Drug Register (August 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 Manufacturer Name of Drug Country of Manufacture Dosage Form Pack Size
NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDMEHTA UNANI PHARMACY & CO LTD-INDIARHINO BALMINDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER
NDA/MAL/HHP/5498AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAJANTA PHARMA LTD 31-0-AJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREACHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAFIGURININDIAORAL SOLID ORDINARY CAPSULES 1.0X6.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5502HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAGASEXINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE)
NDA/MAL/HHP/5503ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDPOOJA DRUGS-POOJA DRUGSAMODEX OINTMENTINDIATOPICAL EXTERNAL OINTMENTS 1.0X25.0 G JAR
NDA/MAL/HHP/5505VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDPLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIAAMPUCARE HERBAL OILINDIATOPICAL EXTERNAL LIQUIDS 1.0X50.0 ML BOTTLE
NDA/MAL/HHP/5508ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN HEALTHCARE LTD, CHENNAI-(42-45),LUZ CHURCH ROAD, MYLAPORE, CHENNAI INDIA -600004AMRUTANJAN DRAGON BALM INDIATOPICAL EXTERNAL OTHER OINTMENTS 1.0X9.0 G CONTAINER
NDA/MAL/HHP/5515HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAMENTATINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5516MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDVITAL CARE PVT LTD-361-362 GIDC POR RAMAGANDI VADODARAANCARE CAPSULESINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5517HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAMENTATINDIAORAL SOLID ORDINARY TABLETS 1.0X50.0 TABLET CONTAINER
NDA/MAL/HHP/5518MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDMEHTA UNANI PHARMACY & CO LTD-INDIAPENODEX OINTMENTINDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER
NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAJANTA 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.APDYL-H, HERBAL COUGH SYRUPINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HHP/5520HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAPILEXINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE),1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5522HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAHIMCOLININDIATOPICAL EXTERNAL EMULSION GELS 1.0X30.0 G TUBE
NDA/MAL/HHP/5524HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAHERBOLAXINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5527HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAKOFLETINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITED288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIAAQUARESTINDIAORAL SOLID ORDINARY POWDERS 1.0X10.0X765.0 MG SACHET
NDA/MAL/HHP/5529HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIALIV.52INDIAORAL 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) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIALIV.52 TABLETSINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE
NDA/MAL/HHP/5531HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIARUMALAYAINDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HHP/5532MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATIATMANANTHAN COLD RUBINDIANASAL TOPICAL OINTMENTS 1.0X12.0 G CONTAINER
NDA/MAL/HHP/5533HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIARUMALAYAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN SAMPLE)
NDA/MAL/HHP/5536ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIMENTHO PLUS PAIN BALMINDIANASAL 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/5538HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIASEPTILININDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5540HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIASEPTILININDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5544BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDPROPYLA BIOLOGICALS PVT LTD INDIA-GAT NO. 123, PIRANGUT,TALUK-MUISH, PUNE-412108BETASIL HERBAL LOZENGESINDIAORAL SOLID ORDINARY LOZENGES 1.0X32.0X2.0 LOZENGE STRIP
NDA/MAL/HHP/5547SHURIK LTDSHURIK LTDMEHTA HERBALS PVT LTD-INDIAMENTHOSIL COUGH DROPINDIAORAL SOLID ORDINARY LOZENGES 1.0X35.0X2.0 LOZENGE STRIP
NDA/MAL/HHP/5548EMAMI LTDJEET PHARMACEUTICALS LIMITEDEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIHIMANI FAST HERBAL PAIN RELIEF OINTMENTINDIATOPICAL 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/5549HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIABONISAN LIQUIDINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HHP/5551EMAMI LTDJEET PHARMACEUTICALS LIMITEDEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIHIMANI FAST HERBAL PAIN BALMINDIATOPICAL EXTERNAL OINTMENTS 1.0X25.0 ML BOTTLE
NDA/MAL/HHP/5553ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDLEAMARK HEALTHCAREPVT LTD-SARKHEJ-BAVLA HIGHWAY MATODA AHMEDABADMENTHOXYL DOUBLE ACTION HERBAL COUGH LOZENGESINDIAORAL SOLID ORDINARY LOZENGES 1.0X10.0X2.0 LOZENGE STRIP,1.0X50.0X2.0 LOZENGE STRIP
NDA/MAL/HHP/5554EMAMI LTDJEET PHARMACEUTICALS LIMITEDEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIHIMANI FIRST HERBAL PAIN RELIF SPRAYINDIATOPICAL EXTERNAL PRESSURISED AEROSOLS 1.0X150.0 ML CANNISTER
NDA/MAL/HHP/5556SHURIK LTDSHURIK LTDMETHA UNANI PHARMACY-INDIACOLD RUB VAPORIZINGINDIANASAL TOPICAL EMULSION OINTMENTS 1.0X5.0 G CONTAINER,1.0X9.0 G CONTAINER,1.0X10.0 G CONTAINER
NDA/MAL/HHP/5557BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDSYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136,BETA HEALTHCARE INTERNATIONAL LTD--PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYANEW BETA GRIPE WATERINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5558EMAMI LTDJEET PHARMACEUTICALS LIMITEDEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARIHIMANI FIRST HERBAL VAPOUR RUBINDIATOPICAL EXTERNAL OTHER OINTMENTS 1.0X25.0 ML JAR
NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDMEHTA UNANI PHARMACY & CO LTD-INDIASTAR SKIN OINTMENTINDIATOPICAL EXTERNAL OINTMENTS 1.0X12.0 G TUBE
NDA/MAL/HHP/5560AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIASTAMINAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5561MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDMEHTA HERBALS PVT LTD-AMRUTMANTHAN HOUSE, SADAR,RAJKOT,GUJARAT - 360 001,INDIA, RAJKOT, GUJARAT 360001, INDIACOLDDROP MEDICATED COUGH DROPSINDIAORAL SOLID ORDINARY LOZENGES 1.0X1.0X100.0 LOZENGE CARTON
NDA/MAL/HHP/5563HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIACYSTONEINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5565ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDPOOJA DRUGS-POOJA DRUGSDENTEX TOOTHACEINDIATOPICAL EXTERNAL LIQUIDS 1.0X5.0 ML BOTTLE
NDA/MAL/HHP/5567ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARINEW EMAMI MENTHOPLUS RELAXING BALMINDIATOPICAL EXTERNAL LIQUIDS 1.0X8.0 ML JAR
NDA/MAL/HHP/5569HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIADIAREXINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/5570PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH ? 173 205SITCOMINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HHP/5571ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN HEALTH CARE LIMITED-PLOT NO 37,38&39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TALUK, KANCHEEPURAM DISTRICT 603110, INDIADRAGON LIQUID BALMINDIATOPICAL EXTERNAL OTHER OINTMENTS 1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER
NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATENEW PINKOO GRIPE WATERINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HHP/5576SHURIK LTDSHURIK LTDMETHA UNANI PHARMACY-METHA UNANI PHARMACY G-524 LODHIKA, G.I.D.C METODANO SCAR CREAMINDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HHP/5580MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY EUGICA SYRUPVIETNAMORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HHP/5583HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAEVECAREINDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER
NDA/MAL/HHP/5593ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSYDLER REMEDIES PVT LTD -M-190, M.I.D.C, WALUJ, AURANGABAD 431 136 (M.S), INDIA. SYDLER GRIPE WATERINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HHP/5595HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIATENTEX ROYALINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5597CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIATOOCHE DROPSINDIAORAL TOPICAL DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HHP/5613ANDYCO PHARMACYANDYCO PHARMACY (UGANDA) LTDDR KIM AYURVEDIC PHARMACY-INDIASMOOTH COUGH DROPSINDIAORAL SOLID ORDINARY LOZENGES 1.0X100.0X2.0 LOZENGE STRIP
NDA/MAL/HHP/5616HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAV-GELINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVITAL CARE-INDIAVYBRANTINDIAORAL SOLID ORDINARY CAPSULES 5.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIAZECUF COLD RUBINDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G CONTAINER
NDA/MAL/HHP/5623UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDUNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210ZECUF HERBAL COUGH LOZENGES(FRUITY FLAVOUR)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP
NDA/MAL/HHP/5629UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAZECUF HERBAL COUGH LOZENGES(ORANGE FLAVOUR)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP
NDA/MAL/HHP/5630UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAZECUF HERBAL COUGH REMEDYINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/5631UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAZECUF HERBAL COUGH LOZENGES(LEMON)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP
NDA/MAL/HHP/6863KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIAKOFFENGES LOZENGES (HONEY & LEMON FLAVOUR)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER
NDA/MAL/HHP/7926HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDHOVID BERHAD-121, JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIAHOVID GINKO MALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HHP/7931DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDKIMSY MEDS LTDDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD,-NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN.LIBLAB SYRUPJORDANORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORISENSUR RUBEFACIENTINDIATOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HHP/7936SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212GILOBA 60 CAPSULEBANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X5.0X6.0 CAPSULE BLISTER
NDA/MAL/HHP/7937GLENMARK PHARMACEUTICAL LTD STAR PHARMACEUTICALS LTDGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORISENSUR OILINDIATOPICAL EXTERNAL LIQUIDS 1.0X10.0 ML VIAL
NDA/MAL/HHP/7938SQUARE HERBAL AND NUTRACEUTICALS LTD GAMA PHARMACEUTICALS (U) LIMITEDSQUARE HERBAL AND NUTRACEUTICALS LTD -48 MOHAKHALI COMERCIAL AREA, DHAKA-1212SILYBIN 140BANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/7939SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212GINTEXBANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X5.0X6.0 CAPSULE STRIP
NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORISENSUR LOTIONINDIATOPICAL EXTERNAL OTHER CREAMS 1.0X50.0 ML BOTTLE
NDA/MAL/HHP/7942MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY EUGICA FORTTHAILANDORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/7945STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDFAGRIS MEDICA PVT LTD-255,SATYAM MALL SATELLITE,AHMEDABAD 380015KOFKICH LOR HERBAL INDIAORAL SOLID ORDINARY LOZENGES 1.0X20.0 LOZENGE CARTON,1.0X50.0 LOZENGE CARTON,1.0X150.0 LOZENGE CARTON
NDA/MAL/HHP/7947UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAZECUF HERBAL COUGH LOZENGES(HONEY LEMON)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP
NDA/MAL/HHP/7948STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDFAGRIS MEDICA PVT LTD-255,SATYAM MALL SATELLITE,AHMEDABAD 380015KOFKICH LOR (LEMON FLAVOUR)INDIAORAL SOLID ORDINARY LOZENGES 1.0X20.0 LOZENGE CARTON,1.0X50.0 LOZENGE CARTON,1.0X150.0 LOZENGE CARTON
NDA/MAL/HHP/7949UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDUNIQUE PHARMACEUTICALS LABORATORIES--SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ?PLOT NO. 215-219, 396 210 INDIAZECUF HERBAL COUGH (SUGAR FREE)INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE CONTAINER
NDA/MAL/HHP/7950UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAZECUF HERBAL COUGH LOZENGES(RASPBERRY)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP
NDA/MAL/HHP/7954UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDUNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAZECUF HERBAL COUGH LOZENGES(PINEAPPLE)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE STRIP
NDA/MAL/HHP/7955KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA DICLODAY ROLL-ONINDIATOPICAL EXTERNAL EMULSIONS 1.0X50.0 ML BOTTLE
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NDA/MAL/HHP/7958KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIAKOFFENGES(GINGER FLAVOUR)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER
NDA/MAL/HHP/7960KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIAKOFFENGES(ORANGE FLAVOUR)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER
NDA/MAL/HHP/7961KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIAKOFFENGES LOZENGES MINTINDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0 LOZENGE BLISTER
NDA/MAL/HHP/7962GOODDAY P HARMACYL IMITEDGOOD DAY PHARMACY LIMITEDKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506KREMOINT BABY CARE GRIPE WATERINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X135.0 ML BOTTLE
NDA/MAL/HHP/7963KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA KOFFENGES(LEMON FLAVOUR)INDIAORAL SOLID ORDINARY LOZENGES 1.0X5.0X4.0 LOZENGE BLISTER
NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDPLANET PHARMACEUTICALS UGANDA LTDBHARGAVA PHYTOLAB PVT LTD-B-92, SECTOR ? 2 , NOIDA ? 201301, U.P. ( INDIA)KIDFLAMEINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0 TABLET BLISTER
NDA/MAL/HHP/7967STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDFAGRIS MEDICA PVT LTD-255,SATYAM MALL SATELLITE,AHMEDABAD 380015KOFKICH MIX HERBALINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/8070LEXINE TECHNOCHEM PVT LTD MUKWANO PHARMACEUTICALS LTDLEXINE TECHNOCHEM PVT LTD.-INDIAKWIK PAIN RELIEVING CREAM INDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HHP/8071EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTMOOVE MASSAGE CREAMEGYPTTOPICAL EXTERNAL LOTIONS 1.0X1.0X40.0 G TUBE
NDA/MAL/HHP/8215AMRUTANJAN HEALTH CARE LTD ABACUS PHARMA (A) LTD - WILSON LANEAMRUTANJAN HEALTH CARE LTD -103 COLD NO (42-45),LUZ CHURCH ROAD, MYLAPORE, CHENNAI INDIA -600004AMRUTANJAN DRAGON BACK PAIN ROLL-ONINDIATOPICAL EXTERNAL LOTIONS 1.0X50.0 ML CONTAINER
NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABADNOCOLICINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HHP/8288HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIADIABECONINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HHP/8289HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAGERIFORTEINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HHP/8290HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIAOPTHCAREINDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
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NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITED CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011M2 TONE TABLETINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8385GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHMEBOSCAR OINTMENTUNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (A) LTD - WILSON LANE CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011LIVOMYN SYRUPINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE
NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITED CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011ALKA 5 SYRUP INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/8507SYDLER REMEDIES PVT LTD M-190ROYAL PHARMA 2011 LIMITEDSYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136CUFSOL LOZENGES ORANGEINDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X50.0 LOZENGE BLISTER
NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITED CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011KOFOL SF SYRUPINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/8509CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITED CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011EVANOVA CAPSULEINDIAORAL SOLID ORDINARY CAPSULES 1.0X20.0 CAPSULE BLISTER
NDA/MAL/HHP/8510 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAFRICKS COUGH SYRUPINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIATHUNDER-MINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HHP/8548ARTURA PHARMACEUTICALS PVT LTDMEDVIN PHARMA LIMITEDARTURA PHARMACEUTICALS PVT LTD-PLOT NO. 1505 PORTIA ROAD SIRI CITY SEZ SATYAVEDU MANDAL CHITTOOR DISTRICT ANDHRA PRADESHI - 517 588 INDIAPEPSOLINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
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NDA/MAL/HHP/8550 UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL HARIDWAR-249403 UTTARAKHANDUNOCALMINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8551AMRUTANJAN HEALTHCARE LIMITEABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN 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, INDIAAMRUTANJAN RELIEF COUGH AND COLD SYRUPINDIAORAL LIQUID ORDINARY UNIT DOSE LIQUIDS 1.0X8.0 ML SACHET
NDA/MAL/HHP/8552AMRUTANJAN HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN 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, INDIAAMRUTANJAN DRAGON BALM INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X10.0 G TUBE
NDA/MAL/HHP/8553RAZA INTERNATIONALWIDE SPECTRUM ENTERPRISES (U) LIMITEDOZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANY?-SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET. OZONE INDUSTRIAL COMPLEX. P.O. BOX : 1764. AMMAN 11953, JORDANHONEY CUREJORDANTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HHP/8554OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LTDISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIADIGLOCINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8555MUSANA PHARMACEUTICALS LIMITEDMUSANA PHARMACEUTICALS LTDNIXON BIOTECH PRIVATE LIMITED-PLOT NO. 861 INDUSTRIAL AREA-4 LUDHIANA-3(PUNJAB) INDIANATURAL AIDINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X30.0 CAPSULE BOTTLE
NDA/MAL/HHP/8556MANKIND PHARMA LTD.TATA UGANDA LIMITEDTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAUNIORTHO-500INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HHP/8557MANKIND PHARMA LTD.TATA UGANDA LIMITEDTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAUNIORTHO-250INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
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NDA/MAL/HHP/8674OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LTDISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIAPYLKER TABLETSINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8675OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LTDISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIADIBCARE TABLETSINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8676OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LTDISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIASUTRIM TABLETSINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HHP/8837PILLAR LOGISTICS LIMITEDPILLAR LOGISTICS LIMITEDMILENNIUM HERBAL CARE LTD-12B, NIRMAL, 241/242, BACKBAY RECLAMATION, NARIMAN POINT, MUMBAI 400 021HEPTOVITINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/8840 UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL HARIDWAR-249403 UTTARAKHANDOBECONINDIAORAL SOLID ORDINARY CAPSULES 1.0X60.0 CAPSULE BOTTLE
NDA/MAL/HHP/8841DEWYX INTERNATIONAL LTDDEWXY PHARMACEUTICALS LTDBIO GALLERY-SDN BHDM-ENERGEX CAPSULESMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X50.0X1.0 CAPSULE BLISTER,1.0X25.0X1.0 CAPSULE BLISTER
NDA/MAL/HHP/8842DEWYX INTERNATIONAL LTDDEWXY PHARMACEUTICALS LTDBIO GALLERY-SDN BHDM-ENERGEX COFFEEMALAYSIAORAL SOLID ORDINARY POWDERS 1.0X10.0X20.0 G SACHET
NDA/MAL/HHP/8892NANO BIOPHARMA LIMITED UNEED GLOBAL GROUP LIMITEDNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRANANGIPARSIRANTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HHP/8893NANO BIOPHARMA LIMITED UNEED GLOBAL GROUP LIMITEDNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRANANGIPARSIRANORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HHP/8899LEXINE TECHNOCHEM PVT LTD MUKWANO PHARMACEUTICALS LTDLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373, OPP. RAMAKAKA DERI CHHANI, VADODARA ? 391704 GUJARAT, INDIA LEXICOF HERBAL COUGH SYRUPINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HHP/8900UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNOSOURCE PHARMA LTD -503/504, HUBTOWN SOLARIS, N.S PHADKE MARG, ANDHERRI EAST, MUMAI 400069 INDIAMIGROSTOPINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X60.0 CAPSULE CONTAINER
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NDA/MAL/HHP/8902NANO BIOPHARMA LIMITED UNEED GLOBAL GROUP LIMITEDNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRANANGIPARSIRANORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 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/0002ABACUS PARENTERAL DRUGS LIMITEDNAABACUS 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/0003UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOXIL CLAV 625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGUNI MEDICOLABS-21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 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/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/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/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/0008STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITEDOMEPRICOMEPRAZOLE DELAYED-RELEASE20MGACME FORMULATION PVT LTD.-ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID RETARD CAPSULES 1.0X10.0X10.0 CAPSULE 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/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/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/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/0016REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0017SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDHYCORTHYDROCORTISONE100MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X7.5 ML VIAL
NDA/MAL/HDP/0021SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDQUINSQUININE DIHYDROCHLORIDE 300MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE
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/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/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/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/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/0031MANKIND PHARM LTDTATA UGANDA LIMITEDCEFTATIME-SB 1.5CEFTRIAXONE+SULBACTAM1000MG+500MGMANKIND PHARMA LTD--VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESHINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.5 G VIAL
NDA/MAL/HDP/0036MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDDOCETAXEL FOR INJECTION DOCETAXEL40MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA. INDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL + 1*6ML SOLVENT FOR RECONSTITUTION
NDA/MAL/HDP/0037MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDL-ASPASEL-ASPARGINASE 1000 I.UNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA. INDIAPARENTERAL ORDINARY I M VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/0038MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDARZI 200DACARBAZINE FOR INJECTION USP200MGNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA. INDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/0039MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNZYTOPETOPOSIDE INJECTION USP100MGNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA. INDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL
NDA/MAL/HDP/0041 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCIMETIDINE200MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0042MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDCISPLATINCISPLATIN1MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA. INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML VIAL
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/0044MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRO-TAXPACLITAXEL6MG/MLNAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA. INDIAPARENTERAL ORDINARY OTHER VIALS 1.0X1.0X20.0 ML VIAL
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/0046MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDABINGEM GEMCITABINE1GNAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/0047MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIHOPE ETEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG + 300MG + 300MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK ?N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/0051H. LUNDBECK A/S PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBYDENMARKPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICALS CO -36 DR MOHAMED HASSAN EL GAMAL ST. 6TH DISTRICT NASR CITY, CAIROEGYPTTOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/0053H. LUNDBECK A/S PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGENDENMARKPARENTERAL RETARD AMPOULES 1.0X1.0 ML AMPOULE
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/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGENDENMARKPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPS DICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIAINDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS 1.0X30.0 ML BOTTLE
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/0059NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. PAKISTANTOPICAL EXTERNAL CREAMS 1.0X40.0 G TUBE + 1 APPLICATOR
NDA/MAL/HDP/0060MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 300 IU/0,5 ML (22 ?G/0,5 ML)FOLLITROPIN ALFA22 ?G/0,5 MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.0 CARTRIDGE PREFILLED PEN + 5 NEEDLES FOR INJECTION, 1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION
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/0064MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 450 IU/ IE 0,75 ML (33 ?G)FOLLITROPIN ALFA33?G/ 0.7MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY CARTRIDGES 1.0X1.0 CARTRIDGE PREFILLED PEN + 7 NEEDLES FOR INJECTION, 1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION
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/0067SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDARTEES?-? ARTEETHER75MG/MLSAKAR HEALTHCARE PVT LTD --406, SILVER OAKS COMMERCIAL COMPLEX,INDIAPARENTERAL ORDINARY AMPOULES 1.0X3.2 ML AMPOULE
NDA/MAL/HDP/0069PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN10MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICOGERMANYORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BLISTER
NDA/MAL/HDP/0070PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN20MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICOGERMANYORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BLISTER
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/0072VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTDAMTERICINAMPHOTERICIN50MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X50.0 MG VIAL
NDA/MAL/HDP/0075 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSYNRIAMARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE150 MG + 750 MGSUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER
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/0079MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDREVOKE 72LEVONORGESTREL750MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER
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/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/0083MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDZINNIA-FLEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE150MCG + 30MCG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X28.0 TABLET BLISTER
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/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/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/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/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/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/0097MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0098MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 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/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/0102MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X2.0 TABLET BLISTER
NDA/MAL/HDP/0103MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0104MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X2.0 TABLET 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/0106MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDSAFELEVOLEVOFLOXACIN500MG/100MLMARCK BIOSCIENCES -PLOT NO 876, NH NO 8 HARIYALA KHEDA- 387411 GUJARAT, INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0107NVS KENYA LTD SURGIPHARM (U) LIMITEDASUNRA DEFERASIROX400MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSESWITZERLANDORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X5.0X6.0 TABLET BLISTER
NDA/MAL/HDP/0110MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0111MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0112NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE 5MG/160MGAMLODIPINE + VALSARTAN5 MG + 160 MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAINSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/0114MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDBREATHEZY 4MONTELUKAST SODIUM 4MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0116MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 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/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/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/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/0129HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPIOGENPIOGLITAZONE HYDROCHLORIDE15MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY 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/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
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/0142PFIZER LAB LTDLABOREX UGANDA LIMITEDPREVENAR 13PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT.ADSORBED)2.2MCG OF POLYSACCHARIDE FOR SEROTYPES 1,3,4,5,6A,7F.9V,14,18C,19A,19F,23F,AND 4.4MCG FOR SEROTYPE 6BWYETH PHARMACEUTICALS INC-401 N MIDDLETOWN RD PEARL RIVER NY 10965UNITED STATESPARENTERAL ORDINARY VIALS 1.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/0143UNIMED INDIAMETAPLUS (U) LIMITEDSPECTRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLUNIMED INDIA.-UNI-MED HOUSE, 86,MAROL COOPORATIVE INDUSTRIAL ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0144MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDNEXQUIN 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0145MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDTELKAST 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0146MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCEF2 250CEFUROXIME AXETIL250MGMEDREICH LIMITED UNIT-5-PLOT 45 A & B, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, TELANGANA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0147MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCEF 2 500CEFUROXIME AXETIL500MGMEDREICH LIMITED UNIT-5-PLOT 45 A & B, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, TELANGANA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0148MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSYNCLAV 1000AMOXICILLIN + CLAVULANATE POTASSIUM875 MG + 125 MGMEDREICH LIMITED UNIT 1-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR, BANGOLORE-560049,MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/0149MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSYNCLAV 625AMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA ,MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/0150MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSYNCLAV 228AMOXYCILLIN + CLAVULANATE POTASSIUM200 MG + 28.5 MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/0151MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCARDITEL 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY 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/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0158MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0161RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0162 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENAREN PROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/0168MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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/0175BAYER PHARMA AGSURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0177MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDILET B2 GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG+500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0178REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAYTIME AND NIGHT TIME CAPSULE DAY TIME(PARACETAMOL +CAFFEINE ANHYDROUS+PSEUDOEPHDRINE HCL) AND NIGHT TIME(PARACETAMOL +CHLORPHENIRAMINE MALEATE)DAY TIME (500MG + 30MG + 30MG) AND NIGHT TIME (500MG +2MG)REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X3.0X8.0 CAPSULE BLISTER
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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
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NDA/MAL/HDP/0298SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDSEFIXI-50 DRY SYRUPCEFIXIME50MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE
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/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/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/0303HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDABACAVIR SULPHATE ABACAVIR SULPHATE300MGHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER
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/0305SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250 DRY SYRUPCEFALEXIN250MG/5MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0308SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250CEFALEXIN250MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0310YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDLATRENPENTOXIFYLLINE0.5MG/MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/0312SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPA ORAL SOLUTION 125CLOXACILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA -BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844UNITED KINGDOMORAL LIQUID ORDINARY LIQUIDS 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/0316YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDOFLOXACIN-UFOFLOXACIN2MG/MLYURIA-PHARM, LTD. -18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE..UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/0317YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDCIPROFLOXACIN-UFCIPROFLOXACIN2MG/MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE
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/0322MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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/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/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/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/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/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/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/0337IND-SWIFTTATA UGANDA LIMITEDSWAZI *500 AZITHROMYCIN500MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 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/0339IND-SWIFTTATA UGANDA LIMITEDSWAZI *250 AZITHROMYCIN250MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER
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/0341IND SWIFT LTDTATA UGANDA LIMITEDTELSWIFT- H 40TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0342IND SWIFT LTDTATA UGANDA LIMITEDTELSWIFT- H 80TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER
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/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/0349SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDCLAXY 1.2 GCOAMOXICLAV1.2GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.2 G VIAL
NDA/MAL/HDP/0350 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/0352HARLEYS UGANDA LIMITEDHARLEYS UGANDA LIMITEDANLODIN TABLET 5MG AMLODIPINE5MGY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIAMALAYSIAORAL 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/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/0355SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/0356DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 50OLEVOFLOXACIN HEMIHYDRATE500MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0358SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY I M VIALS 1.0X1.0 G VIAL
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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
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NDA/MAL/HDP/0365UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDSULFRAN- DSTRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
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/0368ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDQUININE DI HYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUCHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0372UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEZYNCETLEVOCETIRIZINE 5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER,5.0X2.0X10.0 TABLET BLISTER
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
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NDA/MAL/HDP/0380MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAVERNOLCARVEDILOL6.25NGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0381MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDEFAVIRENZ/EMTRICITABINE/TENOFOVIR EFAVIRENZ + EMTRICITABINE + TENOFOVIR600MG + 200MG + 300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
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
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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/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/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/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/0390PT NOVELL PHARMACEUTICAL LABORATORIES ECHO PHARMACY (U) LIMITEDTUSSIGONDEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE/CHLORPHENAMINE/GUAIFENESIN10MG/30MG/2MG/100MGPT NOVELL PHARMACEUTICAL LABORATORIES -J1 WANAHERANG NO. 35, TLAJUNG UDIK, GUNUNG PUTRI, BORGO 16962 INDONESIAINDONESIAORAL LIQUID ORDINARY LIQUIDS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
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/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/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/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/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/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/0403NEON LABARATORIES LTDAIVEEN (U) LIMITEDSUPRIDOLTRAMADOL HYDROCHLORIDE 50MG/ML NEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRAINDIAPARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE
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/0405NEON LABARATORIES LTDAIVEEN (U) LIMITEDCHEMLETLETROZOLE2.5MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0406NEON LABARATORIES LTDAIVEEN (U) LIMITEDEVATOCINOXYTOCIN10 I.U./ ML NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/0407NEON LABARATORIES LTDAIVEEN (U) LIMITEDNEOROFPROPOFOL1%W/VNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRAINDIAPARENTERAL ORDINARY I V AMPOULES 1.0X20.0 ML AMPOULE
NDA/MAL/HDP/0408MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDALGIC - PACECLOFENAC + PARACETAMOL100 MG + 500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0409NEON LABARATORIES LTDAIVEEN (U) LIMITEDTYDE-S*CHLORAMPHENICOL SODIUM SUCCINATE1G/VIALNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/0410MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDLDNIL 20ROSUVASTATIN CALCIUM 20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLA SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS 1.0X3.0X1.0 IMPLANT STRIP
NDA/MAL/HDP/0412MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDLDNIL 5ROSUVASTATIN CALCIUM5MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0413NEON LABARATORIES LTDAIVEEN (U) LIMITEDXSPASHYOSCINE BUTYLBROMIDE20MG/MLNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRAINDIAPARENTERAL ORDINARY I V AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/0415MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRELEXDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL14.03MG+138MG+57.03MG+0.90MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
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/0421MSN LABORATORIES LTDSTAR PHARMACEUTICALS LTDPREGASAFE 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
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/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
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/0427MICRO LABS LTD LABOREX UGANDA LIMITEDAMLOZAAR -HLOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE50MG + 5MG + 12.5MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0428MICRO LABS LTD LABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X5.0 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/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/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/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/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/0449PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD GRANULESCYANOCOBALAMIN5MCGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY GRANULES 1.0X10.0X5.0 G SACHET
NDA/MAL/HDP/0453PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD LIQUIDAMINO ACIDS + MULTIVITAMINSMULTI INGREDIENTS STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE
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/0458NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE 5MG/80MGAMLODIPINE + VALSARTAN5 MG + 80 MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE,NOVARTIS FARMACEUTICA SA,-BARBERA DEL VALLES BARCELONA SPAINSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 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/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/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/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/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/0468NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXIT 750CEFUROXIME750MGNECTAR LIFESCIENCES LIMITED-VILL. BHATOLIKALAN, ADJOININGJHARMJRI, P.O BAROTIWALA DIST SOLAN H.P 173205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X750.0 MG VIAL + 10ML WFI AMPOULE
NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY DRY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN
NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN
NDA/MAL/HDP/0472SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDBCG VACCINE (FREEZE DRIED)BCG VACCINE(FREEZE DRIED)1.33*100000 C.F.U/0.1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 ML VIAL,1.0X0.5 ML VIAL
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/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/0481BIOCON LTDABACUS PHARMA (AFRICA) LIMITEDERYPRO SAFE 4000RECOMBINANT HUMAN ERYTHROPOETIN 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/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/0483FOUNTIL LIFE SCIENCES PVT LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDULGICID TABLETSALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE+ MAGNESIUM TRISILICATE + SIMETICONE200MG + 250MG + 250MG + 250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/0484KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPILPLAN PLUSETHINYLESTRADIOL + 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/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/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/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/0490SISONKELABOREX UGANDA LIMITEDORELOXCEFPODOXIME200MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE 56, RUE DE CHOISY AU BAC 60205 COMPI?GNE FRANCEORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
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/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/0493MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDPRASUSAFE 10PRASUGREL10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 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/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
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/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/0499NVS KENYA LTD SURGIPHARM (U) LIMITEDBANEOCIN OINTMENTBACITRACIN ZINC+NEOMYCIN SULPHATE250I.U + 5000I.UMERCK KGAA & CO.-HOSSLGASSE 20 9800 SPITTAL DRAU/ AUSTRIAAUSTRIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE
NDA/MAL/HDP/0502STEDMAN PHARMACEUTICALS LTDVEERAM HEALTHCARE (U) LIMITEDDREZ GARGLEIODINATED POVIDONE2%W/VSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0504NVS KENYA LTD SURGIPHARM (U) LIMITEDBANEOCIN POWDERBACITRACIN/NEOMYCIN SULPHATE250/5000I.U/5MGPHARMAZEUTISCHE FABRIK MONTAVIT GES M.B.H-SALZBERGSTRABE 96 6060 ABSAM/ TYROL,AUSTRIAAUSTRIATOPICAL EXTERNAL POWDERS 1.0X10.0 G CONTAINER
NDA/MAL/HDP/0505MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE75MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0506REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.OPTA-ATROPINE EYE DROPSATROPINE SULPHATE1%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAMPAKISTANOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/0507FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDFILDILOL 12.5CARVEDILOL12.5 MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 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/0509FOURRTS (INDIA) LABORATORIES (PVT) LTDDELMAW ENTERPRISES LIMITEDFILDILOL 25CARVEDILOL25MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/0511STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDLAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE150MG + 200MG + 300MGSTRIDES ARCOLAB LIMITED .-PLOT 9-12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR, MAHARASHTRA 401404INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/0512FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 10ATORVASTATIN CALCIUM10MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, 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/0515FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 20ATORVASTATIN20MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0517SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDSHANVAC -BR- DNA HEPATITIS -B SURFACE ANTIGEN PURIFIED20MCG/MLSHANTHA BIOTECHNICS LTD -SURVEY NO. 274, ATHVELLI VILLAGE, MEDCHAL MANDAL ? 501401, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X35.0X1.0 ML VIAL (1 ADULT DOSE),1.0X35.0X0.5 ML VIAL (1 PEDIATRIC DOSE)
NDA/MAL/HDP/0518RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCYCLORENACICLOVIR200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
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/0520FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDFILSTAT 40ATORVASTATIN CALCIUM40MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL 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/0522MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDVAZORTAN 50 LOSARTAN POTASSIUM50MGMEDLEY PHARMACEUTICALS LTD -PLOT NO. 18 AND 19, SURVEY NO. 378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM , DAMAN-396 210, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0524MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDXAFEN-60FEXOFENADINE HYDROCHLORIDE 60MGMEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 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/0527MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDXAFEN-120FEXOFENADINE HYDROCHLORIDE120MGMEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 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/0529 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV AMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGMEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML CONTAINER
NDA/MAL/HDP/0530MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDXAFEN-180FEXOFENADINE HYDROCHLORIDE180 MGMEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 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/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/0533MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDTELKAST 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0534 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 375AMOXICILLIN + POTASSIUM CLAVULANATE250 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X6.0 TABLET BLISTER
NDA/MAL/HDP/0536 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 625AMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X6.0 TABLET BLISTER
NDA/MAL/HDP/0538MICRO LABS LTD LABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0539MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDTELKAST 4MONTELUKAST SODIUM4MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 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/0543UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 2GLIMEPIRIDE2MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0548UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICAST MONTELUKAST 5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITYJORDANORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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/0551SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDREDAMOXAMOXICILLIN + CLAVULANIC ACID125 MG/ 5 ML + 31.25 MG/ 5 ML SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/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/0554ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINDOCAP-25INDOMETHACIN25 MG 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/0555HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDCARZEPINCARBAMAZEPINE200MGHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/0557SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDREDAMOX 312.5AMOXICILLIN + POTASSIUM CLAVULANATE250 MG/5 ML + 62.5 MG/5 MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/0559HOVID BHD MEDICAL ACCESS (UGANDA) LIMITEDDIABETMIN RETARDMETFORMIN HYDROCHLORIDE850MGHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIAMALAYSIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0560UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 1GLIMEPIRIDE1MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITYJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET 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/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/0563IND SWIFT LTDTATA UGANDA LIMITEDEZO 40ESOMEPRAZOLE MAGNESIUM 40MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIINDIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0565YURIA PHARM LTDYURIA PHARM EAST AFRICA LIMITEDAMINOCAPROIC ACID-UFAMINOCARPROIC ACID5G/100MLYURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0566SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTIL SUSPENSIONCEFUROXIME AXETIL125MG/5MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1.0X50.0 ML BOTTLE
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/0568 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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/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/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/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/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/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/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/0578TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDXYKAA RAPIDPARACETAMOL500MGTROIKAA PHARMACUETICALS LIMITED-C-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/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/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/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/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/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/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/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/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/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/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/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/0596MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
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/0599MICRO LABS LTD LABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 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/0603MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDGROMIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
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/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/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/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/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/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID126 MG/ 5 ML + 31.25 MG/ 5 ML SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE
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/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/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/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/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/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
NDA/MAL/HDP/0625SANOFI PASTEURLABOREX UGANDA LIMITEDVERORABRABIES VACCINE1 DOSESANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY VIALS 1.0X1.0 DOSE VIAL
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/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/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/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/0634MEDLEY PHARMACEUTICALS MEDVIN PHARMA LIMITEDTRISOLIVANDROGRAPHOLIDES/TRICHOLINE CITRATE50MCG+50MG/MLMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
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/0636MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDREVOKE-1.5LEVONORGESTREL1.5MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
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/0639NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/0640SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDBIODROXIL 250MG/5MLCEFADROXIL (ANHYDROUS)250MG/5MLSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
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/0642SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES.SURGIPHARM (U) LIMITEDBIODROXIL 125MG/5ML CEFADROXIL (ANHYDROUS)125MG/5MLSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/0647SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDBIODROXIL 1000MG TABLETSCEFADROXIL (ANHYDROUS)1000MGSANDOZ GMBH-BIOCHEMIESTRA?E 10 A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY TABLETS 1.0X2.0X6.0 TABLET BLISTER
NDA/MAL/HDP/0651SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDBIODROXIL 500MGCEFADROXIL (ANHYDROUS)500MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/0652NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUSVILDAGLIPTIN50MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS BARBERA -SPAINSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER
NDA/MAL/HDP/0654NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/0657NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS MET VILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER
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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/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
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NDA/MAL/HDP/0666HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDIRBIS-H 300IRBESARTAN300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
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/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/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/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
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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/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/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/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/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/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/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/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/0690MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHEALTHEASE CREAMBECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/0691MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET 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/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250 AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
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/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/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/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 G VIAL
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/0704HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDM-FLOXMOXIFLOXACIN HYDROCHLORIDE400MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA,HETERO LABS LTD-UNIT II & III BADDI THE NALAGARH DIST SOLAN H.PINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER, 10.0X1.0X5.0 TABLET BLISTER
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/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/0707HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPENVIR 500FAMCICLOVIR500MGHETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 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/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/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
NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLINGERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X14.0 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/0719WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 4000RECOMBINANT HUMAN ERYTHROPOIETIN4000 I.UWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.4 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/0720STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDJUSDEE 400 DROPSCOLECALCIFEROL400 I.U/MLSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE
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/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/0724JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDNIZORALKETOCONAZOLE200MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X10.0 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/0726TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE 50MGTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/0727MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTOMACH FIT SYRUPBISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL140MG+9MG+0.15MG+0.2/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X225.0 ML BOTTLE
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/0734ANHIUMAISHA MEDICAL SUPPLIES LIMITEDOMMED -20OMEPRAZOLE20MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/0736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMABRON 50TRAMADOL HYDROCHLORIDE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0737SANOFI AVENTIS LABOREX UGANDA LIMITEDTAXOTERE 80MGDOCETAXEL TRIHYDRATE80MG/4MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X4.0 ML VIAL
NDA/MAL/HDP/0738INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDCIPRIND-500CIPROFLOXACIN500MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X200.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0739SANOFI AVENTISLABOREX UGANDA LIMITEDTAXOTERE 20MGDOCETAXEL TRIHYDRATE20MG/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOESCHST,BRUNINGSTRASSEN BUIDING,H65065926, FRANKFURT AM MAINGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0 ML VIAL
NDA/MAL/HDP/0740MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCOTRIMCO-TRIMOXAZOLE960MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY TABLETS 1.0X17.0X6.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
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/0742MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDBROTMETFORMIN HYDROCHLORIDE500MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 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/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/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/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/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/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/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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/0754DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDTORAS DENK 10TORASEMIDE10MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0755TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDT- DOL TRAMADOL HYDROCHLORIDE50MG/ML TROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE
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/0759MICRO LABS LTDLABOREX UGANDA LIMITEDCOTRIMOXAZOLECOTRIMOXAZOLE960MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/0760STRIDESSUPER PHARMACEUTICALS LIMITEDCEFAXCEFTRIAXONE1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X1.0 G VIAL
NDA/MAL/HDP/0761BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDBENZILINBENZATHINE BENZYLPENICILLIN 2.4MEGA/VIALREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X2.4 MU VIAL
NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/0765PHARM ACCESS AFRICA LTDUNITED HEALTHCARE DISTRIBUTORS LTDLEVOPLANTLEVONORGESTREL75MGSHANGHAI DAHUA PHARMACEUTICAL CO. LTD-CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAICHINAPARENTERAL RETARD IMPLANTS 1.0X10.0X2.0 ROD IMPLANT
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/0769BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDAMPIL-1000AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0 VIAL CARTON
NDA/MAL/HDP/0770BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDAMPIL-500AMPICILLIN500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X500.0 MG VIAL
NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
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/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 75PREGABALIN75MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE 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/0779STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDVITAFIL ZCHROMIUM + ZINC + THIAMINE + RIBOFLAVINE + PYRIDOXINE + FOLIC ACID + NICOTINAMIDE + ASCORBIC ACID1.667MG + 42MG + 12MG + 11.5MG + 3.6MG + 1.2MG + 52.5MG + 165MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE 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/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/0787MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV DRY SYRUPAMOXICILLIN + CLAVULANIC ACID250 MG + 62.5 MG/5 MLMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/0794REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.AMYGYDEXTOBRAMYCIN/DEXAMETHASONE3MG+1MG/MLREMINGTON PHARMACEUTICALS (PVT) LTD-18KM, MULTAN ROAD, LAHORE 53800, PAKISTANPAKISTANOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/0795 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOPEN-250PHENOXYMETHYL PENICILLIN POTASSIUM250MGMILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI)INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0796HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDAMLO-H 5AMLODIPINE BESILATE5MGHETERO 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 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0797NVS KENYA LTD SURGIPHARM (U) LIMITEDAFINITOR 5MGEVEROLIMUS5MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BLISTER
NDA/MAL/HDP/0798HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDAMLO-H 10AMLODIPINE BESILATE10MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0799NVS KENYA LTD SURGIPHARM (U) LIMITEDAFINITOR 10MGEVEROLIMUS10MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BLISTER
NDA/MAL/HDP/0802NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE HCT 5MG/ 160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE5MG+ 160MG+ 12.5MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAINSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/0806SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSQUARE ZINCZINC SULPHATE20MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0808PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDISOFLURANEISOFLURANE250MLPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESHINDIAOTHER SYSTEMIC LIQUID INHALATIONS 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0809BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDPARAPAEDPARACETAMOL120MG/5MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELANDIRELANDORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0812BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDFENPAEDIBUPROFEN100MG/5MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELANDIRELANDORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0814MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDCANCYTCYTARABINE100MG/5MLNAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA INDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL
NDA/MAL/HDP/0815NAPROD LIFE SCIENCES PVT LTDAIVEEN (U) LTD - WILSON ROADABINGEM-200GEMCITABINE200MGNAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X200.0 MG VIAL
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/0820MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFIXIME 400MG CEFIXIME400MGNKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X1.0X10.0 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/0822ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM FOR INJECTION500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 G VIAL
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/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/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER
NDA/MAL/HDP/0832MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 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/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/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/0841MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDETHOMIDETHIONAMIDE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
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/0843MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDCOXERINCYCLOSERINE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP
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/0846MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/0849MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMONOPAS-4GPARA-AMINOSALICYLATE SODIUM60%W/WMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIAORAL SOLID RETARD GRANULES 1.0X30.0X4.0 G SACHET
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/0852MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDKAPOCIN-1GCAPREOMYCIN1000MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0 VIAL CARTON
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/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/0856MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDKANAMAC-1000KANAMYCIN1GMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X1000.0 MG VIAL
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/0858ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/0860MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDFLOXSAFE 400MOXIFLOXACIN HYDROCHLORIDE 400MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/0861SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDPROZINEPROMETHAZINE25MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 2.0X5.0X2.0 ML AMPOULE
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/0864HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM40 MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/0867HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDPANTIN-20PANTOPRAZOLE SODIUM20MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0868SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDVARMIKA-500AMIKACIN500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/0869SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDLARTRMARTEMETHER80MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE
NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/0871SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDDEXADEXAMETHASONE SODIUM4MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY DRY VIALS 2.0X6.0X2.0 ML VIAL
NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN 10I.U/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
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/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/0882MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/2.5MGMETFORMIN + GLIBENCLAMIDE500MG + 2.5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER
NDA/MAL/HDP/0883MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/5MGMETFORMIN + GLIBENCLAMIDE500MG + 5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER
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/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/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/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTH SODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/0898HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLOSAGEN 50 LOSARTAN POTASSIUM50MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 10 ML VIAL WFI
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/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/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/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/0905NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPODCEFPODOXIME PROXETIL200MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE
NDA/MAL/HDP/0907NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXITCEFUROXIME AXETIL250MGNECTAR LIFE SCIENCES LTD--UNIT VI BHATOLIKALAN DIST SOLAN H.PINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET STRIP
NDA/MAL/HDP/0908VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYOPT PLUSSODIUM HYALURONATE11.9MG/0.85MLVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.85 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/0909NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDFIXINECTCEFIXIME100MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP
NDA/MAL/HDP/0911VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHEALACE RECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B100MCG/GVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE
NDA/MAL/HDP/0913NOVARTIS PHARMA SURGIPHARM (U) LIMITEDFEMARA LETROZOLE2.5MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0914VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDOSTEOTIDETERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION250MCG/MLVIRCHOW BIOTECH PVT LTD -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT ANDHRA PRADESHINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X3.0 ML VIAL
NDA/MAL/HDP/0915NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAM AMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X2.0 TABLET STRIP
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/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP
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/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/0931LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH JUNIORALPHA-BETA ARTEETHER75MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X3.0X1.0 ML AMPOULE
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/0938FEROZSONS LABORATORIES LTDTOP UNIVERSAL MEDICARE LIMITEDESOMEGA 20MGESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE PELLETS20MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/0939LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARHALPHA -BETA ARTEETHER150MG /2MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X3.0X2.0 ML AMPOULE
NDA/MAL/HDP/0940FEROZSONS LABORATORIES LTDTOP UNIVERSAL MEDICARE LIMITEDESOMEGA 40MG ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE PELLETS40MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
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/0942LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH FORTEALPHA -BETA ARTEETHER225MG/ 3MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X3.0X3.0 ML AMPOULE
NDA/MAL/HDP/0943MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSTREPTOMYCIN INJECTION BPSTREPTOMYCIN1GMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAPARENTERAL ORDINARY DRY VIALS 1.0X100.0X1.0 G VIAL
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/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/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/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/0951NEON LABARATORIES LTDAIVEEN (U) LIMITEDNORADSTERILE NORADRENALINE CONCENTRATE2MG/2MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY S C AMPOULES 1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/0952NEON LABARATORIES LTDAIVEEN (U) LIMITEDEFECATALCEFTRIAXONE1GNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/0953NEON LABARATORIES LTDAIVEEN (U) LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/0954NEON LABARATORIES LTDAIVEEN (U) LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL RETARD OTHER VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/0957MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDLYRED SYRUPVITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC2500 IU + 10 IU + 50MG + 35MCG + 3MGTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
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, 1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER
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/0966SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCLOFENAC DTDICLOFENAC SODIUM50MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0967I CARE PHARMA LIMITEDVITACARE LTDSTREPTOMYCIN STREPTOMYCIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY VIALS 1.0X10.0 VIAL CARTON
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/0971I CARE PHARMA LIMITEDVITACARE LTDBENZYLPENICILLIN INJECTIONBENZYL PENICILLIN SODIUM1MUREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY I M VIALS 1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON
NDA/MAL/HDP/0972 PHARCO PHARMACEUTICALS COMPANY LTDECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN DIHYDRATE200 MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/0974SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME100MG/5MLSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/0975 PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDCETRAK SYRUPCETIRIZINE DIHYDROCHLORIDE5MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/0977 PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDCETRAKCETIRIZINE DIHYDROCHLORIDE10MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0978SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDAMBROX 75 SR CAPSULEAMBROXOL75MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0980 PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN250MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL SOLID ORDINARY CAPSULES 1.0X1.0X6.0 CAPSULE 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/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/0983SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDANADOL CAPSULESTRAMADOL HYDROCHLORIDE 50MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE 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/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/0987SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALATROL TABLETS CETIRIZINE10MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 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/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/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/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/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/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/1000TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE
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/1002SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCIPROCIN T 750CIPROFLOXACIN750MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 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/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 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/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/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/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/1012NEON LABARATORIES LTDAIVEEN (U) LIMITEDLOX 2%LIDOCAINE2% W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY OTHER VIALS 1.0X50.0 ML VIAL
NDA/MAL/HDP/1013NEON LABARATORIES LTDAIVEEN (U) LIMITEDTHIOSOLTHIOPENTAL SODIUM500MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X20.0 ML VIAL
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/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/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/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/1023MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDZINNIA PLEVONORGESTREL + ETHINYLESTRADIOL 150MCG + 30MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, INDIAORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BLISTER
NDA/MAL/HDP/1025SANOFI ?AVENTIS DEUTSCHLANDLABOREX UGANDA LIMITEDINSUMAN COMB 30INSULIN HUMAN100IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X3.0 ML PRE- FILLED SYRINGE
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/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/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/1034VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX AMOXICILLIN250MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUSCYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/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/1038SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME TRIHYDRATE 200MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X2.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/1040SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3 DSCEFIXIME TRIHYDRATE 400MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X1.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/1041SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITINRECOMBINANT HUMAN ERYTHROPOIETIN4000 I.U/1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X1.0X1.0 ML VIAL
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/1043SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDFLEXI 100 ACECLOFENAC100MGSQUARE PHARMACEUTICALS LTD-KALIAKOIRBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1044UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDANGINET 80MGVALSARTAN80MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1045SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIMAX 500 AZITHROMYCIN500MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/1047UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 180MGFEXOFENADINE 180MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X15.0 TABLET BLISTER
NDA/MAL/HDP/1048UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 120MGFEXOFENADINE120MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X15.0 TABLET BLISTER
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/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/1051UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIVAL 300MGSODIUM VALPROATE300MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X50.0 TABLET CONTAINER
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/1053AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN-125 DT AMOXICILLIN125MGMILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI)INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
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
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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
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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
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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
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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
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NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
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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
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NDA/MAL/HDP/1141LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONECALCIUM CARBONATE + COLECALCIFEROL250MG+125MG/5MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
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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
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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/1148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONTMONTELUKAST10MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1149UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDNEUROBAGABAPENTIN300MGUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYUKENYAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1154 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITED-INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 1.0X30.0 ML VIAL
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/1157Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDTRETINON TRETINOIN0.05%W/WY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/1159Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDVORENDICLOFENAC SODIUM 50MGY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIAMALAYSIARECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X10.0X10.0 SUPPOSITORY STRIP
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/1163NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDFRUSEMIDE FUROSEMIDE40MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE ? 401 210, MAHARASHTRA ? INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1166PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/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/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/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/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/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/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/1179MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDOVITRELLECHORIOGONADOTROPIN ALFA250MCG/0.5MLMERCK SERONO SA-1170 AUBONNE(SWITZERLAND),MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALYSWITZERLANDPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/1180SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIF TIMED RELEASED CAPSULESDRIED FERROUS SULPHATE+ZINC SULPHATE MONOHYDRATE+FOLIC ACID150MG+61.8MG+0.5MGSQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID RETARD CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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/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/1194VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDPISAPIPERACILLIN + TAZOBACTAM4000MG/VIAL + 500MG/VIALVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X30.0 ML VIAL
NDA/MAL/HDP/1195UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDALTRINECETIRIZINE5MG/5MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE
NDA/MAL/HDP/1196UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDACNESOLTRETINOIN0.05%W/WUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYUKENYATOPICAL EXTERNAL CREAMS 1.0X25.0 G TUBE
NDA/MAL/HDP/1202MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDQUINIMIX SYRUPQUININE HYDROCHLORIDE100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1205MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDEFAVIRENZEFAVIRENZ600MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE ,MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/1206THE METHOLATUM CO. LTDHARLEYS UGANDA LIMITEDDEEP RELIEFIBUPROFEN + MENTHOL5%W/W + 3% W/WTHE MENTHOLATUM CO. LTD. -1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDEUNITED KINGDOMTOPICAL EXTERNAL OTHER GELS/SOLS 1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER
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/1209MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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/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/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/1217SANOFI AVENTIS LABOREX UGANDA LIMITEDINSUMAN BASALRECOMBINANT HUMAN INSULIN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING H650 65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS 1.0X5.0X3.0 ML CARTRIDGE,1.0X5.0 ML VIAL
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/1219DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 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/1223REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X1.0X25.0 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/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/1226AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, ROYAL PHARMA 2011 LIMITEDSALBUTAMOLSALBUTAMOL4MGSTRIDES ARCOLAB LIMITED .-DEWAN & SONS IND. AREA, VEOOR, PALGHAR, MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET 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/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/1230MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDLOXAMPAMPICILLIN + CLOXACILLIN250 MG + 250 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1231NORVIK ENTERPRISES LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125AMOXYCILLIN125MG/5MLMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1232MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOCILLIN 125AMPICILLIN125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1234MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDBISACODYL TABLETS BPBISACODYL5MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/1238PHARMACARE LIMITEDBETA HEALTHCARE UGANDA LIMITEDSEPTRIN INJECTIONCO-TRIMOXAZOLE 480MG/5MLDRAXIS PHARMA INC.- QUEBEC, CANADACANADAPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0 ML AMPOULE
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/1240BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDCETIRIZINE HYDRCHLORIDECETIRIZINE HYDROCHLORIDE5MG/5MLPINEWOOD LABORATORIES LTD. -BALLYMACARBRY, CLONMEL, TIPPERARY, IRELANDIRELANDORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
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/1243DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 250LEVOFLOXACIN HEMIHYDRATE250MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 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/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/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/1250STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDSTRIMOL EXTRAPARACETAMOL+CAFFEINE500MG+30MGSTRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAWADICROSS ANEKAL TALUK BANYALURE-562106INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
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/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/1256SIRMAXO CHEMICALS PVT LTDSUPER MEDIC LTDSANIQUAD PVP TPOVIDONE IODINE10%W/WSIRMAXO CHEMICALS PVT LTD-PLOT NO. E-35. TARAPRU MIDC BOISAR, THANE, MUMBAI, INDIAINDIATOPICAL EXTERNAL LIQUIDS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
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/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/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/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/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/1274SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN250MGNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/1275REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 10 F.C TABLETSNIFEDIPINE10MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1277SANOTI AVENTISLABOREX UGANDA LIMITEDINSUMAN RAPIDINSULIN HUMAN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY S C VIALS 1.0X5.0 ML VIAL
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/1282ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDLOSABERGLOSARTAN POTASSIUM50MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1287SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX- DS 100CEFIXIME100MG/5MLSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/1290SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX 400 CAPCEFIXIME400MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1293ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEGRA - 100SILDENAFIL CITRATE100MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
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/1295SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.ZEPARALBENDAZOLE200MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/1297CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDOLMY 40OLMESARTAN40MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 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/1299SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANAXONE PLUS-1000CEFTRIAXONE+SULBACTAM1000MG+500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.5 G VIAL
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/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/1302CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDHIPEN CAPSULESAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. INDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1304MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN1MG + 500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1310ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEMYCIN-300CLINDAMYCIN300MG THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE 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/1315ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-20 ESOMEPRAZOLE20MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1319REMEDICA LTDGOODMAN INTERNATIONAL LTDZESTAVAL 200 F.C TABLETSALBENDAZOLE200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 50.0X2.0 TABLET BLISTER
NDA/MAL/HDP/1324MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X18.0 ML BOTTLE
NDA/MAL/HDP/1325MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/1326IDAKIMSY MEDS LTDCO-TRIMOXAZOLE 480MGCO-TRIMOXAZOLE480MGMEDOPHARM--34-B, INDUSTRIAL AREA, MALUR 563 160 KARNATAKE,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X100.0 TABLET BLISTER
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/1329STRIDES SHASUN LIMITED .DELMAW ENTERPRISES LIMITEDVITAVITEMULTI-INGREDIENTVITAMINS AND MINERALSSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X15.0 CAPSULE BLISTER
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/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/1334MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE30MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER,1.0X30.0 CAPSULE CONTAINER
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/1336MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE45MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER, CAPSULE CONTAINER
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/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/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/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/1344GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDLIDOCAINELIDOCAINE2%W/VNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANGCHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
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/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/1347MICRO LABS LIMITEDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1348TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 500SODIUM VALPROATE (CONTROLLED RELEASE)500MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/1351MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDATORINATORVASTATIN CALCIUM20MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAMINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1352MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPLATFREECLOPIDOGREL75MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1353MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDKITPYLO - CLANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN30MG +500MG + 250MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAMINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)
NDA/MAL/HDP/1354PFIZER LABS LIMITED LABOREX UGANDA LIMITEDARTHROTECDICLOFENAC SODIUM + MISOPROSTOL50MG + 200MCGPIRAMAL HEALTHCARE UK LTD--WHALTON ROAD MORPETH NORTHUMBERLAND NE613 YA UK UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1355PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDSEVOFLURANESEVOFLURANE100% V/VPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESHINDIAOTHER SYSTEMIC LIQUID INHALATIONS 1.0X250.0 ML BOTTLE
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/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/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/1361SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE120MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE
NDA/MAL/HDP/1362MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN + CLAVULANATE875 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X7.0 TABLET STRIP
NDA/MAL/HDP/1366F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDHERCEPTIN 440MGTRASTUZUMAB440MGF. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGSTSWITZERLANDPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X440.0 MG VIAL ,2OML VIAL OF SOLVENT
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/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/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/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/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/1377OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDWATER FOR INJECTIONWATER FOR INJECTIONN/AOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0 ML AMPOULE
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/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/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
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/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/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/1389UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDNELSTATNYSTATIN 100000 I.U/MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL TOPICAL SUSPENSIONS 1.0X30.0 ML BOTTLE
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/1391UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDUNIVIR 5%ACYCLOVIR5%W/WUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYATOPICAL EXTERNAL CREAMS 1.0X1.0X10.0 G TUBE
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/1393SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANFURCEFUROXIME500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1394SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANPIME -1000CEFEPIME1000MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X15.0 ML VIAL
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/1397ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
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/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/1403VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTDDOMAXIN-RD 10MGDOXORUBICIN HCL10MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 MG VIAL
NDA/MAL/HDP/1404MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRODOX-10DOXORUBICIN HCL100MGNAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA INDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL
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/1407PHARMATHEN S.AGOODMAN INTERNATIONAL LTDBELIFAXOMEPRAZOLE 20MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECEGREECEORAL SOLID ORDINARY CAPSULES 1.0X14.0 CAPSULE BOTTLE
NDA/MAL/HDP/1409SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN200MG/5MLNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.PAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X15.0 ML BOTTLE
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/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/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/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/1418NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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/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/1422SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDBINOZYT 500MGAZITHROMYCIN MONOHYDRATE500MGSANDOZ SRL LTD-LIVEZENI STREET 7A540472 TARGU MURES ROMANIAROMANIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/1423SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXYCILLIN + POTASSIUM CLAVULANATE500MG+125MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X2.0 TABLET 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/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/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/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/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/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA AG -MULLERSTRASSE 178, 13353, BERLINGERMANYPARENTERAL ORDINARY AMPOULES 1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML AMPOULE
NDA/MAL/HDP/1436MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 10BISOPROLOL HEMIFUMARATE10MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT,WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE)GERMANYORAL SOLID ORDINARY FILM-COATED 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/1446 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN B COMPLEXVITAMINS B1 + B2 + B6 + NIACINAMIDE0.5 MG + 0.5MG + 7.5MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
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/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/1449SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.ZEPAR SUSPENSIONALBENDAZOLE200MG/5MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTANPAKISTANORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/1450GLAXOSMITHKLINE LIMITED LIKONIUNITED HEALTHCARE DISTRIBUTORS LTDVOLTAREN EMULGEL 1%DICLOFENAC DIETHYLAMMONIUM1%W/VNOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLANDSWITZERLANDTOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE,1.0X50.0 G TUBE
NDA/MAL/HDP/1451NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN INJECTIONDICLOFENAC25MG/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDPARENTERAL ORDINARY AMPOULES 1.0X3.0 ML AMPOULE
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/1453ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-40 ESOMEPRAZOLE40MGMADRAS PHARMACEUTICALS -137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI ? 600 096, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1454 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPAINEXPARACETAMOL + ASPIRIN + CAFFEINE500MG + 400MG + 50 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET STRIP
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/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/1457NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/1458STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDCLAVICIN INJECTIONAMOXICILLIN + POTASSIUM CLAVULANATE1.2GSTRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD BANGALORE 560076 INDIA INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.2 G VIAL
NDA/MAL/HDP/1459NVS KENYA LTD SURGIPHARM (U) LIMITEDTASIGNA 200NILOTINIB200MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/1460VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDPARIN EENOXAPARIN80MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X10.0X2.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/1461STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDCLAVICINAMOXICILLIN + POTASSIUM CLAVULANATE500MG + 100MGSTRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD BANGALORE 560076 INDIA INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X600.0 MG VIAL
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/1465NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTFASTDICLOFENAC POTASSIUM50MGMIPHARM S.P.A -VIA BERNARDO QUARANTA, 12-20141, MILANO ITALY.ITALYORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X3.0 G SACHET
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/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/1469VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 125AMOXICILLIN125MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUSCYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1472GLAXO WELLCOME (KENYA) LTDERIS LTDFORTUM INJECTIONCEFTAZIDIME1GMGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY VIALS 1.0X1.0 G VIAL
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/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/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/1482SANOFI PASTEURLABOREX UGANDA LIMITEDSTAMARIL PASTEURYELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED)NLT 1000 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY VIALS 1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE
NDA/MAL/HDP/1484SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.CLYCIN.VCLINDAMYCIN2%W/WSHAIGAN PHARMACEUTICALS (PVT) LIMITED-14 KM ADYALA RD, RAWALPINDI, PAKISTANPAKISTANTOPICAL EXTERNAL OTHER CREAMS 1.0X40.0 G TUBE + APPLICATOR
NDA/MAL/HDP/1485UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDDICLOFEN 25DICLOFENAC25MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANRECTAL SYSTEMIC SUPPOSITORIES 1.0X10.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/1486ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-1AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 G VIAL
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/1488ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAUGERMANYRECTAL SYSTEMIC ADULT SUPPOSITORIES 10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP
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/1492ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY.GERMANYPARENTERAL ORDINARY AMPOULES 1.0X10.0X3.0 ML AMPOULE
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/1495WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPELOX-400PEFLOXACIN400MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET STRIP
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/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/1500MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADANETHERLANDSORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/1501REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCURAQUIN SYRUPQUININE HYDROCHLORIDE100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1503MEDICAL UNION PHARMACUITICALS KARURI PHARMACEUTICALS LTD.SEDIPROCT CREAMHYDROCORTISONE+CINCHOCAINE0.5%W/W + 0.5%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT EGYPTTOPICAL EXTERNAL OTHER CREAMS 1.0X20.0 G TUBE
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/1506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 2000RECOMBINANT HUMAN ERYTHROPOIETIN2000 IUWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/1508DAWA LIMITEDSUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 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/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/1516WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL PTRAMADOL/ PARACETAMOL37.5MG/ 325MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH - INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1517NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDVEST MENTAMU BALMCOMPOUND METHYLSALICYLATEMULTI INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
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/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/1522GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPENAMOXAMOXYCILLIN250MGMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/1523RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIRENAMPICILLIN 125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1524RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE125 MG / 5 MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/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/1527MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV AMOXICILLIN + CLAVULANATE POTASSIUM200MG + 28.5MG/ 5MLMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO.KG DOBEREINERSTRASSE 20 99427 WEIMARGERMANYORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1531CIPLA LTDQUALITY CHEMICALS LTD - HUMANNOVATAXCEFOTAXIME1GMMEDISPRAY LABORATORIES PVT LTD --L-1/1, L-1/2/2, ADDITIONAL MIDC SATARA 415004INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/1532BF BIOSCIENCES LTDTOP UNIVERSAL MEDICARE LIMITEDNOVAPRESSINTERLIPRESSIN1MG/VIALBF BIOSCIENCES LTD. -RAIWIND,PAKISTANPAKISTANPARENTERAL ORDINARY VIALS 1.0X1.0 MG VIAL
NDA/MAL/HDP/1533OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITED5DGLUCOSE50G/LOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/1534BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDPARACETAMOLPARACETAMOL500MGSHANDONG XIER KANGTAI PHARMACEUTICAL CO LTD-YANZHOU CITY, CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1535ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFORTIWIN-4FORTIFIED PROCAINE PENICILLIN SODIUM4 M.UREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X4.0 MU VIAL
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/1540STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDNAT-E 400VITAMIN E400I.USTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE BOTTLE
NDA/MAL/HDP/1543MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDPROMAZINE ELIXIRPROMETHAZINE HYDROCHLORIDE5MG/MLMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDAUGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X60.0 ML BOTTLE
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/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511INDIAORAL SOLID ORDINARY CAPSULES 1.0X5.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1547MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDLUSIA-FNORGESTREL/ ETHINYL ESTRADIOL + FERROUS FUMARATE0.3MG/ 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X28.0 TABLET BLISTER
NDA/MAL/HDP/1549REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.PREDNICOL EYE DROPSPREDNISOLONE/CHLORAMPHENICOL5MG/2MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAMPAKISTANOPHTHALMIC DROPS 1.0X10.0 ML VIAL
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/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/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/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/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/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/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/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/1558PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDGABBRORALAMINOSIDINE SULPHATE250MGPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMORAL SOLID ORDINARY TABLETS 1.0X12.0 TABLET STRIP
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/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/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
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/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/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/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/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/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/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/1577SEARLE PAKISTAN LTDHEALTHCARE LTD.SPIROMIDESPIRONOLACTONE + FRUSEMIDE50MG+20MGSEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTANINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/1581MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPANTOTABPANTOPRAZOLE40MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/1583INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDABZEEALBENDAZOLE200MG/5MLINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/1584UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUCLOXCLOXACILLIN SODIUM500MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/1585WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDUDIHEP FORTEURSODEOXYCHOLIC ACID300MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1588TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOZAAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGTORRENT PHARMACEUTICALS LIMITED -AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X4.0X7.0 TABLET BLISTER
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/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/1605RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER
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/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/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/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/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/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/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/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/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/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/1636NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDVIGAMOXMOXIFLOXACIN5MG/MLS.A.ALCON COUVREUR N.V-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
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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
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NDA/MAL/HDP/1655UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDUNIGENTYLSECNIDAZOLE500MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER
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NDA/MAL/HDP/1676KOPRAN LIMITEDTATA UGANDA LIMITEDCLOXIN-250CLOXACILLIIN250MGKOPRAN 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
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NDA/MAL/HDP/1678ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MG/VIALZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X100.0 MG VIAL
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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
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NDA/MAL/HDP/1691WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN500MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X3.0 CAPSULE BLISTER
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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
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NDA/MAL/HDP/1707XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDFEBRICOL TABLETSPARACETAMOL / PSEUDOEPHEDRINE / CHLORPHENIRAMINE500MG / 30MG /2MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BLD -1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
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/1709REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDLUCIN CREAMHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE
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/1712I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 VIAL CARTON
NDA/MAL/HDP/1713MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDLUMITERARTEMETHER + LUMEFANTRINE20 MG + 120 MG MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.,OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X8.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER
NDA/MAL/HDP/1714REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.REMICOL EAR DROPSCHLORAMPHENICOL1%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAMPAKISTANOTIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/1715SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN SYRUPAMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMOHEXINE50MG+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/1723ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT MULTIVITAMINMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESAINDIAORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE
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/1725REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL CREAM 1%CLOTRIMAZOLE1%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/1726GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDHAVRIX 720INACTIVATED HEPATITIS A VIRUS ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED720 ELISA UNITS ADSORBED ON 0.25MG ALUMINIUM HYDROXIDESMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUMBELGIUMPARENTERAL ORDINARY VIALS 1.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/1727MISSION PHARMAJOINT MEDICAL STORE (UPMB - UCMB)TETRACYCLINE HYDROCLORIDETETRACYCLINE HYDROCHLORIDE3%W/WNANJING BAIJINGYN PHARMACEUTICALS CO.LTD NO-1 HUIZHONG ROAD NANJING ECONOMIC AND TECHNICAL DEVELOPMENT ZONECHINATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
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/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/1731REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMEDIVEN-S OINTMENTBETAMETHASONE VALERATE + SALICYLIC ACID0.05%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/1732MICRO LABS LTD LABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1734KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMOMINTCOMPOUND MAGNESIUM TRISILICATE500MGTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER
NDA/MAL/HDP/1736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDKLERIMEDCLARITHROMYCIN 500MG MEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
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/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/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/1743MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDDAPRILLISINOPRIL DIHYDRATE10MGMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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
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/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/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/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/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/1755MEMPHIS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDDOPAGON TABLETSBROMOCRIPTINE2.5MGMEMPHIS COMPANY--8 EL SAWAH STREET, CAIRO. EGYPTEGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
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/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/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/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/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/1765 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDRILIF PLUSACECLOFENAC + PARACETAMOL100MG + 500MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1766 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOLDEASE CAPSULESPARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE400MG+30MG+4MG+30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 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/1768GLAXO SMITHKLINE LTD(ITALY)ERIS LTDULTIVA INJECTION 2MGREMIFENTANIL2MGGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
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/1770NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDDIOVAN 160MG TABLETSVALSARTAN160MGNOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAINSPAINORAL SOLID ORDINARY TABLETS 1.0X1.0X28.0 TABLET STRIP
NDA/MAL/HDP/1771MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)ORAL REHYDRATION SALTS BPMULTI-INGREDIENTMULTI-INGREDIENTMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X100.0X20.5 G SACHET
NDA/MAL/HDP/1772 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDGESTID TABLETSCOMPOUND MAGNESIUM TRISILICATE385MGSUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1773MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MG MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X5.0 TABLET 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/1778 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCONCIL 500MG CAPSULESAMOXYCILLIN TRIHYDRATE500MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
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/1780RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML 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/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/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/1784MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDAZICURE-500AZITHROMYCIN500MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK ?N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 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/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/1790REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM TABLETCO-TRIMOXAZOLE480MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
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/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/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/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/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/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/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/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
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/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/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/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/1807GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMPICLOX NEONATAL DROPSAMPICILLIN + CLOXACILLIN60 MG / 0.6 ML + 30 MG / 0.6 MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X8.0 ML BOTTLE
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/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/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/1812 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN TABLETSQUININE SULPHATE300MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
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/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
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/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/1822 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDEPHEDRINE EPHEDRINE HYDROCHLORIDE 30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1824NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDGLANDIN E2 GELDINOPROSTONE0.5MGNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. PAKISTANTOPICAL EXTERNAL GELS AND SOLS 1.0X3.0 G TUBE WITH STERILE CATHETER
NDA/MAL/HDP/1825RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCOLDEASE SYRUPPARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+2MG+15MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1826WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDLOGICAN-200FLUCONAZOLE 200MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X4.0 CAPSULE BLISTER
NDA/MAL/HDP/1827REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL SUSPENSIONALBENDAZOLE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE
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/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/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/1838INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDABZEEALBENDAZOLE400MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
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/1840REMEDICA LTDGOODMAN INTERNATIONAL LTDOVA-MITCLOMIPHENE50MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
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/1843USV LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058 INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 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/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/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/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/1850RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDALZOL TABLETSALBENDAZOLE400MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/1851PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCAPSIFENAC GELCAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE0.438 G + 0.335 G + 0.135 G + 0.918 GSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL EMULSION GELS 1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE
NDA/MAL/HDP/1852 RANBAXY LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDVERCEF ORAL SUSPENSIONCEFACLOR125MG/5MLRANBAXY LABORATORIES-LABORATORIES LIMITED INDUSTRIAL AREA 3 DEWAS 455001INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 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/1856COSMOS LTDASTRA PHARMA (U) LIMITEDPROPRANOLOL TABLETS B.P. 40MGPROPRANOLOL HYDROCHLORIDE40MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
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/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/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/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/1866JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1867RENE PHARMACY(R) LTD..RENE PHARMACY LTDLEVATEX TABLETSLEVAMISOLE HYDROCHLORIDE40MGCYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS 500.0 TABLET CONTAINER,1.0X10.0X3.0 TABLET BLISTER
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/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/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
NDA/MAL/HDP/1877 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMINT-O-COOLDRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE120MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1879SPARSH BIO-TECH PVT LTD ABACUS PHARMA (AFRICA) LIMITEDSPENIV PHENOXYMETHYL PENICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1880SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1881SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. INDIAORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1882SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE 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/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/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/1891MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 500LEVOFLOXACIN 500MG MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X5.0 TABLET BLISTER
NDA/MAL/HDP/1892MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 250LEVOFLOXACIN 250MG MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X5.0 TABLET BLISTER
NDA/MAL/HDP/1893UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDTRIKA 0.25 TABLETSALPRAZOLAM0.25MGUNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/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/1898WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDZAPACID - 30LANSOPRAZOLE30MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH - INDIA INDIAORAL SOLID ORDINARY CAPSULES 3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1899INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDTUSPRESS COUGH SUPPRESSANTMULTI-INGREDIENTMULTI-INGREDIENTINDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722INDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
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/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/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/1903DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 100ARTEMETHER100MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY I M AMPOULES 1.0X1.0X1.0 ML AMPOULE
NDA/MAL/HDP/1905ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDOXYTOCIN INJECTIONOXYTOCIN 10I.U/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE,1.0X100.0X1.0 ML AMPOULE
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/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/1908CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLMY 20OLMESARTAN20MGCADILA 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/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/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/1914 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCHLORPHENIRAMINECHLORPHENIRAMINE4MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1915HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDATAZANAVIR SULPHATE + RITONAVIRATAZANAVIR SULPHATE + RITONAVIR300 MG + 100 MGHETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH ,,HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/1918UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDUNIVIRACYCLOVIR200MGUNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X1.0X30.0 TABLET STRIP
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/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/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/1924ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGCSPC ZHONGNUO (SHIJIAZHUANG) PHARMACEUTICAL CO LTD-NO. 47 FENGSHOU ROAD SHIJIAZHUANG,CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X500.0 MG VIAL
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/1927REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDINTAPLEX TABLETVITAMIN B COMPOUNDN/AREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1928STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDNEUTRAFLUXALGINIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE200MG + 250MG +250MG +250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1929CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDARTORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/1934 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR SUSPENSIONCHLORAMPHENICOL125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1935NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDSULPHA KREAM-NSULPHANILAMIDE15%W/WNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.PAKISTANTOPICAL EXTERNAL CREAMS 1.0X1.0X80.0 G TUBE
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/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/1938YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDINFULGANPARACETAMOL10MG/MLYURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE
NDA/MAL/HDP/1940REMEDICA LTDGOODMAN INTERNATIONAL LTDCLOXACILLIN CAPSULESCLOXACILLIN SODIUM250MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
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/1942RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDAMCLORENAMPICILLIN + CLOXACILLIN250 MG + 250 MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CONTAINER
NDA/MAL/HDP/1943MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDNITROCONTIN 2.6NITROGLYCERIN (CONTROLLED RELEASE)2.6MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATEINDIAORAL SOLID RETARD TABLETS 1.0X25.0 TABLET CONTAINER
NDA/MAL/HDP/1946WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDSOLUDOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH - INDIA INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 10.0X10.0 TABLET STRIP
NDA/MAL/HDP/1948PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYDRATE500MGHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELEFRANCEORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDNORVIK ENTERPRISES LIMITEDTRENAXA 500TRANEXAMIC ACID500MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X6.0 TABLET BLISTER
NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCLOPI 75CLOPIDOGREL75MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP
NDA/MAL/HDP/1952JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL LIQUID SOAPS/WASHES 1.0X80.0 ML BOTTLE
NDA/MAL/HDP/1953UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDRANTAB-150RANITIDINE150MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 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/1955MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILCILLINAMPICILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1956MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/1957MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILCILLINAMPICILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1958MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1959MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDBETRIM 480CO-TRIMOXAZOLE480MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
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/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/1963MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOFENAC GELDICLOFENAC1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X35.0 G TUBE
NDA/MAL/HDP/1964MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLONEXCLOTRIMAZOLE1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/1966MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPARACIN PARACETAMOL 500MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1969NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SR 75MGDICLOFENAC SODIUM75MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NAITALYORAL SOLID RETARD TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMAC CETIRIZINE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1971AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMPICLOX ORAL SUSPENSIONAMPICILLIN + CLOXACILLIN125 MG/5ML + 125 MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1974SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTILCEFUROXIME AXETIL500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 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/1976CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDOROGELCHOLINE SALICYLATE+LIGNOCAINE HCL+BENZALKONIUM CHLORIDE8.7%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/1977UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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/1987FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFOMYCETINCHLORAMPHENICOL250MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
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/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/1991BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDTETRACYCLINETETRACYCLINE250MGSHANDONG XIER KANGTAI PHARMACEUTICAL CO LTD-YANZHOU CITY, CHINACHINAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
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/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/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/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/1999TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CARBATOL 200CARBAMAZEPINE200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2000TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CALCIGARD RETARDNIFEDIPINE(SR)20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIAINDIAORAL SOLID RETARD TABLETS 10.0X10.0 TABLET BLISTER
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/2004MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDR.B.TONEFERROUS GLUCONATE + VITAMIN C + VITAMIN B12 + VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + CALCIUM PANTOTHENATE + VITAMIN B3 + FOLIC ACID + DIBASIC CA PO4 + ZINC SULPHATE200MG + 38MG + 4MCG + 3MG + 2.5MG + 1MG + 2.5MG + 1MG + 2.5MG + 23MG + 0.5MG + 100MG + 33MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X15.0 CAPSULE 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/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/2008GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- CREAMCLOTRIMAZOLE + BECLOMETASONE DIPROPIONATE CREAM1%W/W + 0.025%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
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
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/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
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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/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/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/2021 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDPREGVIT ZINCMULTIVITAMIN/MINERALSMULT-INGREDIENTPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL SOLID ORDINARY CAPSULES 1.0X12.0X2.0 CAPSULE BLISTER
NDA/MAL/HDP/2022MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTORACTINCYPROHEPTADINE2MG/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/2024TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.NEXPRO - 40ESOMEPRAZOLE MAGNESIUM TABLET40MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
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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/2027UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 160/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2028SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.SELANZ - SRLANSOPRAZOLE30MGSEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTANPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X1.0X7.0 CAPSULE 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/2033MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-50LOSARTAN POTASSIUM50MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP
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/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/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/2039GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDRANITIDINE INJECTION USPRANITIDINE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X2.0 ML AMPOULE
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/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/2042NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBURNCURESILVER SULFADIAZINE1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 1.0X200.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/2043COSMOS LTDASTRA PHARMA (U) LIMITEDDIASTOP TABLETSATTAPULGITE/ ALUMINIUM HYDROXIDEN/ACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET STRIP
NDA/MAL/HDP/2045CLARIS INJECTABLES LTDREDDYS PHARMA LIMITEDBUPICANBUPIVACAINE0.5% W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
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
NDA/MAL/HDP/2047MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDRITONAVIRRITONAVIR100MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE
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/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/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/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/2056WOCKHARDT LTDSTAR PHARMACEUTICALS LTDBRO-ZEDEXTERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL 1.25MG+ 4 MG+50 MG+2.5 MG/5 MLWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2058MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDQUININE SULPHATEQUININE SULPHATE300MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL. 0.15MG / 0.03MGBAYER PHARMA AG -MULLERSTRASSE 178, 13353, BERLIN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X2.0X28.0 TABLET BLISTER
NDA/MAL/HDP/2066REMEDICA LTDGOODMAN INTERNATIONAL LTDMETHOTREXATEMETHOTREXATE2.5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2067UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDZYNCETCETIRIZINE DIHYDROCHLORIDE10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDDOMADOLTRAMADOL HYDROCHLORIDE50MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2069SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSK DERMBETAMETHASONE + CLOTRIMOXAZOLE + 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
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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/2073SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES VACCINE LIVE ATTENUATED(FREEZE-DRIED)MEASLES VIRUSNOT LESS THAN 1000CCID50/ DOSESERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 DOSE VIAL + 0.5ML AMPOULE OF STERILE WATER FOR INJECTION,1.0X10.0 DOSE VIAL + 5ML AMPOULE OF STERILE WATER FOR INJECTION
NDA/MAL/HDP/2074AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN ORAL SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/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/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/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/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/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/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/2085COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORHEXIDINE GLUCONATE SOLUTIONCHLORHEXIDINE GLUCONATE20%W/VCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYATOPICAL EXTERNAL LIQUIDS 1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN,1.0X5.0 L JERRYCAN
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/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/2089HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN XR 500MGMETFORMIN HCL EXTENDED RELEASE500MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIAMALAYSIAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2090 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCIPRORENCIPROFLOXACIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/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/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/2094MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT-750LEVOFLOXACIN HEMIHYDRATE750MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 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/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/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/2099XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDHYDROCORTISONE 1% CREAMHYDROCORTISONE1%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/2100MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDORALCON - FLEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE0.15MG + 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X28.0 TABLET BLISTER
NDA/MAL/HDP/2101COSMOS LTDASTRA PHARMA (U) LIMITEDCARDISPRINACETYL SALICYLIC ACID75MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/2102MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/2103MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 1000 TABAMOXYCILLIN + CLAVULANATE POTASSIUM875 MG + 125 MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/2104MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG + 50MG + 60MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/2105MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 156MG/5MLAMOXYCILLIN + CLAVULANATE POTASSIUM125 MG + 31.5 MG/5 MLMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2107MEDREICH PLCLABOREX UGANDA LIMITEDAMEDIN 10AMLODIPINE10 MGMEDREICH STERILAB LIMITED--AVAILAHALI, BANGALORE-560 062 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X14.0X2.0 TABLET BLISTER
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/2112MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR200MG + 50MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER
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/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/2116MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMLOVAS-10AMLODIPINE BESILATE10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET STRIP
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/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/2123VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTDPLATFIRSTCISPLATIN1MG/MLVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
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/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/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/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/2133NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPIDHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/2135VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTDSOLITAXCEFTRIAXONE1GVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/2136MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT SUPOSITORYHYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN5MG + 5MG +10MG +10MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT EGYPTTOPICAL EXTERNAL SUPPOSITORIES 1.0X6.0 SUPPOSITORY STRIP
NDA/MAL/HDP/2137REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.SEPRODERM OINTMENTSALICYLIC ACID + SULPHUR COMPOUND3.6 + 2.4 MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAMPAKISTANTOPICAL EXTERNAL OINTMENTS 1.0X20.0 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/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/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/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.LIMITEDLABOREX UGANDA 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/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA AG -MULLERSTRASSE 178, 13353, BERLIN GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
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/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/2159SANOFI PASTEURLABOREX UGANDA LIMITEDVAXIGRIPINFLUENZA VIRUS STRAINS H1N1 + H3N2 + B15MCG + 15MCG + 15MCGSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)
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/2161REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX CREAMACICLOVIR5%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSTOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/2165 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE 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/2168ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDHYDROCORTISONE INJECTIONHYDROCORTISONE SODIUM SUCCINATE100MGROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAUGERMANYPARENTERAL ORDINARY DRY VIALS 1.0X8.0 ML VIAL
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/2171IDA KIMSY MEDS LTDCO-TRIMOXAZOLECO-TRIMOXAZOLE100MG/200 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
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/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/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/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/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/2179BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDPENICINBENZYLPENICILLIN1MEGAREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0 VIAL CARTON
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/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/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/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/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/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/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
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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/2194INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDCALCIUM D SYRUPCALCIUM CARBONATE/VITAMIN D250MG+125IU/5MLINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/2195XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDEUDERM CREAMUREA10%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X45.0 G TUBE
NDA/MAL/HDP/2196PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDMYCOBUTINRIFABUTIN150MGPHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALYITALYORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE BOTTLE
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/2199MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 50MCGLEVOTHYROXINE SODIUM50MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER
NDA/MAL/HDP/2203REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL 100 VAGINAL TABLETSCLOTRIMAZOLE100MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSVAGINAL TABLETS 1.0X2.0X3.0 PESSARY STRIP
NDA/MAL/HDP/2204IND SWIFT LTDTATA UGANDA LIMITEDATSTATATORVASTATIN100MGIND SWIFT LTD-GBU JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALIINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2205IND SWIFT LTDTATA UGANDA LIMITEDC-SWIFTCETIRIZINE HCL10MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
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/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
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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/2216GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOCLOPRAMIDE METOCLOPRAMIDE5MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
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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/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER WEIMAR GMBH & CO.KG DOBEREINERSTRASSE 20 99427 WEIMARGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER
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
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NDA/MAL/HDP/2224VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 500AMOXICILLIN500MGVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2226WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ GRANULESL-ORNITHINE-L-ASPARTATE3G/5GWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESHINDIAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES 1.0X10.0X5.0 G SACHET
NDA/MAL/HDP/2230STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDNEUTRAFLUX CHERRY FLAVOURALGNIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE200MG +250MG + 250MG + 250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/2231MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDPIRITEX WITH CODEINEMULTI-INGREDIENTMULTI-INGREDIENTMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2232UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICASTMONTELUKAST10MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 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/2235WOCKHARDT LTDTATA UGANDA LIMITEDWOSULIN-NINSULIN HUMAN(RECOMBINANT DNA ORIGIN)100IU/MLWOCKHARDT-WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRAINDIAPARENTERAL ORDINARY S C VIALS 1.0X3.0 ML VIAL,1.0X10.0 ML VIAL
NDA/MAL/HDP/2236NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALYITALYORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2237WOCKHARDT LTDTATA UGANDA LIMITEDWOSULIN-30/70INSULIN HUMAN(RECOMBINANT DNA ORIGIN)100I.U/MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X3.0 ML VIAL
NDA/MAL/HDP/2238UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOCLOXAMPICILLIN + CLOXACILLIN125MG +125MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2239NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL ORAL SUSPENSIONCARBAMAZEPINE20MG/MLDELPHARMA HUNINGUE S.A.S-26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/2240NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDDIOVAN 80VALSARTAN80MGNOVARTISPHARMA AG -LICHTSTRASSE 35 CH-4056 BASEL SWITZERLAND, AND NOVARTISPHARMA STEIN AG SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND SWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X1.0X28.0 TABLET STRIP
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/2242REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX 200 TABLETSACYCLOVIR200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2243AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, ROYAL PHARMA 2011 LIMITEDSIMDOL TABLETSPARACETAMOL500MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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/2245RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PEL MEBENDAZOLE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2247CIPLA LTD.QUALITY CHEMICALS LTD - HUMANESOMACESOMEPRAZOLE20MGOKASA PHARMA PVT LTD-L-2, ADDITIONAL M.I.D.C. AREA, SATARA SATARA-415004, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/2249WOCKHARDT LTDTATA UGANDA LIMITEDWOSULIN-RINSULIN 100MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY S C VIALS 1.0X3.0 ML VIAL,1.0X10.0 ML VIAL
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/2252JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE500MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/2253GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDINDOMETHACININDOMETHACIN25MGNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2254MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDBURN CUR CREAMACRIFLAVINE/THYMOLN/ATORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/2256GLAXOSMITH KLINE LTDERIS LTDAUGMENTIN 457MG/5MLAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MG / 5 MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X70.0 ML BOTTLE
NDA/MAL/HDP/2258MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZ300MG/300MG/600MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE ,MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA,GREEN STONE LIMITED-PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONEINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE,1.0X1.0X30.0 TABLET BOTTLE
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/2263OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDCELEMIN 10 PLUSAMINO ACIDS/ELECTROLYTES10%W/V+10%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION BAGS 1.0X500.0 ML BAG
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/2265HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDTENOFOVIR/ LAMUVIDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG + 300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA,HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/2267MYLAN LABORATORIES LIMITED.KIMSY MEDS LTDTENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG+300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE ,MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/2269DAWA LIMITEDSUPER MEDIC LTDDAWAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/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/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/2274ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDPARACETAMOL TABLETS 500MGPARACETAMOL 500MGZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2276MEDREICH PLCLABOREX UGANDA LIMITEDFUNGRALKETOCONAZOLE200MGMEDRIECH STERILAB LTD,BANGALORE-MEDRIECH STERILAB LTD, AVALAHALLI BANGALORE 560062INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2278AVENTIS INTERCONTINENTALLABOREX UGANDA LIMITEDORELOXCEFPODOXIME PROXETIL100MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE 56, RUE DE CHOISY AU BAC 60205 COMPI?GNE FRANCEORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2280REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.BETADROP-NBETAMETHASONE + NEOMYCIN0.1 %W/V + 0.5 %W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAMPAKISTANOPHTHALMIC DROPS 1.0X7.5 ML VIAL
NDA/MAL/HDP/2281SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDLUMFORTLORATADINE10MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/2283SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA TETANUS PERTUSISDIPTHERIA TOXOID+TETANUS TOXOID+B.PERTUSIS ADSORBED ON ALUMINIUM PHOSPATE>25LF(>30IU)+>5LF(>40IU)+<16OU(>4PU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)
NDA/MAL/HDP/2284SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDLUMFORT SYRUPLORATADINE5MG/5MLNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/2285MEDREICH PLCLABOREX UGANDA LIMITEDBRUMEDIBUPROFEN100MG/5MLMEDRIECH STERILAB LTD-AVALAHALLI BANGALORE-560 049, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 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/2289GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLORAMPHENICOLCHLORAMPHENICOL250MGNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINACHINAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/2290MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE ,MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/2291HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDVALOVIRVALACYCLOVIR500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA,HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2292MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 1200AMOXYCILLIN + CLAVULANATE POTASSIUM100 MG + 200 MGNATCO PHARMA LTD-VIJAYAPUR, NORTH NAGARIJUNA SAGA,INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X5.0X20.0 ML VIAL
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/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/2296ERIS LTDBENLE CONSULT LIMITEDRANI-DENK 150RANITIDINE150MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529GERMANYORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CONTAINER
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/2298MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDSAFELEVO 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/2303MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2304MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 10/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE10 MG + 6.25 MG MERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2305MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 2.5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE2.5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA AG -MULLERSTRASSE 178, 13353, BERLIN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X35.0 TABLET BLISTER
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/2312REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2313REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 375AMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2314MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRABEMAC-20RABEPRAZOLE SODIUM20MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/2315MICRO LABS LTD LABOREX UGANDA LIMITEDGRAMOCEF-O-50CEFIXIME50MG/5MLMICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE
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/2318MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE-4GLIMEPIRIDE4MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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/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/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/2324SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDSWISSCLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X7.5 ML VIAL
NDA/MAL/HDP/2325IDA FOUNDATIONKIMSY MEDS LTDPARAMOMYCINPARAMOMYCIN375MG/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/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/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/2330NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCOARTEMARTEMETHER + LUMEFANTRINE20MG + 120MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND,BEIJING NOVARTIS PHARMA LTD-31ST YONG'AN ROAD, CHANGPING DISTRICT, BEIJING P.R,NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, SWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X24.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER
NDA/MAL/HDP/2333SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA & TETANUS VACCINE ADSORBED(PEDIATRIC)DIPTHERIA TOXOID+TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE>25LF(>30IU)+>5LF(>40IU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)
NDA/MAL/HDP/2334SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES MUMPS & RUBELLAMEASLES VIRUS+MUMPS VIRUS+RUBELLA VIRUSNLT 1000 CCID50+NLT 5000 CCID50 +NLT1000 CCID50 SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT
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/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/2338GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE
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/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/2348SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) ADULTHEPATITIS B VACCINE(RDNA) ADULT20MCG/MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY I M VIALS 1.0X10.0X10.0 ML VIAL (10 DOSE VIAL),1.0X50.0X1.0 ML VIAL (1 DOSE VIAL)
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/2350ASTRA ZENECA ABMACNAUGHTON LIMITEDPULMICORT TURBUHALERBUDESONIDE200MCGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENLUNG ADMINISTRATION METERED-DOSE INHALER 1.0X100.0 DOSE CANNISTER
NDA/MAL/HDP/2352REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAY TIMEPARACETAMOL/PSEUDOEPHEDRINE HCL/CAFFEINE500MG+30MG+30MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X1.0X12.0 CAPSULE 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/2354STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/2356GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININEQUININE DIHYDROCHLORIDE600MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/2357ACINO PHARMA AGGOODMAN INTERNATIONAL LTDTRABILIN- 50 CAPSULESTRAMADOL50MGMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEURENGERMANYORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2359REMEDICA LTDGOODMAN INTERNATIONAL LTDASPIREM 75ASPIRIN75MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X2.0X28.0 TABLET BLISTER
NDA/MAL/HDP/2361REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAREM 500CLARITHROMYCIN500MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
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/2363GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGENTAMICIN SULPHATEGENTAMICIN SULPHATE80MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE
NDA/MAL/HDP/2364MEDICO REMEDIES PVT LTDMAISHA MEDICAL SUPPLIES LIMITEDVOXEL-500LEVOFLOXACIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2365STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG+50MG+60MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/2366UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDIFICIPRO INJECTIONCIPROFLOXACIN200MG/100MLUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2367REMEDICA LTDGOODMAN INTERNATIONAL LTDFELEXIN 125CEPHALEXIN MONOHYDRATE125MG/5MLREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2368REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDERMIDEX CREAMMICONAZOLE NITRATE2%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
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/2371PHARMA INTERNATIONAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDTOPIZONE CREAMFUSIDIC ACID + BETAMETHASONE VALERATE20MG/G+1MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/2373INDOCO REMEDIES LTDTATA UGANDA LIMITEDCLOBEN SKIN CREAMCLOTRIMAZOLE/ BECLOMETASONE1%W/W/ 0.025%W/WINDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/2374COSMOS LTDASTRA PHARMA (U) LIMITEDPYRAZINAMIDE TABLETSPYRAZINAMIDE500MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/2375GLAXO SMITHLINE LIMITEDERIS LTDCLAVULIN 1GAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/2376INDOCO REMEDIES LTDTATA UGANDA LIMITEDMETCHEK-500METFORMIN 500MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2377CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDR-LOCK TABLETSRANITIDINE150MGCADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2378GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTINAMOXICILLIN + CLAVULANIC ACID1000 MG + 200 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS 1.0X10.0X1.2 G VIAL
NDA/MAL/HDP/2383GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTINAMOXICILLIN + CLAVULANIC ACID500 MG + 100 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS 1.0X10.0X25.0 ML VIAL
NDA/MAL/HDP/2384PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCLARIX 500CLARITHROMYCIN500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
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
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/2387DAWA LIMITEDSUPER MEDIC LTDVERMOUTMEBENDAZOLE100MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
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/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/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/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/2399 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDVOLINI MULTI INGREDIENTMULTI INGREDIENTSUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIAINDIATOPICAL EXTERNAL OTHER GELS/SOLS 1.0X1.0X30.0 G TUBE
NDA/MAL/HDP/2400PHARMA INTERNATIONAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDTOPIDIC 2% FUSIDIC ACID20MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/2401MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDENAT NATURAL VITAMIN E400IUMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
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/2404UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDLOSAR 50LOSARTAN POTASSIUM50MGUNICHEM LABORATORIES LTD---VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2405INDOCO REMEDIES LTDTATA UGANDA LIMITEDERYTHROMYCIN STEARATEERYTHROMYCIN STEARATE250MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2408RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRON TONICMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/2409TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.DEPLATT CLOPIDOGREL75MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2410 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDDOXYRENDOXYCYCLINE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2411STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZPOVIDONE IODINE + METRONIDAZOLE5%W/W + 1%W/WSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE
NDA/MAL/HDP/2414SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 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/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/2420INDOCO REMEDIES LTDTATA UGANDA LIMITEDLIDOCAINE INJ.BPLIDOCAINE2% W/VINDOCO REMEDIES LTD-L-32,33 AND VERNA INDUSTRIAL ESTATE VERNA ? SALCATTE GOA, 403722 INDIAINDIAPARENTERAL ORDINARY OTHER VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/2421INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDTAMIGEN EYE/EAR DROPSGENTAMICIN SULPHATE0.3%W/VINDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE,1.0X10.0 ML BOTTLE
NDA/MAL/HDP/2422INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDTAMIGEN-S EYE/EAR DROPSGENTAMICIN SULPHATE+DEXAMETHASONE0.3%W/V+0.1%W/VINDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722INDIAOTHER SYSTEMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/2423MEDLEY PHARMACEUTICALS MEDVIN PHARMA LIMITEDATORIN ATORVASTATIN10MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAMINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2426MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPROBEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2427NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDCLONEMCLOTRIMAZOLE1%W/WNEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/2428ERIS LTDBENLE CONSULT LIMITEDCLOTRI-DENK 1% CREAMCLOTRIMAZOLE1%W/WRUBIEPHARM ARZNEIMITTEL GMHH--BRUDER-GRIMU, STRABE 62, GERMANY GERMANYTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/2429ERIS LTDBENLE CONSULT LIMITEDCLOTRI-DENK 100 VAGINALCLOTRIMAZOLE100MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY,ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANYGERMANYVAGINAL TABLETS 1.0X6.0 PESSARY CARTON
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/2434STRIDES SHASUN LIMITED .DELMAW ENTERPRISES LIMITEDSOLCEROMEPRAZOLE40MGSTRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD BANGALORE 560076 INDIA INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 ML VIAL
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/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/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/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/2451ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN 75 SRDICLOFENAC SODIUM75 MGMEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASELSWITZERLANDORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2452REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDDELASED CHEST COUGH SYRUP (NON DROWSY)GUAIFENESIN + MENTHOL100MG/5ML + 1.1MG/5MLREGAL PHARMACEUTICALS-PLOT 7879/18 BABA DOGO ROAD NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2453ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDNORVIRRITONAVIR80MG/MLAESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENTUNITED KINGDOMORAL LIQUID ORDINARY LIQUIDS 1.0X90.0 ML BOTTLE
NDA/MAL/HDP/2455ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 600/750 LACTABARTESUNATE + MEFLOQUINE200 MG + 250 MGMEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASELSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/2458XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDPRISTINEX 2% CREAMKETOCONAZOLE2%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 2.0X15.0 G TUBE
NDA/MAL/HDP/2459MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDP2LEVONORGESTREL0.75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/2460COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS 2MGBENZHEXOL HCL2MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2461 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDUMERAN SR - 100DICLOFENAC100MGUMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2462REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDHISTALIN SYRUPCHLORPHENIRAMINE MALEATE/PROMETHAZINE/DIPHENHYDRAMINE/EPHEDRINE/AMMONIUM CHLORIDE/SODIUM CITRATE1.0MG+ 2.5MG+5.0MG+7.5MG+90.0MG+48.0MG/ 5ML.REGAL PHARMACEUTICALS LTD..-PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN
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/2470GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDEURAXCROTAMITON10%W/WNOVATIS CONSUMER HEALTH INC -ZYMA SA-CH- 1260 NYON SWITZERLANDSWITZERLANDTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/2471GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.1% NASAL DROPSXYLOMETAZOLINE0.1%W/VNOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLANDSWITZERLANDNASAL SYSTEMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/2472NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTRAN-GELDICLOFENAC DIETHYLAMMONIUM1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE,1.0X20.0 G TUBE
NDA/MAL/HDP/2473MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUGRELCLOPIDOGREL75MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2474SANOFI PASTEURLABOREX UGANDA LIMITEDTYPHIM VIPOLYSACCHARIDES OF SALMONELLA TYPHI(TY2 STRAIN)25MCGSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)
NDA/MAL/HDP/2475WIN-MEDICURE LTDSURGIPHARM (U) LIMITEDURGENDOL INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA.INDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE
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/2477WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDLOGICAN-150FLUCONAZOLE150MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X1.0 CAPSULE BLISTER
NDA/MAL/HDP/2478WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL PLUSPARACETAMOL+DICLOFENAC500MG+50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH -INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2479SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANCEPH-250 CAPCEPHALEXIN250MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2480DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 40ARTEMETHER40MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
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/2489 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDUMETAC-150RANITIDINE150MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/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/2500MACLEODS PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDCHLORAMPHENICOL SODIUM SUCCINATE INJECTION BPCHLORAMPHENICOL SODIUM SUCCINATE1GMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.INDIAPARENTERAL RETARD DRY VIAL 1.0X1.0 G VIAL
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/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/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/2506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDNADOXINNADIFLOXACIN1%W/WWOCKHARDT LTD -VILLAGE KUNJHAL P.O BAROTIWALA DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
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/2508GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHYOSCINEHYOSCINE20MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANGCHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
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/2510 PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDGIROORDNIDAZOLE 500MGPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH ? 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X2.0X10.0 TABLET BLISTER
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/2512ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDDICLOFENAC SODIUM INJECTABLE SOLUTIONDICLOFENAC SODIUM25MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X3.0 ML AMPOULE
NDA/MAL/HDP/2513REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN DRY SYRUPPHENOXYMETHYLPENICILLIN125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2515AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, ROYAL PHARMA 2011 LIMITEDSIMFEN 200 TABLETSIBUPROFEN200MGSTRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA,AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2516REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIAMP DRY SUSPENSIONAMPICILLIN125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2519MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDVITA CAPMULTI-INGREDIENTMULTI-INGREDIENTMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2521MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDMOTINORMDOMPERIDONE10MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2522MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPANTAZ TABLETSPANTOPRAZOLE40MGMEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2523NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDSULPHUR OINTMENTSULPHUR10%W/WNEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE
NDA/MAL/HDP/2524MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPRIMODIL-5AMLODIPINE BESYLATE5MGMEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210 INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2525ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RETARDDICLOFENAC SODIUM100MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID RETARD TABLETS 10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2526REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN COMBI PACKCLOTRIMAZOLE500MG & 1 %W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAVAGINAL COMBINATION PACK TABLETS 1.0X1.0 PESSARY BLISTER + 1*20G TUBE
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/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/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/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/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/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/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/2555COSMOS LTDASTRA PHARMA (U) LIMITEDPHENOBARBITONE TABLETS BP 30MGPHENOBARBITONE 30MGCOSMOS 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,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/2556GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDTRUVADAEMTRICITABINE/TENOFOVIR200MG/300MGPATHEON INC-ADDRESS: 2100 SYNTEX COURT, MISSISSAUGA, ONTARIO L5N 7K9 COUNTRY: CANADA ,TAKEDA GMBH-16515 ORANIENBURG GERMANY,ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICAUNITED STATESORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/2557REMEDICA LTDGOODMAN INTERNATIONAL LTDEPSITRON 25 TABLETSCAPTOPRIL25MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 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/2559 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDERYTHRORENERYTHROMYCIN STEARATE250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2561PHARMATHEN LTDGOODMAN INTERNATIONAL LTDLANOMYCINAMIKACIN SULPHATE500MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECEGREECEPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/2562ACINO PHARMA AGGOODMAN INTERNATIONAL LTDTRABILIN-100TRAMADOL100MG/2MLMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEURENGERMANYPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X2.0 ML AMPOULE
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/2566MEDREICH PLCLABOREX UGANDA LIMITEDZEBENALBENDAZOLE400MGMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
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/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/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/2570REMEDICA LTDGOODMAN INTERNATIONAL LTDAMOXAPEN 250 CAPSULESAMOXYCILLIN250MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,100.0X10.0 CAPSULE BLISTER
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/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/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/2577TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOPCEF 200CEFIXIME200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2578REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMAGNOMINT TABLETSMAGNESIUM TRISILICATE+ALUMINIUM HYDROXIDE250MG+120MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2579ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 300/375 LACTABARTESUNATE + MEFLOQUINE300 MG + 375 MGMEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASELSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/2580ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDHEDON TABLETSPARACETAMOL + ASPIRIN + CAFFEINE250 MG+ 300 MG + 30 MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA,LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA,MILAN LABORATORIES (INDIA) PVT LTD - -63,67,87,35,36, 6KENYAORAL SOLID ORDINARY TABLETS 1.0X50.0X2.0 TABLET STRIP
NDA/MAL/HDP/2581MICRO LABS LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAVAS-10ATORVASTATIN10MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 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/2591SWISS PHAMACEAUTICAL PUT LTDHEALTHCARE LTD.VITAGLOBIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTSWISS PHARMACEUTICALS PVT LTD-A159 SINDH INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE
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/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/2595MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDZEPILENCEFAZOLIN1000MGMEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUSCYPRUSPARENTERAL ORDINARY DRY VIALS 1.0X10.0 VIAL CARTON
NDA/MAL/HDP/2596REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDURISEPTICNALIDIXIC ACID500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2597E DENK OHGBENLE CONSULT LIMITEDPARA DENK 250PARACETAMOL250MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANYGERMANYRECTAL SYSTEMIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/2600IND SWIFT LTDTATA UGANDA LIMITEDCLARIE-ODCLARITHROMYCIN(EXTENTED RELEASE)500MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/2601MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 750MGCEFUROXIME 750MGMEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUSCYPRUSPARENTERAL ORDINARY DRY VIALS 1.0X10.0 VIAL CARTON
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/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/2604ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT SYRUPMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2606SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDPROTAS 40ESOMEPRAZOLE40MGSQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2607 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDFLOTRALALFUZOSIN HCL10MGSUN PHARMACEUTICAL INDUSTRIES LTD-VILLAGE GANGUWALA, PAONTA SAHIB,173 025,DISTRICT SIRMOUR HIMACHAL PRADESH INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2610GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDATROPINEATROPINE1MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/2612RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRONMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2614REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDDIALINLOPERAMIDE HCL2MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
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/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/2628MICRO LABS LTD LABOREX UGANDA LIMITEDAZILIDE-500AZITHROMYCIN500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 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/2641MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 250MGCEFUROXIME AXETIL250MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP
NDA/MAL/HDP/2642MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMEDOXANUMCEFTRIAXONE1GMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 10 ML AMPOULE WFI
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/2645SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANZIDIME 1000CEFTAZIDIME 1000MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/2647DENK PHARMABENLE CONSULT LIMITEDIBUPROFEN DENK 400MGIBUPROFEN400MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2648E DENK OHGBENLE CONSULT LIMITEDPARA DENK 125PARACETAMOL125MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANYGERMANYRECTAL SYSTEMIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/2650DENK PHARMABENLE CONSULT LIMITEDVIT-B-DENKTHIAMINE HCL + PYRIDOXINE HCL100MG + 200MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 M?NCHEN, G?LLSTR. 1, 84529 TITTMONING, GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2651REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINAVIT SYRUPMULTIVITAMINMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 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/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/2654MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.BEBE VITVITAMIN A+ VITAMIN D3+VITAMIN E+ VITAMIN C +VITAMIN B1 + VITAMIN B2 1500IU+ 400IU+ 5MG+ 40MG+0.5MG+0.6MGMEDICAL UNION PHARMACEUTICALS -HEAD OFFICE 36 6TH DISTRICT NASR CITY CAIRO EGYPT PLANT ABUSULTAN ISMAILIAEGYPTORAL LIQUID ORDINARY LIQUIDS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/2656ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDAMINOPHYLLINEAMINOPHYLLINE100MGSHANDONG XIER KANGTAI PHARMACEUTICAL CO. LTD-PRIVATE ECONOMY ZONE,YANZHOU DISTRICT,SHANDONG, CHINA PRCHINAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2670CLARIS INJECTABLES LTDREDDYS 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/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/2672ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDLIDOCAINELIDOCAINE2%W/VROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY VIALS 1.0X25.0X20.0 ML VIAL
NDA/MAL/HDP/2673PHARMATHEN LTDGOODMAN INTERNATIONAL LTDSTRADUMELALLOPURINOL300MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECEGREECEORAL SOLID ORDINARY TABLETS 1.0X28.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE
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/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/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/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/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/2688ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMOXYN-250AMOXICILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2690ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-250AMPICILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/2691ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-500AMPICILLIN500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X500.0 MG VIAL
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/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/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/2697REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDLUCIN OINTMENTHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/2698CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAZICIN-500AZITHROMYCIN500MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 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/2703AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT 312.50 CO-AMOXICLAV (AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNATE)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/2704MACLEODS PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDPRIMACORT-100HYDROCORTISONE SODIUM SUCCINATE100MGMACLEODS PHARMACEUTICALS LTD-MAHIM ROAD, NEAR KULDEEP NAGAR REGAR(W0 MAHARASHTRAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X100.0 MG 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/2706SOLVAY PHARMACEUTICALS BVSTAR PHARMACEUTICALS LTDDUSPATALINMEBEVERINE HCL135MGSOLVAY PHARMACEUTICALS PV-VEERVEG 12 8121 AA 0187 NETHERLANDNETHERLANDSORAL SOLID ORDINARY TABLETS 1.0X10.0X5.0 TABLET BLISTER
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/2708MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHYPER TABLETSPROPRANOLOL HYDROCHLORIDE40MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER
NDA/MAL/HDP/2710GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTIN BDAMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/2712NEON LABARATORIES LTDAIVEEN (U) LIMITEDANAWINBUPIVACAINE0.025%W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROADINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/2714NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDANAFRANILCLOMIPRAMINE25MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NAITALYORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/2715MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINELAMIVUDINE150MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X60.0 TABLET 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/2719SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDLORASEDLORATADINE10MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/2720SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDFLUCAMOX 250MG POWDER FOR ORAL SUSPENSIONAMOXICILLIN +FLUCLOXACILLIN125MG/5ML+125MG/5MLSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X80.0 ML BOTTLE
NDA/MAL/HDP/2721MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRIMAFEN TABLETIBUPROFEN + PARACETAMOL400MG + 325MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2722MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDNO SORESCHOLINE SALICYLATE/LIDOCAINE8.7%W/W+2%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL TOPICAL GELS AND SOLS 1.0X10.0 G TUBE
NDA/MAL/HDP/2724UNEED GLOBAL GROUP LIMITEDASTRA PHARMA (U) LIMITEDCHLORAMPHENICOL 250MG CAPSULES BPCHLORAMPHENICOL250MGZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINACHINAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2726ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDQUININE INJECTIONQUININE DIHYDROCHLORIDE600MG/2MLZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD-KAIFA ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/2730MISSION PHARMA A/S INDIAJOINT MEDICAL STORE (UPMB - UCMB)TRICLOVERAMEDROXYPROGESTERONE ACETATE150MG/MLPT TUNGGAI IDAMAN ABDI,-J1.JEND.YANI NO.7 JAKARTA TIMURINDONESIAPARENTERAL ORDINARY I M VIALS 1.0X20.0X1.0 ML VIAL
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/2735SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDFORCECEFPIROME1GSQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHPARENTERAL ORDINARY VIALS 1.0X1.0 G VIAL + 1*10 ML AMPOULE WFI
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/2738WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDHEPA-MERZ INFUSIONL-ORNITHINE- L-ASPARTATE5MG/MLWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESHINDIAPARENTERAL ORDINARY I V VIALS 1.0X5.0X10.0 ML VIAL
NDA/MAL/HDP/2739REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL TABLETHYOSCINE BUTYLBROMIDE10MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL 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/2745 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENFORMINMETFORMIN HYDROCHLORIDE500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2746ERIS LTDBENLE CONSULT LIMITEDACYCLOVIR DENK 200ACYCLOVIR200MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X25.0 TABLET BLISTER
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/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/2753MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRASILMETOCLOPRAMIDE HYDROCHLORIDE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 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/2756PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDCYTOTEC MISOPROSTOL200MCGPIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND NE 613YAUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/2760REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDDELASED DRY COUGH SYRUPDIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN+SODIUM CITRATE+MENTHOL14MG+6.5MG+57MG+2MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2761REMEDICA LTDGOODMAN INTERNATIONAL LTDTRIFLUOPERAZINETRIFLUOPERAZINE HYDROCHLORIDE5MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2765CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HAEM FFOLIC ACID+ 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/2767MISSION PHARMA A/S INDIAJOINT MEDICAL STORE (UPMB - UCMB)PHENOXYMETHYLPENICILLIN TABLETS BPPHENOXYMETHYLPENICILLIN 250MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
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/2770WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDRELISUREMEFENAMIC ACID 250MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH - INDIA INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE 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/2773REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL ELIXIRHYOSCINE-N-BUTYLBROMIDE5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA, NAIROBI, KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML 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/2776UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDTENSIMIN-100ATENOLOL100MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,14.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2777NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCO-DIOVAN 160/12.5MG TABLETSVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 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/2780NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCO-DIOVAN 160/25MG TABLETSVALSARTAN + HYDROCHLOROTHIAZIDE160 MG + 25MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND,NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALYSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER
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/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/2783NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 25MGDICLOFENAC SODIUM25MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUEFRANCERECTAL SYSTEMIC SUPPOSITORIES 1.0X1.0X10.0 SUPPOSITORY STRIP
NDA/MAL/HDP/2784MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)AMOXICILLIN ORAL SUSPENSIONAMOXICILLIN125MG/5MLMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2787MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDAMOXICILLIN TABLETS FOR ORAL SUSPENSIONAMOXICILLIN125MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/2788RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMULTIVITAMIN TABLETSMULTIINGREDIENTN/ARENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2790UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 20ATORVASTATIN20MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2790UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 20ATORVASTATIN20MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2792UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 10ATORVASTATIN10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2793GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDVIREADTENOFOVIR DISOPROXIL FUMARATE300MGPATHEON YM INC. TORONTO- TORONTO, CANADA,ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICA,TAKEDA GMBH,PLANT ORANIENBURG-LEHNITZSTRASSE 70-98,16515,ORANIENBURG-GERMANYCANADAORAL SOLID ORDINARY TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/2796ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1,000,000I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 VIAL CARTON
NDA/MAL/HDP/2797 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDLUMARENARTEMETHER + LUMEFANTRINE20 MG + 120 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X3.0X8.0 TABLET BLISTER
NDA/MAL/HDP/2798UMEDICA LABS PVT LTDGITTOES PHARMACEUTICALS LIMITEDOMEGARDOMEPRAZOLE20MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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/2800NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPID HM PENFILLHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.5 ML PREFILLED PEN,1.0X3.0 ML PREFILLED PEN
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/2805REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 20R TABLETSNIFEDIPINE20MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
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/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/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/2811REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSULPHUR OINTMENTSULPHUR PRECIPITATED10%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE
NDA/MAL/HDP/2812DAFRA PHARMA LTDLABOREX UGANDA LIMITEDCO-ARTESIANEBETA ARTEMETHER + LUMEFANTRINE180 MG/60ML + 1080 MG/60MLMANUFACTURING PACKAGING FARMACIA APPELHOF OUDEHASK-NETHERLANDSNETHERLANDSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/2813REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDINTACYCLINE SKIN OINTMENTTETRACYCLINE HYDROCHLORIDE3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
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/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/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/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/2830MEDIPHARM SALES (E.A) LTDMEDIPHARM INDUSTRIES (E.A) LTDQUINIMIX MIXTUREQUININE HYDROCHLORIDE100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD (BWEYOGERERE)UGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2832ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN 100 RECTOCAPDICLOFENAC100MGR P SCHERER GMBH & CO. EBERBACH BALEN-R P SCHERER GMBH & CO. EBERBACH BALENGERMANYRECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY 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/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/2838MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDDILCONTIN XL 120CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE120MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATEINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/2848MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROGENTA OINTMENTBETAMETHASONE /GENTAMICIN SULPHATE0.5MG/G+1.0MG/GSCHERING-PLOUGH LABONV-INDUSTRIE PARK 30, B-220 HEIST-OP-DEN-BERG, BELGIUMCANADATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/2850MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM20MGMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPTEGYPTPARENTERAL ORDINARY AMPOULES 1.0X3.0X1.0 ML AMPOULE
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/2858GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDVIBROCILPHENYLEPHRINE + DIMETHINDENE MALEATE0.25% W/V + 0.025% W/VNOVARTIS CONSUMER INT. INC.-ZYMASA-CH-1260, NYON SWITZERLANDSWITZERLANDNASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE
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/2867SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII RABIVAXRABIES VACCINE2.5I.U/MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
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/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/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/2875GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.05% NASAL DROPSXYLOMETAZOLINE0.05%W/VNOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLANDSWITZERLANDNASAL TOPICAL DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/2878 PHARCO PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCOCIN CREAMGENTAMYCIN SULPHATE0.1%W/WPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
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/2880REMEDICA LTDGOODMAN INTERNATIONAL LTDCARBIMAZOLE 5CARBIMAZOLE5MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2882TATA UGANDA LIMITEDTATA UGANDA LIMITEDHYOSCINE BROMIDEHYOSCINE BROMIDE20MG/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/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/2885MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDFORECOX-TRACRIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL150MG + 75MG+ 400MG + 275MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER
NDA/MAL/HDP/2887MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)QUININE SULPHATEQUININE SULPHATE300MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/2888VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD SUCCICORTHYDROCORTISONE SODIUM SUCCINATE100MG/VIALVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL
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/2891MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDTORVAST 20ATORVASTATIN20MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2892UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDNICARDIA-20 TABLETSNIFEDIPINE20MGUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI ? 394 116, GUJARAT, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2893DAWA LIMITEDSUPER MEDIC LTDSTOPACID SUSPENSIONMAGNESIUM TRISILICATE + ALUMINIUM HYDROXIDE250MG/5ML + 120MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2894EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDMUCOGEL SUSPENSIONDRIED ALUMINIUM HYDROXIDE + MAGNESSIUM HYDROXIDE + OXETHAZAINE 8G/100ML + 2G/100ML + 0.2 G/100MLEGYPIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO EIPICO-10TH OF RAMADAN CITY-FIRST INDUSTRIAL AREA -EGYPTEGYPTORAL LIQUID ORDINARY SUSPENSIONS 1.0X125.0 ML BOTTLE
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/2897REMEDICA LTDGOODMAN INTERNATIONAL LTDSTORILATCARBAMAZEPINE200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2898MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDTORVAST 10ATORVASTATIN10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2900MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-200CEFIXIME 200MGMICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/2902MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMEGALIS-20TADALAFIL20MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK ?N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X15.0X1.0X4.0 TABLET STRIP
NDA/MAL/HDP/2903STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDABACAVIR SULPHATE TABLETSABACAVIR SULFATE300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/2904PHARMATHEN LTDGOODMAN INTERNATIONAL LTDNELTOLON SOLUTIONBIFONAZOLE10MGPHARMATHEN LTD.-6 DERVENAKION STR. 153 51 PALLINI-GREECEGREECETOPICAL EXTERNAL LIQUIDS 1.0X15.0 ML BOTTLE
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/2906MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRIFAMPICIN/ISONIAZID/ETHAMBUTOLRIFAMPICIN+ISONIAZID+ETHAMBUTOL150MG+75MG+275MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X24.0X28.0 TABLET 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/2908NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDPAINGO MEDICATED CREAMMETHYLSALICYLATE+CAPSICUM OLEORESIN+TURPENTINE OIL15%W/W + 1%W/W + 1.47%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 1.0X2.0X15.0 G TUBE
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/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/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/2914REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCHLOROCIDE SYRUPCHLORAMPHENICOL PALMITATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2915VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDTREXOLMETHOTREXATE50MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY VIALS 1.0X1.0X2.0 ML VIAL
NDA/MAL/HDP/2917REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCETAMOL TABLETSPARACETAMOL500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X50.0X2.0 TABLET STRIP,1.0X100.0X10.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
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/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/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/2926ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDTETRACYCLINE 250MG CAPSULES BPTETRACYCLINE 250MG ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINACHINAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 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/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/2937REMEDICA LTDGOODMAN INTERNATIONAL LTDPEN-A-CLOX CAPSULESAMPICILLIN + CLOXACILLIN250 MG + 250 MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
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/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/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/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/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/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/2945MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDONCETCETIRIZINE DIHYDROCHLORIDE10MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 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/2948DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDMETFORMIN DENK 850METFORMIN HYDROCHLORIDE850MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X15.0 TABLET BLISTER,1.0X8.0X15.0 TABLET BLISTER
NDA/MAL/HDP/2949MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL V TABLETCLOTRIMAZOLE100MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAVAGINAL TABLETS 1.0X6.0 PESSARY STRIP
NDA/MAL/HDP/2950PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDXALATANLATANOPROST0.005%W/VPFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURSBELGIUMOPHTHALMIC DROPS 1.0X2.5 ML BOTTLE
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/2954REMEDICA LTDGOODMAN INTERNATIONAL LTDVELORIN 100 F.C TABLETSATENOLOL100MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2955SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.CLOZOXCLOTRIMAZOLE2%W/WSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTANPAKISTANVAGINAL CREAMS 1.0X1.0X35.0 G TUBE + TWO APPLICATORS
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/2957MEDIPHARM SALES (E.A) LTDABACUS PHARMA (AFRICA) LIMITEDMEDITROLCALCITRIOL0.25MCGMEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND THAILANDORAL SOLID ORDINARY CAPSULES 1.0X6.0X5.0 CAPSULE BLISTER
NDA/MAL/HDP/2959REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCETAMOL SYRUPPARACETAMOL120MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
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/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/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/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/2969UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDTENSIMIN-50ATENOLOL50MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,14.0X10.0 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/2971TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.LEFRA-20 TABLETSLEFLUNOMIDE20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2972SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.ANTIMIN SYRUPLORATIDINE5MG/MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 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/2978SANOFI PASTEURLABOREX UGANDA LIMITEDTETAVAXTETANUS VACCINE40 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)
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/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/2981SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.STAMINCETIRIZINE DIHYDROCHLORIDE1MG/MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTANPAKISTANORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X60.0 ML BOTTLE
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/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/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/2987STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDSALDOPAMETHYLDOPA250MGSTRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAVADI CROSS ANECAL TULK BANGALORE 562 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2990MICRO LABS LTD LABOREX UGANDA LIMITEDPULMOCEF-500CEFUROXIME AXETIL USP500MGMICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X4.0 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/2992GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDHAVRIX1440HEPATITIS A ANTIGEN(HM 175 STRAIN)NLT 1440 ELISA UNITS OF VIRAL ANTIGENS(HM 175 STRAIN)SMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUMBELGIUMPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL (1 DOSE)
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/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/2997MEDLEY PHARMACEUTICALS MEDVIN PHARMA LIMITEDACENAC TABLETSACECLOFENAC100 MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2998MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDFITIN-5LEVOCETIRIZINE DIHYDROCHLORIDE5MGMEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2999MISSION PHARMA A/S INDIAJOINT MEDICAL STORE (UPMB - UCMB)AMOXICILLINAMOXICILLIN TRIHYDRATE250MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO. LTD-NO. 6 HYANXING RD ZNONGHU SHIJIAZHUANGCHINAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER
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/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/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/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/3008VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD BLEOSOLBLEOMYCIN15 UNITSVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X5.0 ML VIAL
NDA/MAL/HDP/3009VENUS REMEDIES LIMITEDHARLEYS UGANDA LIMITEDSULBACTOMAX 1.5GCEFTRIAXONE+SULBACTAM1000MG+500MGVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY DRY VIALS 1.0X20.0 ML VIAL
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/3012WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH - INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/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/3017ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDLIDOCAINE INJECTIONLIDOCAINE HYDROCHLORIDE 20MG/MLZHEJIANG RUIXIN PHARMACEUTICALS CO LTD-KAIFA ROAD TIANNING IDOUS ZONE LISHUI CITY CHINAPARENTERAL ORDINARY VIALS 1.0X25.0X20.0 ML VIAL
NDA/MAL/HDP/3019MJ BIOPHARM PRT LTDTATA UGANDA LIMITEDBIOSULIN 30/70INSULIN SOLUBLE + INSULIN ISOPHANE30 I.U + 70 I.UMJ BIOPHARM PRT LTD-L-7 MIDC INDUSTRIAL AREA, TALOJA, NARI MUMBAI MAHARASHTRAINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
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/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/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/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/3024MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE150MG + 200MG + 300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE ,MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
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/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/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/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/3032ACINO PHARMA AGGOODMAN INTERNATIONAL LTDXYLO-ACINO 0.05%XYLOMETAZOLINE0.05%W/VMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEURENGERMANYNASAL TOPICAL SPRAYS WITHOUT GAS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/3033GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDPENAMOXAMOXICILLIN125MG/5MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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
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/3043INDOCO REMEDIES LTDTATA UGANDA LIMITEDFEBREX TABLETSPARACETAMOL500MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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/3045REMEDICA LTDGOODMAN INTERNATIONAL LTDBRAMESTON 2.5BROMOCRIPTINE MALEATE2.5MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3046GLAXO SMITHLINE LIMITEDERIS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/3047MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDABACAVIR SULFATE+LAMIVUDINE+ZIDOVUDINEABACAVIR SULFATE + LAMIVUDINE + ZIDOVUDINE300 MG + 150 MG + 300 MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. ? 431136, MAHARASHTRA STATE, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/3048AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO-DS TABLETSSULFAMETHOXAZOLE/TRIMETHOPRIM800MG/160MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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/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
NDA/MAL/HDP/3054INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDNOSICDOXYLAMINE SUCCINATE + PYRIDOXINE HYDROCHLORIDE10MG+10MGINDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 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/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/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/3058SANOFI-AVENTISLABOREX UGANDA LIMITEDXATRAL LP 10MGALFUZOSIN10MGSANOFI WINTHROP INDUSTRIE,-30-36, AVENUE GUSTAVEEIFFEL BP 27166 - 37071 TOURS CEDEX 2FRANCEORAL SOLID ORDINARY COATED TABLETS 1.0X3.0X10.0 TABLET 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/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/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/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/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/3068REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.OPTACHLOR EYE DROPSCHLORAMPHENICOL0.5%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAMPAKISTANOPHTHALMIC DROPS 1.0X10.0 ML VIAL
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/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/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/3073COSMOS LTDASTRA PHARMA (U) LIMITEDCARDINOL TABLETATENOLOL50MGCOSMOS 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/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/3077REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDUNISTEN HC CREAM CLOTRIMAZOLE + HYDROCORTISONE1%W/W + 1%W/WREGAL PHERMACUTICALS -PLOT 7879/18 OFF BABA RWARAKA NAIROBI KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
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/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/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/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/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/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/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/3090PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOXCEFPODOXIME PROXETIL100MG/5MLPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHAJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/3091SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDONDIONDANSETRON2MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/3092NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDEXFORGE HCT 10MG/160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE10MG + 160MG +12.5MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAINSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
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/3097PHARMA INTERNATIONAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDDEBACRONGLICLAZIDE80MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BLISTER
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/3099PHARMA INTERNATIONAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDZONA 0.1% CREAMHYDROCORTISONE 17-BUTYRATE 0.1%W/WPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANTOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE
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/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/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/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/3106GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDLABOREX UGANDA LIMITEDPENAMOXAMOXICILLIN250MG/5MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/3110VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDZYDOTUMCEFTAZIDIME + SULBACTAM1000 MG + 500 MGVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY DRY VIALS 1.0X20.0 ML VIAL
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/3112HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDBUPROL 400MGIBUPROFEN BP400 MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIAMALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3113ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDPANCURONIUMPANCURONIUM BROMIDE4MG/2MLROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAUGERMANYPARENTERAL ORDINARY AMPOULES 1.0X1.0X10.0X2.0 ML AMPOULE
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/3118CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLUMARTEMARTEMETHER /LUMEFANTRINE20MG /120MGQUALITY CHEMICAL INDUSTRIES LIMITED. -PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3122ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVITMULTI-INGREDIENTMULTI-INGREDIENTREMIDEX PHARMA PVT LTD- B-249+ 250 II STAGE PEENYA INDUSTRIAL ESTATE BANGLORE 560058.INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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/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/3134 PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDTOFF PLUSPARACETAMOL+CHLORPHENIRAMINE MALEATE+ DEXTROMETHORPHAN + PHENYLEPHRINE500 MG + 2 MG + 15 MG + 10 MGPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3136MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/3138JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANUSOL SUPPOSITORYBISMUTH SUBGALLATE + BISMUTH OXIDE + ZINC OXIDE59 MG + 24 MG + 296 MGPERFORMANCE HEALTH LTD-241 NAIN ROAD RETREAT SOUTH AFRICA 7945SOUTH AFRICATOPICAL EXTERNAL SUPPOSITORIES 1.0X10.0 SUPPOSITORY BLISTER
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/3140GLAXO SMITHKLINE LTDERIS LTDULTIVA INJECTION 1MGREMIFENTANIL1MLGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAITALYPARENTERAL ORDINARY VIALS 1.0X1.0 VIAL CARTON
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/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/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/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/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/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/3150VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD MTX-VHBMETHOTREXATE50MG/2MLVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X2.0 ML VIAL
NDA/MAL/HDP/3151UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDCLOTRINE 100 MG PESSARIESCLOTRIMAZOLE100MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAVAGINAL TABLETS 1.0X6.0 PESSARY STRIP
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/3155MEDREICH PLCLABOREX UGANDA LIMITEDBIOFERONFERRIC AMMONIUM CITRATE + CYANOCOBALAMIN + FOLIC ACID200MG/5ML + 10MG/5ML + 750MCG/5MLMEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062,TEJKAMAL PHARMACEUTICALSPVT. LTD--SURVEY NO. 6/2, ALADAHALLI VILLAGE, SOMAPURA HOBCI NELAMANGALA TALUKI BANGALORE RURALINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
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/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/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/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/3163NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 50MGDICLOFENAC SODIUM50MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUEFRANCERECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X1.0X10.0 SUPPOSITORY STRIP
NDA/MAL/HDP/3165MEDREICH PLCLABOREX UGANDA LIMITEDMUCODIL EXPECTORANTTERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE + GUAIFENESIN2.5MG + 8MG + 100MGMEDREICH LTD-4/3 OFF KANAPURA ROAD, AVALAHALLI, A, TEJKAMAL PHARMACEUTICAL PVT, SURVEY NO.6/2 ALADAHALLI,SOMAPURAHOBIL,NELAMANGALA TALUK,BANGALORE RURAL-562111,INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
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/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/3173MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOCILLIN 250AMPICILLIN250MGMEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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/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/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/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/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/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/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/3185ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMINOPHYLLINE INJECTIONAMINOPHYLLINE25MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X5.0X10.0X10.0 ML AMPOULE,1.0X10.0X10.0 ML AMPOULE
NDA/MAL/HDP/3186IDA FOUNDATIONKIMSY MEDS LTDPARACETAMOLPARACETAMOL500MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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/3192MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDANZAVIR-RATAZANAVIR + RITONAVIR300 MG + 100 MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
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/3196MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDMOTINORMDOMPERIDONE10MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/3197ERIS LTDBENLE CONSULT LIMITEDTRIAM-DENK 40 INJECTION TRIAMCINOLONE ACETONIDE40 MG/MLDENK PHARMA, GOLLSTR.,-1-D-845 529 TITTMONING GERMANY GERMANYPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/3198AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPEN-125PHENOXYMETHYL PENICILLIN SODIUM125MG/MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3199MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDISENTRESSRALTEGRAVIR400MGZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD -ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD XUNQIAE LINHAI ZHIJIANGCHINAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
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/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/3203SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDTETANUS ANTITOXINTETANUS ANTITOXIN1500 I.USERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X50.0X1.0 ML AMPOULE (1 DOSE AMPOULE)
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/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/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/3207MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDDILCONTIN XL 90CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE90MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATEINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP
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/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/3214MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDINDICONTININDAPAMIDE1.5MGMODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM ? 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 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/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/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/3221REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.OPTADEX-N EYE DROPSDEXAMETHASONE/NEOMYCIN1MG/3MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAMPAKISTANOPHTHALMIC DROPS 1.0X5.0 ML VIAL
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/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/3226SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.PEDITRALORAL REHYDRATION SALTN/ASEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTANPAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X29.5 G SACHET
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/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/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/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/3233NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDWHITFIELD'S OINTMENT BPBENZOIC ACID + SALICYLIC ACID0.06G+0.03GNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE
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/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/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/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/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/3244UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMICILLINAMPICILLIN250MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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/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/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/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/3254VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDROBOLDOXORUBICIN HCL50MG/25MLVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY I V VIALS 1.0X30.0 ML VIAL
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/3258STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDLAMIVUDINE/ ZIDOVUDINE & EFAVIRENZ COMBIPACKLAMIVUDINE/ ZIDOVUDINE + EFAVIRENZ150MG/300MG + 600MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE,1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/3259NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTIGBODERM BETAMETHASONE + CHLOROCRESOL + GENTAMICIN + CLIOQUINOL + TOLNAFTATE 0.05% W/W + 0.1% W/W + 0.1% W/W + 1% W/W + 1% W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 1.0X3.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/3261MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDTENOFOVIR DF + EMTRICITABINE + EFAVIRENZTENOFOVIR DF + EMTRICITABINE + EFAVIRENZ300MG+200MG+600MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE ,MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA,MYLAN LABORATORIES LIMITED -PLOT NO. 11,12&13 INDORE SPECIAL ECONOINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/3262RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEGELMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE250MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CHEWABLE COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3263REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDTRIMEX MUCOLYTIC SYRUPSALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN2MG/5ML + 4MG/5ML + 100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 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/3270ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDFORTIFIED PROCAINE PENICILLINFORTIFIED PROCAINE PENICILLIN4000000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 VIAL CARTON
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/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/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/3278PHARMA INTERNATIONAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDTOPIDIC 2% OINTMENTSODIUM FUSIDATE20MG/GPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHAJORDANTOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/3279ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDHAEMOFORTE SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA,BAROQUE PHARMACEUTICALS PVT LTD --S.NO.192/2 & S.NO.192/2 &3 SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/3280INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDTUSPEL PLUS EXPECTORANTBROMHEXINE HYDROCLORIDE + TERBUTALINE SULPHATE + AMMONIUM CHLORIDE + MENTHOL8 MG + 2.5 MG + 100 MG + 1.5 MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3282MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDKOFF-GOPHENYLEPHRINE HCL + CHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN5MG/5ML + 2MG/5ML + 10MG/5MLTORQUE PHARMACEUTICALS (P) LTD-P.O.DAPPAR VILLISSINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
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/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/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/3288REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDELASED SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 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/3292REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDELASED PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL7MG+28.5MG+0.55MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3294WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL CAPSULESTRAMADOL HYDROCHLORIDE50 MGWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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/3296MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR100MG / 25MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER
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/3299SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.METODINE-DF SUSPENSIONMETRONIDAZOLE/DILOXANIDE FUROATE200MG/250MGSEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTANPAKISTANORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3300MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.MUCOSOL PEDIATRIC SYRUPCARBOCISTEINE125 MG/5 MLMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT EGYPTORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
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/3302CIPLA LTDQUALITY CHEMICALS LTD - HUMANAMOXICILLIN ORAL SUSPENSIONAMOXICILLIN125MG/5MLOKASA PVT LTD-346 KUNDAIM INDUSTRIAL ESTATE GOA, 403115INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3304REMEDICA LTDGOODMAN INTERNATIONAL LTDFELEXINCEFALEXIN MONOHYDRATE250MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3305TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDSPASMOTROYDROTAVERINE HYDROCHLORIDE20MG/MLTROIKAA PHARMACEUTICALS LIMITED -THOL,DIST,MEHSANA PIN:382728 GUJARAT AHMEDABAD INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/3309 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDCLOTRIMAZOLE PESSARIESCLOTRIMAZOLE100MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAVAGINAL TABLETS 1.0X6.0 PESSARY STRIP
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/3312TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TIDOMET FORTECO-CARELDOPA25MG/250MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3314 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSILVEREX SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE10MG/G+10MG/GSUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X250.0 G TUBE,1.0X25.0 G TUBE,1.0X10.0 G TUBE
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/3316SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3318RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM TABLETSCO-TRIMOXAZOLE480MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3319MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDFERROTONE CAPSULESFERROUS FUMERATE+FOLIC ACID+VITAMIN B12162MG +0.75MG +7.5MCGMEGA LIFESCIENCES LTD.-384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKANTHAILANDORAL SOLID ORDINARY CAPSULES 1.0X5.0X10.0 CAPSULE 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/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/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/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/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
NDA/MAL/HDP/3330SWISS PHAMACEAUTICAL PUT LTDHEALTHCARE LTD.DEXA-NDEXAMETHASON+NEOMYCIN SULPHATE1%W/W+0.5%W/WSWISS PHARMACEUTICALS PVT LTD-A159 SINDH INDUSTRIAL AREA KARACHIPAKISTANTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
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/3333CIPLA LTD.QUALITY CHEMICALS LTD - HUMANNOVACLAV-625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGOKASA PVT LTD-346 KUNDAIM INDUSTRIAL ESTATE GOA, 403115INDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3334UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMYCLAV 375AMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP,1.0X10.0X6.0 TABLET 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/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/3342SEARLE PAKISTAN LTDHEALTHCARE LTD.METODINE DF TABLETSMETRONIDAZOLE+DILOXANIDE400MG+500MGSEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTANPAKISTANORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X3.0X5.0 TABLET BLISTER
NDA/MAL/HDP/3343REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMEDIVEN-CREAMBETAMETHASONE VALERATE0.1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
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/3346WOCKHARDT LTDSTAR PHARMACEUTICALS LTDZEDEXBROMHEXINE +AMMONIUM CHLORIDE+ MENTHOL + DEXTROMETHORPHAN8MG+100MG+5MG+10MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3347REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN TABLETSPHENOXYMETHYLPENICILLIN250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3348VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDPIMCEFCEFEPIME USP1GVENUS REMEDIES LTD.-UNIT 11 HOLL TOP INDUSTRIAL ESTATE JHARMAJRIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X20.0 ML VIAL
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/3354REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMEDIVEN OINTMENTBETAMETHASONE VALERATE0.1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
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/3356CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYCEL-100 CAPSULESCELECOXIB100MGCADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
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/3359SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDARTIARTEMETHER80MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE
NDA/MAL/HDP/3360GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLORAMPHENICOL EAR DROPSCHLORAMPHENICAL5%W/VNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAOTIC DROPS 1.0X10.0 ML VIAL
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/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/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/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/3368PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDVIAGRA 50MGSILDENAFIL50MGPFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSEFRANCEORAL SOLID ORDINARY TABLETS 1.0X12.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X4.0 TABLET 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/3370RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDDERMOREN 500GRISEOFULVIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3372S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDMUCOLEXAMBROXOL HYDROCHLORIDE + SALBUTAMOL SULPHATE + GUAIFENESIN30MG +1MG + 30MG /5MLS KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3373UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMYCLAV 625AMOXILLICIN/CLAVULANATE500MG/125MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP
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/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/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/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/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/3381TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDHYDROCORTISONE SODIUM SUCCINATE FOR INJECTIONHYDROCORTISONE SODIUM SUCCINATE 100MGTROIKAA PHARMACEUTICALS LIMITED -THOL,DIST,MEHSANA PIN:382728 GUJARAT AHMEDABAD INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X100.0 MG VIAL
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/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/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/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/3386MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDAMBROSE 2CHLORAMBUCIL2MGNAPROD LIFE SCIENCES PVT LTD-G17 MDC TARAPUR IND AREA THONE, MUMBAI INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BOTTLE
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/3389BAYER PHARMA AGSURGIPHARM (U) LIMITEDCLARINASE REPE TABSLORATADINE + PSEUDOEPHEDRINE5MG + 120MGSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUMBELGIUMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
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/3392SWISS PHAMACEAUTICAL PUT LTDHEALTHCARE LTD.TRAMACIN POWDERNEOMYCIN + BACITRACIN0.052G + 0.0432GSWISS PARENTERALS PVT LTD- 809, KERALA INDUSTRIAL ESTATE, G.I.D.C, BAVIA ROAD, DIST, AHMEDABAD, GUJARAT, INDIA INDIATOPICAL EXTERNAL POWDERS 1.0X10.0 G CONTAINER
NDA/MAL/HDP/3393GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTIN 375MGAMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL SOLID ORDINARY TABLETS 2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3396CLARIS INJECTABLES LTDREDDYS 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/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/3399MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDLDNIL 10ROSUVASTATIN10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3400ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN GELDICLOFENAC SODIUM1%W/WMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEURENGERMANYTOPICAL EXTERNAL GELS AND SOLS 1.0X50.0 G TUBE,1.0X20.0 G TUBE
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/3404GLAXO SMITHLINE LIMITEDERIS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID500 MG + 100 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS 1.0X10.0X600.0 MG VIAL
NDA/MAL/HDP/3405GLAXO SMITH KLINE LTDERIS 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/3409BAYER PHARMA AGSURGIPHARM (U) LIMITEDCLARITINELORATADINE10MGSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUMBELGIUMORAL SOLID ORDINARY TABLETS 3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3410MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDNAPRODOX-50DOXORUBICIN50MGNAPROD LIFE SCIENCES PVT LTD-G17 MDC TARAPUR IND AREA THONE, MUMBAI INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0 MG VIAL
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/3412GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTETRACYCLINETETRACYCLINE HYDROCHLORIDE250 MGNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
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/3414NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE 10MG/160MGAMLODIPINE + VALSARTAN10 MG + 160 MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAINSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
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/3419MEDIPHARM (EA) LTDMEDIPHARM INDUSTRIES (E.A) LTDPIRITEX BABY COUGH LINCTUSCOUGH LINCTUS WITH DILUTE ACETIC ACID0.42ML/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3422GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGENTAMICIN EYE/ EAR DROPSGENTAMYCIN0.3%W/VNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/3423DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDAMOXICLAV-DENK 1000/125AMOXICILLIN TRIHYDTATE + POTASSIUM CLAVULANATE1000 MG + 125 MGPENCEF PHARMA GMBH-BRITENBACHSTR ASSE 13 D-13509 BERLINGERMANYORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X12.0X3.0 G SACHET,1.0X8.0X3.0 G SACHET
NDA/MAL/HDP/3426REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRUBEM CREAMMETHYL NICOTINATE + CAPSICUM OLEORESIN+ METHYLSALICYLATE 1%W/W+0.1%W/W+5%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X25.0 G TUBE
NDA/MAL/HDP/3427UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDSULFRANCOTRIMOXAZOLE480MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3428MEDI PHARMA IDUSTRIES E.A LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE CO-PACKMULTI INGREDIENTMULTI INGREDIENTMEDI PHARMA INDUSTRIES E.A LTD-PLOT 65 KAKAJJO ROAD BWEYOGEREREUGANDAORAL SOLID ORDINARY OTHER SPECIAL FORMS 1.0X2.0X20.5 G SACHET + 1*60.0 ML BOTTLE
NDA/MAL/HDP/3429XEPA-SOUL PATTINSONDELMAW ENTERPRISES LIMITEDEZEDELORATADINE10MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3431UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDNAZOL-200KETOCONAZOLE200MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3433NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCO-DIOVAN 80/12.5VALSARTAN + HYDROCHLOROTHIAZIDE80 MG +12.5 MGNOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
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/3437REMEDICA LTDGOODMAN INTERNATIONAL LTDREMYCIN 100 CAPSULESDOXYCYCLINE HYDROCHLORIDE100MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3438MEDREICH PLCLABOREX UGANDA LIMITEDPROXACINCIPROFLOXACIN500MGMEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3439RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR CAPSULECHLORAMPHENICOL250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,10.0X10.0 CAPSULE BLISTER
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/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/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/3444UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 10AMLODIPINE BESILATE10MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/3446SANOFI-AVENTISLABOREX UGANDA LIMITEDCORDARONEAMIODARONE HYDROCHLORIDE50MG/MLSANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE FRANCEPARENTERAL ORDINARY AMPOULES 1.0X3.0 ML AMPOULE
NDA/MAL/HDP/3449VENUS REMEDIES LIMITEDHARLEYS UGANDA LIMITEDIMMUNOXCEFTRIAXONE SODIUM1000MGVENUS REMEDIES LTD-VNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL, 1.0X10.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/3450DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTRAMADEX 50TRAMADOL50MGAEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIACYPRUSORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE 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/3452VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDPAXOLPACLITAXEL USP30MG/5MLVENUS REMEDIES LTD-VNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIAINDIAPARENTERAL ORDINARY OTHER VIALS 1.0X5.0 ML 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/3455MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE30MG + 60MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/3457JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANUSOL OINTMENTBISMUTH SUBGALLATE + BISMUTH OXIDE + ZINC OXIDE22.5 MG + 8.75 MG + 107.5 MGPERFORMANCE HEALTH LTD-241 NAIN ROAD RETREAT SOUTH AFRICA 7945SOUTH AFRICATOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE
NDA/MAL/HDP/3458REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIXILAMOXYCILLIN TRIHYDRATE250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
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/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/3461MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZIDOVUDINEZIDOVUDINE300MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. ? 431136, MAHARASHTRA STATE, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/3462VENUS REMIDIES LTDAARON PHARMACEUTICALS LTDPLATOLCISPLATIN500MG/100MLVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
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/3465MONDI-MUNDI PHARMA PVT LIMITEDSURGIPHARM (U) LIMITEDFECONTIN-ZFERROUS GLYCINE SULPHATE+ZINC SULPHATE+FOLIC ACID100MG+61.8MG+0.5MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATEINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/3467VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDRONEMMEROPENEM TRIHYDRATE1000MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL
NDA/MAL/HDP/3471VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDPAXOLPACLITAXEL100MG/16.7MLVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/3473ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTRIXONECEFTRIAXONE1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100,SHANDONG P.R & INJECT CARE PARENTERALS PVT LTD-PLOT 130, SILVASSA ROAD,G.I.D.C,VAPI-396195,GUJARAT,INDIACHINAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL
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/3475VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDRONEMMEROPENEM500MGVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/3476FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDPARAFILPARACETAMOL500MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER, 1.0X1000.0 TABLET CONTAINER, 1.0X10.0X10.0 TABLET BLISTER
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/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/3482AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCLOX-250CLOXACILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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/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/3489PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDNEO MEDROLMETHYLPREDNISOLONE ACETATE+ NEOMYCIN SULFATE 2.5MG+2.5MGPATHEON YM INC. TORONTO- TORONTO, CANADACANADATOPICAL EXTERNAL LOTIONS 1.0X25.0 ML BOTTLE
NDA/MAL/HDP/3490MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.LAXOLAC SYRUPLACTULOSE67G/100MLMEDICAL UNION PHARMACEUTICALS LTD-ABU SULTAN, ISMAILLIA, EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
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/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/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/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/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/3497MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDLIVOLIN FORTEMULTI-INGREDIENTMULTI-INGREDIENTMEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND THAILANDORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE 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/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/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/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/3506ABBVIE (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDULTANESEVOFLURANE100%W/WAESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENTUNITED KINGDOMNASAL SYSTEMIC UNIT DOSE LIQUIDS 1.0X250.0 ML BOTTLE
NDA/MAL/HDP/3507MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 250AMOXICILLIN250MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/3512NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDLAMISIL 250MGTERBINAFINE250MGNORVATIS PHARMA PRODUKTIONS GMBH -79644 WEHR/BADEN-GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET CARTON
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/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/3517ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTOTO ZINCZINC SULPHATE 20MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 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/3519STRIDES ARCOLAB LIMITEDDELMAW ENTERPRISES LIMITEDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/3520STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZ POWDERPOVIDONE IODINE + METRONIDAZOLE1%W/W + 5%W/WSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL POWDERS 1.0X100.0 G BOTTLE,1.0X10.0 G BOTTLE
NDA/MAL/HDP/3522GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCLOXACILLIN SODIUM FOR INJECTIONCLOXACILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY VIALS 1.0X10.0X500.0 MG VIAL
NDA/MAL/HDP/3525AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCLLINAMPICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3526CYANO PHARMA(P)RENE PHARMACY LTDPROMETHAZINE TABLETSPROMETHAZINE HYDROCHLORIDE25MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
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/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/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/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/3532ACINO PHARMA AGGOODMAN INTERNATIONAL LTDSIMEPAR CAPSULESMULTINGREDIENTMULTINGREDIENTMEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASELSWITZERLANDORAL SOLID ORDINARY CAPSULES 1.0X40.0 CAPSULE CONTAINER
NDA/MAL/HDP/3533ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDLEVOZINLEVOCETIRIZINE 5MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 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/3536SANOFI PASTEURLABOREX UGANDA LIMITEDTETRAXIMDIPHTHERIA/ TETANUS/ PERTUSSIS (ACELLULAR, COMPONENT) POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED)301IU/ 401IU/ 25MCG/ POLIOMYELITIS - 40DU (TYPE 1)/ 8DU TYPE 2/ 32DU TYPE 3SANOFI PASTEUR CAMPUS MERIEUX--1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/3537PHARMATHEN LTDGOODMAN INTERNATIONAL LTDNELTOLON GELBIFONAZOLE1%W/WPHARMATHEN LTD.-6 DERVENAKION STR. 153 51 PALLINI-GREECEGREECETOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE
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/3541VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDCARBOLCARBOPLATIN450MG/45MLVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY VIALS 1.0X45.0 VIAL CARTON
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/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/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/3546RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM D.SSULPHAMETHOXAZOLE + TRIMETHOPRIM800MG + 160MGRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3547UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORBIS-10BISOPROLOL10 MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP
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/3549REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDTRIMEX PAEDIATRIC COUGH EXPECTORANTCHLORPHENIRAMINE MALEATE+PSEUDO EPHEDRINE HCL+GUAIPHENISIN+MENTHOL1.0MG+15.0MG+50.0MG+0.5MG / 5MLREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3550VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDDOXOLDOCETAXEL20MG/0.5MLVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY VIALS 1.0X7.5 ML VIAL
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/3552VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDCARBOLCARBOPLATIN150MG/15MLVENUS REMEDIES LTD-VNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
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/3556REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDGRISACTIN-500 TABLETSGRISEOFULVIN TABLETS500MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/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/3561 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCILLIN ORAL SUSPENSIONAMPICILLIN TRIHYDRATE125MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/3564ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDATROPINE INJECTIONATROPINE SULPHATE1MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X100.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/3565PFIZER LABS LIMITED LABOREX UGANDA LIMITEDUNASYNSULTAMICILLIN TOSYLATE DIHYDRATE375MGHAUPT PHARMA LATINA S.R.L -S.S 156 KM BORGO SAN MICHELE LATINAITALYORAL 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/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/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/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/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/3573VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDPARIN-EENOXAPARIN SODIUM40MG/0.4MLVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0 ML PRE- FILLED SYRINGE
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/3575PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFIX 400 CAPSULESCEFIXIME 400MGPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANORAL SOLID ORDINARY CAPSULES 1.0X1.0X5.0 CAPSULE BLISTER
NDA/MAL/HDP/3577ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDMETOCLOPRAMIDEMETOCLOPRAMIDE5MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/3578REMEDICA LTDGOODMAN INTERNATIONAL LTDCINNARON 25CINNARIZINE25MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 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/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/3582RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDSULPHADIMIDINESULPHADIMIDINE500MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA KAMPALA,UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3583DENK PHARMA GMBH & COBENLE CONSULT LIMITEDSIMVA-DENK 40SIMVASTATIN40MGDENK PHARMA GMBH & CO-G0 11 STR.1 84529 T,HMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/3586VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDDOXOLDOCETAXEL80MG/2MLVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
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/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/3590REMEDICA LTDGOODMAN INTERNATIONAL LTDALFOXAN 500 FC TABLETSMEFENAMIC ACID500MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3591DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 80MG/MLARTEMETHER80MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY I M AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/3592FOURRTS (INDIA) LABORATORIES PUT LTDDELMAW ENTERPRISES LIMITEDMEGATRIM DSCO-TRIMOXAZOLE TABLETS 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/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/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/3595UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOXIL 125AMOXICILLIN TRIHYDRATE125MG/5MLUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3596NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDSYNTOCINONOXYTOCIN10 I.U/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/3597DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIAN 20MG/MLARTEMETHER20MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY I M AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/3598WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDMYOSPAZPARACETAMOL + CHLORZOXAZONE500MG + 250MGWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3599ASTRA PHARMA LTD ASTRA PHARMA (U) LIMITEDCHLORPROMAZINE INJECTIONCHLORPROMAZINE25MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE
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/3601SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDHYDROKANTHYDROCORTISONE ACETATE1%W/WSKANT HEALTH CARE LTD -1802-1805 GIDC PHASE III VAPI GUJARATINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/3604ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAC-FENACACECLOFENAC100MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3606STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDCELLTRIAXONCEFTRIAXONE1GSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. ,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/3607PHARMA INTERNATIONAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDLINOPRILLISINOPRIL DIHYDRATE20MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X14.0X2.0 TABLET BLISTER
NDA/MAL/HDP/3608SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.MESANNICLOSAMIDE500MGSHAIGAN PHARMACEUTICALS (PVT) LIMITED-14 KM ADYALA RD, RAWALPINDI, PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
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/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
NDA/MAL/HDP/3611SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDCOLDRIL SYRUPPARACETAMOL + CHLORPHENIRAMINE + PSEUDOEPHEDRINE120MG+1MG+10MGSHELYS PHARMACEUTICALS LTD,-NEW BAGAMOYO ROAD, MWENGE, PLOT NO 696,BLOCK NO 32, P.O.BOX 3016, DAR ES SALAAMTANZANIAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X100.0 ML BOTTLE
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/3613HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDZIDOVUDINE ORAL SOLUTIONZIDOVUDINE50MG/5MLHETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH ,INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X240.0 ML BOTTLE
NDA/MAL/HDP/3614RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDERYTHROREN SUSPENSIONERYTHROMYCIN STEARATE125MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3615GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMPICLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE BLISTER
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/3618ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDCLOXACILLIN SODIUMCLOXACILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0 VIAL CARTON
NDA/MAL/HDP/3619ERIS LTDBENLE CONSULT LIMITEDCAPTOPRIL DENK -25CAPTOPRIL25MGDENK PHARMA, GOLLSTR.,-1-D-845 529 TITTMONING GERMANY GERMANYORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3620REMEDICA LTDGOODMAN INTERNATIONAL LTDHALOXEN 10 TABLETSHALOPERIDOL BP10MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 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/3624AVENTIS INTERCONTINENTALLABOREX UGANDA LIMITEDORELOXCEFPODOXIME40MG/5MLSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE 56, RUE DE CHOISY AU BAC 60205 COMPI?GNE FRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/HDP/3625BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDAMOXICILLINAMOXICILLIN250MGSHANDONG XIER KANGTAI PHARMACEUTICAL CO LTD-YANZHOU CITY, CHINACHINAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3626CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDORIPHEX CAPSULESCEPHALEXIN250MGSAKAR HEALTHCARE LIMITED-BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT ? INDIA.,SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3628OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDCELEMIN 5SAMINO ACIDS/SORBITOL5%W/V+5%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION BAGS 1.0X500.0 ML BAG
NDA/MAL/HDP/3630MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDUNICONTIN 600THEOPHYLLINE600MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATEINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3631DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDENA-DENK 10ENALAPRIL MALEATE10MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 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/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/3637NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTINODERMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 1.0X18.0 G TUBE
NDA/MAL/HDP/3638REMEDICA LTDGOODMAN INTERNATIONAL LTDPETILIN 200 SODIUM VALPROATE200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X4.0X10.0 TABLET STRIP
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/3640PHARMATHEN LTDGOODMAN INTERNATIONAL LTDSTABILANOLFLUCONAZOLE100MGPHARMATHEN S.A--6,DERVENAKION STR .153 51,PALLINI,AHICA GREECEGREECEORAL SOLID ORDINARY CAPSULES 1.0X7.0 CAPSULE STRIP
NDA/MAL/HDP/3641MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDTRD-CONTIN 100TRAMADOL HYDROCHLORIDE100MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3642IND-SWIFTTATA UGANDA LIMITEDCLARIE 250CLARITHROMYCIN250MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/3643GLAXOSMITHKLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDLAMISIL CREAMTERBINAFINE1%W/WNOVARTIS CONSUMER HEALTH-SWITZERLANDSWITZERLANDTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
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/3648MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDUNICONTIN 400THEOPHYLLINE400MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATEINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3649NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDLAMISILTERBINAFINE125MGNOVARTIS BARBERA -SPAINSPAINORAL SOLID ORDINARY TABLETS 1.0X2.0X7.0 TABLET 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/3651CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDORIPHEX SYRUPCEPHALEXIN125MG/5MLSAKAR HEALTHCARE LIMITED-BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT ? INDIA.,SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/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/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/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/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/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/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/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/3664MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDAZZYAZITHROMYCIN500MGTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER
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/3668GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAUGMENTIN BDAMOXICILLIN + CLAVULANIC ACID200 MG/ 5 ML + 28.5 MG/ 5 MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE,1.0X140.0 ML BOTTLE
NDA/MAL/HDP/3669ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDCO-TRIMOXAZOLESULFAMETHOXAZOLE/TRIMETHOPRIM200MG/40MGMEDICAMEN BIOTECH LTD - -SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3670RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTETRAREN CAPSULESTETRACYCLINE HYDROCHLORIDE250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3671GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCLAVULIN TABLETSAMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET STRIP,10.0X10.0 TABLET STRIP,1.0X20.0 TABLET STRIP
NDA/MAL/HDP/3672MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDNITROCONTIN 6.4NITROGLYCERIN 6.4MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATEINDIAORAL SOLID ORDINARY SUBLINGUAL TABLETS 1.0X25.0 TABLET CONTAINER
NDA/MAL/HDP/3673ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDPROMETHAZINEPROMETHAZINE HCL25MG/MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/3674REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDINTAMINE SYRUPPROMETHAZINE HYDROCHLORIDE5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN
NDA/MAL/HDP/3675ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASCOPANHYOSCINE 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/3676MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCOTRIMOXAZOLECO-TRIMOXAZOLE480MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,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/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/3681RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEDOLPARACETAMOL500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3682NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDEXFORGE 10MG/320MGAMLODIPINE + VALSARTAN1OMG + 320MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 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/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/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/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/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/3688STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDNEUTRAFLUX MINT FLAVOURALGNIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE200MG +250MG + 250MG + 250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE,1.0X30.0 ML BOTTLE
NDA/MAL/HDP/3692MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCOTRIM 120CO-TRIMOXAZOLE120MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3693JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDIMODIUMLOPERAMIDE HCL2MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL SOLID ORDINARY CAPSULES 1.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/3698CADILA HEALTHCARE PVT LTDABACUS PHARMA (AFRICA) LIMITEDHIPHEN SYRUPAMOXICILLIN125MG/5MLSPARSH BIO-TECH LTD -PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR ? 361006 GUJARAT INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/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/3703REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSONATECCETYLPYRIDINIUM CHLORIDE0.05%W/VREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL TOPICAL LIQUIDS 1.0X250.0 ML BOTTLE
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/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/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/3708SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL MGLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG+500MGHANDOK INC-78, DAEPUNGSANDAN-RO, DAESO-MYEON, EUMSEONG-GUN, CHUNGCHEONGBUK-DO, KOREANORTH KOREAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3709MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.NIGHT & DAY -NPARACETAMOL/ DIPHENHYDRAMINE CHLORIDE + PARACETAMOL/ PSEUDOEPHEDRINE500MG/ 25MG +600MG/ 90MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT EGYPTORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
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/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/3712MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLOZAARLOSARTAN POTASSIUM / AMLODIPINE50MG + 5MGMICRO LABS LTD-92,SIPCOT INDUSTRIAL COMPLEX,HOSUR-635-126(T.N)INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/3716I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLIN SODIUM FOR INJECTIONCLOXACILLIN SODIUM FOR INJECTION500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY VIALS 1.0X10.0 VIAL CARTON
NDA/MAL/HDP/3717GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEFTRIAXONE SODIUMCEFTRIAXONE SODIUM1GCSPC ZHONGNUO PHARMACEUTICALS LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G 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/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/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/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/3725MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDNEW TUXIRILDEXTROMETHOPHAN HBR + PHENYLEPHRINE HCL + MENTHOL10MG/ML + 5MG/10ML + 5MG/10MLMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3728ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 50DICLOFENAC SODIUM50MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER + 1 * 10 SAMPLE
NDA/MAL/HDP/3729MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDDECIFEN-SR DICLOFENAC SODIUM100MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL SOLID RETARD ENTERIC-COATED TABLETS 1.0X10.0X20.0 TABLET STRIP
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/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/3732REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL TABLETS 200MGALBENDAZOLE200MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X2.0 TABLET STRIP
NDA/MAL/HDP/3733UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDDOMADOLTRAMADOL HCL100MG/2MLUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0X2.0 ML AMPOULE,1.0X5.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/3734XEPA-SOUL PATTINSONDELMAW ENTERPRISES LIMITEDZARICORT CREAMMICONAZOLE + HYDROCORTISONE2%W/W + 1%W/WXEPA SAUL PATTINSON MALAYSIA-1-5 INDUSTRIAL ESTATE 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
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/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/3737MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDECOFLOX 500 TABLETSCIPROFLOXACIN HYDROCHLORIDE500MGMEDLEY PHARMACEUTICALS LTD..-PLOT NO. 18 & 19, SURVEY NO.378/7&8, 379/2&3,ZARI CAUSEWAY ROAD, KACHIGAM,DAMAN (U.T) 396210-INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/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/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/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/3745MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDWINDERM CREAMBECLOMETHASONE+MICONAZOLE+NEOMYCIN0.025%W/W + 2%W/W + 0.5%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE
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/3747RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDALZOL TABLETSALBENDAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 30.0X2.0 TABLET BLISTER
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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/3753NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDMYFORTIC 180MYCOPHENOLATE SODIUM180MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND,NORVATIS PHARMA PRODUCTIONS GMBH, WEHR-OEFLINGER STR. 4479664 WEHR GERMANYSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X12.0X10.0 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/3757REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3760AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, ROYAL PHARMA 2011 LIMITEDCOMPOUND MAGNESIUM TRISILICATEMAGNESIUM TRISILICATE370MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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/3763PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDNORVASCAMLODIPINE5MGR-PHARM GERMANY GMBH -HEINRICH-MACH-STRASSE 35,89257,ILLERTISSEN,GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3767UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDAMPOXIN 500AMPICILLIN + CLOXACILLIN250 MG + 250 MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE 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/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/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/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/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/3777UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDAMPOXIN 500AMPICILLIN + CLOXACILLIN250 MG + 250 MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG 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/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/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/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/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/3787SPARSH BIO-TECH PVT LTD ABACUS PHARMA (AFRICA) LIMITEDSPENIV PHENOXYMETHYLPENICILLIN125MG/5MLSPARSH BIO-TECH PVT. LTD .-PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR ? 361006 GUJARAT INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
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/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/3792MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 228.5AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE200MG+28.5MGMEDREICH LIMITED UNIT 1-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR, BANGOLORE-560049INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
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/3797CLARIS INJECTABLES LTDREDDYS 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/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/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/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/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/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/3806INDOCO REMEDIES LTDTATA UGANDA LIMITEDNOCID GELALUMINIUM HYDROXIDE + SIMETHICONE + MAGNESIUM400MG/5ML + 25MG/5ML + 100MG/5MLINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE
NDA/MAL/HDP/3807GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDARTEMETHER INJECTIONARTEMETHER80MG/MLNINGBO DAHONGYING PHARMACEUTICALS-N0.396 MINZHU RD NINGBO CITY ZHEJIANG, CHINACHINAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE
NDA/MAL/HDP/3808NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 12.5MGDICLOFENAC SODIUM12.5MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUEFRANCERECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 1.0X1.0X10.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/3809MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDCOLDRID DAY & NIGHTPARACETAMOL+CHLORPHENIRAMINE MALEATE+PHENYLEPRINE HYDROCHLORIDE + CAFFEINE500MG+2MG+5MG+15MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET STRIP
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/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/3813MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDACTIPAR PIPERAZINE CITRATE500MG/5MLTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/3814MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDPETHIDINE INJECTIONPETHIDINE 50MG/1MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
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/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/3817ROYAL PHARMAROYAL PHARMA 2011 LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1000000 I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 MU VIAL
NDA/MAL/HDP/3818SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITINRECOMBINANT HUMAN ERYTHROPOIETIN2000 I.U/0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/3819PHARMATHEN LTDGOODMAN INTERNATIONAL LTDSTRADUMELALLOPURINOL100MGPHARMATHEN S.A--6,DERVENAKION STR .153 51,PALLINI,AHICA GREECEGREECEORAL SOLID ORDINARY TABLETS 1.0X25.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER
NDA/MAL/HDP/3823MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORM ORAL SUSPENSIONALBENDAZOLE200MG/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/3825UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOXIL 250AMOXICILLIN250MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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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/3828MEDREICH PLCLABOREX UGANDA LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL400MG + 325MGMEDREICH STERILAB LTD-UNIT VI 54/2 BOODHIHALLI VIINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER
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/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/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/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/3835GLAXOSMITHKLINE LTDBETA HEALTHCARE UGANDA LIMITEDHEDEX CAPLETS PARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS200MG+400MG+50MGSMITHKLINE BEECHAM (NAIROBI)-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 TABLETS 1.0X20.0 TABLET PACK,1.0X110.0 TABLET PACK,1.0X100.0 TABLET PACK
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/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/3840MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTORACTIN TABLETSCYPROHEPTADINE4MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 2.0X50.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/3843WOCKHARDT LTDSTAR PHARMACEUTICALS LTDAZIWOKAZITHROMYCIN250MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/3844NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN RETARDDICLOFENAC SODIUM100MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NORVATIS FARMA SPA--VIA PROVINCIALE SCHITO, 131 1-80052, TORRE ANNUNCIATA (NA) ITALYSWITZERLANDORAL SOLID RETARD TABLETS 1.0X30.0 TABLET CONTAINER
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/3846BAYER PHARMA AGSURGIPHARM (U) LIMITEDLEVITRAVARDENAFIL HCL20 MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/3848WOCKHARDT LTDSTAR PHARMACEUTICALS LTDAZIWOKAZITHROMYCIN200MG/5MLWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/3850MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3852GLAXOSMITHKLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPROCTO GLYVENOLTRIBENOSIDE + LIDOCAINE HCL5%W/W + 2%W/WNOVARTIS CONSUMER INT. INC.-ZYMASA-CH-1260, NYON SWITZERLANDSWITZERLANDTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/3853MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)ZINC SULPHATE TABLET USPZINC SULPHATE 20MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL SOLID ORDINARY SOLUBLE 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/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/3859UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDIFIMOLPARACETAMOL10MG/MLUNIQUE PHARMACEUTICAL LABORATORIES--PLOT NO. 4 PASE IV, GIDC PANOLI -394 116 GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
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/3862TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.LAMITOR 100LAMOTRIGINE100MGTORRENT PHAMACEUTICALS LTD-TORRENT PHAMACEUTICALS LTD INDRAD 382721 DIST MEHSANA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3865SIRMAXO CHEMICALS PVT LTDSUPER MEDIC LTDSANIQUAD GHSCETRIMIDE + CHLORHEXIDINE GLUCONATE15%W/V + 1.5%W/VSIRMAXO CHEMICALS PVT LTD-PLOT NO. E-35. TARAPRU MIDC BOISAR, THANE, MUMBAI, INDIAINDIATOPICAL EXTERNAL LIQUIDS 1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN
NDA/MAL/HDP/3866ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDRLCOMPOUND SODIUM LACTATE INFUSION BP0.6/ 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/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/3869UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDRANTAB INJECTIONRANITIDINE25MG/MLUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
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/3872UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDZYNCET SYRUPCETIRIZINE HYDROCHLORIDE5MG/5MLUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA,THE MADRAS PHARMACEUTICALS-137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096INDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE
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/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/3875PHAMA INTERNATIONAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIMAL(0.05% GELTRETINOIN USP0.25MG/1GPHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDANJORDANTOPICAL EXTERNAL GELS AND SOLS 1.0X1.0X30.0 G TUBE
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/3879MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDMETRIM SUSPENSIONCO-TRIMOXAZOLE 240MG/5MLMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3881MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.MOXACILAMOXYCILLIN TRIHYDRATE125MG/5MLMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/3883NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDMYFORTIC 360MYCOPHENOLATE SODIUM360MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS PHARMA PRODUKTIONS GMBH-OEFLINGER STR.4479664 WEHR GERMANYSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X12.0X10.0 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/3886PHARMA INTERNATIONAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDDELORCLOBETASOL PROPIONATE0.5 MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANTOPICAL EXTERNAL CREAMS 1.0X25.0 G TUBE
NDA/MAL/HDP/3887PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDLYRICA 150MGPREGABALIN150 MGPFIZER GMBH ARZEIMITELWORK -MOSWALDA 1144 79090 FREUBURGGERMANYORAL SOLID ORDINARY CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/3888 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPYRIRENPYRIDOXINE HYDROCHLORIDE25MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3889PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDLYRICA 75MGPREGABALIN75 MGPFIZER GMBH ARZEIMITELWORK -MOSWALDA 1144 79090 FREUBURGGERMANYORAL SOLID ORDINARY CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/3890UNIMED INDIAMETAPLUS (U) LIMITEDPARACETAMOL SYRUPPARACETAMOL 120MG/5MLUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/3891PHARMATHEN S.AGOODMAN INTERNATIONAL LTDLADININCIPROFLOXACIN500MGPHARMATHEN S.A--6,DERVENAKION STR .153 51,PALLINI,AHICA GREECEGREECEORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3892MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTETRAXLEVAMISOLE HYDROCHLORIDE40MG/5MLTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/3893GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDEPINEPHRINE INJECTION USPEPINEPHRINE HCL1MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
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/3896MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDVALCONTIN 500SODIUM VALPROATE (CONTROLLED RELEASE)500MGMODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM ? 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET 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/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/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/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/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/3903PFIZER LABS LTDERIS LTDCELSENTRI 300MGMARAVIROC300MGGODECKE GMBH -MOOSWALDALLEE 179090, FREIBERG GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0X6.0 TABLET BLISTER, AMPOULE AMPOULE
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
NDA/MAL/HDP/3906SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDLEROLEPANTOPRAZOLE40MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 ML VIAL 1*10ML 0.9%NACL AMPOULE
NDA/MAL/HDP/3907GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDANDREWS LIVER SALT REGULARMAGNESIUM SULPHATE +SODIUM HYDROGEN CARBONATE +CITRIC ACID17.4 %W/W+22.6 % W/W+19.5 % W/WSMITHLINE BEECHAM (NAIROBI)-NAIROBI, KENYAKENYAORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X8.0X5.0 G SACHET,1.0X48.0X5.0 G SACHET
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/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/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/3913MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDVALCONTINSODIUM VALPROATE200 MGMODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM ? 250110 UTTAR PRADESHINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3914GLAXOSMITHKLINE LTDERIS LTDAUGMENTINAMOXICILLIN + CLAVULANATE POTASSIUM875 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X1.0X7.0 TABLET BLISTER
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/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/3922SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDDIAZIDIAZEPAM5MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
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/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/3925GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCALCIUM GLUCONATE INJECTIONCALCIUM GLUCONATE10 %W/VNINGBO DAHONGYING PHARMACEUTICALS-N0.396 MINZHU RD NINGBO CITY ZHEJIANG, CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X50.0X10.0 ML AMPOULE
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/3928 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMALARENSULPHADOXINE + PYRIMETHAMINE500MG/25MGRENE INDUSTRIES LTD .-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER
NDA/MAL/HDP/3931NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOARTEM 80/480ARTEMETHER + LUMEFANTRINE80MG +480MGNORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEYTURKEYORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
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/3933TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOZAAR-50LOSARTAN POTASSIUM50MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY TABLETS 5.0X10.0 TABLET BLISTER
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/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
ANVS KENYA LTD SURGIPHARM (U) LIMITEDSYNTOCINONOXYTOCIN5 I.UNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/3945SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDCEFONECEFTRIAXONE1GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
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/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/3949REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMAGNOMINT SUSPENSIONMAGNESIUM TRISILICATE+ALUMINIUM HYDROXIDE500MG/5ML+250MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3950VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDSTROMTRAMADOL HYDROCHLORIDE50MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/3951SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCLOXAMPICILLIN + CLOXACILLIN125MG/5ML + 125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/3954WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPOWERCEF 1GM INJECTIONCEFTRIAXONE SODIUM1GMZEISS PHARMACEUTICALS PVT. LIMITED-PLOT NO. 72, EPIP I, JHARMAJIRI, BADDI (HP), INDIA,INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/3955STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDNEVIRAPINENEVIRAPINE200 MGSTRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAVADI CROSS ANECAL TULK BANGALORE 562 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/3960UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDIBUPARPARACETAMOL/IBUPROFEN325/400MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/3961MEDREICH PLCLABOREX UGANDA LIMITEDBIOFERONMULTI INGREDIENTN/AMEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE 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/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/3967AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCLOX-125CLOXACILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI). INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML 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/3969 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFAWAR FRUIT EFFERVESCENT GRANULESSODIUM CARBONATE + TARTARIC ACID + CITRIC ACID2.8G + 1.33G + 0.82GPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES 1.0X6.5 G SACHET
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/3971VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONE-SLCEFTRIAXONE + SULBACTAM1G+500MGVIRCHOW HEALTHCARE PVT LTD,-PLOT NO.130, SILVASSA ROAD, GGID VAPI-396 195, GUJURATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON + 10 ML AMPOULE WFI
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/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/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/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/3980UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDAB-TONE TONICVITAMIN B1 + VITAMIN B2 + VITMAIN B6 + VITAMIN B12 + FOLIC ACID + VITAMIN B5 + CALCIUM GLUCONATE + VITAMIN B3 + IRON + ZINC SULPHATE + COPPER SULPHATE + MANGANESE CHLORIDE + LYSINE HCL + HONEY + MALTMG PER 5ML: 5 + 1 + 1 + 5 + 50 + 2 + 20 + 10 + 10 + 3 + 0.2 + 0.25 + 20 + 100 + 100MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X200.0 ML BOTTLE,1.0X90.0 ML BOTTLE
NDA/MAL/HDP/3981GLAXO SMITH KLINE LTDERIS LTDPENAMOXAMOXYCILLIN500MGMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL SOLID ORDINARY CAPSULES 25.0X20.0 CAPSULE BLISTER,10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER
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/3983UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDEXTRADOLPARACETAMOL/CAFFEINE TABLETS500MG/65MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X2.0 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/3987REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDROHISOL SYRUPLEVAMISOLE HYDROCHLORIDE40MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X500.0 ML BOTTLE,1.0X15.0 ML BOTTLE
NDA/MAL/HDP/3989UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELIB 200MGCELECOXIB200MGUNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/3990REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIXIL SYRUPAMOXYCILLIN TRIHYDRATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 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/3993NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDNEM SCABMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/3995STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDLAMIVUDINELAMIVUDINE150 MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
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/3999 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDPANSEC DRPANTOPRAZOLE SODIUM40MGSUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA.INDIAORAL SOLID ORDINARY COATED TABLETS 1.0X4.0X7.0 TABLET STRIP
NDA/MAL/HDP/4000AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIDONE SYRUPCHLORPHENARIMINE 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/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/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/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/4006SANOFI-AVENTISLABOREX UGANDA LIMITEDRHINATHIOL 5% FOR ADULTS SUGARFREECARBOCISTEINE5G/100MLNATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANYGERMANYORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/4007SANOFI PASTEURLABOREX UGANDA LIMITEDSHANCHOL CHOLERA VACCINEV.CHOLERA STRAINS- 01 INABA FORMALDEHYDE KILLED +01 OGAWA HEAT KILLED + 01 OGAWA FORMALDEHYDE KILLED + 01 INABA HEAT KILLED + 0139 FORMALDEHYDE KILLED600 + 300 +300 +300 + 600 ELISA UNITS(EU) OF LIPOPOLYSACCHARIDE (LPS)SHANTHA BIOTECHNICS LTD -SURVEY NO. 274, ATHVELLI VILLAGE, MEDCHAL MANDAL ? 501401, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIAINDIAPARENTERAL ORDINARY I M VIALS 1.0X10.0X1.5 ML VIAL (1 DOSE)
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/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/4014GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDFUSIGENSODIUM FUSIDATE20MG/GGENO PHARMACEUTICALS LIMITED-KARASWADA,MAPUSAINDIATOPICAL EXTERNAL OINTMENTS 1.0X10.0 G TUBE
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/4016OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDCOMPOUND SODIUM LACATE INTRAVENOUS INFUSIONMULTI-INGREDIENTMULTI-INGREDIENTOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 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/4018MEDREICH PLCLABOREX UGANDA LIMITEDZEBENALBENDAZOLE100MG/5MLMEDREICH LTD-4/3 OFF KANAPURA ROAD, AVALAHALLI, A, TEJKAMAL PHARMACEUTICAL PVT, SURVEY NO.6/2 ALADAHALLI,SOMAPURAHOBIL,NELAMANGALA TALUK,BANGALORE RURAL-562111,INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X20.0 ML BOTTLE
NDA/MAL/HDP/4019SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDFLUCAMOX 1GAMOXICILLIN + FLUCLOXACILLIN500 MG + 500 MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTPARENTERAL ORDINARY VIALS 1.0X1.0 G VIAL
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/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/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/4024SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDSEDALAC SYRUPLACTULOSE3.350G/5MLSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X120.0 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/4031SEDICO PHARMACEUTICAL COWIDE SPECTRUM ENTERPRISES (U) LIMITEDSALBUTAMOL SYRUPSALBUTAMOL2MG/5MLSIDECO PHARMACEUTICAL CO LTD- EGYPT-1ST INDUSTRIAL ZONE, 6 OCTOBER CITY- EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X1.0X120.0 ML BOTTLE
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/4035BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDYASMINDROSPIRENONE + ETHINYLESTRADIOL3MG+0.3MGBAYER PHARMA AG -MULLERSTRASSE 178, 13353, BERLIN GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X21.0 TABLET BLISTER
NDA/MAL/HDP/4038NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDPREDSONE-5PREDNISOLONE5MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
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/4042SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDS-CHLORCHLORAMPHENICOL1GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
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/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/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/4050GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLORAMPHENICOL EYE DROPSCHLORAMPHENICOL0.5%W/VNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/4052HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDEFAVIRENZEFAVIRENZ600MGHETERO DRUGS LTD-UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055,HETERO 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/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/4056PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDFASIGYNTINIDAZOLE500MGPFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSEFRANCEORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER,1.0X8.0 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/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/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/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/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/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/4072SIRMAXO CHEMICALS PVT LTDSUPER MEDIC LTDSANIQUAD M 20CHLORHEXIDINE4%W/VSIRMAXO CHEMICALS-PLOT NO E 35, TARAPUR, BOISAR DIST, MUMBAIINDIATOPICAL EXTERNAL LIQUIDS 1.0X500.0 ML BOTTLE,1.0X5.0 L JERRYCAN
NDA/MAL/HDP/4074 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDUMICORT-100HYDROCORTISONE SODIUM SUCCINATE100MGUMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL
NDA/MAL/HDP/4075 RANBAXY LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDCHERICOF COUGH FORMULARCHLORPHENIRAMINE/DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL2MG/10MG/5MGRANBAXY LABORATORIES LTD AT: THE MADRAS PHARMACEUTICALS-137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
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/4079PHARMA INTL CO..WIDE SPECTRUM ENTERPRISES (U) LIMITEDNERVAMINEMECOBALAMIN500MCGPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHAJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
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/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/4085GLAXO WELLCOME (KENYA) LTDERIS LTDZINACEFCEFUROXIME SODIUM750MGGLAXO WELLCOME -VERONA ITALYITALYPARENTERAL ORDINARY DRY VIALS 1.0X750.0 MG VIAL
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/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/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/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/4094STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDEFAVIRENZEFAVIRENZ200MGSTRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAVADI CROSS ANECAL TULK BANGALORE 562 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X90.0 TABLET CONTAINER
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/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/4098STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDEFAVIRENZ TABLETSEFAVIRENZ600MGSTRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAVADI CROSS ANECAL TULK BANGALORE 562 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/4099GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEVO I.VLEVOFLOXAXIN500MG/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/4100REMEDICA LTDGOODMAN INTERNATIONAL LTDNORETHISTERONENORETHISTERONE5MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/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/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/4107ABBOTT HEALTHCARE , SASPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDUSPATALIN 200 MGMEBEVERINE200MGSOLVY PHARMACEUTICALS LTD-VEERWEG 12 NL 8121 NETHERLANDSNETHERLANDSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4112AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED, ROYAL PHARMA 2011 LIMITEDERYTHRONE TABLETS 250MGERYTHROMYCIN250MGSTRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA,AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4113MICRO LABS LTD LABOREX UGANDA LIMITEDEROSTIN 10EBASTINE10 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4114REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINALIN SYRUPCHLORPHENIRAMINE MALEATE2MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4115REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDPREDILONEPREDNISOLONE5.0 MGREGAL PHARMACEUICALS LTD-PLOT NO 7879 OFF BABA DOGO ROAD KUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
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/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/4123HETERO LABS LTD UNIT VIABACUS PHARMA (AFRICA) LIMITEDNEVIRAPINENEVIRAPINE200MGHETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABAD,HETERO LABS LIMITED .-UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/4125MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDPARACETAMOL SUSPENSIONPARACETAMOL 120MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4126UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELIB 100MGCELECOXIB100MGUNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4127SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDEPILIMSODIUM VALPROATE200MG/5MLUNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770FRANCEORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE,1.0X300.0 ML BOTTLE
NDA/MAL/HDP/4128 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAREN SYRUPVITAMIN A + VITAMIN B2 + VITAMIN B1 + VITAMIN B6 + VITAMIN C + VITAMIN E + VITAMIN B31500IU/5ML + 1MG/5ML + 1MG/5ML + 0.5MG/5ML + 20MG/5ML + 100 IU/5ML + 10MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4129IDA FOUNDATIONKIMSY MEDS LTDPRAZIQUANTELPRAZIQUANTEL600MGMICRO LABS LTD --PLOT NO. S-155 TO S-159 VERNA INDUSTRIAL ESTATE III VERNA GOA 403722INDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/4131MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDNEVIRAPINENEVIRAPINE200MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE ,MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/4132CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDZYCELCELECOXIB200MGCADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4134INDOCO REMEDIES LTDTATA UGANDA LIMITEDCITALDISODIUM HYDROGEN CITRATE1.37G/5MLINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4140ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDDIAZEPAM INJECTIONDIAZEPAM INJECTION10MG/2MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
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/4142DAFRA PHARMA LTDLABOREX UGANDA LIMITEDCO-ARTESAINEARTEMETHER + LUMEFANTRINE360MG + 2160MGMPF BV-APPLEHOF 13; NI 8465 RX OUDEHASKE NETHERLANDSNETHERLANDSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/4143MODI NUNDIPHARMA PVT LTDSURGIPHARM (U) LIMITEDTAM CONTIN 0.4TAMSULOSIN HYDROCHLORIDE0.4MGMODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM ? 250110 UTTAR PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/4144COSMOS LTDASTRA PHARMA (U) LIMITEDNYCOSTAT OINTMENTNYSTATIN100.000 I.UCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYATOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HDP/4146AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMPICLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4147ERIS LTDBENLE CONSULT LIMITEDNIFEDI-DENK 20 RETARDNIFEDIPINE20MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529GERMANYORAL SOLID RETARD FILM-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/4148COSMOS LIMITEDASTRA PHARMA (U) LIMITEDAMITRIPTYLINE TABLETSAMITRIPTYLINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
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/4150TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ANGIOPRIL-25CAPTOPRIL25MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)INDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4151IDA KIMSY MEDS LTDAMITRIPTYLINEAMITRIPYTLINE25MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
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/4165CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDZEFONE INJECTIONCEFTRIAXONE SODIUM1GSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA,REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100,INJECTCARE PARENTERALS INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
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/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/4171MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOREXMULTIINGREDIENTN/ATORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4172RENE INDUSTRIESRENE INDUSTRIES LIMITEDKOF OFF EXPECTORANTMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X110.0 ML BOTTLE
NDA/MAL/HDP/4173MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNASONEXMOMETASONE FUROATE MONOHYDRATE0.05%W/VMSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685,SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUMBELGIUMNASAL SYSTEMIC METERED-DOSE LIQUIDS 1.0X1.0X120.0 METERED DOSE CANNISTER
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/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/4181UMEDICA LABS PVT LTDGITTOES PHARMACEUTICALS LIMITEDUSTREPSTREPTOMYCIN SULPHATE1GUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 VIAL CARTON
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/4183GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLORPROMAZINECHLORPROMAZINE25MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/4187BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORIGYNON ESTRADIOL VALERATE +NORETHINDRONE ENANTHATE 5 MG+50 MG / MLBAYER PHARMA AG -MULLERSTRASSE 178, 13353, BERLIN GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
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/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/4241GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMPICILLIN SODIUM FOR INJECTION BPAMPICILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X500.0 MG VIAL
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/4275F. HOFFMANN LA-ROCHELABOREX UGANDA LIMITEDAVASTIN 100MG/4MLBEVACIZUMAB100 MG/ 4MLF.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL,ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-683