULPHATE + LAMIVUDINE ABACAVIR SULFATE + LAMIVUDINE600MG + 300MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/0272HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLEVIN 250LEVOFLOXACIN250MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0618HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDVALSAR 160VALSARTAN160MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0621HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDALZERDONEPEZIL HYDROCHLORIDE10MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0894HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDGIAGRA 100SILDENAFIL CITRATE100MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0085HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDPIOGEN-30PIOGLITAZONE HYDROCHLORIDE30MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0301HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDMONTE - H 10 MONTELUKAST SODIUM10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0615HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDVALSAR 80VALSARTAN80MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6997HETERO LABS LTD ABACUS PHARMA (AFRICA) LIMITEDEC-PRAM 10ESCITALOPRAM OXALATE10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0304HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDDARUNAVIRDARUNAVIR400MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/0426HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLAMIVUDINE + ZIDOVUDINE + NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG +300MG + 200MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/0696HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/0855HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1178HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/6237HETERO LABS LTD ABACUS PHARMA (AFRICA) LIMITEDLOPINAVIR/RITONAVIRLOPINAVIR/ RITONAVIR100MG/25MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X120.0 TABLET BOTTLE
NDA/MAL/HDP/7660SPECPHARM (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTENEMCOMEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE200MG + 300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/4557HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDLAMIVUDINELAMIVUDINE150MGHETERO LABS LTD-HETERO LABS LTD, UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055,HETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABADINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/1145HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HILACLACTULOSE68%W/VHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/1374HILTON PHARMA (PVT) LTDHEALTHCARE LTD.VALODIN -125CEPHADRINE125MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1375HILTON PHARMA (PVT) LTDHEALTHCARE LTD.VALODIN CAPSULESCEPHADRINE250MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X3.0X4.0 CAPSULE BLISTER
NDA/MAL/HDP/2128HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN INJECTION 500MGTRANEXAMIC ACID500MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0 ML AMPOULE
NDA/MAL/HDP/2386HILTON PHARMA (PVT) LTDHEALTHCARE LTD.NEOGABGABAPENTIN100MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2575HILTON PHARMA (PVT) LTDHEALTHCARE LTD.MYTEKAMONTELUKAST SODIUM10MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/3277HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN CAPSULES 500MGTRANEXAMIC ACID500MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4047HILTON PHARMA (PVT) LTDHEALTHCARE LTD.NEOGABGABAPENTIN300MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4336HILTON PHARMA (PVT) LTDHEALTHCARE LTD.NEOGABGABAPENTIN400MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4763HILTON PHARMA (PVT) LTDHEALTHCARE LTD.FEROSOFTIRON(III) HYDROXIDE POLYMALTOSE COMPLEX100MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4765HILTON PHARMA (PVT) LTDHEALTHCARE LTD.FEROSOFT-FAIRON(III)HYDROXIDE POLYMALTOSE COMPLEX/FOLIC ACID100MG/0.35MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5045HILTON PHARMA (PVT) LTDHEALTHCARE LTD.MAXIT TABLETSDICLOFENAC50MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5190HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HICLORCEFACLOR250MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/5198HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HICLORCEFACLOR500MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/5366HILTON PHARMA (PVT) LTDHEALTHCARE LTD.CEFIMCEFIXIME400MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X5.0 CAPSULE STRIP
NDA/MAL/HDP/5367HILTON PHARMA (PVT) LTDHEALTHCARE LTD.CEFIMCEFIXIME100MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE
NDA/MAL/HDP/2820HILTON PHARMA (PVT) LTDHEALTHCARE LTD.VALODIN 500MG CAPSULESCEPHADRINE250MGHILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.PAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X6.0 CAPSULE STRIP
NDA/MAL/HDP/3301HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN CAPSULES 250TRANEXAMIC ACID250MGHILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.PAKISTANORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4760HILTON PHARMA (PVT) LTDHEALTHCARE LTD.FEROSOFTIRON (III) HYDROXIDE POLYMALTOSE COMPLEX50MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.PAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/5387HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN INJECTION 250MGTRANEXAMIC ACID250MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.PAKISTANPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0 ML AMPOULE
NDA/MAL/HDP/4091HILTON PHARMA PVT LTDHEALTHCARE LTD.MYTEKA TABLETSMONTELUKAST SODIUM5MGHILTON PHARMA PVT,LTD-13 SECTOR 15,KORANG,IND.AREA,8TH FLOOR PROGRESSIVE PLAZA,BEAMONT RD,KARACHIINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/0981HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOFENAC SR TABLETS DICLOFENAC SODIUM100MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIAMALAYSIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1301 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCOSAMINE PLUSGLUCOSAMINE SULPHATE + CHONDROITIN SULPHATE250MG + 200MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5449HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOFENAC 50DICLOFENAC SODIUM50MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIAMALAYSIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7070 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN 1000 MG FILM-COATED TABLETMETFORMIN HYDROCHLORIDE1000MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIAMALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7356 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN TABLET 500MGMETFORMIN HYDROCHLORIDE500MGHOVID BERHAD-121, JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIAMALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X20.0 TABLET BLISTER
NDA/MAL/HDP/0006HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDDIAMIDEGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG,500MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X12.0 TABLET BLISTER
NDA/MAL/HDP/0014HOVID BHD (IPOH SITE)UNITED HEALTHCARE DISTRIBUTORS LTDMONTELAIR 10MG TABLETMONTELUKAST10MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1298HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDNEUROVIT FORTETHIAMINE MONONITRATE/ PYRIDOXINE/ CYANOCOBALAMIN245.5MG/ 250MG/ 1.4MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1383HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOFEN GELKETOPROFEN2.5%W/WHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G CONTAINER
NDA/MAL/HDP/7711 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN 850 MG METFORMIN HYDROCHLORIDE850MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0353HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDEROX-10AMLODIPINE BESILATE10MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X3.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1104HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDLIPIDUCE 10ATORVASTATIN10MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0 TABLET BLISTER
NDA/MAL/HDP/3145HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXICAPAMOXYCILLIN500MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6132HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOVIDKETOCONAZOLE2%W/WHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIATOPICAL EXTERNAL LIQUID SOAPS/WASHES 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/6203HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDDEROX-5AMLODIPINE BESILATE5MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6771 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIFLUVIDFLUCONAZOLE150MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE BLISTER
NDA/MAL/HDP/7053 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOVID CREAMKETOCONAZOLE2%W/WHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/7055 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDVIREST 400ACICLOVIR400MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 5.0X5.0 TABLET BLISTER
NDA/MAL/HDP/7057 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDVIREST CREAM 5%ACICLOVIR5%W/WHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE
NDA/MAL/HDP/0065HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDALENDRONATE 70MGALENDRONATE SODIUM70MGHOVID BHD-LOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMORMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0012HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDPENGESIC SR TRAMADOL HYDROCHLORIDE SR 100MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIAMALAYSIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1382HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDINOX CAPSULESITRACONAZOLE100MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIAMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X7.0X4.0 CAPSULE BLISTER
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NDA/MAL/HDP/8649INJECTCARE PARENTERALS PVT. LTDMATRIX (U) LTDCEFCARECEFTRIAXONE SODIUM1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1431INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDTORTAS 10TORSEMIDE10MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3707INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDOBETAS-120ORLISTAT120MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6491INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDPREGATAS ME 75PREGABALIN +MECOBALAMIN75MG+750MCGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2176INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDRISPITAS-2RISPERIDONE2MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2692INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRAMITAS 5RAMIPRIL5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/2781INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 6.25CARVEDILOL6.25MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3007INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDTORTAS 5TORSEMIDE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3612INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLOSARTAS-HTLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4606INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 10ROSUVASTATIN10MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5232INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDENAPRIL-5ENALAPRIL MALEATE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5245INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDFABUTAS-40FEBUXOSTAT40MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5269INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDIVAA OD 500DIVALPROEX500MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5406INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENAC SRACECLOFENAC200 MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3947INTAS PHARMACUITICALS LTD NORVIK ENTERPRISES LIMITEDRABTAS-20RABEPRAZOLE SODIUM20 MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA,INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3871INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDDOVERIN 40DROTAVERINE HYDROCHLORIDE40MGINTAS PHARMACEUTICALS LIMITED-PLOT NO. 457 / 458 SARKHEJ-BAVLA HIGHWAY, MATODA - 382 210, TALUKA - SANAND, DISTRICT - AHMEDABAD, STATE - INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2782INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDKWINILQUININE DIHYDROCHLORIDE300MG/MLINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY AMPOULES 20.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/2873INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHELIGO KITTINIDAZOLE/CLARITHROMYCIN/LANSOPRAZOLE500MG+ 250MG+30MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X7.0X6.0 TABLET BLISTER
NDA/MAL/HDP/7481ACCORD HEALTH CARE LTDNORVIK ENTERPRISES LIMITEDSILDENAFIL ACCORD 100SILDENAFIL CIRATE100MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/7488ACCORD HEALTH CARE LTDNORVIK ENTERPRISES LIMITEDFINASTERIDE 5MGFINASTERIDE 5MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7490ACCORD HEALTH CARE LTDNORVIK ENTERPRISES LIMITEDSILDENAFIL ACCORD 50SILDENAFIL CITRATE 50MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8407INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDTORTAS 20TORSEMIDE20MGINTAS PHARMACEUTICALS LTD -CAMP ROAD, SELAQUI ? 248 197 DEHRADUN (UK)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1798INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDCARDITAS RETARDNIFEDIPINE20MGINTAS PHARMACEUTICALS LTD, VATVA-7/3 G.I.D.C. ESTATE, PHASE-1, B/H DENA BANK VATVA, AHMEDABAD-382 445 GUJARAT, INDIA ,INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID RETARD FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0X5.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/2438INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENACACECLOFENAC100MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3854INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLOSARTAS 50 TABLETSLOSARTAN POTASSIUM50MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE 10MG INTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1799INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSECZOL DSSECNIDAZOLE1GMINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/5231INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDENAPRIL 10ENALAPRIL MALEATE10MGINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA ,INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5404INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENAC PACECLOFENAC + PARACETAMOL100 MG + 500 MGINTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0743INTRACIN PHARMACEUTICAL PVT LTDVEERAM HEALTHCARE (U) LIMITEDTRY-PZPIPERACILLIN+TAZOBACTAM5MG+500MGINTRACIN PHARMACEUTICAL PVT LTD-C-1, B -53, G.I.D.C ESTATE, NADIAD ? 387001 GUJARAT, INDIA.,INDIAPARENTERAL ORDINARY VIALS 1.0X30.0 ML VIAL
NDA/MAL/HDP/1400MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITED PANFOR SR 500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST), DISTRICT THANE, 421 0506, DIST. THANE, MAHARASHTRA, INDIA. INDIAORAL SOLID RETARD TABLETS 1.0X5.0X20.0 TABLET BLISTER
NDA/MAL/HDP/1402MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITED PANFOR SR 1000METFORMIN HYDROCHLORIDE1000MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST), DISTRICT THANE, 421 0506, DIST. THANE, MAHARASHTRA, INDIA. INDIAORAL SOLID RETARD TABLETS 1.0X5.0X20.0 TABLET BLISTER
NDA/MAL/HDP/4976MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPERGLIM 2GLIMEPIRIDE2MGINVENTIA HEALTHCARE PVT. LTD .-FI ? FI /1 ADDITIONAL AMBERNATH(EAST) ? 421 506,MAHARASHTRA DIST. THANE, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6621MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDBAROLE 20RABEPRAZOLE20MGINVENTIA HEALTHCARE PVT. LTD .-FI ? FI /1 ADDITIONAL AMBERNATH(EAST) ? 421 506,MAHARASHTRA DIST. THANE, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6790MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIMZEROMEPRAZOLE + DOMPERIDONE20MG + 30MGINVENTIA HEALTHCARE PVT. LTD-FI ? FI /1 ADDITIONAL AMBERNATH, M.I.D.C. AMBERNATH (EAST) ? 421 506, DIST. THANE, INDIA INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/1330IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDRAPICLAV-625AMOXYCILLIN+CLAVULANIC ACID500MG+125MGIPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X2.0 TABLET STRIP,1.0X7.0X3.0 TABLET STRIP
NDA/MAL/HDP/3816IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDRAPICLAV-375AMOXYCILLIN + CLAVULANIC ACID250 MG + 125 MGIPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X7.0X3.0 TABLET STRIP,1.0X5.0X2.0 TABLET STRIP
NDA/MAL/HDP/6388IPCA LABORATORIES LTD SURGIPHARM (U) LIMITEDRAPICLAV 250 DTAMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE250MG + 62.5MGIPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARATINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X5.0X3.0 TABLET BLISTER
NDA/MAL/HDP/3656IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDLARITEMARTEMETHER / LUMEFANTRINE80MG/480MGIPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3973IPCA LABORATORIES LIMITED MEDVIN PHARMA LIMITEDLARITHERARTEMETHER80MG/MLIPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067INDIAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE,1.0X8.0X1.0 ML AMPOULE
NDA/MAL/HDP/5388IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDLARINATEARTESUNATE60MGIPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067INDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 1*5 ML SODIUM CHLORIDE INJECTION + 1*1 ML AMPOULE OF SODIUM BICARBONATE INJECTION
NDA/MAL/HDP/1239IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDPECTYLIN-CDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM HYDROCHLORIDE+SODIUM CITRATE+MENTHOL14MG+135MG+57MG+1.1MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1922IPCA LABORATORIES LIMITED MEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X3.0 TABLET BLISTER
NDA/MAL/HDP/3108IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDZERODOLACECLOFENAC100MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3205EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDAZIFAST-250AZITHROMYCIN250MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X6.0 TABLET BLISTER
NDA/MAL/HDP/7670 IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDICHLOR 50CHLORTHALIDONE50MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7671 IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDICHLOR-25CHLORTHALIDONE25MGIPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3540EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDCLOPACT-75CLOPIDOGREL75 MGIPCA LABORATORIESLIMITED-IPCA LABORATORIES LTD P.O SEJANTA DISTRICT RATLAM 457002 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7334 IPCA LABORATORIES LTDSURGIPHARM (U) LIMITEDETOVA 400ETODOLAC 400MGIPCA LABORATORIESLIMITED-IPCA LABORATORIES LTD P.O SEJANTA DISTRICT RATLAM 457002 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOPUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4617ASTRA ZENECA MACNAUGHTON LIMITEDCRESTORROSUVASTATIN10MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOPUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4645ASTRA ZENECA MACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM20MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOPUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/2081IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDCOMPOUND SODIUM LACTATESODIUM LACTATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE+ CALCIUM CHLORIDE DIHYDRATE0.32G+0.6G+0.04+0.027/100MLIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 KENYAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/1420IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDSODIUM CHLORIDE + GLUCOSESODIUM CHLORIDE + GLUCOSE0.9%W/V + 5%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/6775IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYSOLONEPREDNISOLONE ACETATE1%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC SUSPENSIONS 1.0X5.0 ML VIAL
NDA/MAL/HDP/6780IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYTIMOLTIMOLOL MALEATE0.5%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6782IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYXOLOLBETAXOLOL HYDROCHLORIDE0.5%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6784IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYZOXANCIPROFLOXACIN HYDROCHLORIDE0.3%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5191IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYBETASONE EYE DROPSBETAMETHASONE1MG/MLIVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE, LR NO.18474/84, ATHI RIVER,KENYA KENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6370IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITED IVYCROM EYE DROPSSODIUM CROMOGLYCATE2%W/VIVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE, LR NO.18474/84, ATHI RIVER,KENYA KENYAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/6372ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDIVYTIMOL EYE DROPSTIMOLOL MALEATE0.25%W/VIVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE, LR NO.18474/84, ATHI RIVER,KENYA KENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/0402IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYSONE OPHTHALMIC SUSPENSIONHYDROCORTISONE ACETATE1%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC SUSPENSIONS 5.0 ML VIAL
NDA/MAL/HDP/2241IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYPHENOCOL EYE DROPSCHLORAMPHENICOL0.5%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5.0 ML VIAL,10.0 ML VIAL
NDA/MAL/HDP/2244IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXNICOL EYE DROPSDEXAMETHASONE/CHLORAMPHENICOL0.1% & 1%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/2370IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYBETANEOCIN EYE DROPSBETAMETHASONE + ENOMYCIN0.1 %W/V + 0.35 %W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE
NDA/MAL/HDP/2799IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYCHLORNICOL EAR DROPSCHLORAMPHENICOL5%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOTIC DROPS 1.0X5.0 ML BOTTLE,1.0X10.0 ML BOTTLE
NDA/MAL/HDP/3654IVEE AQUA EPZ LTDASTRA PHARMA (U) LIMITEDIVYNOZVIN A NASAL DROPSXYLOMETAZOLINE HYDROCHLORIDE1MG/MLIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYANASAL TOPICAL DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/4084IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDWATER FOR INJECTIONSTERILIZED WATER FOR INJECTIONN/AIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL
NDA/MAL/HDP/5192IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXGENT EYE/EAR DROPSDEXAMETHASONE/GENTAMICIN0.1% & 0.3%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5193IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXNEOCIN EYE DROPSDEXAMETHASONE/NEOMYCIN0.1% & 0.35%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5194IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXONE EYE DROPSDEXAMETHASONE0.1%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5.0 ML BOTTLE
NDA/MAL/HDP/5195IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYFRIN P NASAL DROPSEPHEDRINE HYDROCHLORIDE0.5%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYANASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE,1.0X10.0 ML BOTTLE
NDA/MAL/HDP/5196IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYFRIN NASAL DROPSEPHEDRINE HYDROCHLORIDE1%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYANASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/5197IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYGENTACIN EYE/EAR DROPGENTAMICIN SULPHATE0.3%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5.0 ML BOTTLE,10.0 ML BOTTLE,7.5 ML BOTTLE
NDA/MAL/HDP/6128IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYFLURFLURBIPROFEN SODIUM0.03%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6130ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDIVYSINE EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE0.05%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/5014UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDVERMOREX SUSPENSIONMEBENDAZOLE100MG/5MLJ.B CHEMICALS & PHARMACEUTICALS LTD-128/1 GIDC ANKLESHWAR 393 022 GUJARAT INDIA,UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/1992UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDUNIKPEFPEFLOXACIN400MGJ.B CHEMICALS-ANKLESHWAR, GUJARAT 393002 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2270UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZITHROCIN 500AZITHROMYCIN500MGJ.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, G.I.D.C. INDUSTRIAL AREA, ANKLESHWAR, GUJARAT 393002 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/1994UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDPANUM 40PANTOPRAZOLE40MGJ.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5215J.B CHEMICALS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDMETROGYL TABLETSMETRONIDAZOLE200MGJ.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3882UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDPEDIVIT FORTE CAPSULESMULTIINGREDIENTN/AJ.B. CHEMICALS AND PHARMACEUTICALS LTD-J.B. CHEMICALS & PHARMACEUTICALS LTD, 215/216, GIDC, PANOLI, GUJARATINDIAORAL SOLID ORDINARY CAPSULES 3.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/0393NAARI AGECHO PHARMACY (U) LIMITEDMISO-KAREMISOPROSTOL200MCGJAGSONPAL PHARMACEUTICALS LTD-PLOT NO.14-16,55-57,SECTOR-5,IIE PANT NAGAR,SIDCUL,RUDRAPUR UDHAM SINGH NAGAR,UTTARAKHAND-263153 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/8143 NAARI AGECHO PHARMACY (U) LIMITEDLYDIA POSTPILLEVONORGESTREL1.5MGJAGSONPAL PHARMACEUTICALS LTD-PLOT NO.14-16,55-57,SECTOR-5,IIE PANT NAGAR,SIDCUL,RUDRAPUR UDHAM SINGH NAGAR,UTTARAKHAND-263153 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/6257JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDEDURANTRILPIVIRINE25MGJANSSEN CILAG S.P.A-VIA C.JANSSEN, BORGOITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/4389PHARMACARE LTDMEDICAL ACCESS (UGANDA) LIMITEDPREZISTADARUNAVIR600MGJANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/6792JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDPREZISTADARUNAVIR400MGJANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/7337JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDPREZISTA 150 DARUNAVIR150MGJANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X240.0 TABLET BOTTLE
NDA/MAL/HDP/8315JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDPREZISTA 75DARUNAVIR75MGJANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X480.0 TABLET BOTTLE
NDA/MAL/HDP/0364JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDHALDOLHALOPERIDOL5MG/MLJANSSEN PHARMACEUTICAL NV-TURNHOUTSEWEG 30 B-2340 BEERSE BELGIUM BELGIUMPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/3720JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDHALDOL DECANOASHALOPERIDOL DECANOATE50MG/MLJANSSEN PHARMACEUTICAL NV-TURNHOUTSEWEG 30 B-2340 BEERSE BELGIUM BELGIUMPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/5181JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDGYNO-DAKTARIN OVULESMICONAZOLE NITRATE400MGJANSSEN PHARMACEUTICAL PTY LTD-15TH ROAD HALFWAY HOUSESOUTH AFRICAVAGINAL SUPPOSITORIES 1.0X3.0 OVULE BLISTER
NDA/MAL/HDP/6127JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDINTELENCEETRAVIRINE25MGJANSSEN-CILAG S.P.A.-VIA C. JANSSEN BORGO S. MICHELE 04100 LATINAITALYORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET BOTTLE
NDA/MAL/HDP/6169JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDINTELENCEETRAVIRINE100MGJANSSEN-CILAG S.P.A.-VIA C. JANSSEN BORGO S. MICHELE 04100 LATINAITALYORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET BOTTLE
NDA/MAL/HDP/4937JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDMOTILIUMDOMPERIDONE10MGJANSSEN-CILAG-27 100 VAL DE REUIL, FRANCEFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0 TABLET CARTON,1.0X30.0 TABLET CARTON
NDA/MAL/HDP/5412UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDIFICIPRO 250CIPROFLOXACIN250MGJB CHEMICALS AND PHARMACEUTICALS-128/1,CIIDC ANKLESHWER 393 002GUAZARAT INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7682ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAB-TETRA-250TETRACYCLINE250MGJIANGSU PENGYAO PHARMACEUTICAL CO LTD .-NO. 10 CHAQUAN ROAD YICHENG TOWN YIXING CITY JIANGSU PROVINCECHINAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8098ROYAL GROUPHARLEYS UGANDA LIMITEDCHLORAMPHENICOL CAPSULES BPCHLORAMPHENICOL250MGJIANGSU PENGYAO PHARMACEUTICAL CO LTD .-NO. 10 CHAQUAN ROAD YICHENG TOWN YIXING CITY JIANGSU PROVINCECHINAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0302ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCINAMET-400CIMETIDINE400MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCECHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1819ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDCINAMET-200CIMETIDINE200MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCECHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3834ROYAL GROUPHARLEYS UGANDA LIMITEDTETRACYCLINETETRACYCLINE250MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCECHINAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/6096ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDABGYL-200METRONIDAZOLE200MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCECHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3487ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDR-ETHERARTEMETHER80MG/MLJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRCHINAPARENTERAL ORDINARY AMPOULES 1.0X8.0 ML AMPOULE,1.0X6.0 ML AMPOULE
NDA/MAL/HDP/5446ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDPHENICOL- 250CHLORAMPHENICOL250MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRCHINAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0561ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDFALCIMAX-600QUININE DIHYDROCHLORIDE 600MG/2MLJIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/5390ROYAL GROUPHARLEYS UGANDA LIMITEDARTEMETHER INJECTIONARTEMETHER80MG/MLJIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINACHINAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE
NDA/MAL/HDP/7687ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDDI - QUIN DIHYDROARTEMISININ+PIPERAQUINE PHOSPHATE 40MG + 320MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X9.0 TABLET BLISTER
NDA/MAL/HDP/8323MOONLINK PHARMACEUTICALS LTDMOONLINK PHARMACEUTICALS LTDNEOPROFANE 400IBUPROFEN 400 MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0998ROYAL GROUPHARLEYS UGANDA LIMITEDQUININE DIHYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE600MG/2MLJIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA,GRAND PHARMACEUTICAL (CHINA) CO. LTD--LAKE ROAD NELL JINYINHU ECOLOGICAL PARKDONG XI HU DISTRICT, WUHAN, HEBEI PROVINCE.CHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/0300ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAB-DOX-100DOXYCYCLINE100MGJIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRCHINAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1764JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFRESH BURST LISTERINEALCOHOL + THYMOL95 % W/V + 12 MGJOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794 SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER
NDA/MAL/HDP/3464JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTARTAR CONTROL LISTERINE ANTISEPTICZINC CHLORIDE + DENATURED ALCOHOL MENTHOL 95% + THYMOL18MG/ 20ML + 0.9ML/20ML + 12.7MG/20MLJOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794 SOUTH AFRICAORAL LIQUID ORDINARY OTHER LIQUIDS 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/1510JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLISTERINE ANTISEPTICTHYMOL + ALCOHOL 95%12.78MG/20ML + 5.60ML/MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/2321JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN CHESTYORCIPRENALINE+BROMHEXINE5MG/5ML+ 4MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3078JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB ALLERGY CONGESTIONPARACETAMOL/ CHLORPHENIRAMINE/ EPHEDRINE500MG/ 2MG/ 30MGJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3156PFIZER LABORATORIES (PTY)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN FOR COLDSPSEUDOEPHEDRINE HCL + IBUPROFEN30MG + 200MGJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/3413JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCOMBANTRINPYRANTEL PAMOATE125MGJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/3483JOHNSON&JOHNSON PTY LTD. 241PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSINUTAB 3-WAYIBUPROFEN + PSEUDOEPHEDRINE HCL200MG + 30MGJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4033JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE7MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4949JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN DRY COUGH DMDEXTROMETHORPHAN HYDROBROMIDE15MG/MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4951JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN ORIGINALDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE 12.5 MG/5ML + 125 MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X2.5 L BOTTLE
NDA/MAL/HDP/4952JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN WITH CODEINEDIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + CODEINE PHOSPHATE12.5MG/5ML +125MG/5ML +10MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/4972JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCOOLMINT LISTERINEMENTHOL + ALCOHOL 95%0.02% + 4.58MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER
NDA/MAL/HDP/5377JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN FOUR FLU LIQUIDDIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE25MG/20ML + 1G/20ML + 45MG/20MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8953JOHNSON &JOHNSON (PTY) LTDERIS LTDBENYLIN CHILDREN'S WET COUGHGUAIFENESIN100MG PER 10MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8954JOHNSON &JOHNSON (PTY) LTDERIS LTDBENYLIN WET COUGHGUAIFENESIN200MG PER 10MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE
NDA/MAL/HDP/0949JULPHAR GULF PHARMACEUTICAL INDUSTRIESGAMA PHARMACEUTICALS (U) LIMITEDVANCOLONVANCOMYCIN0.5G/VIALJULPHAR GULF PHARMACEUTICAL INDUSTRIES-DIGDIGA AREA, AIR PORT ROAD P.O BOX 977 RAS-AL KHAIMAH UAEUNITED ARAB EMIRATESPARENTERAL ORDINARY I V VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/0950JULPHAR GULF PHARMACEUTICAL INDUSTRIESGAMA PHARMACEUTICALS (U) LIMITEDEPOTINERYTHROPOIETIN4000I.UJULPHAR GULF PHARMACEUTICAL INDUSTRIES-DIGDIGA AREA, AIR PORT ROAD P.O BOX 977 RAS-AL KHAIMAH UAEUNITED ARAB EMIRATESPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X10.0 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/0043KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL JUNIORPARACETAMOL250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0388KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE STRIP,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0562KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM COTRICO-TRIMOXAZOLE240MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 100.0 ML BOTTLE,60.0 ML BOTTLE
NDA/MAL/HDP/1570KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM AMOXYAMOXYCILLIN125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1701KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFORMIN METFORMIN HYDROCHLORIDE500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1886KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM QUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1887KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOLPARACETAMOL500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1889KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PREDSOLPREDNISOLONE5MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON
NDA/MAL/HDP/2020KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDQUINEQUININE SULPHATE300MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER
NDA/MAL/HDP/2035KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDNEOSIDARSULPHADOXINE + PYRIMETHAMINE500MG + 25MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER
NDA/MAL/HDP/2177KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM ERYMYCINERYTHROMYCIN ESTOLATE125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2180KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PEN VPHENOXYMETHYLPENICILLIN125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2181KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PHENPHENOXYMETHYLPENICILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,250.0 TABLET CONTAINER
NDA/MAL/HDP/2184KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM QUIN MIXTURESQUININE100MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/2440KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL KIDSPARACETAMOL250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3236KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM COTRICO-TRIMOXAZOLE480MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3273KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDBETASOL CREAMBETAMETHASONE VALERATE0.1%W/WKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/3361KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUCLOXAMPICILLIN + CLOXACILLIN250 MG / 5 ML + 250 MG / 5 MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3812KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDB-TONEPHENOBARBITONE30MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4010KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPYRIPYRIDOXINE HYDROCHLORIDE25MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4043KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM AMPIAMPICILLIN125MG/MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4569KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL SYRUPPARACETAMOL120MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5248KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM-AMPIAMPICILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1000.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER
NDA/MAL/HDP/5260KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDERYMYCINERYTHROMYCIN ESTOLATE250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6752KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDVITACEEASCORBIC ACID100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8080KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCEFTONECEFTRIAXONE1GKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION
NDA/MAL/HDP/8089KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM-AMOXYAMOXYCILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER
NDA/MAL/HDP/1960KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENACDICLOFENAC SODIUM50MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4933KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUDOXDOXYCYCLINE HYDROCHLORIDE100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/6385KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKPI HEALTHCARE LIMITEDAMOXIKID-250AMOXICILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/8085KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCIPROL-500CIPROFLOXACIN500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0627KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAMOXIKIDAMOXICILLIN TRIHYDRATE125MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1359KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENAC-100 SRDICLOFENAC SODIUM100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID RETARD CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1888KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM QUIN SYRUPCHLOROQUINE PHOSPHATE80MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2707KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMCLOXACLOXACILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY CAPSULES 100.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,10.0 CAPSULE CONTAINER
NDA/MAL/HDP/3741KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDACTIZINECETIRIZINE HYDROCHLORIDE10MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X15.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3974KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMCLOXACLOXACILLIN125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 100.0 ML BOTTLE
NDA/MAL/HDP/3839KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLURID ACETAMINOPHEN + PHENIRAMINE MALEATE500 MG + 10.5 MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT M 444B STRETCHER NTINDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X50.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1842KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDSUGAQUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDAUGANDAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5205KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM-VENTSALBUTAMOL4MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET JAR,1.0X500.0 TABLET JAR,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/0580KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPMULTINGREDIENTMULTINGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1018KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM CHLORCHLORAMPHENICOL250MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 100.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER
NDA/MAL/HDP/1380KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDHYCORT CREAMHYDROCORTISONE1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/1902KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMODIUMLOPERAMIDE HYDROCHLORIDE2MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3224KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM FLUFED ELIXIRMULTI-INGREDIENTMULTI-INGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3325KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDRAPIDEXACETAMINOPHEN+ASPIRIN+CAFFEINE200MG+ 400MG+50MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3735KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMSPROACETYL SALICYLIC ACID300MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,100.0 TABLET CONTAINER
NDA/MAL/HDP/3924KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUFEDPARACETAMOL+PSEUDOEPHEDRINE HYDROCHLORIDE+TRIPOLIDINE HYDROCHLORIDE300MG+36MG+1.5MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4892KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUFED COUGH FORMULAMULTI-INGREDIENTMULTI-INGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5201KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM BENDAZOLEMEBENDAZOLE100MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5203KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM METROMETRONIDAZOLE200MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/5204KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM METROMETRONIDAZOLE BENZOATE200MG/5MLKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5467KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMSIDARSULFADOXINE/PYRIMETHAMINE525MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5566KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDHYCORT OINTMENTHYDROCORTISONE1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/6750KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDNYTINNYSTATIN500,000IUKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/3144KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDULSECOMEPRAZOLE20MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/3443KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDBETASOL OINTMENTBETAMETHASONE VALERATE0.1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDATOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/3845KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCARDIPACAMLODIPINE5MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7365AUROCHEM PHAMACEAUTICALS (1) LTD)SUPER MEDIC LTDDOLOACT MRPARACETAMOL+ DICLOFENAC POTASSIUM+CHLORZOXAZONE 500 MG+50 MG+250 MGKARALEX PHARMA-58, PALGHAR TALUKA, INDUSTRIAL CO.-OP. ESTATE LTD.PALGHAR ?INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1797KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDAMPICILLIN+CLOXACILLINAMPICILLIN + CLOXACILLIN250 MG + 250 MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X500.0 MG VIAL
NDA/MAL/HDP/3738KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X500.0 MG VIAL,1.0X50.0X500.0 MG VIAL
NDA/MAL/HDP/4546KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDCHLORAMPHENICOL INJECTION IGCHLORAMPHENICOL SODIUM SUCCINATE1GKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058INDIAPARENTERAL ORDINARY DRY VIALS 1.0X100.0X1.0 G VIAL,1.0X50.0X1.0 G VIAL
NDA/MAL/HDP/5648KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDCLOXACILLIN SODIUMCLOXACILLIN SODIUM500MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X500.0 MG VIAL
NDA/MAL/HDP/8419ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDVB COMPLEX VIT B1+ VIT B2 +VIT B3 + NICOTINAMIDE+PANTOTHENOL10MG +1MG +1MG +16MG +0.5MGKIVI PHARM CO. LTD .-NO.5 HANGTIAN STREET, DONGSHAN HIGH TECH INDUSTRIAL DEVELOPMENT ZONE,SHALINGZI TOWN, XUANHUA,ZHANGJIAKOU CITY,HEBEI 075100, CHINA * CHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE
NDA/MAL/HDP/0024KOPRAN LIMITEDTATA UGANDA LIMITEDAMPICLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0333KOPRAN LIMITEDTATA UGANDA LIMITEDCLAVAMYN-625 AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG +125MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0338KOPRAN LIMITEDTATA UGANDA LIMITEDKORAB 20 RABEPRAZOLE SODIUM 20MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0354KOPRAN LIMITEDTATA UGANDA LIMITEDLEVOKOPLEVOFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1300KOPRAN LIMITEDTATA UGANDA LIMITEDATENOLOL-100ATENOLOL100MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X16.0X14.0 TABLET BLISTER
NDA/MAL/HDP/1711KOPRAN LIMITEDTATA UGANDA LIMITEDAMYN-250AMOXYCILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/1795KOPRAN LIMITEDTATA UGANDA LIMITEDAMPIK-250AMPICILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/1894KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-480CO-TRIMOXAZOLE480MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4922KOPRAN LIMITEDTATA UGANDA LIMITEDCIPROQUIN-500CIPROFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0228KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-960TRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1676KOPRAN LIMITEDTATA UGANDA LIMITEDCLOXIN-250CLOXACILLIN250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6746KOPRAN LTD TATA UGANDA LIMITEDFLUPEN-250FLUCLOXACILLIN SODIUM250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7015KOPRAN LIMITEDTATA UGANDA LIMITEDLOKITOMEPRAZOLE20MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8319KOPRAN LIMITEDTATA UGANDA LIMITEDERYKO-250ERYTHROMYCIN STEARATE TABLETS BP 250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/0569KOTRA PHARMA SDN BDNUNITED HEALTHCARE DISTRIBUTORS LTDAXCELLRIDIN LINCTUSPHOLCODINE10MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE
NDA/MAL/HDP/0571KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL KAOPEC LIGHT KAOLIN + PECTIN (CITRUS)1G + 20MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/0573KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL PARACETAMOL-250 PARACETAMOL250MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0667KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXEL MICONAZOLEMICONAZOLE NITRATE2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/0671KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL LIGNOCAINELIDOCAINE2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/0678KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL HYDROCORTISONE CREAMHYDROCORTISONE1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/1342KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL CEPHALEXIN 250CEPHALEXIN MONOHYDRATE250MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1554KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL CETIRIZINECETIRIZINE DIHYDROCHLORIDE5MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/2178KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL CEFUROXIME-250CEFUROXIME AXETIL250MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2189KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL BETAMETHASONEBETAMETHASONE0.1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/2208KOTRA PHARMA SDN BDNUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL CEPHALEXINCEPHALEXIN MONOHYDRATE500MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2911KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL LORATADINELORATADINE10MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3026KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL DETROMETHORPHAN-15 SYRUPDEXTROMETHORPHAN HYDROBROMIDE15MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3927KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL CEPHALEXIN 125CEPHALEXIN MONOHYDRATE125MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4917KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL EVILINE FORTE SUSPENSIONMAGNESSIUM HYDROXIDE +ALUMINIUM HYDROXIDE+SIMETHICONE400MG/5ML+400MG/5ML+40MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/4919KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL FUSIDIC ACID- B CREAMFUSIDIC ACID+BETAMETHASONE 17 VALERATE2%,W/W,+0.1% W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/5422KOTRAPHARMA (M) SDN.BHDUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFUROXIME-750CEFUROXIME750MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5441KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL NASATAB TABLETSPARACETAMOL+CHLORPHENIRAMINE+PSEUDOEPHEDRINE500MG+4MG+60MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6249KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL METRONIDAZOLE -200 TABLETSMETRONIDAZOLE200MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6774KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL FLEMIN EXPECTORANTDIPHENHYDRAMINE HYDROCHLORIDE +AMMONIUM CHLORIDE12.5MG+130MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6777KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL FUSIDIC ACIDFUSIDIC ACID2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/6778KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL IBUPROFENIBUPROFEN100MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/8950KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFEPIME-1G INJECTIONCEFEPIME HYDROCHLORIDE1 GKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/5475KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFTAZIDIMECEFTAZIDIME1GKOTRA PHARMA (M) SDN.BHD,-1,2 & 3 JALAN TTC 12 CHENG INDUSTRIAL ESTATE 75250 MELAKAMALAYSIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/8494KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFOBACTAMCEFOPERAZONE SODIUM+SULBACTAM SODIUM500MG + 500MGKOTRA PHARMA (M) SDN.BHD,-1,2 & 3 JALAN TTC 12 CHENG INDUSTRIAL ESTATE 75250 MELAKAMALAYSIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/0567KOTRA PHARMA SDN BDNUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFTRIAZONE 500MGCEFTRIAXONE500MGKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/0669KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXEL FUNGICORT CREAMMICONAZOLE NITRATE + HYDROCORTISONE2% W/W + 1% W/WKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/1224KOTRAPHARMA (M) SDN.BHDUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFTRIAXONECEFTRIAXONE1GKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/0675KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKOTRA PHARMA-BHD 1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA MALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2186KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL DIPHENHYDRAMINE PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE7MG+67.5MG/5MLKOTRA PHARMA-BHD 1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA MALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/2091KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCAMSTONCLOTRIMAZOLE1%W/WKPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDA UGANDATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/5333KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDIBUFENIBUPROFEN200MGKPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0X10.0 TABLET BLISTER,500.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,250.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0626KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCARDIPAC-10AMLODIPINE BESILATE10MGKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2890KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDBETASOL N BETAMETHASONE+NEOMYCIN1MG/G+5MG/GKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALAUGANDATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/2896KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDMCG CREAMMICONAZOLE NITRATE BP + CLOBETASOL PROPIONATE BP + GENTAMYCIN SULPHATE2.0%W/W + 0.05%W/W + 0.1 %W/WKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALAUGANDATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X25.0 G TUBE
NDA/MAL/HDP/0054GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDFUNGOALCLOTRIMAZOLE1%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/0287GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDPOWER HEATMETHYL SALICYLATE BP 15000MGKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS 1.0X25.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/0340GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDSONADAYCLOBETASOL-17-BUTYRATE + GENTAMYCIN SULPHATE + MICONAZOLE NITRATE0.05%W/W+0.1%W/W+2%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/0343GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDWHITFIELD'S OINTMENT B.PBENZOIC ACID + SALICYLIC ACID 6% W/W + 3% W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE
NDA/MAL/HDP/0703GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDDICLODAY GELDICLOFENAC DIETHYLAMINE+ LINSEED OIL+ METHYL SALICYLATE +MENTHOL11.6MG + 30MG + 100MG + 50MGKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/3179GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDSULPHUR OINTMENTSULPHUR10%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL OINTMENTS 1.0X1.0X25.0 G TUBE
NDA/MAL/HDP/0335GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDNEOMYCIN SULPHATE CREAM USPNEOMYCIN SULPHATE CREAM USP 0.5%WWKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE
NDA/MAL/HDP/6651GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDCYCLOVEERACICLOVIR5%W/WKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/2863KWALITY AFRO-ASIA LTDKWALITY AFRO ASIA LIMITEDK-MOLPARACETAMOL120MG/5MLKWALITY AFROASIA LTD-KAWEMPEUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/1539KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDK-TRIMSULFAMETHOXAZOLE + TRIMETHOPRIM200MG + 40MGKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3856KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDQUININE-KQUININE HYDROCHLORIDE100MG/5MLKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4860KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDK-FEN SUSPENSIONIBUPROFEN100MG/5MLKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5596KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDGERMILONCHLORHEXIDINE GLUCONATE + CETRIMIDE0.3%W/V + 3%W/VKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X5.0 L BOTTLE
NDA/MAL/HDP/6168KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDK-HEMFERROUS GLUCONATE + THIAMINE MONONITRATE + RIBOFLAVIN + PYRIDOXINE HCL + NIACINAMIDE + VITAMIN B12300MG + 5MG + 5MG + 1.5MG +45MG + 15MCGKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8236KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LTDHYDROGEN PEROXIDEHYDROGEN PEROXIDE6%W/VKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDATOPICAL EXTERNAL LIQUIDS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8679KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LTDK COUGH-DBROMOHEXINE HYDROCHLORIDE + AMMONIUM CHLORIDE + DEXTROMETHORPHAN HYDOBROMIDE + MENTHOL8MG + 10MG + 100MG + 5MGKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8172ACINO PHARMA AGGOODMAN INTERNATIONAL LTDCOAMOX-ACINO 875AMOXICILLIN + CLAVULANIC ACID875MG + 125 MGLABESFAL LABORATORIES ALMIRO S.A-LAGEDOSANT, SOLVENIASLOVENIAORAL SOLID ORDINARY TABLETS 1.0X3.0X4.0 TABLET BLISTER
NDA/MAL/HDP/5476ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMESPORIN 1000MG I.VCEFTRIAXONE1000MGLABESFAL LABORATORIES-ALMIRO S.A ZONA INDUSTRIAL DO LAGEDO, 3465-157, SANTIAGO DE BESTERIROS PORTUGALPORTUGALPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL + 10 ML WFI
NDA/MAL/HDP/4012ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMESPORIN 2000CEFTRIAXONE2000MGLABESFAL LABORATORIOS ALMIRO, S.A ,.-ZONA INDUSTRIAL DO LABENGO, 3465-157 SANTIAGO DE BESTEIROSPORTUGALPARENTERAL ORDINARY DRY VIALS 1.0X1.0X50.0 ML VIAL
NDA/MAL/HDP/4579ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMESPORIN 500 IV VIALSCEFTRIAXONE 500MGLABESFAL LABORATORIOS ALMIRO, S.A ,.-ZONA INDUSTRIAL DO LABENGO, 3465-157 SANTIAGO DE BESTEIROSPORTUGALPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL + 1*5 ML WFI AMPOULE
NDA/MAL/HDP/0549ABOTT LABORATORIES S.A (PTY) LTDLABOREX UGANDA LIMITEDHIDRASECRACECADOTRIL100 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0552ABOTT LABORATORIES S.A (PTY) LIMITEDLABOREX UGANDA LIMITEDHIDRASEC INFANTSRACECADOTRIL10 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCEFRANCEORAL LIQUID ORDINARY OTHER POWDERS/GRANULES 1.0X16.0 SACHET CARTON
NDA/MAL/HDP/0556ABOTT LABORATORIES S.A (PTY) LTDLABOREX UGANDA LIMITEDHIDRASEC CHILDRENRACECADOTRIL30 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCEFRANCEORAL LIQUID ORDINARY OTHER POWDERS/GRANULES 1.0X30.0 SACHET CARTON
NDA/MAL/HDP/1763LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDASPIRIN TABLETS BPACETYL SALICYLIC ACID300MGLABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3833LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABSTATIN VAGINAL TABLETSNYSTATIN100.000 I.ULABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAVAGINAL TABLETS 1.0X15.0 PESSARY STRIP
NDA/MAL/HDP/1801LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAVAGINAL TABLETS 1.0X1.0X6.0 PESSARY STRIP
NDA/MAL/HDP/2191LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN250MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2528LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABESTENCLOTRIMAZOLE1%W/WLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYATOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE
NDA/MAL/HDP/3116LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN125MG/5MLLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0290LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDNATOAMEBENDAZOLE100MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1497LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE CREAMBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE
NDA/MAL/HDP/1783LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE OINTMENTBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X1.0X15.0 G TUBE
NDA/MAL/HDP/1848LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDPARATALPARACETAMOL500MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3200LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLETRAXLEVAMISOLE HYDROCHLORIDE40MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X200.0 TABLET CONTAINER,1.0X25.0X3.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/3284LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDCHALEATECHLORPHENIRAMINE MALEATE4MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3710LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLACILLINAMPICILLIN250MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/3723LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLACILLINAMPICILLIN125MG/5MLLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3782LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAE-PEN VPHENOXYMETHYLPENICILLIN250MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3970LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLECOTRIMCO-TRIMOXAZOLE480MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5199LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDHYCORUM OINTMENTHYDROCORTISONE1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/5295LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDDOXYDOXYCYCLINE100MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X280.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8411LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDRHEUMAC GELDICLOFENAC1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/0497LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL DRY SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1708LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDDENTAMOLACETAMINOPHEN500MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2197LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE
NDA/MAL/HDP/4815LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDFERROLIC-LF FERROUS SULPHATE +FOLIC ACID 200MG+0.4MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4818LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDFERROUS SULPHATEFERROUS SULPHATE200MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4926LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDFOLIC ACIDFOLIC ACID5MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5341LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDHYODOPAMETHYLDOPA250MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6340LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDAXYLIN CAPSULESAMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM250MG +250 MG LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6671LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDNOPENASPRIRIN+CAFFEINE350MG+30MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8092LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL 250MGAMOXYCILLIN250MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4627LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDHYCORUM CREAMHYDROCORTISONE1%W/WLABORATORY AND ALLIED LTD-PLOT 209/10349-MOMBASA ROAD NAIROBIKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/5052CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.GLAMIDE TABLETSGLIBENCLAMIDE5 MGLA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 2.0X50.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5436CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFICAD 1000CEFEPIME HCL1000MGLA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1000.0 MG VIAL
NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER
NDA/MAL/HDP/2078LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDALCLOX SYRUPCLOXACILLIN SODIUM125MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4093LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDBECLOMIN OINTMENTBECLOMETHASONE+MICONAZOLE+NEOMYCIN0.025%W/W + 2%W/W + 0.5%W/WLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/4095LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDIBUT-200IBUPROFEN200MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4920LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDFOLIBENFOLIC ACID5MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X20.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5109LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLEBASMA ORAL SOLUTIONSALBUTAMOL2MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5320LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDINDOLINDOMETHACIN25MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDDOXYLEBDOXYCYCLINE 100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDPROHIBINOMEPRAZOLE20MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDMETROLEB METRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDAZILEB-500 AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X3.0 TABLET BLISTER
NDA/MAL/HDP/0486LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDADIFLAM-SRDICLOFENAC SODIUM 100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X20.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0877LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT DS GEL MINT FLAVOURDRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X170.0 ML BOTTLE
NDA/MAL/HDP/1338LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDGRISEBEN 500GRISEOFULVIN500 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCEBAY DRY SYRUPCEFIXIME TRIHYDRATE50MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1426LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDMETROLEBMETRONIDAZOLE200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2097LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDALCLOXCLOXACILLIN250MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2218LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDZINECTIL-100CHLORPROMAZINE100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2675LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLIBITUS PLUS SYRUPTERBUTALINE/ BROMHEXINE/ GUAIPHENESIN1.25MG/ 4MG/ 50 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3002LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDKELVINPARACETAMOL500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3095LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDAMPHEN SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3104LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDNYSTALEB ORAL SUSPENSIONNYSTATIN 100000IU/MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/3232LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDL-TRIMSULFAMETHOXAZOLE + TRIMETHOPRIM400MG + 80MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3535LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDADIFLAM-50DICLOFENAC SODIUM TABLETS BP50MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3784LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCIPIUMCHLORPHENIRAMINE2MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4086LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDKELVIN SUSPENSIONPARACETAMOL120MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/6325LEBEN LABORATORIES PVT. LTD.ANDYCO PHARMACY (UGANDA) LTDPZQ TABLETPRAZIQUANTEL600MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8329LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDARTEFLO - 40PROPRANOLOL HYDROCHLORIDE40 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0531LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDENDERM-GMCLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE0.05%W/W + 0.10%W/W + 2.0%W/WLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDCIPROLEBCIPROFLOXACIN500MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT DS GEL ORANGE FLAVOURALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X170.0 ML BOTTLE
NDA/MAL/HDP/1847LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDMOXILEB-250 CAPSULEAMOXICILLIN250MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1425LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDL-TRIMCOTRIMOXAZOLE240MG/5MLLEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C, INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3079ACINO PHARMA AGGOODMAN INTERNATIONAL LTDCO-AMOX ACINO 457CO-AMOXICLAV400MG+47MG/ 5MLLEK D.D PREVALJE SDOVENIA-DORNACHERSTASSE 144 P.O.BOX 445,CH 4147 AESCH (BASEL) SWITZERLANDSWITZERLANDORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/3080ACINO PHARMA AGGOODMAN INTERNATIONAL LTDCO-AMOX ACINO 156.25CO-AMOXICLAV125MG+31.25MG/ 5MLLEK D.D PREVALJE SDOVENIA-DORNACHERSTASSE 144 P.O.BOX 445,CH 4147 AESCH (BASEL) SWITZERLANDSWITZERLANDORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4409SANDOZ GBH LTDSURGIPHARM (U) LIMITEDROBESTAR 10MGROSUVASTATIN CALCIUM10MGLEK PHARMACEUTICALS .D.D -VEROVSKOVA 57, 1526 LJUBLJANA SLOVENIA SLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6159SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDAMLODIPINEAMLODIPINE10MGLEK PHARMACEUTICALS .D.D -VEROVSKOVA 57, 1526 LJUBLJANA SLOVENIA SLOVENIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4323SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDANDARANIRBESARTAN300 MGLEK PHARMACEUTICALS LTD-LEK PHARMACEUTICALS VEROVSKOVA 57 SI 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4414SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDROBESTAR 20MGROSUVASTATIN CALCIUM20MGLEK PHARMACEUTICALS LTD-LEK PHARMACEUTICALS VEROVSKOVA 57 SI 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4288SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOLESTOPATORVASTATIN10MGLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4298SANDOZ GMBH, KENYA C/O NORVATIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOLESTOPATORVASTATIN40MGLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4355SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDANDARANIRBESARTAN150MGLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6720SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOLESTOPATORVASTATIN20MGLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7728 NORVATIS PHARMA SERVICES INC.SURGIPHARM (U) LIMITEDLINEXLACTOBACILLUS ACIDOPHILUS + BIFIDOBACTERIUM INFANTIS + ENTEROCOCCUS FAECIUM1.2 * 10 TO POWER 7 COLONY FORMING UNITS OF VIABLE LACTIC ACID BACTERIA SPECIESLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X8.0 CAPSULE BLISTER
NDA/MAL/HDP/7632SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDBISOPROLOL 2.5 MG FILM-COATED TABLETSBISOPROLOL FUMARATE 2.5MGLEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HDP/7634SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDBISOPROLOLBISOPROLOL 5 MG LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X25.0 TABLET BLISTER
NDA/MAL/HDP/8658SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDMETFORMIN 1000MGMETFORMIN HYDROCHLORIDE1000MGLEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X15.0 TABLET BLISTER
NDA/MAL/HDP/8659SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDMETFORMIN 500MGMETFORMIN HYDROCHLORIDE500MGLEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0416NORVATIS PHARMA SERVICESSURGIPHARM (U) LIMITEDRAMIZID 5RAMIPRIL5MGLEK S.A-95 - 010 STRYK?W, PODLIPIE 16, POLANDPOLANDORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7635SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDBISOPROLOL 10MG FILM-COATED TABLETS BISOPROLOL FUMARATE10MGLEK S.A-95 - 010 STRYK?W, PODLIPIE 16, POLAND,SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X25.0 TABLET BLISTER
NDA/MAL/HDP/8483SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDGLIMEPIRID SANDOZ? 2MG TABLETSGLIMEPIRIDE2MGLEK S.A--U1, PODLIPIE 16, 95-0140 STRYKOW POLANDPOLANDORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6053SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDGLIMEPIRIDEGLIMEPIRIDE4MGLEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATESPOLANDORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6054SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDGLIMEPIRIDEGLIMEPIRIDE1MGLEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATESPOLANDORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8158SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDGLIMEPIRID SANDOZGLIMEPIRIDE3MGLEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATESPOLANDORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4343PASTEUR MERIEUX CONNANGHTLABOREX UGANDA LIMITEDEUVAX B (PAEDIATRIC)HEPATITIS B VACCINE, RECOMBINANT20MCG/MLLG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JESOUTH KOREAPARENTERAL ORDINARY I M VIALS 1.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/8230LIFEPHARM FZEAIVEEN (U) LIMITEDPANALIFEPARACETAMOL500MGLIFE PHARMA FZE --JEBEL ALI FREE ZONE, PLOT NO. MO 0502, P.O. BOX 17404, DUBAI-UAEUNITED ARAB EMIRATESORAL SOLID ORDINARY TABLETS 1.0X2.0X12.0 TABLET BLISTER
NDA/MAL/HDP/6337LIFEPHARM FZEAIVEEN (U) LTD - WILSON ROADGASTREX SIMETHICONE42MGLIFEPHARMA FZE - -JEBEL ALI FREE ZONE, PLOT NO. MO 0502, P.O. BOX 17404, DUBAI, UAEUNITED ARAB EMIRATESORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7139LIFEPHARM FZEAIVEEN (U) LIMITEDCOLDIFED SYRUPPSEUDOEPHEDRINE HYDROCHLORIDE+HYTRIPROLIDINE HYDROCHLORIDE30MG+1.25MG/5MLLIFEPHARMA FZE .-JEBEL ALI -DUBAI UAEUNITED ARAB EMIRATESORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/2150ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN MIXTUREHUMAN INSULIN70/30 I.ULILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,-INDIANA 46285 USAUNITED STATESPARENTERAL ORDINARY S C VIALS 1.0X4.0 ML VIAL,1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/3772ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN N NPHHUMAN INSULIN ISOPHANE100IULILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,-INDIANA 46285 USAEGYPTPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/3440ELI-LILLY EXPORT SALABOREX UGANDA LIMITEDHUMALOGINSULIN LISPRO100IULILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/4602ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMALOG MIX 50INSULIN LISPRO100 .IU(50 I.U+50 I.U)LILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY S C VIALS 1.0X3.0 ML VIAL,1.0X5.0 ML VIAL
NDA/MAL/HDP/5002ELI-LILLY EXPORT SALABOREX UGANDA LIMITEDHUMALOG MIX 25INSULIN LISPRO + INSULIN LISPRO PROTAMINE 25I.U+75I.ULILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/1984ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDCIALISTADALAFIL20MGLILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRIDSPAINORAL SOLID ORDINARY TABLETS 2.0X2.0 TABLET BLISTER
NDA/MAL/HDP/7406ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDARENAADRENALINE0.1% W/V LINCOLN PARENTERAL LTD -11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/8481LINCOLN PARENTERAL LIMITEDMETRO PHARMACEUTICALS LIMITEDPARACETAMOL BP INJECTIONPARACETAMOL150MG/MLLINCOLN PARENTERAL LTD -11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/1749LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVITAMIN B COMPLEXVITAMIN B COMPLEXN/ALINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/8225LINCOLN PARENTERAL LIMITEDMETRO PHARMACEUTICALS LIMITEDARTELIN 60ARTESUNATE60MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 1*1 ML AMPOULE OF 5.0%W/V SODIUM BICARBONATE INJECTION B.P + 1*5 ML AMPOULE OF 0.9%W/V NACL
NDA/MAL/HDP/8424LINCOLN PARENTERAL LIMITEDMETRO PHARMACEUTICALS LIMITEDHAEMRICHFERRIC AMMONIUM CITRATE+ FOLIC ACID+PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE50MG + 0.55MG +2.4MG + 1.2MG +11MG /5MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE
NDA/MAL/HDP/0540ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDHYDRICORTHYDROCORTISONE SODIUM SUCCINATE100MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X100.0 MG VIAL
NDA/MAL/HDP/0721MISSION PHARMAMETRO PHARMACEUTICALS LIMITEDARH-AARTEMETHER80MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY I M AMPOULES 1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE
NDA/MAL/HDP/1556VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDDOMI UPONDASENTRON2MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/2821LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIOLIN-MGLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS5MG+500MGLINCOLN PHARMACEUTICAL LIMITED..-LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGARINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3087VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDSULPHATRIM TABLETS B.P. 480CO-TRIMOXAZOLE480MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3225LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIFLAME DICLOFENAC DIETHYLAMINE + LINSEED OIL + METHYL SALICYLATE MENTHOLN/ALINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/3231LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCOMOLPARACETAMOL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/CHLORPHENIRAMINE MALEATE500MG/10MG/15MG/2MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3237LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKONAZOL CREAMKETOCONAZOLE2% W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/3666VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDSTROM 50TRAMADOL HYDROCHLORIDE50MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4588LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCAN 200FLUCONAZOLE200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0 TABLET BLISTER
NDA/MAL/HDP/4592LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPENTALINK 40PANTOPRAZOLE40MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4595LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-20ATORVASTATIN20MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5292LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDOMI 10DOMPERIDONE10MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6776LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITED M-FORLIN 500METFORMIN500MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0716LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-1GLIMEPIRIDE+METFORMIN HYDROCHLORIDE1MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY COMBINATION PACK TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0475LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X25.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0836LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONE-500CALCIUM CARBONATE + COLECALCIFEROL1250MG + 250 I.ULINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/0845VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDOLEVO-500LEVOFLOXACIN500 MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0850LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLCT KITLANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)
NDA/MAL/HDP/3275LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDMEFLIN-500MEFENAMIC ACID500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID RETARD LAYERED TABLETS 1.0X10.0X1.0X12.0 TABLET BLISTER
NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS 500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1687LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDALLDOXDOXYCYLINE 100MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2504LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRESTOCINPARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL500MG+ 2MG+ 2MG + 30MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X50.0X1.0X4.0 TABLET STRIP
NDA/MAL/HDP/2835LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSOLUDINE-MPOVIDONE IODINE / METRONIDAZOLE 5%W/W / 1%W/WLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE,1.0X125.0 G TUBE
NDA/MAL/HDP/3297LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDNEPIN-SR-20NIFEDIPINE20MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3321LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDERMOLIN-GMCLOBETASOL+GENTAMICIN+MICONAZOLE0.05%W/W+0.1%W/W+2%W/WLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/3341LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDAZILIN-250AZITHROMYCIN250MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3352LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDOMLINK-20OMEPRAZOLE20MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3369LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDAZILIN-500AZITHROMYCIN500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X3.0 TABLET BLISTER
NDA/MAL/HDP/0217ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPALETHERARTEMETHER80MG/MLLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY I M AMPOULES 2.0X3.0X1.0 ML AMPOULE
NDA/MAL/HDP/0222ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAVIR-200ACYCLOVIR500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0223ABACUS PHARMA LTDABACUS PARENTERAL DRUGS LIMITEDTOPCID-150RANITIDINE150MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/0225ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKON PLUSDICLOFENAC/SALICYLATE/MENTHOL/LINSEED1%W/W+10%W/W+5%W/W+3%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G CONTAINER
NDA/MAL/HDP/0250ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKONDICLOFENAC1%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G CONTAINER
NDA/MAL/HDP/0252LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-40ATORVASTATIN40MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0528ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDCLARY 500CLARITHROMYCIN500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0532ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSARTAN-50LOSARTAN POTASSIUM 50MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0610ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPYLOR KIT LANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)
NDA/MAL/HDP/0617ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSILVEXSILVER SULFADIAZINE + CHLORHEXIDINE1%W/W + 0.2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/0641ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGYNAZOLECLOTRIMAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/1559LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDOLOMOLPARACETAMOL500MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1684LINCOLN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDIBUN-200IBUPROFEN200MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1686LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1975LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBET-CODERM NBETAMETHASONE + NEOMYCIN0.1 W/W + 0.5 W/WLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4273LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSOLUDINE 10%POVIDINE IODINE10 %W/VLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIATOPICAL EXTERNAL LIQUIDS 1.0X1.0 L BOTTLE
NDA/MAL/HDP/4381LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITED DICLOFENAC SODIUMDICLOFENAC SODIUM50MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4402VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDCLOTRILINCLOTRIMAZOLE100MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIAVAGINAL TABLETS 1.0X6.0 TABLET STRIP
NDA/MAL/HDP/0623ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGELCIDMAGNESIUM SULPHATE50%W/VLINCOLN PHARMACEUTICALS LTD--11 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0X10.0 ML AMPOULE,1.0X10.0X5.0X5.0 ML AMPOULE IN BLISTER PACK
NDA/MAL/HDP/0995LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCOMOLPARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE250MG + 5MG + 10MG + 2MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1582LINCON PHARMCUETICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCEEPRO-500CIPROFLOXACIN500MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3241LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCLOTRILINCLOTRIMAZOLE1%W/WLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/4004LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDANTHELALBENDAZOLE400MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/4866LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCANFLUCONAZOLE150MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0 TABLET BLISTER
NDA/MAL/HDP/5100LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDL-GENTAGENTAMICIN0.3%W/VLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/6808ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGLYGEN-500METFORMIN HYDROCHLORIDE500MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8192LINCOLN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDL-KELFINSULPHADOXINE + PYRIMETHAMINE500MG + 25MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/8475LINCOLN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDOROCANMICONAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL TOPICAL GELS AND SOLS 1.0X15.0 G TUBE
NDA/MAL/HDP/4391LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDMOBYLE-AACECLOFENAC + PARACETAMOL100 MG + 325 MGLINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AT & POST KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6267DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDTRAMADOL DENK 50TRAMADOL HYDROCHLORIDE50MGLOSAN PHARMA GMBH- OTTO-HAHN-STR 13 79395 NEUENBURGGERMANYORAL SOLID ORDINARY EFFERVESCENT TABLETS 1.0X10.0 TABLET BOTTLE
NDA/MAL/HDP/8255KORLYNS THERAPEUTICS LTDMEDICATRIX (U) LTDPROSTAN EDLATANOPROST0.005%W/VLUNAN BETTER PHARMACEUTICAL CO., LTD.-NO.209, HONGQI AVENUE, LANSHAN DISTRICT LINYI, SHANDONG, 276006 CHINA +86-5398331258 ?CHINAOPHTHALMIC DROPS 1.0X6.0X2.5 ML BOTTLE
NDA/MAL/HDP/8470LUPIN LIMITEDAIVEEN (U) LIMITEDIXIME 400CEFIXIME400MGLUPIN LIMITED--198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/8471LUPIN LIMITEDAIVEEN (U) LIMITEDIXIME FOR ORAL SUSPENSIONCEFIXIME100MG/5MLLUPIN LIMITED--198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X75.0 ML BOTTLE
NDA/MAL/HDP/3020M.J BIOPHARM PVT LTDTATA UGANDA LIMITEDBIOSULIN NINSULIN ISOPHANE100 I.U/MLM.J .BIOPHARM-L7, M.I.D.C INDUSTRIAL AREA TALOJA, NAVI MUMBAI MAHARAHTRAINDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/3184M.J BOPHARM PUT LTDTATA UGANDA LIMITEDMONAN MEROPENEM1GM.J BIOPHARM PUT LTD -L-7 MIDC INDUSTRIOL DIST GAIDED TOLOJAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/1998M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDTEICO 500CEFEPIME500MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/3022M.J BIOPHARM PVT LTDTATA UGANDA LIMITEDBIOSULIN LINSULIN ZINC SUSPENSION100 I.U/MLM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAIINDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/3030MJ BIOPHARM PVT LTDTATA UGANDA LIMITEDBIOSULIN RINSULIN SOLUBLE100 IU/MLM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAIINDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/3143MJ BIOPHARM PVT LTDTATA UGANDA LIMITEDOMIPIX 20OMEPRAZOLE20 MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAIINDIAORAL SOLID ORDINARY CAPSULES 1.0X5.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3153M.J BIOPHARM PVT LTDTATA UGANDA LIMITEDCEFUROXIME-MJCEFUROXIME 750MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/3158MJ BIOPHARM PVT LTDTATA UGANDA LIMITEDGLIBEX-5GLIBENCLAMIDE5MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAIINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/3167MJ BIOPHARM PVT LTDTATA UGANDA LIMITEDMONAN-0.5GMEROPENEM0.5GM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X0.5 G VIAL
NDA/MAL/HDP/3180MJ BIOPHARM PVT LTDTATA UGANDA LIMITEDLOFIN 500METFORMIN HYDROCHLORIDE500MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAIINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3162M.J BIOPHARM PST LTDTATA UGANDA LIMITEDKLAROL LORATADINE10MGM.J BIOPHARM PVT LTD --L-7 MIDC TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAIINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2687M.J BIOPHARM PVT LTDTATA UGANDA LIMITEDTEICO 1000CEFEPIME1000MGM.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL
NDA/MAL/HDP/3453MJ BIOPHARM PVT LTDTATA UGANDA LIMITEDAMINOPHYLLINEAMINOPHYLLINE25MG/MLM.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAIINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X10.0 ML AMPOULE
NDA/MAL/HDP/4728M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDADRENALINEADRENALINEIMG/MLM.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAIINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0 ML AMPOULE<