Drug Register (October 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. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIAZECUF 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 --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI?394 116,INDIA.ZECUF 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/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIAMANIX HERBAL CAPSULES INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE 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 PHARMACEUTICAL LABORATORIES --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI?394 116,INDIA.ZECUF 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
NDA/MAL/HHP/7956UNIQUE 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 (SUGAR FREE)INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
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 LIMITEDLEXINE 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/8094BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAPOSTORALINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X15.0 TABLET BLISTER
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
NDA/MAL/HHP/8291HIMALAYA DRUG COMPANYMETAPLUS (U) LIMITEDHIMALAYA DRUG COMPANY-27256287 INDIATENETEX FORTEINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER
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/8457BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAGASTICA SYRUPINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE
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/8512BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAINFAB SYRUPINDIAORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDGOOD DAY PHARMACY LIMITEDBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIAMENIPHIBINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X20.0 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
NDA/MAL/HHP/8549 UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMAXCURE NUTRVEDIC LTD-PLOT NO. 13, SECTOR 6-A,INTEGRATED INDUSTRIAL ESTATE(IIE), SIDCUL HARIDWAR-249403 UTTARAKHANDUNOSOYINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X60.0 CAPSULE BOTTLE
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 LIMITEDISHA 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
NDA/MAL/HHP/8672OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIAHYARTHO CAPSULESINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X60.0 CAPSULE BOTTLE
NDA/MAL/HHP/8673OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDISHA AGRO DEVELOPERS PVT.LTD-36A/55AB, LONAVALA CO.OP.INDL.EST.LTD, VILLAGE-NANGARGAON, LONAVALA,TALUKA-MAVAL,DIST. PUNE 410401 MAHARASHTRA INDIACALMLA CAPSULEINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X60.0 CAPSULE BOTTLE
NDA/MAL/HHP/8674OVIANI PHARMACHEM PVT. LTDMUKWANO PHARMACEUTICALS LIMITEDISHA 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 LIMITEDISHA 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 LIMITEDISHA 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 PHARMA 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 LTDDEWYX PHARMACEUTICALS LIMITEDBIO 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 LTDDEWYX PHARMACEUTICALS LIMITEDBIO 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 LIMITEDLEXINE 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
NDA/MAL/HHP/8901NANO BIOPHARMA LIMITED UNEED GLOBAL GROUP LIMITEDNANO HAYAT DAROU (NANO BIOPHARMA)-NO.168/2 16TH NOAVARI STREET, PARDIS TECHNOLOGY PARK-PARDIS-TEHRAN-IRANANGIPARSIRANTOPICAL EXTERNAL PRESSURISED OINTMENTS 1.0X30.0 G TUBE
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
NDA/MAL/HHP/8979LEXINE TECHNOCHEM PVT LTD MUKWANO PHARMACEUTICALS LTDLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373, OPP. RAMAKAKA DERI CHHANI, VADODARA ? 391704 GUJARAT, INDIA KWIK PAIN BALMINDIAORAL TOPICAL CREAMS 1.0X30.0 MG TUBE
NDA/MAL/HHP/9026LEXINE TECHNOCHEM PVT LTD MUKWANO PHARMACEUTICALS LIMITEDLEXINE TECHNOCHEM PVT LTD -SURVEY PLOT NO. 373, OPP. RAMAKAKA DERI CHHANI, VADODARA ? 391704 GUJARAT, INDIA BABY CARE + GRIPE WATER 130MLINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X130.0 ML BOTTLE

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 LIMITEDABACUS PARENTERAL DRUGS LIMITEDX-SONE-NDEXAMETHASONE+NEOMYCIN0.1W/V+ 0.35W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/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/0033ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYVATE CREAMBETAMETHASONE VALERATE0.1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
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 200MGNAPROD 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 + 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 + 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 LTD.AMTERICINAMPHOTERICIN50MGVHB 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/0073NAARI LTDECHO PHARMACY (U) LIMITEDFASILE-ONELEVONORGESTREL TABLETS BP 1.5MGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER
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/0131ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P125CLARITHROMYCIN125MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715SOUTH AFRICAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/0132ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 500MGCLARITHROMYCIN500MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715SOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/0133ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P250CLARITHROMYCIN250MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715SOUTH AFRICAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
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/0155TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ASTHATOR 10MONTELUKAST SODIUM10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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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
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NDA/MAL/HDP/0206MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCARDITEL 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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NDA/MAL/HDP/0284GLAXO SMITHLINE LIMITEDERIS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID1000 MG + 200 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QHUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS 10.0X1.2 G VIAL
NDA/MAL/HDP/0287GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDPOWER HEATMETHYL SALICYLATE BP 15000MGKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIATOPICAL EXTERNAL CREAMS 1.0X25.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/0288UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDDUXCOSPANHYOSCINE BUTYL BROMIDE10MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X10.0 TABLET BLISTER
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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
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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
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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
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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/0354KOPRAN LIMITEDTATA UGANDA LIMITEDLEVOKOPLEVOFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
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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
NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON
NDA/MAL/HDP/0361I CARE PHARMA LIMITEDVITACARE LTDATROPINE INJECTIONATROPINEIMG/MLWUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINACHINAPARENTERAL ORDINARY I V AMPOULES 1.0X5.0X10.0 ML AMPOULE
NDA/MAL/HDP/0362SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/0364JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDHALDOLHALOPERIDOL5MG/MLJANSSEN PHARMACEUTICAL NV-TURNHOUTSEWEG 30 B-2340 BEERSE BELGIUM BELGIUMPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/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/0369ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 250MGCLARITHROMYCIN250MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715SOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
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
NDA/MAL/HDP/0377MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDDUINUMCLOMIFENE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0379I CARE PHARMA LIMITEDVITACARE LTDAMINOPHYLLINE INJECTIONAMINOPHYLLINE250MG/10MLWUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINACHINAPARENTERAL ORDINARY I V VIALS 1.0X10.0X10.0 ML VIAL
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
NDA/MAL/HDP/0383FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMANNITOL FRESENIUSMANNITOL20%W/VFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY INFUSION BAGS 1.0X500.0 ML BAG
NDA/MAL/HDP/0384FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDPANCURONIUM BROMIDE FRESENIUSPANCURONIUM BROMIDE4MG/2MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/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/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IV PARACETAMOL1000MG/100MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
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 LTDECHO PHARMACY (U) LIMITEDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X4.0 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. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL 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) LIMITEDJADELLE 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/0416NORVATIS PHARMA SERVICESSURGIPHARM (U) LIMITEDRAMIZID 5RAMIPRIL5MGLEK S.A-95 - 010 STRYK?W, PODLIPIE 16, POLANDPOLANDORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/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-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL 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/0433PT SAMBE FARMAMEDVIN PHARMA LIMITEDPROANES MCT/LCTPROPOFOL1%W/VPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY I V AMPOULES 1.0X5.0X20.0 ML AMPOULE
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/0436PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 130 POLY (0-2-HYDROXYETHYL) STARCH30GPT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIAINDONESIAPARENTERAL ORDINARY INFUSION BAGS 1.0X500.0 ML BOTTLE
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/0438PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 200POLY (0-2-HYDROXYETHYL) STARCHMW 200,000PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIAINDONESIAPARENTERAL ORDINARY INFUSION BAGS 1.0X500.0 ML BOTTLE
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/0452I CARE PHARMA LIMITEDVITACARE LTDCALCIUM GLUCONATE INJECTIONCALCIUM GLUCONATE INJECTION 1G/10MLGRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCECHINAPARENTERAL ORDINARY INFUSION AMPOULES 1.0X10.0X10.0 ML AMPOULE
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/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE 500 MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 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 PLUSETHINYL ESTRADIOL + LEVONORGESTREL / FERROUS FUMARATE0.03MG+0.15MG/75MGBAYER SCHERING PHARMA AG.-13342, BERLINGERMANYORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0X28.0 TABLET BLISTER
NDA/MAL/HDP/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/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/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) LTDHARLEYS 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) LIMITEDHARLEYS 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/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) LTDHARLEYS 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/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/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,1.0X10.0X5.0X5.0 ML AMPOULE IN BLISTER PACK
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/0643NAARI LTDECHO PHARMACY (U) LIMITEDMISOPROMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHANDARGENTINAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
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
NDA/MAL/HDP/0658NVS KENYA LTD SURGIPHARM (U) LIMITEDGALVUS MET VILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0662PHARMAVET LTDDELMAW ENTERPRISES LIMITEDRECTIN 100INDOMETHACIN100MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/0663BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGLYCERINGLYCERIN1GBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/0665HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDIRBIS-H 150IRBESARTAN150MGHETERO 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/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
NDA/MAL/HDP/0671KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL LIGNOCAINELIDOCAINE2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/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/0681GENNOVA BIOPHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY DRY VIALS 1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI
NDA/MAL/HDP/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/0698ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID+SALICYLIC CID6%W/W + 3%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS 1.0X20.0 G TUBE
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
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 50MG TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/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/0745CADILA HEALTHCARE LTDKARURI PHARMACEUTICALS LTD.TELI 80TELMISARTAN80MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/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- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAPARENTERAL 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/0774CADILA HEALTHCARE LTDKARURI PHARMACEUTICALS LTD.NODONNEBIVOLOL10MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/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/0781TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRICOLDPARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE/CAFFEINE ANHYDROUS/CHLORPHENIRAMINE500MG/10MG/30MG/2MGTRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.PINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER
NDA/MAL/HDP/0783TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDCYPOLIVECYPROHEPTADINE HYDROCHLORIDE4 MGTRIVENI FORMULATIONS LIMITED--PLOT NO: 52,53,54, 62,63 & 64 ALEAP INDUSTRIAL ESTATE SURAMPALI VILLAGE, GANNAVARAM MANDAL KRISHNA (DT) A.PINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X50.0 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/0786TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDDERMA 1GRISEOFULVIN500MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.PINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET 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/0788TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRIDANTINNITROFURANTOIN100 MGTRIVENI FORMULATIONS LIMITED .- PLOT NO 52,53-54,63-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAN MANDAL KRISHNAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/0792ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAS-VPHENOXYMETHYL PENICILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/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 SODIUM500MGREYOUNG 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 MAGNESSIUM TRIHYDRATE PELLETS20MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE 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 MAGNESSIUM TRIHYDRATE PELLETS40MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE 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/0955I CARE PHARMA LIMITEDVITACARE LTDINDOXINDOMETHACIN USP25MGWUHAN GRAND PHARMACEUTICAL GROUP.CO.LTD-NO.5 GUTIAN ROAD WUHAN HUBEL PR OF CHINACHINAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/0956I CARE PHARMA LIMITEDVITACARE LTDGENTAMICIN INJECTION BPGENTAMICIN80MG/2MLGRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCECHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
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/0958I CARE PHARMA LIMITEDVITACARE LTDFUROSEMIDEFUROSEMIDE10MG/2MLGRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCECHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
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,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER
NDA/MAL/HDP/0960I CARE PHARMA LIMITEDVITACARE LTDVITAMIN B COMPLEX INJECTIONVITAMIN B1+VITAMIN B6+ VITAMIN B2+VITAMIN B5+ NICOTINAMIDE20MG+2MG+27.4MG+1MG+30MGWUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
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/2MLGRAND 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 1.0X20.0 ML VIAL, 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/1014ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDTIDAZOL TABLETSTINIDAZOLE500MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0X4.0 TABLET BLISTER
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
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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
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NDA/MAL/HDP/1098IDA FOUNDATIONKIMSY MEDS LTDPRAZIQUANTELPRAZIQUANTEL USP600MGMICRO LABS LTD ..PLOT NO.S-155 TO S-159 & N1,PHASE 111 & IV,VERNA SALCETTE GOA,403722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/1100 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOVIR SKIN CREAMACICLOVIR5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/1101MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O 100CEFIXIME100MGMICRO 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/1102MATRIX UGANDA LTDROYAL PHARMA 2011 LIMITEDOVUREXCLOMIPHENE50MG Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSANMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1103 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1104HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDLIPIDUCE 10ATORVASTATIN10MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X3.0 TABLET BLISTER
NDA/MAL/HDP/1105DAWA LIMITED SUPER MEDIC LTDDERMAZINE PLUS SILVER SULPHADIAZINE AND CHLORHEXIDINE GLUCONATE1%W/W / 10.0%W/WDAWA LIMITED -BABA DOGO RWARAKAKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1106EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1107SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) (PAEDIATRIC))HEPATITIS B VACCINE(RDNA)10MCG /0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY I M VIALS 1.0X25.0X5.0 ML VIAL (10 DOSES),1.0X10.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE 2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/1111DAWA LIMITEDSUPER MEDIC LTDFAST-ACT GEL DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS1.16%W/W + 10%W/W + 3%W/W + 5%W/WDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKAKENYATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/1112AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINE CAPSULESZIDOVUDINE100MGAUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHUINDIAORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CONTAINER
NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE
NDA/MAL/HDP/1114NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTRANGEL ULTRADICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN10MG/80MG/60MG/0.15MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE ? 401 210, MAHARASHTRA ? INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G CONTAINER
NDA/MAL/HDP/1116NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDVITAL ESSENTIAL BALMMENTHOL + CAMPHOR + PEPPERMINT OIL + EUCALYPTUS OIL + CLOVE OIL+ CINNAMON +WINTER GREEN OIL140MG + 140MG + 80MG +80MG +40MG +40MG +120MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE ? 401 210, MAHARASHTRA ? INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X24.0 G CONTAINER
NDA/MAL/HDP/1117NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTETRACYCLINE EYE OINTMENT USP 1%TETRACYCLINE1%W/WNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE ? 401 210, MAHARASHTRA ? INDIAINDIAOPHTHALMIC OINTMENTS 1.0X20.0X3.5 G TUBE
NDA/MAL/HDP/1122ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EAR DROPSCHLORAMPHENICOL5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOTIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL
NDA/MAL/HDP/1123AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPAR PARACETAMOL500 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/1124 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO SCRUBCHLORHEXIDINE GLUCONATE4%W/VAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL LIQUIDS 1.0X1.0X500.0 ML BOTTLE
NDA/MAL/HDP/1125AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXONE 1000CEFTRIAXONE1000MGA-UNIT VI, SY. NO 329/39, 329/INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/1127FEROZSONS LABORATORIES LTDTOP UNIVERSAL MEDICARE LIMITEDCLARION TABLETS 500MGCLARITHROMYCIN500MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY COMBINATION PACK TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS 500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1132STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDM-CALZCALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL1000MG+100MG+4MG+200.I.USTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/1133MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDMEDICOL SUSPENSIONCHLORAMPHENICOL125MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1136AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL EMULSIONS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1138 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO-CALAMINECALAMINE15%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL LOTIONS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1139AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE BETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1140AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/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
NDA/MAL/HDP/1142 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCANDIZOL CLOTRIMAZOLE 1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1145HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HILACLACTULOSE68%W/VHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/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) LIMITEDODIMONT 10MONTELUKAST10MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL 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/1158TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRAMADOL TRAMADOL50MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.PINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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/1162TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDWINKLOTCLOPIDOGREL75MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.PINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 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/1164TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDPIROXICAMPIROXICAM20MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.PINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
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/1182TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 5MONTELUKAST SODIUM5MGTORRENT PHARMACEUTICALS LIMITED-VILLAGE .BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P), INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET 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 LIMITEDROYAL 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+1.1MG IPCA LABORATORIES LTD,PLOT NO. T-139 -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/1259IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ- 6.25CARVEDILOL6.25MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET 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 ORDINARYCAPSULES 1.0X1.0X6.0 CAPSULE 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/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300 IOPROMIDE300MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
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 PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL 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 HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLMY 40OLMESARTAN40MGCADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/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-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL 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/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 LTD.DOMAXIN-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/1408TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ROSUCORROSUVASTATIN20MGTORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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 A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL
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/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/1471PT SAMBE FARMAMEDVIN PHARMA LIMITEDTEMIRALACICLOVIR30MG/GPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAOPHTHALMIC OINTMENTS 1.0X3.5 G TUBE
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, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS)FRANCEPARENTERAL 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/1509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDFEVEREXPARACETAMOL120MG/5MLBETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100,KENYAORAL SOLID ORDINARY SUSPENSION 1.0X60.0 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/1513ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VEXACEFCEFTRIAXONE1GANKUR DRUGS AND PHARMA LTD-WHITE TO OFF WHITE VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NELAGARH DIST.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/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 D-99427 WEIMAR, GERMANYGERMANYORAL 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/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/1537ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLEALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS 1.0X20.0X2.0 TABLET BLISTER
NDA/MAL/HDP/1538ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLE SUSPENSIONALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA KENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/1539KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDK-TRIMSULFAMETHOXAZOLE + TRIMETHOPRIM200MG + 40MGKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/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/1579PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID100MG/MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0 ML AMPOULE
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
NDA/MAL/HDP/1582LINCON PHARMCUETICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCEEPRO-500CIPROFLOXACIN500MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/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
NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.EGYPTORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRAPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON
NDA/MAL/HDP/1641UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDUNIENZYME C MPSNICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL25MG+50MG+30MG+20MG+75MGUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/1642 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDEUCHLOR-1000CHLORAMPHENICOL SODIUM SUCCINNATE B.P1GUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAPARENTERAL ORDINARY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/1645ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTAZOLEMEBENDAZOLE100MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1646BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETROZOLE TABLETSMETRONIDAZOLE+DILOXANIDE200MG+250MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BLISTER
NDA/MAL/HDP/1650NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL CR 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALYITALYORAL SOLID RETARD TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1651FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDMEGATRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE, 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/1652TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 300SODIUM VALPROATE300MGTORRENT 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/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
NDA/MAL/HDP/1656ANHIUMAISHA MEDICAL SUPPLIES LIMITEDAZIGYL-500AZITHROMYCIN500MGMEDICO 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/1660AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP
NDA/MAL/HDP/1661ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIA 100/25LOPINAVIR/ RITONAVIR100MG/25MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY.GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE
NDA/MAL/HDP/1665 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOXIN CAPSULESAMOXICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1666SANOFI AVENTIS LABOREX UGANDA LIMITEDAMARYL 1GLIMEPIRIDE1MG SANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1669SANOFI AVENTIS LABOREX UGANDA LIMITEDAMARYL 2GLIMEPIRIDE2MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1670SANOFI AVENTIS LABOREX UGANDA LIMITEDAMARYL 4GLIMIPIRIDE4MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIASOUTH AFRICAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1673GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN250MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1675MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDGARDASILQUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18)(20MCG+40MCG+40MCG+20MCG)/0.5MLMERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USAUNITED STATESPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X10.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/1676KOPRAN LIMITEDTATA UGANDA LIMITEDCLOXIN-250CLOXACILLIN250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1677MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDZIDOVUDINEZIDOVUDINE300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
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
NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDCIPROLEBCIPROFLOXACIN500MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1680NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/1681CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 25LOSARTAN POTASSIUM25MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1683Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDVOREN PLUSDICLOFENAC10MG/ML Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSANMALAYSIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE,1.0X45.0 G TUBE
NDA/MAL/HDP/1684LINCOLN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDIBUN-200IBUPROFEN200MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1686LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1687LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDALLDOXDOXYCYLINE 100MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/1690PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE1MG/MLPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
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
NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/1693PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDOPTIMAL (0.05%) CREAMTRETINOIN USP0.5MG/1GPHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDANJORDANTOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE
NDA/MAL/HDP/1694GLAXO WELLCOME(KENYA),LTDERIS LTDBETNOVATE CREAMBETAMETHASONE VALERATE0.1%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/1697PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1698CIPLA LTDQUALITY CHEMICALS LTD - HUMANAZEE-500AZITHROMYCIN500MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/1701KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFORMIN METFORMIN HYDROCHLORIDE500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/1702PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDDELOR CLOBETASOL PROPIONATE0.05%W/WPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANTOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE
NDA/MAL/HDP/1704DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAGTURKEYORAL SOLID ORDINARY TABLETS 1.0X3.0X5.0 TABLET BLISTER
NDA/MAL/HDP/1705IND-SWIFTTATA UGANDA LIMITEDMETSWIFTMETFORMIN 500MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
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
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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+BROMHEXINE50MG+2MG+5MG+4MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA,SHELYS PHARMACEUTICALS LTD,-NEW BAGAMOYO ROAD, MWENGE, PLOT NO 696,BLOCK NO 32, P.O.BOX 3016, DAR ES SALAAMTANZANIA/KENYAORAL 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
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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
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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
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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/1761EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDATAZOR-RATAZANAVIR + RITONAVIR300 MG + 100 MGEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/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/1768GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS 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
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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 + PARACETAMOL600MG+50MG+300MGBETA 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
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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/1804TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LISTRILLISINOPRIL5MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/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/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-BERGBELGIUM/SOUTH AFRICAORAL 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 1.0X10.0X1.0 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 HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL 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/1920STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDASCORBIC ACID TABLETASCORBIC ACID100MG STRIDES ARCO LAB LTD-K.R.S GARDENS SURAGAJAKKANAHALLI,INDLAWADI CROSS ANEKAL TALUK,BANGALOREINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/1922IPCA LABORATORIES LIMITED MEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500MG IPCA LABORATORIES LTD,PLOT NO. T-139 -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) LIMITEDATORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL 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/1932ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCANDISTAT CREAMCLOTRIMAZOLE1%W/WELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA KENYAORAL TOPICAL CREAMS 1.0X20.0 G TUBE
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/1961TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDMUILTIZEBEXVITAMIN A + CHOLECALCIFEROL + THIAMINE + RIBOFLAVINE + PYRIDOXINE + NICOTINAMIDE2500 IU + 200IU + 1MG +1MG + 0.5MG +15MGTRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.PINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/1962GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS 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 CHL8.7%W/W+2%W/W+0.01%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAORAL TOPICAL GELS AND SOLS 1.0X10.0 G TUBE
NDA/MAL/HDP/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/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 DIPROPRIONATE 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
NDA/MAL/HDP/2014SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCANI-MAKSCLOTRIMAZOLE1%W/W S KANT HEALTHCARE LTD-1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE
NDA/MAL/HDP/2016GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID CREAMCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/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
NDA/MAL/HDP/2025REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDFERRO-B COMPLEX SYRUPMULTI-INGREDIENTMULTI-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/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/2045ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICANBUPIVACAINE0.5% W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/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
NDA/MAL/HDP/2061RENE PHARMACY(R) LTD..RENE PHARMACY LTDADSOCARB TABLETSACTIVATED CHARCOAL250MGCYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL. 0.15MG / 0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X2.0X28.0 TABLET BLISTER
NDA/MAL/HDP/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
NDA/MAL/HDP/2070BAYER PHARMA AGSURGIPHARM (U) LIMITEDMIRENALEVONORGESTREL52MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS 1.0X1.0 IMPLANT CARTON
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/2108ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYMOX CAPSULES 250MGAMOXYCILLIN250MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES CAPSULE BLISTER, AMPOULE AMPOULE, CAPSULE CONTAINER
NDA/MAL/HDP/2111HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR200MG /50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.,HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET CONTAINER
NDA/MAL/HDP/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/2122ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYMOLPARACETAMOL120MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE, 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/2123VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.PLATFIRSTCISPLATIN1MG/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/2124ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYMOXAMOXYCILLIN125MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS ML BOTTLE
NDA/MAL/HDP/2125CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE 100BECLOMETASONE100MCG/DOSECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIANASAL SYSTEMIC METERED-DOSE LIQUIDS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/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 LTD.SOLITAXCEFTRIAXONE1GVHB 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.LIMITEDDELMAW ENTERPRISES LIMITEDDICLOFEN -50DICLOFENAC50MGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANYGERMANYPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/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, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS)FRANCEPARENTERAL 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/2164ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCORTHYDROCORTISONE1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS 1X15.0GM 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
NDA/MAL/HDP/2189KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL BETAMETHASONEBETAMETHASONE0.1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X5.0 G TUBE
NDA/MAL/HDP/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
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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
NDA/MAL/HDP/2211GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBENZYL BENZOATEBENZYL BENZOATE 25%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701 INDIA INDIATOPICAL EXTERNAL EMULSIONS 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
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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/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/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
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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
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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
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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 LIMITEDROYAL 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
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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 BOTTLE
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
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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
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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 A.G-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/2323ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDALPRIMCO-TRIMOXAZOLE240MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE, 1.0X5.0 L JERRYCAN
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/2360ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDFUNGISTIN PESSARIESNYSTATIN100000 IUELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIINDIAVAGINAL TABLETS 1.0X14.0 PESSARY PACK,5.0X3.0 PESSARY STRIP,1.0X100.0 PESSARY CONTAINER
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 COOMAB UGANDA 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-LOC 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/2379PT SANBE FARMAMEDVIN PHARMA LIMITEDPUMPITOROMEPRAZOLE40MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY VIALS 1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT
NDA/MAL/HDP/2381AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDSIMTRIM-480 TABLETSCO-TRIMOXAZOLE480MGAFRICURE 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/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/2389ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELOCIN ERYTHROMYCIN 250ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD PLOT NO. 209/8927 INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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 COOMAB UGANDA 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, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS)FRANCEPARENTERAL 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 AMPOULES 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/2511GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDULTIVA INJECTION 5MGREMIFENTANIL5MGGLAXOSMITHKLINE 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) LTDROYAL PHARMA 2011 LIMITEDSIMFEN 200 TABLETSIBUPROFEN200MGAFRICURE 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/2560MICRO LABS LTDLABOREX UGANDA LIMITEDLANCID-30LANSOPRAZOLE30MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
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 HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, 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/2670ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDSENSINILLIDOCAINE2%W/VCLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL,1.0X20.0 ML VIAL,1.0X30.0 ML VIAL
NDA/MAL/HDP/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 LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOAINDIAORAL 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 BVHARLEYS UGANDA LIMITEDDUSPATALINMEBEVERINE 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/2763ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCANDISTATCLOTRIMAZOLE100MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAVAGINAL SUPPOSITORIES PESSARY STRIP, PESSARY STRIP, KG AMPOULE
NDA/MAL/HDP/2765CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HAEM FFOLICACID+ VITAMIN B12+IRON AMMONIUM CITRATE1MG+5MCG+200MG/15MLCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/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/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 BROMIDE2OMG/MLGLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/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/2897+A823REMEDICA 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, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS)FRANCEPARENTERAL 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/2985SANOFI WINTHROP LTDLABOREX UGANDA LIMITEDEPILIM CHRONOSODIUM VALPROATE PH. EUR500MGSANOFI WINTHROP INDUSTRIE-1,RUE DE LA VIERGE ,AMBARES ET LAGRAVE 33565,CARBON BLANC CEDEX FRANCEFRANCEORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET 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/3018ROYAL PHARMA 2011 LIMITEDSINO AFRICA MEDICINES & HEALTH LTDDICLOFENAC SODIUMDICLOFENAC SODIUM75MG/3MLKIVI PHARM CO. LTD-DONGSHAN HIGH TECH INDUSTRIAL DEVELOPMENT ZONE,XUANHUA,ZHANGJIAKOU CITY,HEBEI CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X3.0 ML AMPOULE
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/3036BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGBETA HEALTH CARE INTERNATIONAL LTD-INDUSTRIAL AREA BONDO RD PLOT NO.7261/207 NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X200.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/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,1.0X60.0 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 COOMAB UGANDA 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 COOMAB UGANDA 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/3140GLAXOSMITHKLINE PHARMACEUTICAL KENYA 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/3229ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCIFLOCIPRFLOXACIN500MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
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/3251SCHERING N.V.SA...SURGIPHARM (U) LIMITEDUROGRAFINDIATRIZOIC ACID76%W/VSCHERING N.V, SA-SPAINSPAINPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X20.0 ML VIAL
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 COOMAB UGANDA 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,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 1.0X60.0 TABLET CONTAINER, 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/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-NDEXAMETHASONE+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/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/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/3390ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDALUGELALUMINIUM HYDROXIDEL / MAGNESIUM TRISLICATE 120MG/250MG ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS ML BOTTLE, L JERRYCAN
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/3396ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICAN HEAVYBUPIVACAINE HYDROCHLORIDE IN DEXTROSE 0.5%W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X25.0X4.0 ML AMPOULE
NDA/MAL/HDP/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 LTDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL BABY AND INFANT 120MG/5MLPARACETAMOL 120MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/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/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, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS)FRANCEPARENTERAL 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/3585ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDAMPILINAMPICILLIN250MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER
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 1.0X5.0X1.0 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/3603ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDVUMTREX SYRUPLEVAMISOLE40MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS ML BOTTLE
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.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/3607PHARMA INTERNATIONAL COOMAB UGANDA 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 SALAAM, BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYATANZANIA/KENYAORAL 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/3621ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDAMPILINAMPICILLIN125MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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/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 BOTTLE
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/3645TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDNEUROBEXTHIAMINE + RIBOFLAVIN + PYRIDOXINE + CYANOCOBALAMIN+ FOLIC ACID250MG + 15MG + 200MG + 250MG + 500MCGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.PINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
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) LIMITEDASCOPAN - SCHYOSCINE BUTYLBROMIDE10MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/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/3690REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDINTUSSED SYRUPDEXTROMETHORPHAN HBR BP+EPHEDRINE HCL BP+ PROMETHAZINE HCL BP8MG+8MG+4MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 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/3694CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLORIDIN RAPITABLORATADINE10MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/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/3719ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDPARACETAMOL TABLETSPARACETAMOL 500MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS TABLET BLISTER, AMPOULE AMPOULE, TABLET CONTAINER
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 TUXIRILDEXTROMETHORPHAN 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
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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
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NDA/MAL/HDP/3765ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDALPRIMCO-TRIMOXAZOLE480MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/3766ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDBUKOL TABLETSHYOSCINE N-BUTYLBROMIDE10MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY OTHER COATED TABLETS TABLET BLISTER, AMPOULE AMPOULE, TABLET CONTAINER
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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
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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
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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
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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
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NDA/MAL/HDP/3797ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDPROVIVE 1%PROPOFOL10MG/MLCLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL
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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/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/3841FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDMEGATRIM TABLETSCO-TRIMOXAZOLE480MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 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/3847ROYAL PHARMAROYAL PHARMA 2011 LIMITEDFORTIFIED PROCAINE PENICILLINFORTIFIED PROCAINE PENICILLIN4 MEGA UNITSHIJIAZHUANG PHARMA GROUP-ZHOUGNUO, PHARMACEUTICALCHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0 VIAL CARTON,1.0X10.0 VIAL CARTON
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 COOMAB UGANDA 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 COMPANYOMAB UGANDA 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
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/3926ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDMIFUPEN TABLETSASPIRIN + CAFFEINE350 MG + 50 MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET STRIP
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
NDA/MAL/HDP/3943NVS 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), INDIAINDIAPARENTERAL 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/3963NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOARTEM DISPERSIBLE TABLETSARTEMETHER + LUMEFANTRINE20MG + 120MGNORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEYTURKEYORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,2.0X1.0X24.0 TABLET BLISTER,2.0X1.0X18.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER
NDA/MAL/HDP/3965EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDOROFER SYRUPIRON(II) HYDROXIDE POLYMALTOSE COMPLEX50MG/5MLEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/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 A.G-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/4066UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDUNIBROLAMINOSIDINE125MG/MLUNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X60.0 ML BOTTLE
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..OMAB UGANDA 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/4089ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCONAZOLKETOCONAZOLE200MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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/4102TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.AZULIX-2GLIMEPIRIDE2MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 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 , SASHARLEYS 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 LIMITEDROYAL PHARMA 2011 LIMITEDERYTHRONE TABLETS 250MGERYTHROMYCIN250MGAFRICURE 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 HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDZYCEL 200CELECOXIB200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4133ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCETINCHLORAMPHENICOL125MG/MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE, 1.0X5.0 L JERRYCAN
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/4138ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCLOX CAPSULESAMPICILLIN + CLOXACILLIN250MG + 250MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER, 1.0X500.0 CAPSULE CONTAINER
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/4149GLAXOSMITHKLINE PHARMACEUTICAL KENYA 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 A.G-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-68305 MANNHEIM GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0X4.0 ML VIAL
NDA/MAL/HDP/4276SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE60MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 5 ML NACL + 1 ML SODIUM BICARBONATE
NDA/MAL/HDP/4277NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDVIVIRON PLUS SYRUP FERRIC AMMONIUM CITRATE +FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE50MG + 0.5MG + 2.2MG + 1.3MG +11MGNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.PAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/4279AUROLABSWASTIK PHARMACEUTICAL LTDAUROTIMTIMOLOL MALEATE0.5% W/VAUROLAB-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAIINDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4280MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDABACAVIR SULFATE+LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE600 MG + 300 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/4284F. HOFFMANN LA-ROCHELABOREX UGANDA LIMITEDAVASTIN 400MG/4MLBEVACIZUMAB400MG/4MLF.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL,ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0X16.0 ML VIAL
NDA/MAL/HDP/4286ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEGRA-50SILDENAFIL CITRATE50MGTHE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4287SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANAXONE 1000CEFTRIAXONE1000MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 ML VIAL,1.0X50.0X10.0 ML VIAL
NDA/MAL/HDP/4288SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOLESTOPATORVASTATIN10MGLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4289GLAXOSMITHKLINE LTDERIS LTDTWINRIX ADULTINACTIVATED HEPATITIS A ANTIGEN + HEPATITIS B SURFACE ANTIGEN720 ELISA UNITS + 20MCGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL (1 DOSE)
NDA/MAL/HDP/4291GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDVITAMIN B COMPLEX INJECTIONVITAMIN B COMPLEX 10MG/2MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/4294GLAXO SMITHLINE LIMITEDERIS LTDFLIXOTIDE ACCUHALER 250FLUTICASONE PROPIONATE250MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCELUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X60.0 METERED DOSE CANNISTER
NDA/MAL/HDP/4295ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTRAFLAM TABLETSPARACETAMOL + IBUPROFEN500MG + 400MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4297INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDCLOBEN-GCLOTRIMAZOLE/BECLOMETHASONE/GENTAMYCIN1%W/W+0.025%W/W+0.1%W/WINDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4298SANDOZ GMBH, KENYA C/O NORVATIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOLESTOPATORVASTATIN40MGLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4302GLAXO SMITH KLINE LTDERIS LTDFLIXOTIDE ACCUHALER 500FLUTICASONE PROPIONATE500MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCELUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X60.0 METERED DOSE CANNISTER
NDA/MAL/HDP/4303PFIZER LABORATORIES (PTY)LABOREX UGANDA LIMITEDSAYANA PRESSMEDROXYPROGESTERONE ACETATE104MG/0.65MLPFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURSBELGIUMPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X200.0X0.65 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/4309HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 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 FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/4310GLAXOSMITHLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED SYRUPTRIPLORIDINE HCL/PSEUDOEPHEDRINE1.25MG/30MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN
NDA/MAL/HDP/4312MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-FFOLLITROPIN ALFA75IU/IEMERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY,MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON + 1 PRE FILLED SYRINGE OF WFI
NDA/MAL/HDP/4315DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDDESLORA-DENK 5DESLORATIDINE5MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4317DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDCOLOSAR-DENK 50/12.5LOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4318UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDAKUGABALIN PREGABALIN75 MGAKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4320STRIDES ARCOLAB LIMITEDROYAL PHARMA 2011 LIMITEDHYOSCINE BUTYL BROMIDEHYOSCINE BUTYL BROMIDE10MGSTRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4321NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCUSIMOLOL 0.5%TIMOLOL MALEATE0.5% W/VALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAINSPAINOPHTHALMIC DROPS 1.0X5.0 ML VIAL
NDA/MAL/HDP/4322DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDVALSAR-DENK 160VALSARTAN160MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/4323SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDANDARANIRBESARTAN300 MGLEK PHARMACEUTICALS LTD-LEK PHARMACEUTICALS VEROVSKOVA 57 SI 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4324MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDPRASUSAFE 5PRASUGREL5MGMSN 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/4325AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDACTINAC 100ACECLOFENAC100MGGLENMARK PHARMACEUTICALS LTD (UNIT III)-B-4/5/6 MIDC INDUSTRIAL AREA,CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4326NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCUSICROM 4% EYE DROPSSODIUM CROMOGLYCATE4 %W/VALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAINSPAINOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/4329AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CPMCHLORPHENIRAMINE MALEATE2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4330SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDFLUCLOXACILLIN CAPSULES FLUCLOXACILLIN250MGSPARSH BIO-TECH PVT. LTD.--PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR ? 361006 GUJARAT INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/4331STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDSTEDNACACECLOFENAC100MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4332DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDVALSAR-DENK 320VALSARTAN320MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/4333ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDCARVIBERGCARVEDILOL USP6.25MGTHE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4334DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDLOSAR-DENK 50LOSARTAN50MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 M?NCHEN, G?LLSTR. 1, 84529 TITTMONING, GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4335DAWA LIMITEDSUPER MEDIC LTDCURAMOL SUSPENSIONPARACETAMOL120MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4336HILTON PHARMA (PVT) LTDHEALTHCARE LTD.NEOGABGABAPENTIN400MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4337DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDVALSAR-DENK 80VALSARTAN80MGDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4338MISSION PHARMAJOINT MEDICAL STORE (UPMB - UCMB)ALBENDAZOLEALBENDAZOLE400MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/4339GLAXOSMITHKLINE LIMITEDERIS LTDSERETIDE 125 EVOHALERSALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG/125MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUXFRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/4340ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDVITAMIN B COMPLEXVITAMIN B1 + VITAMIN B2 + SODIUM NICOTINAMIDE + VITAMIN B6 + D-PANTHENOL SODIUM10MG + 1.37MG + 15MG + 1MG + 0.5MGZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/4343PASTEUR MERIEUX CONNANGHTLABOREX UGANDA LIMITEDEUVAX B (PAEDIATRIC)HEPATITIS B VACCINE, RECOMBINANT20MCG/MLLG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JESOUTH KOREAPARENTERAL ORDINARY I M VIALS 1.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/4347GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDVERTIGONCINNARIZINE25MGGENO PHARMACEUTICALS LTD. -TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA, GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4348REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDMEDICLOAMP SYRUPCLOXACILLIN+AMPICILLIN250MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4350ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN-75DICLOFENAC SODIUM75MG/2MLMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEURENGERMANYPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/4351CIPLA LTDQUALITY CHEMICALS LTD - HUMANABACAVIR SULFATEABACAVIR SULPHATE60MGCIPLA LTD-PATALGANGA UNIT II PLOT MO A-33 A42 MIDC RAIGADINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/4352RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN SYRUP QUININE HYDROCHLORIDE100MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4354UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDRUXID 300ROXITHROMYCIN300MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS 1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/4355SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDANDARANIRBESARTAN150MGLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4356ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDFRESHENBISACODYL5 MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X12.0 TABLET BLISTER
NDA/MAL/HDP/4358A.MENARINI INDUSTRIE FARMACEUTICHE S.R.IPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLIOTONHEPARIN SODIUM1000I.U/GA. MENARINI MANUFACTURING LOGICTICS AND SERVICES-VIA 3 SETTE SANTI FLORENCE 50131 ITALYITALYTOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/4360ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL5MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4361: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDTAXIM-OCEFIXIME200MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4362MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 750LEVOFLOXACIN HEMIHYDRATE750MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4363ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEPTRINCO-TRIMOXAZOLE480MGTHE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4364CADILA HEALTHCARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVOMIZ OD 8ONDANSETRON HYDROCHLORIDE DIHYDRATE8MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4365AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDACTINAC PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGAJANTA PHARMA LIMITED-B-4/5/6,MIDC AREA, PAITHAN,431 148 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4366SPARSH BIO-TECH PVT LTD ABACUS PHARMA (AFRICA) LIMITEDCLOXISPACLOXACILLIN250MGSPARSH 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/4367ASTRA ZENECA MACNAUGHTON LIMITEDATACAND 8MGCANDESARTAN8MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJESWEDENORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4369KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPCHLORPHENAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE+PARACETAMOL1.25MG+10MG+120MGTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4371MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDNEVIHOPE 200NEVIRAPINE200MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/4373ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDAZIBERGAZITHROMYCIN DIHYDRATE500MGTHE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/4375PFIZER LAB LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYDRATE200MG/5MLHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELEITALYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE
NDA/MAL/HDP/4376CIPLA LTD.QUALITY CHEMICALS LTD - HUMANEFAVIRENZ+LAMIVUDINE & TENOFOVIR TABLETSEFAVIRENZ + LAMIVUDINE + TENOFOVIR600MG +300MG + 300MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/4377MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTEANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + POTASSIUM CHLORIDE13.5MG + 2.6MG + 2.9MG + 1.5MGMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X20.5 G SACHET,1.0X10.25 G SACHET
NDA/MAL/HDP/4379LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDSINURHONMULTI-INGREDIENTN/A LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY TABLETS 1.0X12.0X40.0 TABLET BLISTER,1.0X1.0X6.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
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NDA/MAL/HDP/4381LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITED DICLOFENAC SODIUMDICLOFENAC SODIUM50MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 10.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/4388SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDTAZOBAKPIPERACILLIN SODIUM + TAZOBACTAM SODIUM 4.0G + 0.5GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X4.5 G VIAL
NDA/MAL/HDP/4389PHARMACARE LTDMEDICAL ACCESS (UGANDA) LIMITEDPREZISTADARUNAVIR600MGJANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/4390AUROLABSWASTIK PHARMACEUTICAL LTDAUROCOLCHLORAMPHENICOL0.5%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/4391LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDMOBYLE-AACECLOFENAC + PARACETAMOL100 MG + 325 MGLINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AT & POST KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4392IND SWIFT LTDTATA UGANDA LIMITEDCAPLORCLOPIDOGREL75MGIND SWIFT LTD-GBU JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALIINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4394ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDNSSODIUM CHLORIDE0.9% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/4396MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDABACAVIR SULPHATEABACAVIR SULFATE300MGMYLAN 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/4397AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBISODAC-HF 2.5BISOPROLOL FUMARATE 2.5MGAUROBINDO PHARMA LTD UNIT III.-SURVEY NO.313 BACHUPALL VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4398 NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARESUPER MEDIC LTDSODIUM CHLORIDESODIUM CHLORIDE0.9 % W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/4399FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDGEFILCOMPOUND MAGNESIUM TRISILICATEALUMINIUM HYDROXIDE & MAGNESIUM TRISILICATE 132 &FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADCHINAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4400COSMOS LTDASTRA PHARMA (U) LIMITEDORAL REHYDRATION SALT (DTS)ORAL REHYDRATION SALT N/ACOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0X20.6 G SACHET,1.0X100.0X10.3 G SACHET
NDA/MAL/HDP/4401EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE DISODIUM2G EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X2.0 G VIAL + 2*5 ML OF WFI GLASS AMPOULES
NDA/MAL/HDP/4402VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDCLOTRILINCLOTRIMAZOLE100MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA INDIAVAGINAL TABLETS 1.0X6.0 TABLET STRIP
NDA/MAL/HDP/4404BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDFOLIGRAFRECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE75I.U/ VIALBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL RETARD OTHER VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/4406AGOG PHARMAGITTOES PHARMACEUTICALS LIMITEDSATISFIL -100SILDENAFIL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4407FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDSUXAMETHONIUM CHLORIDE- FRESENIUSSUXAMETHONIUM CHLORIDE100MG/2ML FRESENIUS KABI MANUFACTURING S.A (PTY) LTD ?-6 GIBAUD?ROAD KORSTEN, PORT ELIZABETH, SOUTH AFRICA.SOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/4408REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN CREAMCLOTRIMAZOLE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/4409SANDOZ GBH LTDSURGIPHARM (U) LIMITEDROBESTAR 10MGROSUVASTATIN CALCIUM10MGLEK PHARMACEUTICALS .D.D -VEROVSKOVA 57, 1526 LJUBLJANA SLOVENIA SLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4410AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDM-KAST 4MONTELUKAST CHEWABLE TABLETS 4 MG4MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4411ASTRA ZENECA MACNAUGHTON LIMITEDATACAND PLUSCANDESARTAN + HYDROCHLOROTHIAZIDE16 MG + 12.5 MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJEUNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4412AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDM-KAST 5MONTELUKAST SODIUM5MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4413EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE1G EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 2 PLASTIC AMPOULES OF WFI
NDA/MAL/HDP/4414SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDROBESTAR 20MGROSUVASTATIN CALCIUM20MGLEK PHARMACEUTICALS LTD-LEK PHARMACEUTICALS VEROVSKOVA 57 SI 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4415NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCATAFLAM 5OMG TABLETSDICLOFENAC POTASSIUM50MGNOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS--URUNLERI INSTABUL TURKEYITALYORAL SOLID ORDINARY COATED TABLETS 10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4417EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICEPHINCEFTRIAXONE SODIUM500MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X0.5 G VIAL + 1*5 ML OF WFI GLASS AMPOULES
NDA/MAL/HDP/4418MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDVALORANCEFOTAXIME1000MGMEDOCHEMIC LTD-1-10 ASTRONAFTON & CONSTANTINOPOLEOS 3505 LIMASSOLCYPRUSPARENTERAL ORDINARY DRY VIALS 1.0X10.0 VIAL CARTON
NDA/MAL/HDP/4419EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIGONAL 75HUMAN MENOPAUSAL GONADOTROPHIN75IU/5ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL + 1 ML AMPOULE 0.9%W/V NACL
NDA/MAL/HDP/4425RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN FCQUININE 300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4446AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDHI-ALFA 2.5ALFUZOSIN HYDROCHLORIDE2.5MGAUROBINDO PHARMA LTD UNIT III.-SURVEY NO.313 BACHUPALL VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4468AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTOPRAZ 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGAUROBINDOPHARMA LIMITED,-UNIT VII, SEZ APIIC, PLOT NO.SI SURVEY NO?S 425, 434,435 & 458 GREEN INDUSTRIAL PARK, POLEPALLY VILLAGEJEDCHERTA MANDAL, MAHABOOBNAGAR DISTTRICT, ANDRA PRADESH, INDIA.INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4480MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 5MONTELUKAST5MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/4523ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDBIGOMET SR 500METFORMIN HYDROCHLORIDE500MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESHINDIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4524DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZAL 150FLUCONAZOLE150MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X1.0 CAPSULE BLISTER
NDA/MAL/HDP/4526AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/4528ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPIOSAFE MF 15/500PIOGLITAZONE + METFORMIN15 MG + 500 MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4530DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTREDOL 100ATENOLOL100MGAEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIACYPRUSORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4531DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTREDOL 50ATENOLOL50MGAEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIACYPRUSORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4532DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIRUCID 400ACICLOVIR400 MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY OTHER TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4534DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDLORYTEC 10LORATADINE10MGDELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4535DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 250CLARITHROMYCIN250MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/4536SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDFLUCAMOXFLUCLOXACILLIN + AMOXICILLIN250MG+250MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTORAL SOLID ORDINARY CAPSULES 1.0X4.0X4.0 CAPSULE STRIP
NDA/MAL/HDP/4539VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDCRISTOLVINCRISTINE SULPHATE1MGVENUS REMIDIES LTD-UNIT-11 HILL TOP INDUSTRIAL ESTATE JHARMATIINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X1.0 ML VIAL
NDA/MAL/HDP/4540DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIPROLOX500CIPROFLOXACIN500MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4541GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMOXILAMOXYCILLIN500MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4542DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCLERON 500CLARITHROMYCIN500MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/4543SANOFI-AVENTISLABOREX UGANDA LIMITEDRHINATHIOL 5% CARBOCISTEINE5%W/VNATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANYGERMANYORAL LIQUID ORDINARY SYRUPS 1.0X125.0 ML BOTTLE
NDA/MAL/HDP/4544COSMOS LTDASTRA PHARMA (U) LIMITEDSALBUT TABLET 4MGSALBUTAMOL4MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/4545CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDCACH-ART 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X8.0 TABLET BLISTER
NDA/MAL/HDP/4546KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDCHLORAMPHENICOL INJECTION IGCHLORAMPHENICOL SODIUM SUCCINATE1GKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058INDIAPARENTERAL ORDINARY DRY VIALS 1.0X100.0X1.0 G VIAL,1.0X50.0X1.0 G VIAL
NDA/MAL/HDP/4549REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIXIL 500MGAMOXYCILLIN TRIHYDRATE500MGREGAL 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/4550SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDRHINATHIOL 2%CARBOCISTEINE20MG/MLUNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770,A. NATTERMANN & CIE GMBH.-NATTERMANNALLEE 1 ,50829 COLOGNE, GERMANYFRANCEORAL LIQUID ORDINARY SYRUPS 1.0X125.0 ML BOTTLE
NDA/MAL/HDP/4553GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUN ARTESUNATE30MGGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXICHINAPARENTERAL ORDINARY DRY VIALS 1.0X30.0 MG VIAL + 1*0.5 ML SODIUM BICARBONATE
NDA/MAL/HDP/4556ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 375AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM250MG + 125MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/4557HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDLAMIVUDINELAMIVUDINE150MGHETERO LABS LTD-HETERO LABS LTD, UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055,HETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABADINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/4558UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDIFICIPRO 500CIPROFLOXACIN500MGUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4559MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDPREGASAFE 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/4561TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LORVAS SRINDAPAMIDE1.5MGTORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET CONTAINER
NDA/MAL/HDP/4562F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDPEGASYSPEGINTERFERON ALPHA 2A180MCG/2MLF.HOFFMANN- LA ROCHE LTD-CH-4070 BASEL SWITZERLANDSWITZERLANDPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X2.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/4563TATA UGANDA LIMITEDTATA UGANDA LIMITEDQUININE DIHYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLGLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/4566TATA UGANDA LIMITEDTATA UGANDA LIMITEDFUROSEMIDE INJECTION BPFUROSEMIDE10MG/MLGLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/4568ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 625AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM500MG + 125MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/4569KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL SYRUPPARACETAMOL120MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4570AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINENEVIRAPINE200MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/4571ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASPICLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE STRIP,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/4573ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM DT 228.5MGAMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM200MG + 28.5MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/4575FDC LTDAIVEEN (U) LIMITEDPYRICORT EYE/EAR DROPSDEXAMETHASONE+GENTAMICIN 0.1%+0.3%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4577ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDMAGTAMCEFOPERAZONE + SULBACTAM500 MG + 500 MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/4579ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMESPORIN 500 IV VIALSCEFTRIAXONE 500MGLABESFAL LABORATORIOS ALMIRO, S.A ,.-ZONA INDUSTRIAL DO LABENGO, 3465-157 SANTIAGO DE BESTEIROSPORTUGALPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL + 1*5 ML WFI AMPOULE
NDA/MAL/HDP/4581ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1000AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM875MG + 125MGALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/4587CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIRATROATROPINE1MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/4588LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCAN 200FLUCONAZOLE200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0 TABLET BLISTER
NDA/MAL/HDP/4589FEROZSONS LABORATORIES LTDTOP UNIVERSAL MEDICARE LIMITEDLEFOXCIN-500LEVOFLOXACIN HEMIHYDRATE500MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER PAKHTOONKHWA), PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4591S KAGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSILVER KANTSILVER SULPHADIAZINE USP1%W/WS.KANT HEALTHCARE LTD-1802-18-5 GIDC PHASE III, VAPI-396195,GUJARAT INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4592LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPENTALINK 40PANTOPRAZOLE40MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4594CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTINIBA-500 TABLETSTINIDAZOLE500MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0X4.0 TABLET BLISTER,1.0X25.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4595LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-20ATORVASTATIN20MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4596INDOCO REMEDIES LTDTATA UGANDA LIMITEDTRIZ TABLETSCETIRIZINE10MGINDOCO REMEDIES LTD, B-20,-B-20 MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0X10.0 BLISTER BLISTER,1.0X5.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4598 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/4601SANOFI PASTEURLABOREX UGANDA LIMITEDPENTAXIM VACCINEMULTI-INGREDIENTMULTI-INGREDIENTSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS)FRANCEPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE,1.0X0.5 ML VIAL
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NDA/MAL/HDP/4603REMEDICA LTDGOODMAN INTERNATIONAL LTDHALOXEN - 5HALOPERIDOL5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4605AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODRYL SYRUPBROMHEXINE HCL+DEXTROMETHORPHAN HBR+AMMONIUM CHLORIDE+MENTHOL4MG/5ML+5MG/5ML+50MG/5ML+2.5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4606INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 10ROSUVASTATIN10MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4609ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCORTHYDROCORTISONE1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4611DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE200MG + 28MGBILIM PHARMACEUTICALS-ISLETMESI 59501 CERKEZKOY TEKIRDAGTURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/4614GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCOMPOUND BENZOIC ACID OINTMENTBENZOIC ACID + SALICYLIC ACID6 %W/W + 3 %W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL OINTMENTS 1.0X25.0 G TUBE,1.0X500.0 G TUBE
NDA/MAL/HDP/4615NVS KENYA LTD SURGIPHARM (U) LIMITEDTASIGNA 150NILOTONIB HYDROCHLORIDE MONOHYDRATE150MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDORAL SOLID ORDINARY CAPSULES 1.0X7.0X4.0 CAPSULE BLISTER
NDA/MAL/HDP/4617ASTRA ZENECA MACNAUGHTON LIMITEDCRESTORROSUVASTATIN10MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOPUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
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NDA/MAL/HDP/4621CADILA HEALTH CARE LIMITED ABACUS PHARMA (AFRICA) LIMITEDCARVIL 6.25CARVEDILOL6.25MGCADILA HEALTHCARE LTD--PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA 403401INDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/4629DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN MONOHYDRATE125MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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NDA/MAL/HDP/4636DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDZOLARAM 0.5ALPRAZOLAM0.5MGAEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIACYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/4645ASTRA ZENECA MACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM20MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICOPUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
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NDA/MAL/HDP/4650NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDDUOTRAVTRAVOPROST + TIMOLOL MALEATE40MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X1.0X2.5 ML VIAL
NDA/MAL/HDP/4652SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII TETANUS TOXOID VACCINETETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE? 5 LF (? 40 IU) ON ? 1.25 MG OF ALUMINIUM PHOSPHATESERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE (1 DOSE AMPOULE),1.0X10.0 ML VIAL (20 DOSE VIAL)
NDA/MAL/HDP/4655YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDDECASANDECAMETHOXIN0.2MG/1MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINETOPICAL EXTERNAL LIQUIDS 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X400.0 ML BOTTLE,1.0X1000.0 ML CONTAINER,1.0X2.0 ML CONTAINER
NDA/MAL/HDP/4656ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASCETCETIRIZINE10MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/4658PT SANBE FARMAMEDVIN PHARMA LIMITEDMEROSAN 0.5MEROPENEM0.5GPT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS 1.0X0.5 G VIAL
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NDA/MAL/HDP/4661YURIA PHARM EAST AFRICA LIMITEDYURIA PHARM EAST AFRICA LIMITEDFLUCONAZOLE-UFFLUCONAZOLE2MG/MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
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NDA/MAL/HDP/4666DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDANTIPLEX CLOPIDOGREL BISULFATE30MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/4677: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEFCEFUROXIME125MG/5MLALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X30.0 ML BOTTLE,1.0X70.0 ML BOTTLE
NDA/MAL/HDP/4678: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDZOCEF-500CEFUROXIME AXETIL500MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4680SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANCEPH DSCEPHALEXIN125MG/5MLSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
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NDA/MAL/HDP/4690ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYPENPHENOXYMETHYL PENICILLIN250MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER
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NDA/MAL/HDP/4694 MERCK SHARP & DOHME INTAPHARMAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDROTATEQROTAVIRUS LIVE REASSORTANT VIRUS G1+G2+G3+G4 &P12.2M IU+2.8M IU+2.2M IU+2.0M IUMERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USAUNITED STATESORAL LIQUID ORDINARY EMULSIONS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/4697PT SAMBE FARMAMEDVIN PHARMA LIMITEDSANBE CLANEKSIAMOXICILLIN + CLAVULANIC ACID1000 MG + 200 MGPT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIAINDONESIAPARENTERAL ORDINARY VIALS 1.0X6.0 VIAL CARTON
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NDA/MAL/HDP/4707WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL INJECTIONDICLOFENAC SODIUM25MG/MLWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH - INDIA INDIAPARENTERAL ORDINARY AMPOULES 1.0X3.0 ML AMPOULE
NDA/MAL/HDP/4708MEDIPHARM SALES (E.A) LTDMEDIPHARM INDUSTRIES (E.A) LTDMEDIFENIBUPROFEN100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4710COSMOS LTDASTRA PHARMA (U) LIMITEDMEDOPRESS TABLETS 250MGMETHYLDOPA250MGCOSMOS LIMITED..-RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
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NDA/MAL/HDP/4714 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDCEPHOXIN 250MG/5MLCEPHALEXIN250MG/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 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4715BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDMEFTAL FORTEMEFENAMIC ACID + PARACETAMOL500MG + 450MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4717BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDMEFTAL-SPASMEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE250MG + 10MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X20.0 TABLET BLISTER
NDA/MAL/HDP/4718MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDACNOTIN 20ISOTRETINOIN20MGMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4719MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDACNOTIN 10ISOTRETINOIN10MGMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4720SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEFTRONCEFTRIAXONE1GSQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*10 ML AMPOULE WATER FOR INJECTION
NDA/MAL/HDP/4721PT SAMBE FARMAMEDVIN PHARMA LIMITEDMEGABALMECOBALAMIN5000MCGPT SANBE FARMA,UNIT 1-JI INDUSTRI NO.9 LEUWIGAJAH CIMINDI CIMAHI WEST JAVA,INDONESIAINDONESIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/4722GLAXO SMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED COLD TABLETSTRIPROLIDINE HYDROCHLORIDE+PSEUDOPHEDRINE HYDROCHLORIDE2.5MG+60MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X96.0 TABLET BLISTER,1.0X480.0 TABLET BLISTER
NDA/MAL/HDP/4723REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDMEGYL SUSPENSIONMETRONIDAZOLE BENZOATE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4724GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED DRY COUGH & COLDTRIPROLIDINE HYDROCHLORIDE+PSEUDOEPHEDRINE HYDROCHLORIDE+DEXTROMETHORPHAN1.25MG+30MG+10MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X2.0 L BOTTLE
NDA/MAL/HDP/4725REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMEGYL TABLETMETRONIDAZOLE200MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4726MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDADB MIN MULTIPOWERMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X300.0 ML BOTTLE
NDA/MAL/HDP/4727STRIDES SHASUN LIMITED .DELMAW ENTERPRISES LIMITEDMELONAXMELOXICAM15MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4728M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDADRENALINEADRENALINEIMG/MLM.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAIINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0 ML AMPOULE
NDA/MAL/HDP/4729STRIDES SHASUN LIMITED .DELMAW ENTERPRISES LIMITEDMELONAXMELOXICAM7.5MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4730SANOFI PASTEURLABOREX UGANDA LIMITEDMENACTRAMENINGOCOCCAL GROUPS (A + C +Y + W-135) + POLYSACCHARIDE DIPTHERIA TOXOID CONJUGATE VACCINE4MCG + 4MCG + 4MCG + 4MCG + 48MCGSANOFI PASTEUR-INC DISCOVERY DRIVE SWIFTWATER PENNSYLVANIA 183370-0187UNITED STATESPARENTERAL ORDINARY I M VIALS 1.0X5.0 ML VIAL (10 DOSE VIAL)
NDA/MAL/HDP/4731SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDMENAFRIVACMENINGOCOCCAL A CONJUGATE VACCINE10MCG/ 0.5ML + 10-33MCG/0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X10.0 DOSE VIAL + 1*5ML AMPOULE OF DILUENT
NDA/MAL/HDP/4734SANOFI PASTEURLABOREX UGANDA LIMITEDMENINGOCOCCAL VACCINE A+CMENINGOCOCCAL A+C VACCINE50MCG/0.5ML + 50MCG/0.5MLSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS)FRANCEPARENTERAL ORDINARY I M VIALS 1.0X10.0 DOSE VIAL
NDA/MAL/HDP/4735MENTHOLATUMHARLEYS UGANDA LIMITEDMENTHOLATUM BALMMULTI-INGREDIENTMULTI-INGREDIENTTHE MENTHOLATUM COMPANY LTD- TWYFORD, BENKSHIRE, EUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE,1.0X4.0 G TUBE
NDA/MAL/HDP/4736ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMEPHAQUIN LACTABMEFLOQUINE250MGACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BLSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4737CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCICOL DROPSDICYCLOMINE HYDROCHLORIDE + SIMETICONE10MG + 40MG/ 5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/4738NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDCILOXANCIPROFLOXACIN0.3%W/VALCON -ALCON COUVREUR NV B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4739SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDMEROMEROPENEM1GSWISS 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/4740ASTRA ZENECA MACNAUGHTON LIMITEDMERONEMMEROPENEM500MGSUMITOMO PHARMACEUTICALS CO. LTD-JAPAN,ACS-DOBFAR ITALIAJAPANPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/4742ASTRA ZENECA MACNAUGHTON LIMITEDMERONEMMEROPENEM1GSUMITOMO PHARMACEUTICALS CO. LTD-JAPAN,ACS-DOBFAR ITALIAJAPANPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/4743DAFRA PHARMA N.V/S.ALABOREX UGANDA LIMITEDMERONIA 1000MEROPENEM1000MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECEGREECEPARENTERAL ORDINARY VIALS 1.0X1000.0 MG VIAL
NDA/MAL/HDP/4744DAFRA PHARMA N.V/S.ALABOREX UGANDA LIMITEDMERONIA 500MEROPENEM500MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECEGREECEPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/4745ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDPIPZOPIPERACILLIN + TAZOBACTAM4.5GALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X4.5 G VIAL
NDA/MAL/HDP/4746MIRACALUS PHARMA PVT.LTDAIVEEN (U) LIMITEDABINGEM-200GEMCITABINE200MGNAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAIINDIAPARENTERAL ORDINARY VIALS 1.0X200.0 MG VIAL
NDA/MAL/HDP/4747RIVA PHARMA FREE ZONEWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN200MG/5MLRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X22.5 ML BOTTLE
NDA/MAL/HDP/4748MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ACICONE-S CHEWABLE TABLETMAGALDRATE+SIMETHICONE720MG+25MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT EGYPTORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X5.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4749PT SANBE FARMAMEDVIN PHARMA LIMITEDMEROSANMEROPENEM1GPT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/4750BAYER AGSURGIPHARM (U) LIMITEDCIPROBAY I.VCIPROFLOXACIN2MG/MLBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4751 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFEROLFERROUS SULPHATE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4752PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDADRIBLASTINA RDDOXORUBICIN HYDROCHLORIDE10MGPHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALYITALYPARENTERAL ORDINARY OTHER VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/4753BAYER AGSURGIPHARM (U) LIMITEDCIPROBAY 750CIPROFLOXACIN750MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4754BAYER PHARMASURGIPHARM (U) LIMITEDCIPROBAY XRCIPROFLOXACIN500MGBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYORAL SOLID RETARD TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/4755BAYER SCHERING AGSURGIPHARM (U) LIMITEDADVANTAN CREAMMETHYL PREDNISOLONE ACEPONATE0.1%W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4757ERIS LTDBENLE CONSULT LIMITEDMETFORMIN-DENK 500METFORMIN500MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4758DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDMETFORMIN DENK 1000METFORMIN1000MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HDP/4759DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCIPRODARCIPROFLOXACIN500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4760HILTON PHARMA (PVT) LTDHEALTHCARE LTD.FEROSOFTIRON (III) HYDROXIDE POLYMALTOSE COMPLEX50MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.PAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/4763HILTON PHARMA (PVT) LTDHEALTHCARE LTD.FEROSOFTIRON(III) HYDROXIDE POLYMALTOSE COMPLEX100MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4765HILTON PHARMA (PVT) LTDHEALTHCARE LTD.FEROSOFT-FAIRON(III)HYDROXIDE POLYMALTOSE COMPLEX/FOLIC ACID100MG/0.35MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4766GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBEN SUSPENSIONMEBENDAZOLE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/4768REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.METHACHLOR EYE DROPSDEXAMETHASONE/CHLORAMPHENICOL1MG/2MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAMPAKISTANOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4769 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOBEXMEBENDAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4771ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDMETHYLERGOMETRINEMETHYLERGOMETRINE MALEATE20MCG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/4773IDA FOUNDATIONKIMSY MEDS LTDMETHYLERGOMETRINEMETHYLERGOMETRINE0.2MG/MLGLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESHINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/4774EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFERROFOL VIT-ZFERROUS SULPHATE+FOLIC ACID+ASCORBIC ACID+THIAMINE MONONITRATE+RIBOTLAVINE+PYRIDOXINE HCL+NICOTINAMIDE+ZINC150MG+0.5MG+50MG+2MG+2MG+1MG+10MG+25MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES 1.0X5.0X6.0 CAPSULE BLISTER
NDA/MAL/HDP/4777MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCRIXIVANINDINAVIR SULPHATE400MGMERCK SHARP & DOHME B.V-WAARDENWEG 392031 BN, HAARLEMNETHERLANDSORAL SOLID ORDINARY CAPSULES 1.0X180.0 CAPSULE BOTTLE
NDA/MAL/HDP/4778 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDCURISAFECEFADROXIL MONOHYDRATE125MG/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 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4779GLAXO WELLCOME (KENYA) LTDERIS LTDCUTIVATEFLUTICASONE PROPIONATE0.05%W/WGLAXO WELLCOME (UK)-UKUNITED KINGDOMTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/4780GLAXO WELLCOME (KENYA) LTDERIS LTDCUTIVATEFLUTICASONE PROPIONATE0.005%W/WGLAXO WELLCOME (UK)-UKUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HDP/4781CYANO PHARMA(P)RENE PHARMACY LTDCYANO IRON TABLETSFERROUS SULPHATE200MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4782VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.CYBIN PFCYTARABINE100MG/MLVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/4783CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCYPOTINCYPROHEPTADINE HYDROCHLORIDE2MG/5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4784ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD50GLUCOSE INTRAVENOUS INFUSION50%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4785JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDDAKTACORTMICONAZOLE NITRATE+HYDROCORTISONE2%W/W+1%W/WSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4786MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)COTRIMOXAZOLE 960MGSULPHAMETHOXAZOLE + TRIMETHOPRIM800MG + 160MGMEDICAMEN 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/4787JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDDAKTARINMICONAZOLE NITRATE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/4788JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDDAKTARIN ORAL GELMICONAZOLE NITRATE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL TOPICAL GELS AND SOLS 1.0X40.0 G TUBE
NDA/MAL/HDP/4789PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN HYDROCHLORIDE300MGFAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CARTON,1.0X2.0X8.0 CAPSULE STRIP
NDA/MAL/HDP/4790PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN HYDROCHLORIDE150MGFAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCEBELGIUMORAL SOLID ORDINARY CAPSULES 1.0X2.0X8.0 CAPSULE STRIP,1.0X100.0 CAPSULE CARTON
NDA/MAL/HDP/4791PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN PALMITATE75MG/5MLPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMORAL LIQUID ORDINARY OTHER POWDERS/GRANULES 1.0X80.0 ML BOTTLE
NDA/MAL/HDP/4792PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN CCLINDAMYCIN PHOSPHATE150MG/MLPFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUMBELGIUMPARENTERAL ORDINARY VIALS 1.0X4.0 ML VIAL,1.0X2.0 ML VIAL
NDA/MAL/HDP/4793PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDALACIN TCLINDAMYCIN PHOSPHATE1%W/VPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMTOPICAL EXTERNAL LIQUIDS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/4794NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDDALADOLDICLOFENAC SODIUM + PARACETAMOL50MG+500MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4795DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDDAROXIMECEFUROXIME500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BOTTLE
NDA/MAL/HDP/4796ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDARROWS SOLUTION (HALF STRENGTH)POTASSIUM CHLORIDE+SODIUM CHLORIDE+SODIUM LACTATE0.13%+0.20%+0.30%ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/4798VENUS REMIDIES LTDAARON PHARMACEUTICALS LTDCITABOLGEMCITABINE2MG/MLVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/HDP/4799 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDCITROLIN SOLUTIONCETRIMIDE+LIDOCAINE25MG+3MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL TOPICAL LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/4800DAWA LIMITEDSUPER MEDIC LTDDAWAVITE SYRUPMULTI-INGREDIENTMULTI-INGREDIENTDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4801AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDAZEL KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4804DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCLAVODARAMOXICILLIN + CLAVULANIC200MG + 28MG /5MLDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/4805 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFENIBUPROFEN200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4806 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFERFERROUS SULPHATE+FOLIC ACID200MG + 0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4807 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOFORMINMETFORMIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4809 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCORTHYDROCORTISONE0.1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4810TATA UGANDA LIMITEDTATA UGANDA LIMITEDMETHYLERGONOVINEMETHYLERGONOVINE MALEATE0.2MG/MLGLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESHINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/4811 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOGYLMETRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4812 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMETROL SUSPENSIONMETRONIDAZOLE BENZOATE125MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4813 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOMETROL TABLETS (THANE)METRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4814EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDMETLIFEMETRONIDAZOLE500MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4815LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDFERROLIC-LF FERROUS SULPHATE +FOLIC ACID 200MG+0.4MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4817CYANO PHARMA(P)RENE PHARMACY LTDMETOCLOPRAMIDE TABLETSMETOCLOPRAMIDE10MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4818LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDFERROUS SULPHATEFERROUS SULPHATE200MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4819FDC LTDAIVEEN (U) LIMITEDORAL REHYDRATION SALTORAL REHYDRATION SALT27.9GMFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X27.9 G SACHET
NDA/MAL/HDP/4820IDAKIMSY MEDS LTDFERROUS SULPHATE+FOLIC ACIDFERROUS SULPHATE+FOLIC ACID200MG+0.4MGBIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLIINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4821EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDMETPURE-XL 50METOPROLOL50MGEMCURE PHARMACEUTICALS LIMITED -LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4823OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDMETRIS INFUSIONMETRONIDAZOLE5MG/MLOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4824MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)FERROUS SULPHATE+FOLIC ACIDFERROUS SULPHATE+FOLIC ACID200MG+0.25MGBIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLIINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4825INDOCO REMEDIES LTDTATA UGANDA LIMITEDALOHA LIQUIDMULTI-INGREDIENTN/AINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/4826UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDMETROGYL DENTA GELMETRONIDAZOLE + CHLORHEXIDINE1%W/W + 0.25%W/WUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL TOPICAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/4828UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDMETROGYL GELMETRONIDAZOLE1%W/WUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIATOPICAL EXTERNAL EMULSION GELS 1.0X30.0 G TUBE
NDA/MAL/HDP/4830UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDMETROGYL INJECTIONMETRONIDAZOLE5MG/MLUNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116,UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--304-308 GIDC INDUSTRIAL AINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4832UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDMETROGYL SUSPENSIONMETRONIDAZOLE200MG/5MLUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI ? 394 116, GUJARAT, INDIA. ,J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARATINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4836AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETRONMETRONIDAZOLE200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4839PHARMAVET LTDDELMAW ENTERPRISES LIMITEDANOMEXZINC OXIDE+LIDOCAINE+HYDROCORTISONE+ALLANTOIN5%W/W+3%W/W+0.25%W/W+0.5%W/WBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X1.0X5.0 SUPPOSITORY BLISTER,1.0X2.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/4845TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ANTIDEPIMIPRAMINE25MGTORRENT 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,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4849UNI-MED INDIAMETAPLUS (U) LIMITEDMETRONIDAZOLE ORAL SUSPENSIONMETRONIDAZOLE BENZOATE125MG/5MLUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4854RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMETROREN FCMETRONIDAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4855GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDASCORIL EXPECTORANTBROMHEXINE+MENTHOL+TERBUTALINE+GUAIFENESIN2MG+0.5MG+1.25MG+50MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4856RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMETROREN METRONIDAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4858RENE INDUSTRIESRENE INDUSTRIES LIMITEDMETROREN SUSPENSIONMETRONIDAZOLE BENZOATE200MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4859GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDFLOXAPENFLUCLOXACILLIN250MGSMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEXUNITED KINGDOMORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CARTON
NDA/MAL/HDP/4860KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDK-FEN SUSPENSIONIBUPROFEN100MG/5MLKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/4862GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDFLOXAPEN SYRUPFLUCLOXACILLIN125MG/5MLMEDREICH LIMITED-12TH MIL,OLD MADRAS ROAD,VIRGONAGAR,BANGALORE-560 049,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4863MEDICAL UNION PHARMACUITICALS KARURI PHARMACEUTICALS LTD.MICONAZ ORAL GELMICONAZOLE2%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT EGYPTORAL TOPICAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/4865MEDICAL UNION PHARMACUITICALS KARURI PHARMACEUTICALS LTD.MICONAZ CREAMMICONAZOLE NITRATE 2%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT EGYPTVAGINAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/4866LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCANFLUCONAZOLE150MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0 TABLET BLISTER
NDA/MAL/HDP/4867CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDMICONA ORAL GELMICONAZOLE20MGCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAORAL TOPICAL GELS AND SOLS 1.0X40.0 G TUBE,1.0X20.0 G TUBE
NDA/MAL/HDP/4868 NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARESUPER MEDIC LTDFLUCANIRFLUCONAZOLE2MG/MLNIRMA LIMITED (HEALTHCARE DIVISION)-VILLAGE-SACHANA, TALUKA-VIRAMGAM DISTRICT- AHMEDABAD 382 150, GUJARAT, INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4869CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANMICOGEL CREAMMICONAZOLE NITRATE2%W/WCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4870ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFLUCASFLUCONAZOLE150MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1.0 CAPSULE BLISTER
NDA/MAL/HDP/4871STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDMICOBACT POWDERMICONAZOLE + CHLOROHEXIDINE2%W/W + 0.05%W/WSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL POWDERS 1.0X30.0 G CONTAINER,1.0X50.0 G CONTAINER,1.0X75.0 G CONTAINER,1.0X100.0 G CONTAINER
NDA/MAL/HDP/4872DAWA LIMITEDSUPER MEDIC LTDMICLOCIN CREAMMICONAZOLE NITRATE + CLOBETASOL PROPRIONATE + GENTAMICN2%W/W+0.5%W/W+0.1W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4873ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDFLUCASFLUCONAZOLE200MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE BLISTER
NDA/MAL/HDP/4874SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0X0.6 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/4875PHARM ACCESS AFRICA LTDMARIE STOPES UGANDA LIMITEDMISOCLEARMISOPROSTOL200MCGACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4876SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0X0.8 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/4877SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0X0.4 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/4878EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDFLUCOLIFEFLUCONAZOLE200MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4879SANOFI-AVENTISLABOREX UGANDA LIMITEDCLEXANEENOXAPARIN SODIUM100MG/MLSANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEXFRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0X0.2 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/4880CIPLA LTDQUALITY CHEMICALS LTD - HUMANMISOPROST 200MISOPROSTOL200MCGCIPLA LTD .-CIPLA GOA UNIT 8 L-147 TO L-147/1 L-147-3 TO L-138 VERNA INDUSTRIAL ESTATE VERNA GOAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X4.0 TABLET BLISTER,1.0X7.0X4.0 TABLET BLISTER,1.0X15.0X4.0 TABLET BLISTER
NDA/MAL/HDP/4881ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASDOXINDOXYCYCLINE100MGASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4883ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASFEN-FCIBUPROFEN200MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4884ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASFULVIN-500GRISEOFULVIN500MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4887DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE200MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4888ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASOMYCINERYTHROMYCIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4889DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE50MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/4890DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFLUCOZALFLUCONAZOLE100MGAEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUSCYPRUSORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4891REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDASPEC TABLETASPIRIN+PARACETAMOL+CAFFEINE ANHYDROUS150MG+250MG+300MGREGAL PHARMACEUTICALS LTD-OFF BABA DOGO RD, RUARAKA, NAIROBI, KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/4892KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUFED COUGH FORMULAMULTI-INGREDIENTMULTI-INGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4895DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCLOMIFERTCLOMIPHENE50MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4899CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANCLOSERINECYCLOSERINE250MGCIPLA LTD -CIPLA LTD VERNA IND BT GOA 403722INDIAORAL SOLID ORDINARY CAPSULES 1.0X40.0 CAPSULE CONTAINER
NDA/MAL/HDP/4901BAYER PHARMA AGSURGIPHARM (U) LIMITEDAVELOX IVMOXIFLOXACIN HCL400MG/250MLBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE
NDA/MAL/HDP/4903AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDCMT-TABLETSMAGNESIUM TRISILICATE+DRIED ALUMINIUM HYDROXIDE+PEPPERMINT OIL250MG+120MG+0.003MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4904NOVO NORDISKSTAR PHARMACEUTICALS LTDMIXTARD 30 INSULIN HUMAN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/4905XEPA-SOUL PATTINSONDELMAW ENTERPRISES LIMITEDAVORAX CREAMACYCLOVIR5%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE
NDA/MAL/HDP/4906XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDAVORAX TABLETSACYCLOVIR200MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X5.0X5.0 TABLET STRIP
NDA/MAL/HDP/4908NOVO NORDISKSTAR PHARMACEUTICALS LTDMIXTARD 30 PENFILLBIPHASIC ISOPHANE INSULIN (HUMAN)100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERDDENMARKPARENTERAL ORDINARY CARTRIDGES 1.0X3.0 ML CARTRIDGE,1.0X1.5 ML CARTRIDGE
NDA/MAL/HDP/4909AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDAXAGYLMETRONIDAZOLE0.5%W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4910ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDFLUZOLFLUCONAZOLE200MGABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4911EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDMOFILET-500MYCOPHENOLATE MOFETIL500MGEMCURE PHARMACEUTICALS LIMITED -LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4915FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFOGYL-S TABLETSMETRONIDAZOLE200MGFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4917KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL EVILINE FORTE SUSPENSIONMAGNESSIUM HYDROXIDE +ALUMINIUM HYDROXIDE+SIMETHICONE400MG/5ML+400MG/5ML+40MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/4918FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFOGYL SUSPENSIONMETRONIDAZOLE BENZOATE200MG/5MLFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4919KOTRA PHARMA (M) SDN BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL FUSIDIC ACID- B CREAMFUSIDIC ACID+BETAMETHASONE 17 VALERATE2%,W/W,+0.1% W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/4920LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDFOLIBENFOLIC ACID5MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X20.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4922KOPRAN LIMITEDTATA UGANDA LIMITEDCIPROQUIN-500CIPROFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4924AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDMULTIVIT TABLETMULTIVITAMINMULTI-INGREDIENTAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4926LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDFOLIC ACIDFOLIC ACID5MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4927NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZOPTBRINZOLAMIDE10MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC SUSPENSIONS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/4928AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDFOLIC ACID TABLETSFOLIC ACID5MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4929MARTINDALE AND AURUM PHARMACEUTICAL LABOREX UGANDA LIMITEDMORPHINE INJECTIONMORPHINE15MG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/4931REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDFOLIC ACID TABLETFOLIC ACID5MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4932MARTINDALE AND AURUM PHARMACEUTICAL LABOREX UGANDA LIMITEDMORPHINE INJECTIONMORPHINE10MG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1.0X1.0 ML AMPOULE
NDA/MAL/HDP/4933KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUDOXDOXYCYCLINE HYDROCHLORIDE100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY CAPSULES 1.0X100.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/4935GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDBACTROBAN OINTMENTMUPIROCIN2%W/WGLAXO OPERATIONS UK LTD -PRIORY STREET, WARE HERTFORDSHIRE SG12 0DJ, UK UNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X3.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/4936 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOMBIFENIBUPROFEN + PARACETAMOL400MG + 500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4937JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDMOTILIUMDOMPERIDONE10MGJANSSEN-CILAG-27 100 VAL DE REUIL, FRANCEFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0 TABLET CARTON,1.0X30.0 TABLET CARTON
NDA/MAL/HDP/4938GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDBACTROBAN CREAMMUPIROCIN2%W/WGLAXO OPERATIONS UK LTD -PRIORY STREET, WARE HERTFORDSHIRE SG12 0DJ, UK UNITED KINGDOMTOPICAL EXTERNAL CREAMS 1.0X1.0X15.0 G TUBE
NDA/MAL/HDP/4939 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFOLIRENFOLIC ACID5MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4940 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDFOLONFOLIC ACID5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4941GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDBEECHAMS POWDERS HOT LEMONPARACETAMOL+PHENYLEPHEDRINE600MG+10MGSMITHLINE BEECHAM (NAIROBI)-NAIROBI, KENYAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X48.0X5.6 G SACHET,1.0X5.0X5.6 G SACHET
NDA/MAL/HDP/4943ASTRAZENECAMACNAUGHTON LIMITEDNOLVADEXTAMOXIFEN20MGASTRAZENECA UK LIMITED -ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4944XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDBENA EXPECTORANTDIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + SODIUM CITRATE14MG + 135MG + 57.5MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIAMALAYSIAORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/4945DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDFORMITMETFORMIN850MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4946ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICAL COMPANY LTDMOVATECLOBETASOL0.05%W/WESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY ITALYTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/4948DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDFORMIT 1000METFORMIN HYDROCHLORIDE1000MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4949JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN DRY COUGH DMDEXTROMETHORPHAN HYDROBROMIDE15MG/MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4950DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDFORMIT 500METFORMIN500MGDAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4951JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN ORIGINALDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE 12.5 MG/5ML + 125 MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X2.5 L BOTTLE
NDA/MAL/HDP/4952JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN WITH CODEINEDIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + CODEINE PHOSPHATE12.5MG/5ML +125MG/5ML +10MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/4953MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDNAT-BMULTI-INGREDIENTMULTI-INGREDIENTMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY OTHER CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/4955 NIRMA LIMITED.SUPER MEDIC LTDCOMPOUND SODIUM LACTATE INFU.COMPOUND SODIUM LACTATEMULTI INGREDIENTACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/4956UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDCONTRAPAQUE 30IOHEXOL350MGUNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116INDIAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/HDP/4957GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDMUMFERIRON (111) POLYMALTOSE COMPLEX + FOLIC ACID100MG + 500MCGGLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRAINDIAORAL SOLID ORDINARY CHEWABLE COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4958TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDBENZOSEDMIDAZOLAM1MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/4959STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDCONTUS PAEDIATRIC LINCTUSCHLORPHENIRAMINE / PHENYLEPHRINE / DEXTROMETHORPHAN1MG/ 5MG/ 10MGSTEDMAN 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
NDA/MAL/HDP/4962SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDBETADBETAMETHASONE DIPROPRIONATE0.05%W/WS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARATINDIATOPICAL EXTERNAL CREAMS 1.0X1.0X30.0 G TUBE,1.0X1.0X15.0 G TUBE
NDA/MAL/HDP/4964STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDCONTUS PLUS PAEDIATRIC SUSPENSIONCHLORPHENAMINE+PHENYLEPHRINE+PARACETAMOLIMG+5MG+160MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/4965BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETAFEN SYRUPIBUPROFEN100MG/5MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4966STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDCONTUS-650CHLORPHENIRAMINE + PHENYLEPHRINE + PARACETAMOL2MG + 5MG + 650MGSTEDMAN 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,1.0X50.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/4967MEDIPHARM SALES (E.A) LTDMEDIPHARM INDUSTRIES (E.A) LTDPIRITEX JUNIORMULTI-INGREDIENTMULTI-INGREDIENTMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4968GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFRUSEMIDE INJECTIONFUROSEMIDE10MG/MLNINGBO 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/4969GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENZATHINE PENICILLIN BENZATHINE PENICILLIN2.4 M.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY DRY VIALS 1.0X2.4 MU VIAL
NDA/MAL/HDP/4970MEDIPHARM SALES (E.A) LTDMEDIPHARM INDUSTRIES (E.A) LTDPIRITEX DRY COUGH SYRUPDIPHENHYDRAMINE HCL/ DEXTROMETHORPHAN HBR/ PSEUDOEPHEDRINE HCL14MG+15MG+30MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/4971AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDFRUSEMIDE TABLETSFUROSEMIDE40MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4972JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCOOLMINT LISTERINEMENTHOL + ALCOHOL 95%0.02% + 4.58MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER
NDA/MAL/HDP/4973MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDPERGOVERISFOLLITROPIN ALFA/LUTROPIN ALFA150 I.U/75 I.UMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY DRY VIALS 1.0X1.0 ML VIAL + 1*1ML VIAL OF WFI
NDA/MAL/HDP/4974COSMOS LTDASTRA PHARMA (U) LIMITEDFRUSEMIDE TABLETS BP 40MGFUROSEMIDE40MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4975FREDUN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDFRUSINA TABLETSFUROSEMIDE40MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4976MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPERGLIM 2GLIMEPIRIDE2MGINVENTIA HEALTHCARE PVT. LTD .-FI ? FI /1 ADDITIONAL AMBERNATH(EAST) ? 421 506,MAHARASHTRA DIST. THANE, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4978REMEDICA LTDGOODMAN INTERNATIONAL LTDPERAZONEDEXAMETHASONE0.5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/4979CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDFUROSEMIDEFUROSEMIDE10MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/4982COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMAG TABLETSMAGNESIUM TRISILICATE370MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/4983PT SAMBE FARMAMEDVIN PHARMA LIMITEDPELASTINIMIPENEM + CILASTATIN500MG + 500MGPT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIAINDONESIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/4986IDA FOUNDATIONKIMSY MEDS LTDCO-TRIMOXAZOLECO-TRIMOXAZOLE960MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/4987CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.PYRAZINAMIDEPYRAZINAMIDE400 MGCADILA PHARMACEUTICALS LIMITED-1389,TRASAD ROAD, DHOLKA-382 225, AHMEDABAD GUJARAT STATE,INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X24.0X28.0 TABLET BLISTER
NDA/MAL/HDP/4990IDA FOUNDATIONKIMSY MEDS LTDCOTRIMOXAZOLESULFAMETHOXAZOLE + TRIMETHOPRIM800MG +160MGMEDOPHARM -34B INDUSTRIAL AREA MALUR 563130INDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/4995ROYAL GROUPHARLEYS UGANDA LIMITEDGENTABACT EYE/EAR DROPSGENTAMYCIN SULPHATE0.3%W/VAHLCON PARENTERALS (I) LIMITED-SP-918,INDUSTRIAL AREA,PHASE III BHIWADI DIST, ALWAR (RAJASTHAN) INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/4998MYLAN LABORATORIES LIMITED.NORVIK ENTERPRISES LIMITEDHYANLEVONORGESTREL0.03MGMYLAN 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/4999UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDPAMIDOL*370IOPAMIDOL755.3MG/MLUNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116INDIAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL
NDA/MAL/HDP/5001ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDGENTAMICIN INJECTIONGENTAMYCIN80MG/2MLZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/5002ELI-LILLY EXPORT SALABOREX UGANDA LIMITEDHUMALOG MIX 25INSULIN LISPRO + INSULIN LISPRO PROTAMINE 25I.U+75I.ULILLY FRANCE SA-FRANCEFRANCEPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/5004GLAXOSMITHKLINE LIMITED LIKONIBETA HEALTHCARE UGANDA LIMITEDCOFTA TABLETSMULTI-INGREDIENTN/AGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA,BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY LOZENGES 1.0X100.0 TABLET CARTON,1.0X50.0 TABLET CARTON,1.0X150.0 TABLET CARTON
NDA/MAL/HDP/5005MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDCOLD GOPARACETAMOL+PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE MALEATE+CAFFEINE325MG+10MG+2MG+30MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS 1.0X50.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/5007DELOBORIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDVIRUCIDACYCLOVIR200MGAEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIACYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X25.0 TABLET CONTAINER
NDA/MAL/HDP/5008UNIMEDMETAPLUS (U) LIMITEDCOLDAFEXMULTI-INGREDIENTMULTI-INGREDIENTUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5010XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDZARIN CREAMCLOTRIMAZOLE2%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/5011UNIMEDMETAPLUS (U) LIMITEDCOLDAFEX TABLETSMULTI-INGREDIENTMULTI-INGREDIENTUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL SOLID ORDINARY TABLETS 1.0X50.0X4.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5012ROYAL GROUPHARLEYS UGANDA LIMITEDGENTAMICIN INJECTIONGENTAMYCIN SULPHATE40MG/MLGRAND PHARMACEUTICAL (CHINA) CO. LTD--LAKE ROAD NELL JINYINHU ECOLOGICAL PARKDONG XI HU DISTRICT, WUHAN, HEBEI PROVINCE.CHINAPARENTERAL ORDINARY AMPOULES 1.0X100.0X2.0 ML AMPOULE
NDA/MAL/HDP/5013CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDGENTAMYCIN EYE/EAR DROPSGENTAMYCIN0.3%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5014UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDVERMOREX SUSPENSIONMEBENDAZOLE100MG/5MLJ.B CHEMICALS & PHARMACEUTICALS LTD-128/1 GIDC ANKLESHWAR 393 022 GUJARAT INDIA,UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/5015REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCOLDCAP CAPSULESPHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE5MG+4MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES 1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X8.0X12.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5016IDA FOUNDATIONKIMSY MEDS LTDGENTAMYCIN INJECTIONGENTAMYCIN SULPHATE40MG/MLGLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043INDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/5017REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCOLDCAP SYRUPPARACETAMOL+PROMETHAZINE HYDROCHLORIDE+CODEINE PHOSPATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+6.5MG+5MG+25MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5018GLAXO WELLCOME (KENYA) LTDERIS LTDVENTOLINSALBUTAMOL100MCGGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE NO.2 23, RUE LAVOISIER 27000 EVREUX,FRANCE.FRANCERECTAL SYSTEMIC METERED-DOSE PRESSURISED AEROSOLS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5019EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDCOLOSPASMIN FORTEMEBEVERINE135MGEGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)-EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)EGYPTORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER
NDA/MAL/HDP/5020GLAXO WELLCOME (KENYA) LTDERIS LTDVENTOLINSALBUTAMOL2MG/MLGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROKENYAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5021BAYER SCHERING PHARMA FRANCESURGIPHARM (U) LIMITEDCOMBINATION 3ETHINYL ESTRADIOL+ LEVONORGESTREL+FERROUS FUMARATE0.03MG+0.15MG+75MGDELPHARMA SAS ZONE INDUSTRIELLE -DELPHARMA SAS ZONE INDUSTRIELLE DE ROUBAIX EST RUE DE TOUFFLERS BP 50070 59452 LYS LEZLANNOY CEDEX / BAYER PHARMA AG BERLIN,BAYER PHARMA AG -13353 BERLIN GERMANY,BAYER WEIMAR GMBH UND CO. KG,-WEIMAR DEBEREINERSTRASSE 20, 9FRANCEORAL SOLID ORDINARY TABLETS 1.0X100.0X28.0 TABLET BLISTER
NDA/MAL/HDP/5023GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCOTREICHCO-TRIMOXAZOLE240MG/5MLMEDRIECH STERILAB LTD.--ANALGHALLI, BANGLORE - 560062INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5025THE MENTHOLATUM COMPANY LTDHARLEYS UGANDA LIMITEDDEEP FREEZE COLD GELMENTHOL2%W/WTHE MENTHOLATUM COMPANY LTD, TWYFORD,-TWYFORD, BENKSHIRE, EUNITED KINGDOMTOPICAL EXTERNAL GELS AND SOLS 1.0X35.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE
NDA/MAL/HDP/5027PFIZER LAB LTDLABOREX UGANDA LIMITEDTERRA-CORTRILMULTI-INGREDIENTMULTI-INGREDIENTPFIZER PGM ORLEANS FRANCE-AVENUE DE CONCYR, F-450FRANCEOPHTHALMIC LIQUIDS 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE,1.0X4.0 ML BOTTLE
NDA/MAL/HDP/5028THE MENTHOLATUM COMPANY LTD TWYHARLEYS UGANDA LIMITEDDEEP HEAT SPRAYMULTI-INGREDIENTMULTI-INGREDIENTTHE MENTHOLATUM COMPANY LTD, TWYFORD,-1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLANDUNITED KINGDOMTOPICAL EXTERNAL PRESSURISED AEROSOLS 1.0X150.0 ML CANNISTER
NDA/MAL/HDP/5030PFIZER LAB LTDLABOREX UGANDA LIMITEDSOLU-MEDROLMETHYLPREDNISOLONE HEMISUCCINATE125MG/2MLPFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUMBELGIUMPARENTERAL ORDINARY DRY VIALS 1.0X2.0 ML VIAL,1.0X8.0 ML VIAL
NDA/MAL/HDP/5031THE MENTHOLATUM COMPANY LTDHARLEYS UGANDA LIMITEDDEEP HEAT RUBMULTI-INGREDIENTMULTI-INGREDIENTTHE MENTHOLATUM COMPANY LTD, TWYFORD,-1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLANDUNITED KINGDOMTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X35.0 G TUBE,1.0X67.0 G TUBE,1.0X100.0 G TUBE
NDA/MAL/HDP/5032REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDDELASED DRY COUGH SYRUP (NON DROWSY)DEXTROMETHORPHAN7.5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5033FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDMEBFIL TABLETSMEBENDAZOLE100MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5034REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMEBENDAZOLE TABLETMEBENDAZOLE100MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5035ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMEBENDAZOLEMEBENDAZOLE100MG/5MLMEDICAMEN BIOTECH LTD - -SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/5038UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDM-CAM TABLETSMELOXICAM15MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5039MEGA LIFESCIENCES (AUSTRALIA) PTY LTDSURGIPHARM (U) LIMITEDGILOBAGINKO BILOBA EXTRACT40MGMEGA 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/5040PFIZER LABORATORIES (PTY) LTD BELGIUMLABOREX UGANDA LIMITEDDEPO-MEDROLMETHYLPREDNISOLONE ACETATE40MG/MLPFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUMBELGIUMPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL,1.0X2.0 ML VIAL,1.0X5.0 ML VIAL
NDA/MAL/HDP/5041NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXITROLDEXAMETHASONE/NEOMYCIN/POLYMYXIN B0.1%W/W +0.1%W/W+6000 I.UALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC OINTMENTS 1.0X3.5 G TUBE
NDA/MAL/HDP/5042COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM DS TABLETSCO-TRIMOXAZOLE960MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/5043NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXITROLDEXAMETHASONE/NEOMYCIN/POLYMYXIN B0.1%W/W+3500I.U/ML+6000I.U/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5044PFIZER LABORATORIES (PTY) LTD BELGIUMLABOREX UGANDA LIMITEDDEPO-PROVERAMEDROXYPROGESTERONE ACETATE150MG/MLPFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUMBELGIUMPARENTERAL ORDINARY I M VIALS 1.0X3.5 ML VIAL,1.0X1.0 ML VIAL
NDA/MAL/HDP/5045HILTON PHARMA (PVT) LTDHEALTHCARE LTD.MAXIT TABLETSDICLOFENAC50MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5046DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDGIZLAN PLUS 150/12.5IRBESARTAN+HYDROCHLOROTHIAZIDE150MG+12.5MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/5047VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.MAXINEM 500MGMEROPENEM500MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/5048VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.MAXINEM 1GMEROPENEM1GVHB 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/5049DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDGIZLAN PLUS 300/12.5IRBESARTAN/HYDROCHLOROTHIAZIDE300MG/12.5MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/5050NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDMAXIDEXDEXAMETHASONE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUMBELGIUMOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5051CADILA HEALTHCARE LIMITED SARKHEJABACUS PHARMA (AFRICA) LIMITEDDERIHALERSALBUTAMOL100CMG/DOSECADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5052CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.GLAMIDE TABLETSGLIBENCLAMIDE5 MGLA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 2.0X50.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5054SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDMAALOXMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE200MG + 200MGWINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5055GLAXOSMITHKLINE LTD UKERIS LTDDERMOVATECLOBETASOL PROPIONATE0.05%W/WGLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAMUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE,1.0X25.0 G TUBE
NDA/MAL/HDP/5056AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDMAALOX SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE665MG/5ML + 200MG/5MLWINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SUSPENSIONS 1.0X350.0 ML BOTTLE,1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/HDP/5057SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDMAALOX PLUSMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE200MG + 200MG + 25MGWINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X4.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5059AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDMAALOX PLUS SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE665MG/5ML + 200MG/5MLWINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SUSPENSIONS 1.0X350.0 ML BOTTLE,1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/HDP/5061TATA UGANDA LIMITEDTATA UGANDA LIMITEDMAGNESIUM SULPHATEMAGNESIUM SULPHATE50MG/MLGLAND PHARMA LIMITTED 143-148-SURVEY NOS. 143-148, 150&151, NEAR GANDIMAISAMMA CROSS ROADS. RANGA REDDY DISTRICT HYDERABAD 500043INDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/5062EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDMANNILIFEMANNITOL20MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5066M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDDEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE4MG/ML M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208 NAVI MUMBAI, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X100.0X1.0 ML AMPOULE
NDA/MAL/HDP/5067CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLUFENACDICLOFENAC 25MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X3.0 ML AMPOULE
NDA/MAL/HDP/5068GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE8MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD.-NO. 3986, HI-TECH PARK MINZHU ROAD, NINGBO CITY, ZHEJIANGCHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/5070EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-60ENOXAPARIN SODIUM60MG/0.6MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5071EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-40ENOXAPARIN SODIUM40MG/0.4MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5072CYANO PHARMA(P)RENE PHARMACY LTDDEXAMETHASONE TABLETSDEXAMETHASONE 0.5MGCYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDOREINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5073CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA EYE/EAR DROPDEXAMATHASONE SODIUM PHOSPHATE+NEOMYCIN SULPHATE0.35%W/V+0.1%W/VAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHANINDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE,1.0X2.5 ML BOTTLE
NDA/MAL/HDP/5074CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA INJECTIONDEXAMETHASONE DISODIUM PHOSPHATE4MG/MLCADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X2.0 ML VIAL
NDA/MAL/HDP/5075CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDDEXONA TABLETSDEXAMETHASONE0.5MGCADILA HEALTHCARE LIMITED SARKHEJ-SARKHEJ-BAVLA N.H NO.8A, N.H NO.8A,INDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/5076XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDDEXTRACIN EYE DROPSDEXAMETHASONE + NEOMYCIN0.1MG + 0.5MGXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5078NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDGLANDIN E2 VAGINALDINOPROSTONE3MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANVAGINAL TABLETS 1.0X1.0 TABLET STRIP
NDA/MAL/HDP/5079GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDGLEMONT CT 5MONTELUKAST5MGGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5080GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDLOBAKDICLOFENAC + PARACETAMOL + CHLORZOXAZONE50MG + 325MG + 250MGGENO PHARMACEUTICALS LTD--PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5086FOURRTS (INDIA) LABORATORIES PVT LTD DELMAW ENTERPRISES LIMITEDGLIFIL M FORTGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG+500MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5087 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIABEN TABLETSGLIBENCLAMIDE5MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5092MICRO LABS LTD 92 SIPCOTPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDEGLIMEPIRIDE2MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5093DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDLIPODAR 10ATORVASTATIN10MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5095MICRO LABS LTDLABOREX UGANDA LIMITEDDIAPRIDE PLUSGLIMEPIRIDE + METFORMIN1MG + 500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5097EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDGLUCOLIFEGLUCOSE5%W/VEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5098RIVA PHARMA FREE ZONEWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIARIVDI-IODO HYDROXYQUINOLINE + PHTHALYL SULPHATHIAZOLE + HOMATROPINE + STREPTOMYCIN125MG + 150MG + 1MG + 100MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5099COSMOS LTDASTRA PHARMA (U) LIMITEDGLUCOMETMETFORMIN500MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5100LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDL-GENTAGENTAMICIN0.3%W/VLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5101F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDLEXOTANILBROMAZEPAM1.5MGF. HOFFMANNLA ROCHE LTD BASEL, SWITZERLAND-GRENZACHERSTRASSE 124 4070, BASELSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5102MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOPHAGE 500MGMETFORMIN500MGMERCK SANT?-2, RUE DU PRESSOIR VERT F 45400, SEMOY,NKUNZI PHARMACEUTICALS (PTY) LTD.-259 DAVIDSON ROAD CNR PEDDIE STREET, WADEVILLE EST. 1 GERMISTON 1422FRANCEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X500.0 TABLET CONTAINER,1.0X6.0X15.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER
NDA/MAL/HDP/5103MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOPHAGE 1000MGMETFORMIN1000MGNKUNZI PHARMACEUTICALS (PTY) LTD --259 DAVIDSON ROAD, WADEVILLE, EXT 1, GERMINSTON, SOUTH AFRICAFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X15.0 TABLET BLISTER
NDA/MAL/HDP/5104NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEVEMIR FLEXPENINSULIN DETEMIR100 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/5106ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICAL COMPANY LTDLEMONVATE CREAMCLOBETASOL PROPIONATE0.05%W/WESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY ITALYTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/5107RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDINDOREN CAPSULESINDOMETHACIN25MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/5109LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLEBASMA ORAL SOLUTIONSALBUTAMOL2MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5110 NIRMA LIMITED.SUPER MEDIC LTDGLUCOSE INFUSION BPDEXTROSE5%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/HDP/5112WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL SR TABLETSDICLOFENAC SODIUM100MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH -INDIAINDIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5114NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDLATONE MULTIVITAMINMULTIVITAMINMULTI-INGREDIENTNEM LABORATORIES PVT LTD-NEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5115AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDINDOS-25(THANE)INDOMETHACIN25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1000.0 CAPSULE CONTAINER,20.0X5.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5117VENUS REMEDIES LIMITEDHARLEYS UGANDA LIMITEDLASTINEMIMIPENEM + CILASTATIN500MG + 500MGVENUS REMMEDIES-UNIT II HILLTOP INDUSTRIAL ESTATES JHARMAJRI EPIP PHASE 1 BHOTOLI KALA BADDI INDIA INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5119FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDKONTRAC 200MISOPROSTOL200MCGFOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X2.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5120REMEDICA LTDGOODMAN INTERNATIONAL LTDGLYFORMIN 500 TABLETSMETFORMIN 500MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/5121UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDDICLORAN GELDICLOFENAC DIETHYLAMMONIUM1%W/WUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X50.0 G TUBE,1.0X20.0 G TUBE
NDA/MAL/HDP/5122CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDKOFAREST SYRUPSALBUTAMOL SULPHATE/AMBROXOL SULPHATE/GUAFENESIN/MENTHOL2MG+30MG+100MG+5MG/10MLCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5123REMEDICA LTDGOODMAN INTERNATIONAL LTDGLYFORMIN 850 TABLETSMETFORMIN850MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5124GLAXOSMITHKLINE LTD BELGIUMERIS LTDINFANRIX-HEXADIPHTHERIA + PERTUSSIS + BORDETELLA/PERTUSSIS + PERTUSSIS + HAEMAGGLUTININ + PERTACTIN + (HEPATITIS B/POLIOVIRUS TYPE 1 +2 +3)NLT 30 IU + NLT 40IU + 25MCG + 25MCG + 8MCG + 10MCG + (TYPE I 40D +TYPE 2 + TYPE 3)GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY COMBINATION PACK VIALS 1.0X0.5 ML VIAL (1 DOSE)
NDA/MAL/HDP/5125MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDGLYGESIC FORTE RHUMETIC CREAMMULTI INGREDIENTN/ATORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/5126UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDKNAC-75DICLOFENAC75MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICEKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5127UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDDICLORAN INJECTIONDICLOFENAC SODIUM25MG/MLUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116INDIAPARENTERAL ORDINARY AMPOULES 1.0X100.0X3.0 ML AMPOULE,1.0X5.0X3.0 ML AMPOULE
NDA/MAL/HDP/5128MEDIPHARM SALES LTDABACUS PHARMA (AFRICA) LIMITEDGOFEN 400 CLEARCAPIBUPROFEN400MGMEGA LIFESCIENCES LTD.-384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKANTHAILANDORAL SOLID ORDINARY CAPSULES 6.0X1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5129NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDKLEEN ENEMADISODIUM BISPHOSPHATE/ SODIUM PHOSPHATE19.2G+7.2G/ 120MLNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANRECTAL SYSTEMIC ENEMA LIQUIDS 1.0X135.0 ML BOTTLE
NDA/MAL/HDP/5130UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDDICLORAN MS GELDICLOFENAC+METHYL SALICYLATE+MENTHOL1%W/W+10%W/W+5%W/WUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/5131NOVO NORDISKSTAR PHARMACEUTICALS LTDINSULATARD HMISOPHANE INSULIN (HUMAN)100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5132REMEDICA LTDGOODMAN INTERNATIONAL LTDKETROZOL 200 TABLETSKETOCONAZOLE200MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5133MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 900IU/1.5ML(66MCG/1.5ML)FOLLITROPIN ALFA66MCG/1.5MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLANDSWITZERLANDPARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.0 CARTRIDGE PREFILLED PEN + 20 NEEDLES FOR INJECTION,1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION.
NDA/MAL/HDP/5134BETA HEALTHCARE BETA HEALTHCARE UGANDA LIMITEDGOODMORNING COUGH TABLETSMULTIINGREDIENTN/ABETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CARTON
NDA/MAL/HDP/5135S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDKETOZKETOCONAZOLE2%W/WSK ANT HEALTHCARE LTD-1802-1805 GIDC PHASE III, VAPI-396195 GUJARAT, INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/5136BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDGOODMORNING LUNG TONICMULTIINGREDIENTN/ABETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/HDP/5137 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDKETORENKETOCONAZOLE200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5139NOVO NORDISKSTAR PHARMACEUTICALS LTDINSULATARD HM PENFILLISOPHANE INSULIN (HUMAN)100I.U/MLNOVO NORDISK PHARMA-NOVO ALLEDENMARKPARENTERAL ORDINARY PRE-FILLED PENS 1.0X1.5 ML CARTRIDGE,1.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/5140PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDDIFLUCANFLUCONAZOLE200MGFAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCEFRANCEORAL SOLID ORDINARY CAPSULES 1.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/5141MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDKETOMAC SHAMPOOKETOCONAZOLE2%W/VTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL LIQUID SOAPS/WASHES 1.0X75.0 ML BOTTLE
NDA/MAL/HDP/5142REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDINTAMINE CREAMMEPYRAMINE MALEATE2%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL CREAMS 1.0X25.0 G TUBE,1.0X400.0 G TUBE
NDA/MAL/HDP/5143ASTRA ZENECA MACNAUGHTON LIMITEDBETALOC ZOK - 25MGMETOPROLOL25MGASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDENSWEDENORAL SOLID ORDINARY TABLETS 1.0X1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/5144HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOCONAZOLE 200MGKETOCONAZOLE200MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5146ASTRA ZENECAMACNAUGHTON LIMITEDBETALOC ZOK - 100MGMETOPROLOL100MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)SWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5147ASTRA ZENECAMACNAUGHTON LIMITEDBETALOC ZOK - 50MGMETOPROLOL50MGASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDENSWEDENORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDBETANASE TABLETSGLIBENCLAMIDE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER
NDA/MAL/HDP/5149SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.GRAVINATE SYRUPDIMENHYDRINATE12.5MG/4MLSEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5150GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDKETO PLUS SHAMPOOKETOCONAZOLE/ZINC PYRITHIONE1%W/V+2%W/VGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIATOPICAL EXTERNAL LIQUID SOAPS/WASHES 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5151SOLVAY PHARMACEUTICALS BVHARLEYS UGANDA LIMITEDBETASERCBETAHISTINE8MGSOLVAY PHARMACEUTICALS -VEERWENG 12,8121AA,DIST. THE NETHERLANDSNETHERLANDSORAL SOLID ORDINARY TABLETS 4.0X25.0 TABLET BLISTER
NDA/MAL/HDP/5153SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.GRAVINATE TABLETSDIMENHYDRINATE50MGSEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5154BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETASIL PAEDIATRIC SYRUPIPECACUANHA TINCTURE0.5MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/5155NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBETAVELMULTI-INGREDIENTN/ANEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/5156PHARMATHEN LTDGOODMAN INTERNATIONAL LTDIRIFONE GELETOFENAMATE5%W/WPHARMATHEN LTD.-6 DERVENAKION STR. 153 51 PALLINI-GREECEGREECETOPICAL EXTERNAL OTHER GELS/SOLS 1.0X50.0 G CONTAINER,1.0X100.0 G CONTAINER
NDA/MAL/HDP/5157NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBETAVEL NBETAMETHASONE+NEOMYCIN SULPHATE1MG+5MGNEM 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/5158 NIRMA LIMITED.SUPER MEDIC LTDKETANIRKETAMINE50MG/MLNIRMA LIMITED (HEALTHCARE DIVISION)-VILLAGE-SACHANA, TALUKA-VIRAMGAM DISTRICT- AHMEDABAD 382 150, GUJARAT, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/5161STRIDES ARCOLAB LIMITEDROYAL PHARMA 2011 LIMITEDGRISEOSIM-500GRISEOFULVIN500MGSTRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5162VENUS REMIDIES LTDAARON PHARMACEUTICALS LTDIRINOLIRINOTECAN HYDROCHLORIDE TRIHYDRATE20MG/MLVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HPINDIAPARENTERAL ORDINARY I V VIALS 1.0X2.0 ML VIAL
NDA/MAL/HDP/5163ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDKETAMINE HYDROCHLORIDE INJECTIONKETAMINE HYDROCHLORIDE50MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY VIALS 10.0 ML VIAL
NDA/MAL/HDP/5164COSMOS LTDASTRA PHARMA (U) LIMITEDBROMSAL EXPECTORANTSALBUTAMOL SULPHATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL1MG+2MG+50MG+0.5MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5165REMEDICA LTDGOODMAN INTERNATIONAL LTDGRISEOFULVIN 500 TABLETSGRISEOFULVIN500MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHARCYPRUSORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/5166 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDKETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDE50MG/MLUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5167 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBRUSTAN TABLETSIBUPROFEN + PARACETAMOL400MG + 300MGSUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5169BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGVGYL SUPPOSITORYMETRONIDAZOLE BP500MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/5170GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDITRAL CAPSULEITRACONAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DINDIAORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE STRIP
NDA/MAL/HDP/5171TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDKETAMAX-50KETAMINE50MG/MLTROIKAA PHARMACUETICALS LIMITED-C-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5174BAYER AGSURGIPHARM (U) LIMITEDCANESTEN CREAMCLOTRIMAZOLE1%W/VBAYER AG-D-51368 LEVERKUSEN GERMANYGERMANYTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/5175JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDGYNO-DAKTARINMICONAZOLE NITRATE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAVAGINAL CREAMS 1.0X40.0 G TUBE
NDA/MAL/HDP/5176BAYER AGSURGIPHARM (U) LIMITEDCANESTENCLOTRIMAZOLE100MGBAYER AG -D-51368 LEVERKUSEN GERMANYGERMANYVAGINAL TABLETS 1.0X6.0 TABLET STRIP
NDA/MAL/HDP/5177YURIA PHARM LTDYURIA PHARM EAST AFRICA LIMITEDISONIAZIDISONIAZID100MG/5MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINEORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/5178VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.CARBOTEENCARBOPLATIN450 MG / 45 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/5179PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFIX 200MG CAPSULESCEFIXIME TRIHYDRATE200MGPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMANJORDANORAL SOLID ORDINARY CAPSULES 1.0X1.0X8.0 CAPSULE BLISTER
NDA/MAL/HDP/5180REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDISORYN DROPS ( PAEDRIATRIC)EPHEDRINE HYDROCHLORIDE5MG/MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYANASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/5181JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDGYNO-DAKTARIN OVULESMICONAZOLE NITRATE400MGJANSSEN PHARMACEUTICAL PTY LTD-15TH ROAD HALFWAY HOUSESOUTH AFRICAVAGINAL SUPPOSITORIES 1.0X3.0 OVULE BLISTER
NDA/MAL/HDP/5182REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDISORYN DROPS (ADULT)EPHEDRINE HYDROCHLORIDE10MG/MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYANASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/5183 PHARCO B PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDGYNOZOL VAGINAL CAPSULESMICONAZOLE NITRATE400MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTVAGINAL SUPPOSITORIES 1.0X3.0 CAPSULE BLISTER
NDA/MAL/HDP/5184 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDGYNOZOL VAGINAL CREAMMICONAZOLE NITRATE2%W/WPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTVAGINAL CREAMS 1.0X40.0 G TUBE
NDA/MAL/HDP/5185CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDHB FORTEMULTI INGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/HDP/5186TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDISOTROY 250ISOFLURANE250MLTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIAINDIAOTHER SYSTEMIC LIQUID INHALATIONS 1.0X250.0 ML BOTTLE
NDA/MAL/HDP/5188AGOG PHARMA LTD.GITTOES PHARMACEUTICALS LIMITEDITRAZ CAPSULESITRACONAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X5.0 CAPSULE BLISTER,1.0X6.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5189TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDHEMOZEBEXFERROUS SULPHATE+FOLIC ACID+PYRIDOXINE HCL+CYANOCOBALAMIN+ZINC SULPHATE300MG+1000MCG+1.5MG+7.5MG+61.8MGTRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.PINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5190HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HICLORCEFACLOR250MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/5191IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYBETASONE EYE DROPSBETAMETHASONE1MG/MLIVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE, LR NO.18474/84, ATHI RIVER,KENYA KENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5192IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXGENT EYE/EAR DROPSDEXAMETHASONE/GENTAMICIN0.1% & 0.3%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5193IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXNEOCIN EYE DROPSDEXAMETHASONE/NEOMYCIN0.1% & 0.35%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5194IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYDEXONE EYE DROPSDEXAMETHASONE0.1%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5.0 ML BOTTLE
NDA/MAL/HDP/5195IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYFRIN P NASAL DROPSEPHEDRINE HYDROCHLORIDE0.5%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYANASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE,1.0X10.0 ML BOTTLE
NDA/MAL/HDP/5196IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYFRIN NASAL DROPSEPHEDRINE HYDROCHLORIDE1%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYANASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/5197IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYGENTACIN EYE/EAR DROPGENTAMICIN SULPHATE0.3%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 5.0 ML BOTTLE,10.0 ML BOTTLE,7.5 ML BOTTLE
NDA/MAL/HDP/5198HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HICLORCEFACLOR500MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/5199LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDHYCORUM OINTMENTHYDROCORTISONE1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/5200COSMOS LTDASTRA PHARMA (U) LIMITEDHYDRALAZINE TABLETS B.P 25MG.HYDRALAZINE HYDROCHLORIDE25MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5201KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM BENDAZOLEMEBENDAZOLE100MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5202CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANHYDROCORT INJECTIONHYDROCORTISONE SODIUM SUCCINATE100MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL
NDA/MAL/HDP/5203KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM METROMETRONIDAZOLE200MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/5204KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM METROMETRONIDAZOLE BENZOATE200MG/5MLKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5205KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM-VENTSALBUTAMOL4MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET JAR,1.0X500.0 TABLET JAR,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5206TATA UGANDA LIMITEDTATA UGANDA LIMITEDDIGOXIN INJECTION BPDIGOXIN0.25MG/MLGLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/5207NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDDIGOXIN TABLETSDIGOXIN0.25MGNEM LABORATORIES PVT. LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE ? 401 210, MAHARASHTRA - INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5211SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDDINAC GELDICLOFENAC1%W/WS KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARATINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/5214 NIRMA LIMITED.SUPER MEDIC LTDNIRMETMETRONIDAZOLE500MG/100MLACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5215J.B CHEMICALS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDMETROGYL TABLETSMETRONIDAZOLE200MGJ.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5217ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYDACMULTI-VITAMINMULTI-INGREDIENTELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE, 1.0X5.0 L JERRYCAN
NDA/MAL/HDP/5221GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDICLOFENAC SODIUMDICLOFENAC SODIUM75MG/3MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X3.0 ML AMPOULE
NDA/MAL/HDP/5222MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDEMTRICITABINE+TENOFOVIR DFEMTRICITABINE + TENOFOVIR200MG + 300MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. ? 431136, MAHARASHTRA STATE, INDIA. ,MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5224AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATEEMTRICITABINE + TENOFOVIR DISOPROXIL FUMERATE200MG + 300MGAUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5226HETERO DRUGS LTDABACUS PHARMA (AFRICA) LIMITEDEMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATEEMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE200MG + 300MGHETERO DRUGS LTD-UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055,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/5228CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOGENTADICLOFENAC SODIUM+GENTAMICIN SULPHATE1MG/ML+3MG/MLCENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5231INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDENAPRIL 10ENALAPRIL MALEATE10MGINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA ,INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5232INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDENAPRIL-5ENALAPRIL MALEATE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5233CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ENVAS 10 MG TABLETSENALAPRIL10MGCADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA ? 387 810, AHMEDABAD, GUJARAT STATE INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5234CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ENVAS 5MG TABLETSENALAPRIL MALEATE5MGCADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA ? 387 810, AHMEDABAD, GUJARAT STATE INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5235UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDDICLORAN DELAYED-RELEASE TABLETSDICLOFENAC SODIUM50MGUNIQUE PHARMACEUTICALS LABORATORIES--SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ?PLOT NO. 215-219, 396 210 INDIAINDIAORAL SOLID RETARD ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5236CIPLA LTD.QUALITY CHEMICALS LTD - HUMANETHIONAMIDE TABLETS USPETHIONAMIDE250MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/5237EUROLIFE HEALTHCARE PVT LIMITEDAIVEEN (U) LIMITEDEUROCIPCIPROFLOXACIN200MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHANDINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5242SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.ERGOMINMETHYLERGOMETRINE MALEATE0.125MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X150.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/5243IND SWIFT LTDTATA UGANDA LIMITEDEZO 20ESOMEPRAZOLE MAGNESIUM20MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIINDIAORAL SOLID RETARD TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5245INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDFABUTAS-40FEBUXOSTAT40MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5248KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM-AMPIAMPICILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1000.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER
NDA/MAL/HDP/5249EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDENCIFERIRON SUCROSE100MG/5MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY INFUSION AMPOULES 1.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/5250 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCOLIN SYRUPSALBUTAMOL + AMMONIUM CHLORIDE2MG/5ML +100MG/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/5251PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDDIFLUCANFLUCONAZOLE150MGPFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSEFRANCEORAL SOLID ORDINARY CAPSULES 1.0X1.0 CAPSULE BLISTER
NDA/MAL/HDP/5252CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANENCLEX-40ENOXAPARIN SODIUM40MG/0.4MLCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X2.0X0.4 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5253 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCOZOL SUSPENSIONBENZOYL METRONIDAZOLE200MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/5254PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDFARMORUBICIN RDEPIRUBICIN HYDROCHLORIDE10MGPHARMACIA AND UPJOHN S.P.A.-EUROPEEUROPEPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X10.0 ML VIAL
NDA/MAL/HDP/5255GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDENO LEMONFRUIT SALTMULTI-INGREDIENTMULTI-INGREDIENTGLAXO SMITH KLINE LTD-LIKONI RD, INDUSTRIAL AREA,NAIROBI KENYA,GLAXOSMITHLINE-CAPE TOWN, S.ASOUTH AFRICAORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES 1.0X8.0X4.5 G SACHET,1.0X10.0X4.5 G SACHET,1.0X48.0X4.5 G SACHET
NDA/MAL/HDP/5256MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROFOS INJECTIONBETAMETHASONE DISODIUM PHOSPHATE + BETAMETHASONE DIPROPIONATE2MG + 5MG/ML MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA,SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERGBELGIUMPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/5258MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDERYMED ORAL SUSPENSIONERYTHROMYCIN 125 MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD (BWEYOGERERE)UGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5259COSMOS LTDASTRA PHARMA (U) LIMITEDCARDINOL TABLETATENOLOL100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X14.0 TABLET STRIP
NDA/MAL/HDP/5260KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDERYMYCINERYTHROMYCIN ESTOLATE250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5263MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROSALIC OINTMENTBETAMETHASONE + SALICYLIC ACID0.5 %W/W + 0.3 %W/WSCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERGBELGIUMTOPICAL EXTERNAL OINTMENTS 1.0X30.0 MG TUBE
NDA/MAL/HDP/5265MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROSONE OINTMENTBETAMETHASONE DIPROPIONATE0.5%W/WSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAMBELGIUMTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G CONTAINER,1.0X10.0 G CONTAINER
NDA/MAL/HDP/5267ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDERYTHROMYCIN STEARATEERYTHROMYCIN STEARATE250MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5268MISSION PHARMA A/S INDIAJOINT MEDICAL STORE (UPMB - UCMB)ERYTHROMYCIN STEARATE TABLETSERYTHROMYCIN 100MGMEDICAMEN 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/5269INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDIVAA OD 500DIVALPROEX500MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5271REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDERYTHYL SYRUPERYTHROMYCIN ETHYL SUCCINATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5272 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDIXDIGOXIN0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5274 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDECOZOLEECONAZOLE150MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAVAGINAL TABLETS 1.0X3.0 PESSARY STRIP
NDA/MAL/HDP/5275AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ200MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X90.0 CAPSULE CONTAINER,1.0X30.0 CAPSULE CONTAINER
NDA/MAL/HDP/5276F.HOFFMANN-LA ROCHE LTD LABOREX UGANDA LIMITEDDORMICUM INJECTIONMIDAZOLAM5MG/5MLF. HOFFMAN LA ROCHE LTD-CH-4070 BASEL GRENZACHERSTRASSE 124, 4058 BASELSWITZERLANDPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE
NDA/MAL/HDP/5277MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDEFAVIRENZEFAVIRENZ600MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5278ROCHELABOREX UGANDA LIMITEDDORMICUMMIDAZOLAM7.5MGF. HOFFMAN LA ROCHE LTD-CH-4070 BASEL GRENZACHERSTRASSE 124, 4058 BASELSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5279EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDDOSINDOXAZOCIN2MG EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5281AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXILEFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE600MG +200MG + 300MGAUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5282TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDDORFENACECLOFENAC100MGTRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.PINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5283REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDIBUMEX GELIBUPROFEN5%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYATOPICAL EXTERNAL EMULSION GELS 1.0X25.0 G TUBE
NDA/MAL/HDP/5284HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDEFAVIRENZ+EMTRICITABINE+TENOFOVIREFAVIRENZ + EMTRICITABINE + TENOFOVIR600MG + 200MG + 300MGHETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5287AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATEEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE600MG + 300MG + 300MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5288REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDIBUMEX SUSPENSIONIBUPROFEN100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 100.0 ML BOTTLE,60.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5290MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDELOCOM CREAMMOMETASONE FUROATE0.1%W/WSCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30,B-2220 HEIST-OP-DEN-BERG,BELGIUMBELGIUMTOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/5291REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDIBUMEX TABLETIBUPROFEN200MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER,1.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/5292LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDOMI 10DOMPERIDONE10MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5293MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDELOCOM LOTIONMOMETASONE FUROATE0.1%W/VMSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICASOUTH AFRICATOPICAL EXTERNAL LOTIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/5294MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDELOCOM OINTMENTMOMETASONE FUROATE0.1%W/WSCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30,B-2220 HEIST-OP-DEN-BERG,BELGIUMBELGIUMTOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/5295LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDDOXYDOXYCYCLINE100MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X280.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5296VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.DOMAXIN-RDDOXORUBICIN50MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X50.0 MG VIAL
NDA/MAL/HDP/5297ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELOGYLMETRONIDAZOLE200MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5298ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELOGYLMETRONIDAZOLE200MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5300CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DOLACKETOROLAC TROMETHAMINE30MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/5301SANOFI PASTEURLABOREX UGANDA LIMITEDDULTAVAXDIPHTERIA/ TETANUS/ AND (INACTIVATED) POLIOMYELITIS VACCINE (ADSORBED)2 IU/ 20IU/ POLIOMYELITIS (40DU/ 8DU/ 32DU)SANOFI PASTEUR CAMPUS MERIEUX--1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY I V PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5302 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDIBUGO-COMBIIBUPROFEN + PARACETAMOL + CAFFEINE200MG + 325MG + 30MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5305AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDIBUGOIBUPROFEN200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5307ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDDUOTROLGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG + 500MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5309MISSION PHARMA A/S INDIAJOINT MEDICAL STORE (UPMB - UCMB)DOXYCYCLINE CAPSULES BPDOXYCYCLINE 100MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/5311ABBOTT HEALTHCARE PRODUCTS B.V.HARLEYS UGANDA LIMITEDDUPHASTON TABLETSDYDROGESTERONE10MGABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLSTNETHERLANDSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X20.0 TABLET BLISTER
NDA/MAL/HDP/5312ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDDOXYCYCLINE DOXYCYCLINE100MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER, 1.0X1000.0 CAPSULE CONTAINE
NDA/MAL/HDP/5316TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPARDICLOFENAC SODIUM + PARACETAMOL50MG + 500MG TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5317MACK BROWN SHURIK LTDDR MAC'S COUGH FROMULAGUAIFENESIN+BROMHEXINE100MG + 8MG/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5318TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR AQ (1ML)DICLOFENAC SODIUM75MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/5320LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDINDOLINDOMETHACIN25MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5321DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDIBUGESIC COLD & SINUSIBUPROFEN/PSEUDOEPHEDRINE200MG/30MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY GELATIN-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5323STEDMAN PHARMACEUTICALS LTDVEERAM HEALTHCARE (U) LIMITEDDREZIODINATED POVIDONE + METRONIDAZOLE1.0% W/V + 5.0% W/VSTEDMAN PHARMACEUTICALS PVT LTD...-C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORURINDIATOPICAL EXTERNAL LIQUIDS 1.0X60.0 ML CONTAINER,1.0X30.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X500.0 ML CONTAINER
NDA/MAL/HDP/5324FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDIBUFIL 400IBUPROFEN400MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5326UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDECODAX G CREAMECONAZOLE NITRATE + GENTAMYCIN + BECLAMETASONE1%+0.1%+0.025%UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI ? 394 116, GUJARAT, INDIA. INDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE,1.0X100.0 G TUBE
NDA/MAL/HDP/5327FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDIBUFIL 200IBUPROFEN200MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5328ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDINDOMETACIN 25MG CAPSULES BPINDOMETHACIN25MGZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINACHINAORAL SOLID ORDINARY CAPSULES 1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5329ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDIBUFEN TABLETSIBUPROFEN200MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBIKENYAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5330STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZ-VMICONAZOLE + METRONIDAZOLE2.0%W/W + 1.0%W/WSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/5333KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDIBUFENIBUPROFEN200MGKPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0X10.0 TABLET BLISTER,500.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,250.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5334COSMOS LTDASTRA PHARMA (U) LIMITEDETHAM-400ETHAMBUTOL400MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5336SANOFI PASTEURLABOREX UGANDA LIMITEDAVAXIM 160UINACTIVATED HEPATITIS A VACCINE ADSORBED160 ANTIGEN UNITSSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5337SANOFI PASTEURLABOREX UGANDA LIMITEDAVAXIM 80IU PAEDIATRICINACTIVATED HEPATITIS A VACCINE ADSORBED80 ANTIGEN UNITSSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILEFRANCEPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/5338XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDHYDROSIL TABLETSALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE+SIMETHICONE200MG+200MG+20MGXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIAMALAYSIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X20.0 TABLET BLISTER
NDA/MAL/HDP/5340SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.HYDRYLLIN SYRUPDIPHENHYDRAMINE HCL + DEXTROMETHORPHAN HBR5MG + 6.25MGSEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/5341LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDHYODOPAMETHYLDOPA250MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5342BELL SONS & CO.(DRUGGISTS) LTDECHO PHARMACY (U) LIMITEDBELL'S MUSCLE RUBMULTI-INGREDIENTN/ABELL SONS & CO (DRUGGISTS) LTD-SLAIDBURN CRES CHESHIRE HOUSE/GORSEY LAUNITED KINGDOMTOPICAL EXTERNAL OINTMENTS 1.0X40.0 G TUBE
NDA/MAL/HDP/5343 PHARCO PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCEFORAN 1GMCEFOTAXIME SODIUM1GMPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/5344IDA FOUNDATIONKIMSY MEDS LTDCEFTRIAXONECEFTRIAXONE1GOKASA PHARMA PVT LTD-L-2, ADDITIONAL M.I.D.C. AREA, SATARA SATARA-415004, MAHARASHTRA, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X10.0X1.0 G VIAL
NDA/MAL/HDP/5345VHB MEDI SCIENCES LTDLLOYDS PHARMACY UGANDA LTD.CEFTRIMAXCEFTRIAXONE SODIUM + SULBACTAM1G + 0.5GVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/5346PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFUTIL 500CEFUROXIME AXETIL500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET CONTAINER
NDA/MAL/HDP/5347PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDCEFUTIL 250CEFUROXIME AXETIL250MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5348OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDCELEPID 20INTRAVENOUS FAT EMULSION20%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/HDP/5349MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCELESTAMINE TABLETSBETAMETHASONE + DEXCHLORPHENIRAMINE 0.25MG + 2MGSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAM, MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICABELGIUMORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/5350DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCEPHADAR FORTECEPHALEXIN250MG/5MLDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5351DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDCEPHADAR CEPHALEXIN MONOHYDRATE125MG/5MLDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5352GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDMUMFERIRON(111) POLYMALTOSE COMPLEX50MG/5MLGLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/5355H.HOFFMAN ROCHELABOREX UGANDA LIMITEDBONVIVAIBANDRONIC ACID150MGH. HOFFMAN ROCHE-GRENZACHERSTRASE 124, EXT 4070, BASEL SWITZERLAND & CH-4303 KAISERANGST SWITZERLANDSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/5356NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBURNNEMMULTI-INGREDIENTN/ANEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/5357GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDCA-C 1000CALCIUM CARBONATE+ASCORBIC ACID327MG+1000MGNOVARTIS CONSUMER HEALTH-SWITZERLANDSWITZERLANDORAL SOLID ORDINARY EFFERVESCENT TABLETS 1.0X10.0 TABLET CONTAINER
NDA/MAL/HDP/5358CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCADISTIN EXPECTORANTGUAIFENESIN+AMMONIUM CHLORIDE+CHLORPHENIRAMINE+SODIUM CITRATE80MG+100MG+2MG+44MGSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5360CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANMOXICIP 400MOXIFLOXACIN400MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845 INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/5361MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDCALFICMULTI-INGREDIENTN/ATORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5362ASTRA ZENECA MACNAUGHTON LIMITEDCASODEX 150MGBICALUTAMIDE150MGASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY TABLETS 2.0X14.0 TABLET STRIP
NDA/MAL/HDP/5363ASTRA ZENECAMACNAUGHTON LIMITEDCASODEX 50MGBICALUTAMIDE50MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,,BULK CORDEN PHARMA GMBH-OTT HAHN STRASSE ,68723 GERMANYUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/5364NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCATAFLAM 25MG TABLETSDICLOFENAC POTASSIUM25MGNOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS--URUNLERI INSTABUL TURKEYITALYORAL SOLID ORDINARY COATED TABLETS 1.0X100.0 TABLET CONTAINER,1.0X20.0 TABLET CONTAINER
NDA/MAL/HDP/5365NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDCATAFLAM ORAL DROPSDICLOFENAC POTASSIUM15MG/MLNOVARTIS PHARMA SPA-RUE DE LA CHAPELLE, HUNIGUEFRANCEORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/5366HILTON PHARMA (PVT) LTDHEALTHCARE LTD.CEFIMCEFIXIME400MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X5.0 CAPSULE STRIP
NDA/MAL/HDP/5367HILTON PHARMA (PVT) LTDHEALTHCARE LTD.CEFIMCEFIXIME100MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE
NDA/MAL/HDP/5368PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFIX 100MG/5ML DRY SUSPENSIONCEFIXIME100MG/5MLPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHAJORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5369AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINELAMIVUDINE150MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/5370COSMOS LTDASTRA PHARMA (U) LIMITEDHYOSCINE BUTYLBROMIDEHYOSCINE N-BUTYLBROMIDE10 MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET BLISTER
NDA/MAL/HDP/5371CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANLAMIVUDINELAMIVUDINE10MG/MLCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5372CIPLA LTD QUALITY CHEMICALS LTD - HUMANDUOMUNELAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA,CIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/5374CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANLAMIVIR ORAL SOLUTIONLAMIVUDINE50MG/5MLCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE ?II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH,CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X240.0 ML BOTTLE
NDA/MAL/HDP/5376AUROBINDO PHARMA LTD GITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE & ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG+300MGAUROBINDOPHARMA LIMITED,-SURVEY NO. 313 & 314, BACHUPALLY VILLAGE, QUTHUBULLAPUR MANDAL, HYDERABAD, RANGA REDDY (DT), ANDHRA PRADESH - 500090 INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/5377JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN FOUR FLU LIQUIDDIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE25MG/20ML + 1G/20ML + 45MG/20MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/5378ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDX-VITAMULTIINGREDIENTN/AMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X15.0 CAPSULE BLISTER
NDA/MAL/HDP/5379AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZOLANAS-30LANSOPRAZOLE30MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/5380CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCIROZEPDIAZEPAM5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/5381LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDADIFLAM GELDICLOFENAC DIETHYLAMINE1.16%W/W LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/5385NAPROD LIFE SCIENCES PVT LTDAIVEEN (U) LIMITEDVINROS A-1VINCRISTINE SULPHATE1MGNAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5386WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDUDIHEP TABLETSURSODEOXYCHOLIC ACID150MGWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5387HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN INJECTION 250MGTRANEXAMIC ACID250MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.PAKISTANPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0 ML AMPOULE
NDA/MAL/HDP/5388IPCA LABORATORIES LTD MEDVIN PHARMA LIMITEDLARINATEARTESUNATE60MGIPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067INDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 1*5 ML SODIUM CHLORIDE INJECTION + 1*1 ML AMPOULE OF SODIUM BICARBONATE INJECTION
NDA/MAL/HDP/5389CIPLA LTDQUALITY CHEMICALS LTD - HUMANLUMARTEMARTEMETHER + LUMEFANTRINE20MG + 120 MGCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER
NDA/MAL/HDP/5391 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDNITROFURANTOINNITROFURANTOIN100MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5392DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDAMLO-DENK 10AMLODIPINE MESILATE MONOHYDRATE10MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5393DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDAMLO-DENK 5AMLODIPINE MESILATE MONOHYDRATE5MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5394FOURTS(INDIA) LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDFINAZOLALBENDAZOLE400MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X500.0 TABLET CONTAINER, 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5395MICRO LABS LTD LABOREX UGANDA LIMITEDOFLOXOFLOXACIN200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5397 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-100BECLOMETHASONE100MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA INDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5400GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDALBEN SUSPENSIONALBENDAZOLE400MG/10MLPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/5401PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDHALOTHANEHALOTHANE250MLPIRAMAL ENTERPRISES LTD --DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESHINDIAOTHER SYSTEMIC LIQUID INHALATIONS 1.0X250.0 ML BOTTLE
NDA/MAL/HDP/5404INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENAC PACECLOFENAC + PARACETAMOL100 MG + 500 MGINTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5405CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOLANDUS 10OLANZAPINE10MGCADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA. . INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5406INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENAC SRACECLOFENAC200 MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5409LINCON PHARMCUETICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDMINTO GELALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE150 MG + 150 MG + 25 MGSAKAR 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 1.0X180.0 ML BOTTLE
NDA/MAL/HDP/5410MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.UNICTAM 1500AMPICILLIN + SULBACTAM1000 MG + 500 MG MEDICAL UNION PHARMACEUTICALS LTD - -ABU SULTAN, CR 13363 ISMAILLIA, EGYPTEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/5412UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDIFICIPRO 250CIPROFLOXACIN250MGJB CHEMICALS AND PHARMACEUTICALS-128/1,CIIDC ANKLESHWER 393 002GUAZARAT INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5413PASTEUR MERIEUX CONNANGHTLABOREX UGANDA LIMITEDEUVAX B (ADULT)HEPATITIS B VACCINE1MLPASTEUR MERIEUX CONNANGHT-SOUTH KOREA,LG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JESOUTH KOREAPARENTERAL ORDINARY I M VIALS 1.0X10.0 ML VIAL,1.0X1.0 ML VIAL
NDA/MAL/HDP/5414ACINO PHARMA AGGOODMAN INTERNATIONAL LTDXYLO-ACINO 0.1%XYLOMETAZOLINE0.1 % W/VMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEURENGERMANYNASAL TOPICAL DROPS 1.0X1.0X10.0 ML BOTTLE
NDA/MAL/HDP/5415CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDSINARESTOXYMETAZOLINE0.05%W/VCENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIANASAL TOPICAL DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5416OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDCIPROXCIPROFLOXACIN0.2%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5417PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCIPROPHARMCIPROFLOXACIN500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5418MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPAEDIATRIC CO-TRIMOXAZOLECO-TRIMOXAZOLE240MG/5MLMACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5419AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CPMCHLORPHENIRAMINE4MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5422KOTRAPHARMA (M) SDN.BHDUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFUROXIME-750CEFUROXIME750MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/5423HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDEFAVIRENZ+LAMIVUDINE+TENOFOVIREFAVIRENZ+LAMIVUDINE+TENOFOVIR600MG + 300MG + 300MGHETERO 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 TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/5425ROYAL GROUPHARLEYS UGANDA LIMITEDPARACETAMOLPARACETAMOL500MGHEBEI (JIHENG GRP) PHARMACEUTICALS CO.LTD-INDIACHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5426INDOCO REMEDIES LTDTATA UGANDA LIMITEDCEPROLENCIPROFLOXACIN0.3%W/VINDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/5427 NIRMA LIMITED.SUPER MEDIC LTDNIRCIPCIPROFLOXACIN200MG/100MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5428FOURRTS(INDIA) LABORATORIES PVT.LIMITEDDELMAW ENTERPRISES LIMITEDCIPFIL 500CIPROFLOXACIN500MGFOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103, TAMIL NADU,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5429AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCIPRO-500CIPROFLOXACIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON
NDA/MAL/HDP/5431AUROBINDO PHARMA LTD GITTOES PHARMACEUTICALS LIMITEDZIDOVUDINEZIDOVUDINE300MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/5432HETERO DRUGS LTD ABACUS PHARMA (AFRICA) LIMITEDZIDOVUDINEZIDOVUDINE300MGHETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH ,INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/5433REGAL PHARMACEUTICALS LTD REGAL PHARMA (U) LTDCOLDCAP NIGHT TIMEPARACETAMOL+CHLORPHENIRAMINE500MG+2MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL SOLID ORDINARY CAPSULES 1.0X1.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/5434MEDIPHARM (EA) LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE CO-PACK DT ZINC-20 + ORAL REHYDRATION SALTS (ORS)20G MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA,AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY OTHER SPECIAL FORMS 1.0X2.0X20.5 G SACHET + 1.0*10.0 TABLET BLISTER
NDA/MAL/HDP/5435 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDPICPARACETAMOL+IBUPROFEN+CAFFEINE500MG+200MG+30MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET STRIP
NDA/MAL/HDP/5436CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFICAD 1000CEFEPIME HCL1000MGLA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1000.0 MG VIAL
NDA/MAL/HDP/5437MEDIPHARM (EA) LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE ORANGEGLUCOSE + NACL + TRISODIUM CITRATE + KCL13.5G + 2.6G + 2.9G + 1.5GMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGEREREUGANDAORAL SOLID ORDINARY POWDERS 1.0X20.8 G SACHET,1.0X10.4 G SACHET
NDA/MAL/HDP/5438ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDTAMINPARACETAMOL10MG/MLCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE,1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML VIAL
NDA/MAL/HDP/5439 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENIRON SYRUPVITAMIN B6 + FERROUS GLUCONATE + VITAMIN B1 + VITAMIN C + VITAMIN B22MG/5ML + 200MG/5ML + 2MG/5ML + 20MG/5ML + 2MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5441KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL NASATAB TABLETSPARACETAMOL+CHLORPHENIRAMINE+PSEUDOEPHEDRINE500MG+4MG+60MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5442NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDCHLORAMPHENICOL OPHTHALMIC OINTMENT USP 1%CHLORAMPHENICOL1%W/WNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAOPHTHALMIC OINTMENTS 1.0X20.0X3.5 G TUBE
NDA/MAL/HDP/5444MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAERIUS TABLETSDESLORATIDINE5MG 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-BERGBELGIUM/SOUTH AFRICAORAL SOLID ORDINARY TABLETS 5.0X6.0 TABLET BLISTER
NDA/MAL/HDP/5445ESKAYEF BANGLADESH LTDMEDVIN PHARMA LIMITEDAZITHRAX 500AZITHROMYCIN DIHYDRATE500 MGESKAYEF BANGLADESH LTD--400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X6.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/5448GENO PHARMACEUTICALS PVT LTDHARLEYS UGANDA LIMITEDFLUNER-5FLUNARIZINE5MGGENO PHARMACEUTICALS LTD--PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5449HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOFENAC 50DICLOFENAC SODIUM50MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIAMALAYSIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5453 PHARCO PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCONCIL 250MG/5MLAMOXICILLIN250MG/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 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/5454LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDMOXILEBAMOXICILLIN125MG/5ML LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY POWDERS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5456 PHARCO PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCONCIL 125MG/5MLAMOXICILLIN125MG/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 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/5457CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANFALCIMON 100/270 B/LARTESUNATE+AMODIAQUINE100MG+270MGCIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/5458CIPLA LTDQUALITY CHEMICALS LTD - HUMANFALCIMON 50/135 B/LARTESUNATE+AMODIAQUINE50MG+135MGCIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/5460GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDASAQ GPSCARTESUNATE+AMODIAQUINE50MG+135MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0X20.0 TABLET BLISTER
NDA/MAL/HDP/5461SANOFI AVENTISLABOREX UGANDA LIMITEDARTESUNATE AMODIAQUINEARTESUNATE+AMODIAQUINE25MG+67.5MGMAPHAR S.A. GROUP OF SANOFI,-KM 10, ROUTE COTIERE 111 QUARTIER, INDUSTRIEL ZENATA AIRI SEBAA, 00212522678099 - MOROCCOMOROCCOORAL SOLID ORDINARY LAYERED TABLETS 1.0X25.0X3.0 TABLET BLISTER
NDA/MAL/HDP/5462SANOFI AVENTISLABOREX UGANDA LIMITEDARTESUNATE AMODIAQUINE WINTHROPARTESUNATE+AMODIAQUINE50MG+135MGMAPHAR S.A. GROUP OF SANOFI,-KM 10, ROUTE COTIERE 111 QUARTIER, INDUSTRIEL ZENATA AIRI SEBAA, 00212522678099 - MOROCCOMOROCCOORAL SOLID ORDINARY TABLETS 1.0X25.0X3.0 TABLET BLISTER
NDA/MAL/HDP/5463SANOFI AVENTISLABOREX UGANDA LIMITEDARTESUNATE AMODIAQUINE WINTHROPARTESUNATE+AMODIAQUINE100MG+270MGMAPHAR S.A. GROUP OF SANOFI,-KM 10, ROUTE COTIERE 111 QUARTIER, INDUSTRIEL ZENATA AIRI SEBAA, 00212522678099 - MOROCCOMOROCCOORAL SOLID ORDINARY LAYERED TABLETS 1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/5464AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINE20MG + 120MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X4.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,2.0X6.0 TABLET BLISTER,4.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER
NDA/MAL/HDP/5467KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMSIDARSULFADOXINE/PYRIMETHAMINE525MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5468UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIVAL TABLETSSODIUM VALPROATE200MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS 1.0X50.0 TABLET BOTTLE
NDA/MAL/HDP/5469BAYER PHARMA AGSURGIPHARM (U) LIMITEDNIMOTOPNIMODIPINE0.2MG/MLBAYER PHARMA AG -51368 LEVERKUSEN GERMANYGERMANYPARENTERAL ORDINARY I V VIALS 1.0X50.0 ML VIAL
NDA/MAL/HDP/5470ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)VERIUN CP-325CEFIXIME + CLAVULANATE POTASSIUM200 MG + 125 MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST. SOLAN (HP) ? 174 101(INDIA) INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5471MICRO LABS LTDLABOREX UGANDA LIMITEDAVAS 40ATORVASTATIN40MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5472OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDNSSODIUM CHLORIDE0.9%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABADINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/HDP/5473TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTROYPOFOLPROPOFOL1%W/VTROIKAA PHARMACEUTICALS LTD .-C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197INDIAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL
NDA/MAL/HDP/5474PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOXCEFPODOXIME200MGPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT AL-QARTAL MARKETING DEPARTMENT ALBUJAH COMPLEX, ALJUBAIHAJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5475KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFTAZIDIMECEFTAZIDIME1GKOTRA PHARMA (M) SDN.BHD,-1,2 & 3 JALAN TTC 12 CHENG INDUSTRIAL ESTATE 75250 MELAKAMALAYSIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/5476ACINO PHARMA AGGOODMAN INTERNATIONAL LTDMESPORIN 1000MG I.VCEFTRIAXONE1000MGLABESFAL LABORATORIES-ALMIRO S.A ZONA INDUSTRIAL DO LAGEDO, 3465-157, SANTIAGO DE BESTERIROS PORTUGALPORTUGALPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL + 10 ML WFI
NDA/MAL/HDP/5478CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE-50BECLOMETHASONE DIPROPIONATE50MCG/ACTUATIONCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIALUNG ADMINISTRATION METERED-DOSE INHALER 1.0X1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5479 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDRANFERON 12 CAPSULESMULTI-INGREDIENTMULTI-INGREDIENTSUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE BLISTER
NDA/MAL/HDP/5480CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE NASAL SPRAYBECLOMETHASONE DIPROPIONATE50MCGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIANASAL TOPICAL METERED DOSE AEROSOLS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5482 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOLINSALBUTAMOL2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5483GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDASAQ GPSCARTESUNATE + AMODIAQUINE25 MG + 67.5 MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0X20.0 TABLET BLISTER
NDA/MAL/HDP/5485BEXIMCO PHARMACEUTICALS LIMITEDKIMSY MEDS LTDAZMASOL HFASALBUTAMOL100MCG/ACTUATIONBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5486EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDFOSEAL 400SEVELAMER HCL400MGEMCURE PHARMACEUTICALS LTD .-C-10(12) MIDC BHOSAN PUNEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5487 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-SSALBUTAMOL + BECLOMETASONE100MCG/ACTUATION + 50MCG/ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/5489UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORBIS-5BISOPROLOL5MGUNICHEM 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/5492STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDRIFAMPICIN + ISONIAZIDRIFAMPICIN + ISONIAZID150MG + 75MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X24.0X28.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/5494ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASMOXAMOXYCILLIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/5495 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOCAL TABLETSCALCIUM LACTATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5496ASTRA ZENECA MACNAUGHTON LIMITEDATACAND 16MGCANDESARTAN CILEXETIL16MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)SWEDENORAL SOLID ORDINARY TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/5497ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDEXPENBENZYLPENICILLIN 1MUREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUANCHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X1.0 MU VIAL
NDA/MAL/HDP/5507GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCALADIN LOTIONCALAMINE15 %W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL LOTIONS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/5525UMEDICA LABS PVT LTDGITTOES PHARMACEUTICALS LIMITEDRILIF-SRACECLOFENAC200 MGUMEDICA 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/5566KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDHYCORT OINTMENTHYDROCORTISONE1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X30.0 G TUBE
NDA/MAL/HDP/5575SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDHYOSCINE BUTYL BROMIDEHYOSCINE BUTYL BROMIDE10MGS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5591SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDSWISSCILLINAMPICILLIN500MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/5596KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDGERMILONCHLORHEXIDINE GLUCONATE + CETRIMIDE0.3%W/V + 3%W/VKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X200.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X5.0 L BOTTLE
NDA/MAL/HDP/5619CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.RABELOC 20RABEPRAZOLE SODIUM20MGCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/5634BAYER AGSURGIPHARM (U) LIMITEDCIPROBAYCIPROFLOXACIN500MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/5639GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDFEROMAXIRON SUCROSE20MG/MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA, P.O.BOX: 997, RAS AL KHAIMAH, U.A.E. UNITED ARAB EMIRATESPARENTERAL ORDINARY INFUSION AMPOULES 1.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/5644GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFORTIFIED PROCAINE PENICILLINFORTIFIED PROCAINE PENICILLIN4 MEGA UNITSCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.CHINAPARENTERAL ORDINARY VIALS 1.0X4.0 MU VIAL
NDA/MAL/HDP/5648KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDCLOXACILLIN SODIUMCLOXACILLIN SODIUM500MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X500.0 MG VIAL
NDA/MAL/HDP/5685JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE20MG/5MLSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSESOUTH AFRICAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/6031 NORVATIS PHARMA SERVICES INC.SURGIPHARM (U) LIMITEDEXFORGE HCT 10MG + 160MG +25MGGLIBENCLAMIDE,AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE5MG,10MG + 160MG +25MGNORVATIS PHARMA STEIN-SCHAFFHAUSERSTRASSE 4332 STEINSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6034AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LTD - WILLIAM STREETAGOXIN -250 DTAMOXICILLIN TRIHYDRATE 250 MGMILAN LABS PVT LTD-63-67 JAWAHAR CO.OP. INDUSTRIAL ESTATE KAMOTHE,NAVI MUMBAIINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6037GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAVITVITAMIN A200,000 IU OLIVE HEALTHCARE-197/2, ATHIYAWAD DABHEL VILLAGE DAMAN 396210 (U.T)INDIAORAL SOLID ORDINARY CAPSULES 1.0X30.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 TABLET JAR
NDA/MAL/HDP/6038 UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDFIXDEP-180FEXOFENADINE HYDROCHLORIDE180MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6039GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCOMBIWAVE SF 250SALMETEROL XINAFOATE/FLUTICASONE PROPIONATE25MCG+250MCG/ACTUATIONGLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/6040BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDU-TRYPULINASTATIN100,000 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/6041 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAVAGINAL TABLETS 1.0X6.0 PESSARY STRIP
NDA/MAL/HDP/6042GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDCOMBIWAVE SF 125SALMETEROL XINAFOATE/ FLUTICASONE PROPIONATE25MCG+125MCG/ACTUATIONGLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/6043BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDZEMILASTIMIPENEM + CILASTATIN500MG+500MGZEISS PHARMACEUTICALS PVT. LIMITED-PLOT NO. 72, EPIP I, JHARMAJIRI, BADDI (HP), INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/6044GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDCOMBIWAVE SF 50SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG+50MCG/ACTUATIONGLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/6046MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDACYCLOVIRACYCLOVIR200MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. ? 431136, MAHARASHTRA STATE, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6047MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDHERTRAZ 150TRASTUZUMAB (R-DNA ORIGIN)150MGBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES 1.0X150.0 MG VIAL ,1X10ML VIAL OF WFI
NDA/MAL/HDP/6048GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE AZMOMETASONE FUROATE / AZELASTINE HYDROCHLORIDE50MCG/140MCGGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIAINDIANASAL TOPICAL METERED DOSE AEROSOLS 1.0X150.0 METERED DOSE BOTTLE
NDA/MAL/HDP/6050MICRO LABS LTD LABOREX UGANDA LIMITEDITACAREITRACONAZOLE100MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6051NOVARTIS PHARMA SERVICESSURGIPHARM (U) LIMITEDEXFORGE HCT 10MG + 320MG + 25MGAMLODIPINE BESYLATE + VALSARTAN + HYDROCHLOROTHIAZIDE10MG + 320MG + 25MGNORVATIS PHARMA STEIN-SCHAFFHAUSERSTRASSE 4332 STEINSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6052MICRO LABS LTDLABOREX UGANDA LIMITEDMICROPIMECEFEPIME HYDROCHLORIDE1GMICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*10ML (WFI) LDPE VIAL
NDA/MAL/HDP/6053SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDGLIMEPIRIDEGLIMEPIRIDE4MGLEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATESPOLANDORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6054SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDGLIMEPIRIDEGLIMEPIRIDE1MGLEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATESPOLANDORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6055SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.ALABOREX UGANDA LIMITEDEURARTESIMPIPERAQUINE TETRAPHOSPHATE + DIHYDROARTEMISININ160MG + 20MGSIGMA- TAU I.F.R . S.P.A-VIA PONTINA KM 30,400 POMEZIA ROMEITALYORAL SOLID ORDINARY TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6056SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES.SURGIPHARM (U) LIMITEDTELMISARTANTELMISARTAN20MGSANDOZ GRUP SAGLIK URUNLERI .-ILACLARI SANAYI VE A.S GEBZE 2, GOSB IHSAN DEDE CAD. 900 SOK 41480 GEBZE KOCAELITURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/6057BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 5MGAMLODIPINE BESYLATE5MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6058FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDFENTANYL FRESENIUSFENTANYL100MCG/2MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/6059RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDNEUROZONEMECOBALAMIN + PREGABALIN750MCG + 75MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6060NOVARTIS ACCESSSURGIPHARM (U) LIMITEDSALBUTAMOLSALBUTAMOL100MCGAEROPHARM GMBH...-RUDOLSTADT ALLEMAGNEGERMANYLUNG ADMINISTRATION LIQUID FOR INHALATION 1.0X200.0 METERED DOSE CONTAINER
NDA/MAL/HDP/6061CIPLA LTD..QUALITY CHEMICALS LTD - HUMANNASEHALERMOMETASONE FUROATE50MCG /SPRAYCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIANASAL TOPICAL SPRAYS WITHOUT GAS 1.0X140.0 METERED DOSE BOTTLE
NDA/MAL/HDP/6062AUROLABSWASTIK PHARMACEUTICAL LTDOFPREDOFLOXACIN + PREDNISOLONE SODIUM PHOSPHATE0.3W/V + 0.5%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIAINDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6063CLARIS LIFESCIENCE LTDREDDYS PHARMA LIMITEDANSEDFLUMAZENIL0.1MG/MLCLARIS LIFE SCIENCES LTD-CHACHARWADI-VASANA,SANAND, AHMEDABAD GUJARAT-382213 INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/6064UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDJOCET 10CETIRIZINE DIHYDROCHLORIDE10MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6065 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPROXYRENPIROXICAM20MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6066STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZIODINATED- POVIDONE10%W/VSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6067RENE PHARMACY(R) LTD..RENE PHARMACY LTDDIAZEPAMDIAZEPAM5MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6068EXIR PHARMACEUTICAL COMPANYUNEED GLOBAL GROUP LIMITEDZIMEXIR 250AZITHROMYCIN DIHYDRATE250MGEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANIRANORAL SOLID ORDINARY CAPSULES 1.0X5.0 CAPSULE BLISTER
NDA/MAL/HDP/6069EXIR PHARMACEUTICAL COMPANYUNEED GLOBAL GROUP LIMITEDZIMEXIR 200MGAZITHROMYCIN DIHYDRATE200MG/5MLEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANIRANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/6070DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDVAZKORAMLODIPINE BESILATE10MGDEVA-CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH ATATURK CAD.,NO.: 32 KAPAKLITURKEYORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6071DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDVAZKORAMLODIPINE BESILATE5MGDEVA-CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH ATATURK CAD.,NO.: 32 KAPAKLITURKEYORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6072SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDHYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE20MG/MLSWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARATINDIAPARENTERAL ORDINARY I V AMPOULES 1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/6073EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMILGABENFOTIAMINE + PYRIDOXINE + CYANOCOBALAMIN40MG + 60MG + 20MCGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6074MARCYRL PHARMACEUTICAL INDUSTRIESSHREEJI PHARMACEUTICALS LIMITEDCARDILOL CSCARVEDILOL25MGMARCYRL PHARMACEUTICAL INDUSTRIES -WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITYEGYPTORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6075EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOLOHISTINEOLOPATADINE HYDROCHLORIDE1MG/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6076SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE30MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X30.0 MG VIAL + 1*5 ML OF 0.9%W/V NACL AMPOULE + 1*1 ML OF 5%W/V NAHCO3 AMPOULE
NDA/MAL/HDP/6078EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIMOLOL MALEATETIMOLOL MALEATE5MG/ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6079ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDALLERGEXCHLORPHENIRAMINE MALEATE4MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6080EXPHAR SASURGIPHARM (U) LIMITEDFEBRILEX JUNIORPARACETAMOL+CHLORPHENIRAMINE MALEATE125MG+1MG/5MLGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/6081EXPHAR SASURGIPHARM (U) LIMITEDANTALGEX TPARACETAMOL + TRAMADOL HYDROCHLORIDE325MG + 37.5MGGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6082EXPHAR SASURGIPHARM (U) LIMITEDCROMSOLSODIUM CROMOGLYCATE2%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6086 UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDACEWEL-PACECLOFENAC+PARACETAMOL100MG+500MGAKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6090 UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDPROSTAR 200PROGESTERONE100MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403INDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/6092SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPOTCLAV 1000AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM875 MG + 125 MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6093SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPOTCLAV 625AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM500 MG + 125 MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6094SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPOTCLAV 375AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM250 MG + 125 MGSPARSH BIO-TECH PVT. LTD-PLOT NO. 1; SURVEY NO. 242/243/244, LAKHABAVAD, JAMNAGAR-361 006, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6095S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDDIPGENBETAMETHASONE DIPROPIONATE + GENTAMICIN SULFATE0.64 MG/G + 1 MG/GS KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARATINDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/6099ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDHARIPIL-60ARTESUNATE60MGPSYCHOTROPICS INDIA LTD -PLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 1*5 ML OF 0.9% W/V NACL GLASS AMPOULE + 1*1 ML OF 5%W/V NAHCO3 GLASS AMPOULE
NDA/MAL/HDP/6102ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTELPRESS 80TELMISARTAN80MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6103ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDOZACE MD 5OLANZAPINE5MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6104ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDFUROSEMIDEFUROSEMIDE10MG/MLPSYCHOTROPICS INDIA LTD -PLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIAINDIAPARENTERAL ORDINARY I V AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/6105PSYCHTROPICS INDIA LTDABACUS PHARMA (AFRICA) LIMITEDAZOPIL 200AZITHROMYCIN200MG/5MLPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/6106SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDTREVOX 500LEVOFLOXACIN HEMIHYDRATE500MGSQUARE PHARMACEUTICALS LTD-KALIAKOIRBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6107SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSULPREXIPRATROPIUM BROMIDE+SALBUTAMOL SULPHATE500MCG/2.5ML+2.5MG/2.5MLSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHLUNG ADMINISTRATION LIQUID FOR INHALATION 1.0X10.0 AMPOULE CARTON
NDA/MAL/HDP/6108SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDTREVOX 750LEVOFLOXACIN HEMIHYDRATE750MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6109SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDMEXLOLOMEFLOXACIN HYDROCHLORIDE0.3%W/V SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6110SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDAMBROXAMBROXOL HYDROCHLORIDE15MG/5MLSQUARE PHARMACEUTICAL LIMITED (PABNA UNIT)-SQUARE ROAD, SALGARIA PABNA-6600 BANGLADESHBANGLADESHORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6111SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDMOTIFASTDOMPERIDONE10MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY OTHER TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6112SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSULTOLINSALBUTAMOL SULPHATE2.5MG/2.5ML SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHLUNG ADMINISTRATION LIQUID FOR INHALATION 1.0X10.0X2.5 ML AMPOULE
NDA/MAL/HDP/6114FDC LTDAIVEEN (U) LIMITEDZOXANCIPROFLOXACIN0.3% W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6116DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDZOLEDRO-DENK 4MG/5MLZOLEDRONIC ACID4MG/5ML HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELNGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X5.0 ML VIAL
NDA/MAL/HDP/6117DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDGRAN-DENKGRANISETRON HYDROCHLORIDE1MG/ML HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELNGERMANYPARENTERAL ORDINARY AMPOULES 1.0X5.0 ML AMPOULE
NDA/MAL/HDP/6118LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDL-TRIM DSSULPHAMETHOXAZOLE + TRIMETHOPRIM800MG + 160MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6119 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDSUPER CVAMOXICILLIN SODIUM + POTASSIUM CLAVULANATE1 G + 0.2 G NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY VIALS 1.0X10.0X1.2 G VIAL
NDA/MAL/HDP/6120 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDKMINEKETAMINE HYDROCHLORIDE50MG/MLNATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA NEPALNEPALPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/6121?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LTD DEXIRENDEXKETOPROFEN TROMETAMOL25MG?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1 SEL?UKLU / KONYATURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6122 TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDROCUTROYROCURONIUM BROMIDE10MG TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL
NDA/MAL/HDP/6123OCTOBER PHARMAABACUS PHARMA (AFRICA) LIMITEDMONOMAKISOSORBIDE NITRATE20MGOCTOBER PHARMA-1ST INDUSTRIAL ZONE STREET 25 PLOT 190 6TH OCTOBER CITY CAIROEGYPTORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6124CLARIS LIFE SCIENCES LTDREDDYS PHARMA LIMITEDSPIVAPROPOFOL1%W/VCLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/6126MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DERMOTRACINNEOMYCIN SULPHATE + BACITRACIN165,000 IU + 12,500 IUMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPTEGYPTTOPICAL EXTERNAL PRESSURISED AEROSOLS 1.0X150.0 ML CANNISTER
NDA/MAL/HDP/6127JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDINTELENCEETRAVIRINE25MGJANSSEN-CILAG S.P.A.-VIA C. JANSSEN BORGO S. MICHELE 04100 LATINAITALYORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET BOTTLE
NDA/MAL/HDP/6128IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYFLURFLURBIPROFEN SODIUM0.03%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6129GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDTRIUMEQDOLUTEGRAVIR + ABACAVIR + LAMIVUDINE50MG + 600MG + 300MGGLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)-PRIORY STREET, WARE HERTFORDSHIRE SG12 0DJ, UK UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET CONTAINER
NDA/MAL/HDP/6130ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDIVYSINE EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE0.05%W/VIVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYAKENYAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/6131ACINO PHARMA AGGOODMAN INTERNATIONAL LTDFERRACINIRON (III) HYDROXIDE SUCROSE COMPLEX20MG/MLRAFARM S.A-AGIO LOUKA STR PEANIA ATTIKIGREECEPARENTERAL ORDINARY I V AMPOULES 1.0X5.0X5.0 ML AMPOULE
NDA/MAL/HDP/6132HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOVIDKETOCONAZOLE2%W/WHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIATOPICAL EXTERNAL LIQUID SOAPS/WASHES 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/6133UMEDICA LABORATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDRILIF-100ACECLOFENAC100MGUMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6134MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDZAMADOL PTRAMADOL HYDROCHLORIDE+ACETAMINOPHEN37.5MG+325MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6135ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTRIXONE-SCEFTRIAXONE SODIUM+SULBACTAM 1000MG+500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X20.0 ML VIAL
NDA/MAL/HDP/6137BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDLUPRODEX LEUPROLIDE ACETATE3.75MGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (EAST), INDIA INDIAPARENTERAL ORDINARY S C VIALS 1.0X1.0 ML VIAL + 1*2ML GLASS AMPOULE OF DILUENT (EACH ML CONTAINS 50MG OF D-MANNITOL AND WFI TO Q.S) + 1 DISPOSABLE SYRINGE, 2 NEEDLES AND 2 ALCOHOL SWABS
NDA/MAL/HDP/6139SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSERVIN CAPSULEFERROUS SULPHATE+FOLIC ACID+THIAMINE MONONITRATE+RIBOFLAVIN+PYRIDOXINE HYDROCHLORIDE+NICOTINAMIDE+ASCORBIC ACID150MG+0.5MG+2MG+2MG+1MG+10MG+50MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6140CLARIS OTSUKA LIMITEDREDDYS PHARMA LIMITEDKIDROLYTESODIUM ACETATE + DIBASIC POTASSIUM PHOSPHATE + MAGNESSIUM CHLORIDE + DEXTROSE MONONOHYDRATE + POTASSIUM CHLORIDE(0.32G + 0.026G + 0.031G + 5.50G + 0.13G)/100MLCLARIS OTSUKA LIMITED .-VILLAGE VASANA CHACHARWADI TAL:SANAD DIST -AHMEDABAD 382 213INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/6141UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDACEWELACECLOFENAC100MGAKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6142AGOG PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCARBACTIVATED CHARCOAL0.25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6143MARCYRL PHARMACEUTICAL INDUSTRIESSHREEJI PHARMACEUTICALS LIMITEDCONTRACTUBEXEXTRACT CEPAE FLUID +HEPARIN SODIUM+ALLANTOIN10G+5000 I.U+1G/100GMARCYRL PHARMACEUTICAL INDUSTRIES.-EL OBOUR CITY CAIROEGYPTTOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/6144 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDNIKOPARACETAMOL500MG NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALORAL SOLID ORDINARY TABLETS 1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6145MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDENDULIN SELECTINSULIN GLARGINE(R-DNA ORGIN)100I.U/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA INDIAPARENTERAL ORDINARY PRE-FILLED PENS 1.0X3.0 ML PREFILLED PEN
NDA/MAL/HDP/6147MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDENDULIN VAILINSULIN GLARGINE (R-DNA ORIGIN)100I.U/MLBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA INDIAPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/6150SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDSERVIFLOX 500MGCIPROFLOXACIN500MGSALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6151NITIN LIFESCIENCES LTDHEALTHCARE LTD.NITCAINELIDOCAINE2%W/VNITIN LIFESCIENCES LTD..-RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H.INDIAPARENTERAL ORDINARY VIALS 1.0X10.0X30.0 ML VIAL
NDA/MAL/HDP/6152SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCARVEDILOL SANDOZ 12.5MGCARVEDILOL 12.5MGSALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE GERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6153SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCARVEDILOL SANDOZ 25MGCARVEDILOL25MGSALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE GERMANYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6154NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDEXFORGE 5MG/320MGAMLODIPINE + VALSARTAN5 MG + 320 MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSESWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6158DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDDESEFINCEFTRIAXONE SODIUM1GDEVA LIAC SAN. VE TIC. A.S. -ORGANISE SANAYI BOLGESI ATATURK MAH. ATATURK CAD. NO: 32 KARAAGAC CERKEZKOYTURKEYPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/6159SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDAMLODIPINEAMLODIPINE10MGLEK PHARMACEUTICALS .D.D -VEROVSKOVA 57, 1526 LJUBLJANA SLOVENIA SLOVENIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/6166 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDGMICINGENTAMICIN SULPHATE0.3%W/V NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
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NDA/MAL/HDP/6168KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LIMITEDK-HEMFERROUS GLUCONATE + THIAMINE MONONITRATE + RIBOFLAVIN + PYRIDOXINE HCL + NIACINAMIDE + VITAMIN B12300MG + 5MG + 5MG + 1.5MG +45MG + 15MCGKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/6169JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDINTELENCEETRAVIRINE100MGJANSSEN-CILAG S.P.A.-VIA C. JANSSEN BORGO S. MICHELE 04100 LATINAITALYORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET BOTTLE
NDA/MAL/HDP/6170SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALACOT 0.1% EYE DROPSOLOPATADINE HYDROCHLORIDE0.1%W/VSQUARE PHARMACEUTICALS LTD-KALIAKOIRBANGLADESHOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6171ROTEXMEDICA GMBH ARZNEIMITTELWERKGITTOES PHARMACEUTICALS LIMITEDSUXAMETHONIUM CHLORIDESUXAMETHONIUM CHLORIDE50MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAUGERMANYPARENTERAL ORDINARY DRY AMPOULES 1.0X10.0X2.0 ML AMPOULE
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NDA/MAL/HDP/6175SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDSERVIFLOX 250CIPROFLOXACIN250MGSALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6176BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDG-GLUTAMIN PLUSVITAMIN B1 +B6+B12 WITH L-GLUTAMIC ACID100MG+50MG+100MCG+50MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6179DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDON.SETRON-DENK 4MG ODTONDANSENTRON4MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6181UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDAZINOWEL-500AZITHROMYCIN500MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6182SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDALARIDKETOTIFEN FUMARATE0.025%W/V SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6183CIPLA LTD..QUALITY CHEMICALS LTD - HUMANPRAZIQUANTEL TABLETSPRAZIQUANTEL600MGCIPLA LTD .-352 KUNDAIM INDL. ESTATE KUNDAIM GOA 403 115INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X100.0 TABLET BOTTLE,1.0X500.0 TABLET BOTTLE
NDA/MAL/HDP/6184UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDATOXIA 60MGETORICOXIB60MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6185DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDDOLOFORTE DENKTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6186UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDATOXIA 90MG F.C. TABLETS ETORICOXIB90MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6188DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDKIMSY MEDS LTDGIZLAN 150IRBESARTAN150MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6189UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDWORMEE-4ALBENDAZOLE400MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/6190 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD-LYTEANHYDROUS GLUCOSE,SODIUM CHLORIDE,TRISODIUM CITRATE DIHYDRATE,POTASSIUM CHLORIDE2.7G + 0.52G + 0.58G + 0.30G/ 200MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X500.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X200.0 ML SACHET
NDA/MAL/HDP/6191AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON AMPOULE TRANEXAMIC ACID500MG/5MLAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT EGYPTPARENTERAL ORDINARY AMPOULES 1.0X6.0X5.0 ML AMPOULE
NDA/MAL/HDP/6192GLAXOSMITHKLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDENO FRUIT SALT ORANGESODIUM BICARBONATE + CITRIC ACID 55.80%W/W + 43.20 %W/W GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBIKENYAORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES 1.0X10.0X5.0 G SACHET,1.0X48.0X5.0 G SACHET
NDA/MAL/HDP/6193SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES.SURGIPHARM (U) LIMITEDCEFTRIAXONE SANDOZCEFTRIAXONE SODIUM1GSANDOZ GMBH-BIOCHEMIESTRA?E 10 A6250 KUNDL, TYROL, AUSTRIA AUSTRIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/6194FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDFENTANYL FRESENIUSFENTANYL CITRATE500MCG/10MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X5.0X10.0 ML AMPOULE
NDA/MAL/HDP/6195FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMORPHINE SULPHATE FRESENIUSMORPHINE SULPHATE10MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/6196FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDMORPHINE SULPHATE FRESENIUSMORPHINE SULPHATE15MG/MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETHSOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/6197UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDNYSTATINNYSTATIN100,000 IUMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAVAGINAL TABLETS 1.0X14.0 PESSARY STRIP
NDA/MAL/HDP/6201SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDAMOXICILLIN AND FLUCLOXACILLIN CAPSULES 500MGAMOXICILLIN TRIHYDRATE + FLUCLOXACILLIN SODIUM250MG + 250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/6202MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSALPRAZ 20PANTOPRAZOLE SODIUM20MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6203HOVID BHD UNITED HEALTHCARE DISTRIBUTORS LTDDEROX-5AMLODIPINE BESILATE5MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6205MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDACICLOVIRACICLOVIR400MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. ? 431136, MAHARASHTRA STATE, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6207S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDGO!GELDICLOFENAC DIETHYLAMINE+METHYL SALICYLATE1.16%W/W + 10%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/6208WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWOCKLAVAMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE200MG/5ML+28.5MG/5MLMEDOPHARM PVT LTD-50, KAYARAMBEDU VILLAGE, GUDUVANANCHERRY - 603202, TAMIL NADU, INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6209 UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDRESPIWEL 4RISPERIDONE4MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6211EXPHAR SASURGIPHARM (U) LIMITEDCLOFAINSPARACETAMOL/DICLOFENAC SODIUM500MG/50MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6213 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOXIN 250 DTAMOXICILLIN TRIHYDRATE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6214UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDVIXIBDEXTROMETHORPHAN HYDROBROMIDE33.33%W/WUNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER
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NDA/MAL/HDP/6222NITIN LIFESCIENCES LTDHEALTHCARE LTD.METOCLOPRAMIDE HYDROCLORIDEMETOCLOPRAMIDE HYDROCLORIDE5MG/MLNITIN LIFESCIENCES LTD..-RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H.INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/6223AUROLABSWASTIK PHARMACEUTICAL LTDAUROPROST- RTLATANOPROST0.005%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIAINDIAOPHTHALMIC DROPS 1.0X2.5 ML BOTTLE
NDA/MAL/HDP/6224NITIN LIFESCIENCES LTDHEALTHCARE LTD.NICLOFENDICLOFENAC SODIUM75MG/3MLNITIN LIFESCIENCES LTD--RAMPUR ROAD PAONTA SAHIB DIST. SIRMOUR (H.P) 173 025INDIAPARENTERAL ORDINARY I M AMPOULES 1.0X10.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/6226IDA FOUNDATIONKIMSY MEDS LTDAMOXICILLIN 500+ CLAVULANIC ACID 125MG BPAMOXICILLIN + CLAVULANIC ACID500MG+125MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6227MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDISONIAZIDISONIAZID300MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. ? 431136, MAHARASHTRA STATE, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/6228CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDACINETAMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/6231GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPP DISPERSIBLEDIHYDROARTEMISININ/PIPERAQUINE20MG/160MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6233 NORVATIS PHARMA SERVICES INC.SURGIPHARM (U) LIMITEDCURAM 250MG/5MLAMOXICILLIN + CLAVULANATE250MG + 62.5MG /5MLSANDOZ GMBH-BIOCHEMIESTRA?E 10 A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES 1.0X60.0 ML VIA
NDA/MAL/HDP/6234GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPP DIHYDROARTEMESININE/ PIPERAQUINE PHOSPHATE40MG/320MGGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXICHINAORAL SOLID ORDINARY OTHER TABLETS 1.0X2.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6235UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDANGINET 160MG VALSARTAN160MGUNITED 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/6236MOONLINK PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL ADVANCEPARACETAMOL + IBUPROFEN + CAFFEINE325 MG + 400 MG + 40 MG FREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404INDIAORAL SOLID ORDINARY CAPSULES 1.0X40.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6237HETERO LABS LTD ABACUS PHARMA (AFRICA) LIMITEDLOPINAVIR/RITONAVIRLOPINAVIR/ RITONAVIR100MG/25MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X120.0 TABLET BOTTLE
NDA/MAL/HDP/6238MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG -AMNEBIVOLOL HYDROCHLORIDE + AMLODIPINE BESILATE5MG + 5MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6239 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATEARTESUNATE60MG BLISS GVS PHARMA LTD- PLOT 73 -76 SILVER INDUSTRIAL ESTATE BHIMPORE DAMAN 396 210 (UT)INDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 1*5 ML AMPOULE OF 0.9%W/V NACL + 1*1 ML OF 5%W/V SODIUM BICARBONATE
NDA/MAL/HDP/6242GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ/PIPERAQUINE PHOSPHATE80MG/640MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6243ABBVIE (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDSURVANTABERACTANT100MG/4MLABBVIE NORTH CHICAGO FACILITY-1401 SHERDAN ROAD NORTH CHICAGO FACILITY ILLINOIS 60064 -4000UNITED STATESTOPICAL EXTERNAL INSTILLATION VIALS 1.0X4.0 ML VIAL,1.0X8.0 ML VIAL
NDA/MAL/HDP/6244CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDCABALINPREGABALIN75MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/6245BIOLOGICAL E. LTDABACUS PHARMA (AFRICA) LIMITEDCOSCOPIN LINCTUSNOSCAPINE + CHLORPHENIRAMINE MALEATE + SODIUM CITRATE + AMMONIUM CHLORIDE7MG+2 MG+ 3.25 MG+28 MG/5 ML.BIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6246CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLUTHERARTEMETHER80MG/MLCIRON DRUGS AND PHARMACEUTICALS PVT. LTD-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIAINDIAPARENTERAL ORDINARY I M AMPOULES 1.0X6.0X1.0 ML AMPOULE
NDA/MAL/HDP/6247MILAN LABORATORIES LTD (INDIA) PVT LTDGITTOES PHARMACEUTICALS LIMITEDMILOXY 250-DTAMOXICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIAINDIAORAL SOLID ORDINARY OTHER TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6248NITIN LIFESCIENCES LTDHEALTHCARE LTD.ARTEMETHERARTEMETHER80MG/MLNITIN LIFESCIENCES LTD..-RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H.INDIAPARENTERAL ORDINARY AMPOULES 1.0X6.0X1.0 ML AMPOULE
NDA/MAL/HDP/6249KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL METRONIDAZOLE -200 TABLETSMETRONIDAZOLE200MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6250REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.ROCIP EYE DROPSCIPROFLOXACIN HYDROCHLORIDE3MG/MLREMINGTON PHARMACEUTICAL INDUSTRIES (PVT) LTD-18 KM MULTAN ROAD LAHORE 53800 PAKISTANPAKISTANOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6251TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TORGABALIN 75PREGABALIN75MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6252TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TORGABALIN 150PREGABALIN150MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6256HOVID BHD (IPOH SITE)UNITED HEALTHCARE DISTRIBUTORS LTDAZIMAX- 250AZITHROMYCIN DIHYDRATE250MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X6.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6257JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDEDURANTRILPIVIRINE25MGJANSSEN CILAG S.P.A-VIA C.JANSSEN, BORGOITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/6264ACINO PHARMA AGGOODMAN INTERNATIONAL LTDPARACONICA 1000 MG IVPARACETAMOL10MG/MLS.M FARMACEUTICI SRL-ZONA INDUSTRIALE, 85050 TITO-POTENZA (PZ) ITALY ITALYPARENTERAL ORDINARY I V VIALS 1.0X100.0 ML VIAL
NDA/MAL/HDP/6267DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDTRAMADOL DENK 50TRAMADOL HYDROCHLORIDE50MGLOSAN PHARMA GMBH- OTTO-HAHN-STR 13 79395 NEUENBURGGERMANYORAL SOLID ORDINARY EFFERVESCENT TABLETS 1.0X10.0 TABLET BOTTLE
NDA/MAL/HDP/6270MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDFEBUMAC 80FEBUXOSTAT80MGMACLEODS PHARMACEUTICALS LTD - - VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA 174101 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6295 RANBAXY LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDLIRAPYN 75MGPREGABALIN75MGRANBAXY LABORATORIES LTD-PAONTA SAHIB, DISTRICT ? SIRMOUR, HIRMACHAL INDIAORAL SOLID ORDINARY CAPSULES 1.0X4.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/6299AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLANGEM 5OLANZAPINE5MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6300 GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMOXICILLINAMOXICILLIN250MGSINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINACHINAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6301AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLANGEM 10OLANZAPINE 10MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6305YELURI FORMULATIONS PVT LTDESCORTS PHARMACEUTICALS LIMITEDELMOX-CV 375AMOXICILLIN TRIHYDRATE +CLAVULANATE POTASSIUM 250MG+125MGYELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6 IDA BOLLARAM,MEDAK DIST.502325, TELANGANA,INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X5.0 TABLET BLISTER
NDA/MAL/HDP/6310ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LTDZIMCOX 100CELECOXIB100MGZIM LABORATORIES LTD. B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441 501, DIST. NAGPUR, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULE1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6314YELURI FORMULATIONS PVT LTDESCORTS PHARMACEUTICALS LIMITEDELMOX-CV 625AMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM 500MG+125MGYELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6 IDA BOLLARAM,MEDAK DIST.502325, TELANGANA,INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X5.0 TABLET BLISTER
NDA/MAL/HDP/6315SQUARE PHARMACEUTICALS LTD.PABNA UNITGAMA PHARMACEUTICALS (U) LIMITEDACE SYRUP, 100MLPARACETAMOL120MG/5MLSQUARE PHARMACEUTICAL LIMITED (PABNA UNIT)-SQUARE ROAD, SALGARIA PABNA-6600 BANGLADESHBANGLADESHORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6316SQUARE PHARMACEUTICALS LTD.PABNA UNITGAMA PHARMACEUTICALS (U) LIMITEDOSMOLAX LACTULOSE3.40G/5MLSQUARE PHARMACEUTICAL LIMITED (PABNA UNIT)-SQUARE ROAD, SALGARIA PABNA-6600 BANGLADESHBANGLADESHORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6317YELURI FORMULATIONS PVT LTDESCORTS PHARMACEUTICALS LIMITEDELMOX-CV L000AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM875MG + 125MGYELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6 IDA BOLLARAM,MEDAK DIST.502325, TELANGANA,INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X5.0 TABLET BLISTER,1.0X3.0X5.0 TABLET BLISTER
NDA/MAL/HDP/6322CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDCLAVACE 1000 MG AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM875MG + 125MGALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6325LEBEN LABORATORIES PVT. LTD.ANDYCO PHARMACY (UGANDA) LTDPZQ TABLETPRAZIQUANTEL600MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/6337LIFEPHARM FZEAIVEEN (U) LTD - WILSON ROADGASTREX SIMETHICONE42MGLIFEPHARMA FZE - -JEBEL ALI FREE ZONE, PLOT NO. MO 0502, P.O. BOX 17404, DUBAI, UAEUNITED ARAB EMIRATESORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6339EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOXY-POLOXYTETRACYCLINE HCL + POLYMYXIN B SULPHATE5MG+10000IU/GEGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY ? INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPTEGYPTOPHTHALMIC OINTMENTS 1.0X5.0 G TUBE
NDA/MAL/HDP/6340LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDAXYLIN CAPSULESAMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM250MG +250 MG LABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6341MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDROSUMAC 20ROSUVASTATIN CALCIUM 20MGMACLEODS 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 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/6344S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDLACTEASELACTULOSE3.35G/5MLS KANT HEALTHCARE LIMITED. PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100 ML BOTTLE
NDA/MAL/HDP/6345SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDMAGNABIOTIC 600MG VAILAMOXYCILLIN SODIUM/ CLAVULANATE POTASSIUM500MG/100MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/6348ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDCOMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BPSODIUM LACTATE SOLUTION +SODIUM CHLORIDE + CALCIUM CHLORIDE + POTASSIUM CHLORIDE 0.533 GM +0.600 GM + 0.027G+ 0.040 GM/100ML ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/6349BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATE-120ARTESUNATE120MGBLISS INDASI LIFE SCIENCE PVT.LTD. PLOT NO. 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN (UT), 396210 - INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON + 1X10ML 0.9%W/W SODIUM CHLORIDE SOLUTION AMPOULE + 1X2ML 5.0%W/W SODIUM BICARBONATE SOLUTION AMPOULE
NDA/MAL/HDP/6354EXPHAR SA.SURGIPHARM (U) LIMITEDTIMOSOL ?TIMOLOL MALEATEO.5%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6360 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDETOCOXX 90MGETORICOXIB90MG SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6361S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDNYSTATINNYSTATIN1,00,000 I.U/MLS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARATINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/6363AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMF-DAY 850METFORMIN HYDROCHLORIDE850MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X14.0 TABLET BLISTER
NDA/MAL/HDP/6366BEXIMCO PHARMACEUTICALS LIMITED.ABACUS PHARMA (AFRICA) LIMITEDODYCIN EYE DROPSMOXIFLOXACIN HYDROCHLORIDE5MG/ML"BEXIMCO PHARMACEUTICALS LTD-126 KATHALDIA, AUCHPARA, TONGI-1711, GAZIPUR." BANGLADESHOPHTHALMIC DROPS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/6367AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFINAGEN1FINASTERIDE1 MGAUROBINDO PHARMA LIMITED, UNIT ? III-SURVEY NO.:113 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6368 SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDETOCOXX 120MGETORICOXIB120MG SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6370IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITED IVYCROM EYE DROPSSODIUM CROMOGLYCATE2%W/VIVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE, LR NO.18474/84, ATHI RIVER,KENYA KENYAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/6372ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDIVYTIMOL EYE DROPSTIMOLOL MALEATE0.25%W/VIVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE, LR NO.18474/84, ATHI RIVER,KENYA KENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6374LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDPREDLEB-5 DTPREDNISOLONE5MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X20.0 TABLET BLISTER
NDA/MAL/HDP/6377REGAL PHARMACEUTICALS LTD REGAL PHARMA U LIMITEDEPHICOL CAPSULESCHLORPHENIRAMINE MALEATE+ PARACETAMOL+ CAFFEINE ANHYDROUS+ PHENYLEPHRINE HCL 2MG+500 MG+30 MG+5MGREGAL PHARMACEUTICALS LTD..-PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKAKENYAORAL SOLID ORDINARY CAPSULES 1.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/6380SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDMAGNABIOTIC 1200MG VIAL AMOXICILLIN + CLAVULANIC ACID1000MG+120MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPTEGYPTPARENTERAL ORDINARY DRY VIALS 1.0X1.2 G VIAL
NDA/MAL/HDP/6382AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMF-DAY 500METFORMIN TABLETS BP 500MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X14.0 TABLET BLISTER
NDA/MAL/HDP/6383EXPHAR SA.SURGIPHARM (U) LIMITEDEXXIBCELECOXIB200MGGRACURE PHARMACEUTICALS LIMITED -E- 1105, RIICO INDUSTRIAL AREA, PHASE-III BHIWADI, PIN-301019 DIST. ALWAR, RAJASTHAN, INDIINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6385KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKPI HEALTHCARE LIMITEDAMOXIKID-250AMOXICILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X10.0 TABLET STRIP
NDA/MAL/HDP/6386 STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDJUSDEE 60K GRANULESCOLECALCIFEROL60000 IUSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X8.0X1.0 G SACHET
NDA/MAL/HDP/6388IPCA LABORATORIES LTD SURGIPHARM (U) LIMITEDRAPICLAV 250 DTAMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE250MG + 62.5MGIPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARATINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X5.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6389ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDMETRONIDAZOLE BPMETRONIDAZOLE0.5%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6392AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDMET XL 50METOPROLOL SUCCINATE50 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6396NVS KENYA LTD SURGIPHARM (U) LIMITEDLETROZOLE 2.5LETROZOLE2.5MGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6397MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDINDOSUPP 100INDOMETHACIN100 MGMERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/6399MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDBISUPP 10BISACODYL10 MGMERIDIAN ENTERPRISES PVT. LTD PLOT 418, G.I.D.C. KABILPORE, NAVSARI ? 396 424 - GUJARAT - INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0SUPPOSITORY STRIP
NDA/MAL/HDP/6400MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDFENSUPP-100DICLOFENAC SODIUM 100MGMERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/6401MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDSUPPOL 250 SUPPOSITORIESACETAMINOPHEN 250MGMERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE,NAVSARI 396424 GUJARAT,INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/6404 STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDSTEDNAC GEL ACECLOFENAC + LINSEED OIL + METHYL SALICYLATE1.5%W/W + 3.0W/W +10.0%W/WSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/6405 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLOPRAZ CLOPIDOGREL BISULFATE 75MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6407 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDZIMCOX 200 CELECOXIB 200 MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6411BLISS GVS PHARMA LTDDELMAW ENTERPRISES LTDABTHER-150 INJECTIONALPHA BETA ARTEMETHER120MG/2MLBLISS INDASI LIFE SCIENCE PVT.LTD. PLOT NO. 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN (UT), 396210 - INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X3.0X2.0 ML AMPOULE
NDA/MAL/HDP/6412 PHARCO PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBUCCAZOLE ORAL GELMICONAZOLE 2%W/WPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL TOPICAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/6418KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKPI HEALTHCARE LIMITEDAZOX 250AZITHROMYCIN DIHYDRATE250MGTHE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY.-UM-AL-AMAD/PLANT ( RAZI ).P.O.BOX 151 UM-AL-AMAD 16197 JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6419TWENTY FIRST CENTURY PHARMACEUTICALS PVT. LTDMETRO PHARMACEUTICALS LTDCLINICEF CVCEFIXIME + POTASSIUM CLAVULANATE200MG + 125MGTWENTY FIRST CENTURY PHARMACEUTICALS PVT LIMITED UNIT ? II, KHASRA NO.282, NALHERI DEHVIRAN, PUHANA ? IQBALPUR ROAD, ROORKEE ? 247 668. HARIDWAR DIST. (UTTARAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM COATED TABLETS1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6421ALEMBIC PHARMACEUTICALS LIMITED.GITTOES PHARMACEUTICALS LTDTELLY-HTELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6422INTERNATIONAL ORGANIZATION FOR MIGRATIONAIVEEN (U) LIMITEDEMADONONDANSETRON4MGCORONA REMEDIES PVT LTD--VILLAGE JATOLI,POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. OLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6426ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDSODIUM CHLORIDE INTRAVENOUS INFUSION BPSODIUM CHLORIDE0.9%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/6431BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDBRUMOX 125AMOXICILLIN TRIHYDRATE125MG/5MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6433BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDFICYC CREAMACICLOVIR5%W/WBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/6435BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDFIMABUTE 200CEFIXIME TRIHYDRATE200MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6436GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDMOXAFMOXIFLOXACIN HYDROCHLORIDE 400 MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/6437MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDPILORECTHYDROCORTISONE ACETATE +LIDOCAINE +ZINC OXIDE +ALLANTOIN0.25%W/W+3%W/W+5%W/W+0.5%W/WMERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C., KABILPORE, NAVSARI GUJARAT,INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X1.0X6.0 SUPPOSITORY STRIP
NDA/MAL/HDP/6439MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDLIZOMAC 600LINEZOLID 600MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/6440UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCEFIWEL 400CEFIXIME TRIHYDRATE400MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6441ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDOFLOXACIN INTRAVENOUS INFUSIONOFLOXACIN0.2%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6442 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDAZITO SUSPENSIONAZITHROMYCIN DIHYDRATE200 MG/5ML ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/6444 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCEFRAZ 100CEFIXIME TRIHYDRATE100MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6447BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDAZIBRU 500AZITHROMYCIN DIHYDRATE500MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6448EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIZOLONE-DEPOT 40 MG/ 1 ML VIALMETHYLPREDNISOLONE ACETATE 40 MG/ MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPTEGYPTPARENTERAL ORDINARY VIALS 1.0X1.0X1.0 ML VIAL
NDA/MAL/HDP/6449 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESGAMA PHARMACEUTICALS (U) LIMITEDDESLORAT SYRUPDESLORATIDINE0.5MG/MLEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6455BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDFICYC TABLETSACYCLOVIR200MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6456ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDGLUCOSE INTRAVENOUS INFUSION BP (5% W/V) GLUCOSE ANHYDROUS 5%W/V ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/6457AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMOXIWAR 400MOXIFLOXACIN HYDROCHLORIDE400MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X5.0 TABLET BLISTER
NDA/MAL/HDP/6462ABACUS PHARMA (A) LTDABACUS PHARMA (AFRICA) LIMITEDAMOXYN-500AMOXICILLIN TRIHYDRATE500MGREYOUNG PHARMACEUTICAL CO., LTD. NO.6 ERLANGSHAN ROAD,YIYUAN COUNTY, SHANDONG PROVINCE, P.R. CHINACHINAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6465MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDNEUROGAB 75PREGABALIN 75MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIA INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6466S KAGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDNYSTATIN ORAL TABLETS USP 500,000 I.U.NYSTATIN500,000IUS KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6467GULF PHARMACEUTICAL INDUSTRIES "JULPHAR"GOODMAN INTERNATIONAL LTDCLOFENDICLOFENAC SODIUM 12.5MGGULF PHARMACEUTICAL INDUSTRIES "JULPHAR" P.O. BOX 997 AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAH, U.A.EUNITED ARAB EMIRATESRECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/6468 CIRON DRUGS & PHARMACEUTICAL PVT LTDROYAL PHARMA 2011 LIMITEDCIROLAZINE HYDRALAZINE HYDROCHLORIDE20MG/ML CIRON DRUGS & PHARMACEUTICAL PVT LTD -1, PRABHAT NAGAR, GROUND FLOOR, JOGESHWARI (W), MUMBAI -400 102. INDIA INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/6469GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDJUSPRIN 81 E/C TABLETSASPIRIN81MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X20.0 TABLET BLISTER
NDA/MAL/HDP/6470AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMF-DAY 1000METFORMIN HYDROCHLORIDE1000MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6471GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDCEFUZIME 500CEFUROXIME AXETIL500MGGULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.EUNITED ARAB EMIRATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6475GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDMOXAL SUSPENSIONALUMINIUM HYDROXIDE +MAGNESIUM HYDROXIDE405 MG+100 MG/ 5MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/6476EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIZOLONE-DEPOTMETHYLPREDNISOLONE80MG/2MLEGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY ? INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPTEGYPTPARENTERAL RETARD VIALS 1.0X1.0X2.0 ML VIAL
NDA/MAL/HDP/6478GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDRANTAG INJECTIONRANITIDINE HYDROCHLORIDE50MG/2MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/6479SWISS PARENTERALS PVT. LTD.ROYAL PHARMA 2011 LIMITEDTRAMADOL HYDROCHLORIDE INJECTION 100MG/2MLTRAMADOL HYDROCHLORIDE100MG/2MLSWISS 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/6481GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDMOXAL PLUS CHEWABLE TABLETSDRIED ALUMINIUM HYDROXIDE GEL+MAGNESIUM HYDROXIDE+SIMETHICONE 200MG+200MG+25MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6483GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDMOXAL II SUSPENSIONALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE 215MG+80MG/5MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6485GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDCEFUZIME 750CEFUROXIME SODIUM 750MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA, P.O.BOX: 997, RAS AL KHAIMAH, U.A.E. UNITED ARAB EMIRATESPARENTERAL ORDINARY DRY VIALS 1.0X750.0 MG VIAL
NDA/MAL/HDP/6488GUILIN PHARMACEUTICAL CO.LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPARACETAMOL INJECTIONPARACETAMOL300MG/2MLGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/6489GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDASCORIL-SFSALBUTAMOL+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN2MG+4MG+100MG/10MLGLENMARK PHARMACEUTICALS LTD-VILLAGE, KISHANPURA, BADDI, NALAGARH ROAD, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6490GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSORVATE OINTMENT CALCITRIOL0.0003% W/WGLENMARK PHARMACEUTICALS LIMITED, AT: (UNIT II)-VILLAGE BHATTANWALA, P.O. RAJPURA, NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH, 174 101, INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X10.0 G TUBE
NDA/MAL/HDP/6491INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDPREGATAS ME 75PREGABALIN +MECOBALAMIN75MG+750MCGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6492 UMEDICA LABORATORIES PVT. LTDGITTOES PHARMACEUTICALS LIMITEDLIDOCAINE INJECTION BP 2%W/VLIDOCAINE HYDROCHLORIDE2%W/VUMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X10.0X2.0 ML VIAL
NDA/MAL/HDP/6495DAFRA PHARMA GMBHLABOREX UGANDA LIMITEDMACROLYN? 500 MG FILM COATED TABLETS AZITHROMYCIN DIHYDRATE500MGDEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6496ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEUROKEM 150PREGABALIN150MGALKEM LABORATORIES LTD--167/2, MAHATMA GANDHI UDYOG NAGAR DABHEL, AMALIYA, DAMAN(UT) 396 210 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6498MICRO LABS LIMITEDLABOREX UGANDA LIMITEDAMOXICILLIN DISPERSIBLE TABLETS 250 MGAMOXICILLIN TRIHYDRATE250MGMICRO LABS LIMITED PLOT -NO. 16, VEERASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE ? 560 100. KARNATAKA, INDIAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/6501PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAARTROGYL 200 TABLETMETRONIDAZOLE200MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6505 ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDCO-ARLUMETHER FORTEARTEMETHER + LUMEFANTRINE80MG + 480MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6507 IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDZITRAM PACETAMINOPHEN + TRAMADOL HYDROCHLORIDE325MG + 37.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1, VILLAGE ATHAL, SILVASSA-396230, DADRA AND NAGAR HAVELI, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6509 ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDASPYROX PIROXICAM20MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6512AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDAXACIPCIPROFLOXACIN200MG/100MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6520 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDVOMIKIND-MD 8ONDASENTRON8MGMANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6523EXPHAR SA.SURGIPHARM (U) LIMITEDFLEXDOLIBUPROFEN+METHOCARBAMOL200MG+500MGGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6529MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDPRAZIQUANTEL TABLETS 600 MGPRAZIQUANTEL600MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6532MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDBUNASE 200BUDESONIDE200MCG / ACTUATIONOXALIS LABS--VILLAGE THEDA,P.O.LODHIMAJRA ,TEHSIL BADDI,DIST .SOLAN (HIMACHAL PRADESH) - 174101 INDIAINDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X1.0 CANNISTER CARTON
NDA/MAL/HDP/6534INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDREXIDIN CHLORHEXIDINE GLUCONATE0.2%W/VINDOCO REMEDIES LTD, B-20,-B-20 MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL TOPICAL LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6537EXPHAR SASURGIPHARM (U) LIMITEDCARBOSOL CARMELLOSE SODIUM0.5%W/VAHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA) TEL: +91-1493-305300 (30 LINES) FAX: +91-1493-221045, 305345 INDIAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/6540GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDVANCOLONVANCOMYCIN HYDROCHLORIDE1GGULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.EUNITED ARAB EMIRATESPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/6541GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDDIALON 1000 MG METFORMIN HYDROCHLORIDE1000MGGULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.EUNITED ARAB EMIRATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/6547GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDAMYDRAMINE PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL7MG+28.5MG+0.55 MG/5 MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/6548 CIRON DRUGS & PHARMACEUTICAL PVT LTDROYAL PHARMA 2011 LIMITEDCIROPAIN GEL DICLOFENAC DIETHYLAMINE BP1%W/WCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506INDIATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/6560GULF PHARMACEUTICAL INDUSTRIES "JULPHAR"GOODMAN INTERNATIONAL LTDCEFUZIME 250MGCEFUROXIME AXETIL 250MGGULF PHARMACEUTICAL INDUSTRIES "JULPHAR" P.O. BOX 997 AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAH, U.A.EUNITED ARAB EMIRATESORAL SOLID ORDINARY FILM COATED TABLETS1.0X2.0X5.0 TABLET BLISTER
NDA/MAL/HDP/6561GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDRISEKOMEPRAZOLE20MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY CAPSULES 1.0X14.0 CAPSULE BOTTLE
NDA/MAL/HDP/6568PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDPINNADIP 50 TABLETDICLOFENAC50MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6573MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDEFAVIRENZ TABLETS USP 400MGEFAVIRENZ400MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/6574MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDARCHIFARMEROPENEM1GMEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUSCYPRUSPARENTERAL ORDINARY DRY VIALS 1.0X10.0X1.0 G VIAL
NDA/MAL/HDP/6595RAVIAN LIFE SCIENCE PVT. LTDROYAL PHARMA 2011 LIMITEDMOLURAVLEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MG RAVIAN LIFE SCIENCE PVT LTD-PLOT NO.34,SECTOR-8A,IIE,HARIDWAR-249403, UTTARKHANDINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6610 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDVOMIKINDONDANSENTRON HYDROCHLORIDE2MG/MLMANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESHINDIAPARENTERAL ORDINARY AMPOULES 1.0X4.0X2.0 ML AMPOULE
NDA/MAL/HDP/6612AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAPRAZOLE PLUS-20OMEPRAZOLE + SODIUM BICARBONATE20MG/6G + 1680MG/6GAJANTA PHARMA LTD.-B-4-5-6, MIDC PAITHAN, AURANGABADINDIAORAL SOLID ORDINARY POWDERS 1.0X20.0X6.0 G SACHET
NDA/MAL/HDP/6613MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-40OLMESARTAN MEDOXOMIL40MGMICRO 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/6614MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINECEFUROXIME SODIUM1.5MGMEDOCHEMIC LTD-1-10 ASTRONAFTON & CONSTANTINOPOLEOS 3505 LIMASSOLCYPRUSPARENTERAL ORDINARY VIALS 1.0X10.0 VIAL CARTON
NDA/MAL/HDP/6615UNEED GLOBAL GROUP LIMITEDABACUS PHARMA (AFRICA) LIMITEDPINPAC 50DICLOFENAC SODIUM50MGMAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6616SHIN POONG PHARMACEUTICALS CO.LTDBOOTS PHARMACEUTICALS LIMITEDPYRAMAXPYRONARIDINE TETRAPHOSPHATE + ARTESUNATE180MG + 60MGSHIN POONG PHARMA.CO.LTD-434-4 MOKNAE-DONG ANSAN-SI,KYUGGI DO KOREASOUTH KOREAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X9.0 TABLET BLISTER
NDA/MAL/HDP/6617AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPFLUCHLOROPHENERAMINE + PARACETAMOL + VITAMIN C0.5MG + 120MG + 50MGAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6619ESAPHARMA S.R.L..BYAMAKA PHARMACEUTICAL COMPANY LTDORANVATECLOBETASOL PROPIONATE0.05G/100GESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY ITALYTOPICAL EXTERNAL GELS AND SOLS 1.0X30.0 G TUBE
NDA/MAL/HDP/6620MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET 5MG NEBIVOLOL HYDROCHLORIDE5MGBERLIN-CHEMIE AG-BERLIN-CHEMIE AG GLIENICKER WEG 125 D-12489 BERLINGERMANYORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER
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NDA/MAL/HDP/6622UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCEFIWEL-100 DTCEFIXIME TRIHYDRATE100MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY OTHER TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6623SQUARE PHARMACEUTICALS LTD.PABNA UNITGAMA PHARMACEUTICALS (U) LIMITEDREFINAC SRDICLOFENAC SODIUM100MG SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHORAL SOLID RETARD ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6624SQUARE PHARMACEUTICALS LTD.PABNA UNITGAMA PHARMACEUTICALS (U) LIMITEDCIPROKENCIPROFLOXACIN HYDROCHLORIDE0.3%W/V SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPURBANGLADESHOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6625MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILET PLUS 5/12.5NEBIVOLOL HYDROCHLORIDE + HYDROCHLOROTHIAZIDE5MG + 12.5MGBERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, -) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, BATCH CONTROL) TEMPELHOFER WEG 83 D-12347 BERLIN GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/6627RECKITT BENCKISER HEALTHCARE INTERNATIONALGITTOES PHARMACEUTICALS LIMITEDSTREPSILS HONEY & LEMONMULTI-INGREDIENTMULTI-INGREDIENTRECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED-65 MOO 12,LARD KRABANG-BANGPLEE ROAD, BANGPLEE SAMUTPRAKARAN 10 540, THALANDTHAILANDORAL SOLID ORDINARY LOZENGES 1.0X24.0 LOZENGE PACK,1.0X70.0 LOZENGE PACK
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NDA/MAL/HDP/6630AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTOPRAZ 20PANTOPRAZOLE 20MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6631 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOBURNSILVER SULFADIAZINE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/6632 UMEDICA LABORATORIES PVT. LTDGITTOES PHARMACEUTICALS LIMITEDCIPROFLOXACINCIPROFLOXACIN500MGUMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6633SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDCOLDRILPARACETAMOL + CHLORPHENIRAMINE MALEATE + PSEUDOEPHEDRINE HCL500MG + 30MG + 2MGSHELYS PHARMACEUTICALS LIMITED-PLOT NO. 696, BLOCK NO. 32, MIKOCHENI INDUSTRIAL AREA, NEW BAGAMOYO ROAD, MEWENGE, DAR ES SALAAM, TANZANIA ,BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 425TANZANIA/KENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0X1.0X2.0X10.0 CAPSULE BLISTER
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NDA/MAL/HDP/6640MSN LABORATORIES PVT LTDGOOD DAY PHARMACY LIMITEDSAFETELMI H ( 40/ 12.5)TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/6642UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDDIBETINMETFORMIN HYDROCHLORIDE500MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6645MSN LABORATORIES PVT LTDGOOD DAY PHARMACY LIMITEDSAFETELMI H ( 80/ 12.5)TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6647UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDJOYCLAV -625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG + 125MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6650INDUS LIFE SCIENCES PVT LIMITED PNR PHARMACEUTICALS LIMITEDINTRIAX-S-1CEFTRIAXONE SODIUM+SULBACTAM SODIUM1G+0.5GSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/6651GOOD DAY PHARMACY LIMITEDGOOD DAY PHARMACY LIMITEDCYCLOVEERACICLOVIR5%W/WKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/6652 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLAMIVUDINE +TENOFOVIR DISOPROXIL FUMARATELAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
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NDA/MAL/HDP/6654 PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDLIVOLUK FIBRELACTULOSE + ISPAGHULA HUSK10G + 3.5G/ 15GPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X90.0 G CONTAINER
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NDA/MAL/HDP/6656UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDPLENMOXIMOXIFLOXACIN HYDROCHLORIDE400MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/6660ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDKETAJEXKETAMINE50MG/MLCLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/6662SAKAR HEALTHCARE LIMITEDROYAL PHARMA 2011 LIMITEDDIAPAMDIAZEPAM5MG/MLSAKAR HEALTHCARE PVT LTD --406, SILVER OAKS COMMERCIAL COMPLEX,INDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/6663 PANACEA BIOTEC LTDABACUS PHARMA (AFRICA) LIMITEDSITCOMEUPHORBIA PROSTATA DRY EXTRACT10MG/GPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205INDIATOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/6664SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOX 125 KIDAMOXICILLIN TRIHYDRATE125MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6665REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSALBUMOL SYRUPSALBUTAMOL2MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6666MSN LABORATORIES LTDGOOD DAY PHARMACY LIMITEDNEBIEM 5NEBIVOLOL HYDROCHLORIDE 5MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6667SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOX 250 DTAMOXICILLIN TRIHYDRATE250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA. INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/6668STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDAMPIRONE-250 CAPSULESAMPICILLIN250MGSIMRONE PHARMACEUTICAL INDUSTRIES LTD-DEWAN AND SONS INDUSTRIAL AREA, VECOR PALGHAR INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/6669UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDSUPER WELGRA -100SILDENAFIL CITRATE + DAPOXETINE HYDROCHLORIDE100MG + 60MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/6670AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDMETROSIM-200METRONIDAZOLE200MGAFRICURE 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/6671LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDNOPENASPRIRIN+CAFFEINE350MG+30MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6672STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDMOXIRONE 250 CAPSULESAMOXYCILLINUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/6673ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRIXONE-TZCEFTRIAXONE SODIUM + TAZOBACTAM1000MG + 125MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/6676YSP INDUSTRIES(M) SDN BHDROYAL PHARMA 2011 LIMITEDCASPRINACETYLSALICYLIC ACID100MGYSP INDUSTRIES SND.BHD-LOT 3,5&7 JOLAN P/7 SEC 13,KAWASAN PERINDUSTRIANMALAYSIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 1.0X1.0X30.0 CAPSULE BLISTER
NDA/MAL/HDP/6678BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDTUSQ-DXCHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN HBR + PHENYLEPHRINE2MG/5ML + 15MG/5ML + 5MG/5MLBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010INDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6679BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDWOMIBAN TABLETSALBENDAZOLE400MGBLUE CROSS LABORATORIES LTD-A-12, M.I.D.C AMBAD NASHIK-422010,BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0 TABLET STRIP
NDA/MAL/HDP/6680PHARMEDIC LABORATORIES(PVT) LIMITEDHEALTHCARE LTD.ATELOR TABLETATENOLOL100MGPHARMEDIC LABORATORIES (PVT) LIMITED-16KM MULTAN ROAD,LAHORE-PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X20.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6681UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDWELQUINE LEVOFLOXACIN0.5%W/VAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR, HARIDWAR, UTTARAKHAND INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6682BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDPROCILINFORTIFIED PROCAINE BENZYLPENICILLIN4MUREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON
NDA/MAL/HDP/6685NEON LABARATORIES LTDAIVEEN (U) LIMITEDEVACEFCEFOTAXIME1 GNEON 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/6686DAWA LIMITEDSUPER MEDIC LTDDAWASOLONEPREDNISOLONE5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6688NITIN LIFESCIENCES LTDHEALTHCARE LTD.CAREOCEFCEFTRIAXONE SODIUM1GNITIN LIFESCIENCES LTD..-RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H.INDIAPARENTERAL ORDINARY VIALS 1.0X50.0X1.0 G VIAL
NDA/MAL/HDP/6690SCHERING N.V.SA...SURGIPHARM (U) LIMITEDADVANTAN OINTMENTMETHYLPREDNISOLONE ACEPONATE0.1%W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/6691SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES INC SURGIPHARM (U) LIMITEDAZITHROMYCIN SANDOZAZITHROMYCIN MONOHYDRATE200MG/5MLSANDOZ SRL LTD-LIVEZENI STREET 7A540472 TARGU MURES ROMANIAROMANIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/6692NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDASUNRA 100DEFERASIROX100MGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X5.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6693NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCERTICAN1EVEROLIMUS1MGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY SOLUBLE TABLETS 1.0*6.0*10.0 TABLET BLISTER
NDA/MAL/HDP/6694NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCERTICAN 0.5EVEROLIMUS0.5MGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0*6.0*10.0 TABLET BLISTER
NDA/MAL/HDP/6698COSMOS LTDASTRA PHARMA (U) LIMITEDALBUZOL 400MG TABLETSALBENDAZOLE400MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/6700CACHET PHAMACUITICALS PVT LTD ASTRA PHARMA (U) LIMITEDARTIMEDDICLOFENAC SODIUM50MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6701 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACH-ART DSARTEMETHER / LUMEFANTRINE80MG/ 480MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6703 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHCOLD PLUSPARACETAMOL/ CAFFEINE/ PHENYLEPHRINE/ CHLORPHENIRAMINE500MG/ 30MG/ 5MG/ 2MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X50.0X4.0 TABLET STRIP
NDA/MAL/HDP/6704 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHETCETIRIZINE HCL10MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X5.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6705 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHEWORMMEBENDAZOLE100MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6706 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACH-E-WORMMEBENDAZOLE100MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/6707 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHFERIRON + FOLIC ACID + VITAMIN B1232MG/15ML + 0.5MG/15ML + 7.5MCG/15MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/6708PHARMEDIC LABORATORIES(PVT) LIMITEDHEALTHCARE LTD.CLOMINOL TABLETSCLOMIPHENE50MGPHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6709 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHPARPARACETAMOL500MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6710PHARMEDIC LABORATORIES(PVT) LIMITEDHEALTHCARE LTD.DIABIN TABLETSMETFORMIN500MGPHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6711 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACHPARPARACETAMOL125MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6712 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCACID-OOMEPRAZOLE20MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/6713 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAMETMETOCLOPRAMIDE HYDROCHLORIDE10MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6714SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.HYDRYLLIN SYRUPAMINOPHYLLINE+ AMMONIUM HCL+ DIPHENHYDRAMINE HCL32MG +300MG+8MGSEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/6715 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAZITHROAZITHROMYCIN200MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X15.0 ML BOTTLE
NDA/MAL/HDP/6716NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCATAFLAM 50DICLOFENAC POTASSIUM50MGCATALENT GERMANY EBERBACH GMBH..-GAMMELS BACHERSTRASSE2 GERMANYORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0 CAPSULE BLISTER,1.0X20.0 CAPSULE BLISTER
NDA/MAL/HDP/6717 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCAZITHROAZITHROMYCIN500MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/6718 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDCETPROCYPROHEPTADINE HYDROCHLORIDE2MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6719PHARMEDIC LABORATORIES(PVT) LIMITEDHEALTHCARE LTD.NAPROX-500NAPROXEN SODIUM500MGPHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6720SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCOLESTOPATORVASTATIN20MGLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6722MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDCILZEC 40TELMISARTAN40MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6724MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDCILZEC 80TELMISARTAN80MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6727PHARMEDIC LABORATORIES(PVT) LIMITEDHEALTHCARE LTD.ZYNOL-300MG TABLETALLOPURINOL300MGPHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6728COSMOS LTDASTRA PHARMA (U) LIMITEDCIPROCOS-500 TABLETSCIPROFLOXACIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6729COSMOS LTDASTRA PHARMA (U) LIMITEDCOSCOF 'C' LINCTUSMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE
NDA/MAL/HDP/6730PHARMEDIC LABORATORIES(PVT) LIMITEDHEALTHCARE LTD.CEFOTRIM-1000CEFTRIAXONE1000MGPHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTANPAKISTANPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL + 5 ML AMPOULE OF WATER FOR INJECTION
NDA/MAL/HDP/6731SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES INC SURGIPHARM (U) LIMITEDPIPTAZO 4.5GPIPERACILLIN SODIUM+TAZOBACTAM SODIUM4G+0.5GSANDOZ GMBH-BIOCHEMIESTRA?E 10 A6250 KUNDL, TYROL, AUSTRIA AUSTRIAPARENTERAL ORDINARY DRY VIALS 1.0X4.5 ML VIAL
NDA/MAL/HDP/6732COSMOS LTDASTRA PHARMA (U) LIMITEDCOSCOF EXPECTORANT ORIGINALMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6733PACIFIC PHARMACEUTICALS LTDHEALTHCARE LTD.LOMEXINFENTICONAZOLE2%W/WPACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 1.0X40.0 G TUBE
NDA/MAL/HDP/6734 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDEASCOFBROMHEXIDINE HCL + SALBUTAMOL SULPHATE + GUAIPHENESIN24MG/100ML + 42MG/100ML + 1G/MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6735PACIFIC PHARMACEUTICALS LTDHEALTHCARE LTD.NAPREBENNAPROXEN BETAINE SODIUM10%W/WPACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTANPAKISTANTOPICAL EXTERNAL GELS AND SOLS 1.0X25.0 G TUBE
NDA/MAL/HDP/6736NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDSANDOSTATINOCTREOTIDE ACETATE0.05MGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/6737 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDESENVITGLYCERIN/ ZINC SULPHATE/ SODIUM MOLYBDATE/ MANGANESE CHLORIDE/ LYSINE HCL5.0G/ 263.83MG/ 0.4035MG/ 57.66MG/ 612MGCACHET PHARMACEUTICALSPVT.LTD.--415,SHAH NAHAR,WORLI MUMBAIINDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6738NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDSEEBRI BREEZHALERGLYCOPYRRONIUM BROMIDE50MCGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDLUNG ADMINISTRATION INHALER CAPSULES 1.0X1.0 CANNISTER CARTON + 30 CAPSULE BLISTER
NDA/MAL/HDP/6739PACIFIC PHARMACEUTICALS LTDHEALTHCARE LTD.PACIFIC'S JACK & JILL CHILDREN'S FORMULA DEXTROMETHORPHAN + CHLORPHENIRAMINE10MG + 2MG / 5MLPACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/6740SCHERING N.V.SA...SURGIPHARM (U) LIMITEDTRAVOGEN CREAMISOCONAZOLE NITRATE1%W/WBAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALYITALYTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/6741NVS KENYA LTD SURGIPHARM (U) LIMITEDULTIBRO BREEZHALERINDACATEROL MALEATE+GLYCOPYRRONIUM BROMIDE110MCG+50MCGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDLUNG ADMINISTRATION INHALER CAPSULES 1.0X30.0 CAPSULE BLISTER
NDA/MAL/HDP/6742PACIFIC PHARMACEUTICALS LTDHEALTHCARE LTD.RIFIN FORTE RIFAMPICIN +ISONIAZID+ PYRAZINAMIDE+ETHAMBUTOL 150MG + 75MG+400MG+275MGPACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS 1.0X10.0X8.0 TABLET BLISTER
NDA/MAL/HDP/6744M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDCEFTRIAXONE FOR INJECTIONCEFTRIAXONE1GM.J.BIOPHARM PVT LTD-L-7 MIDC INDUSTRIAL AREA TALOYA NAVI MUMBAIINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/6745PACIFIC PHARMACEUTICALS LTDHEALTHCARE LTD.TYZORIN MOUTH WASHTIBEZONIUM IODIDE0.05G/100MLPACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTANPAKISTANTOPICAL EXTERNAL LIQUIDS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/6746KOPRAN LTD TATA UGANDA LIMITEDFLUPEN-250FLUCLOXACILLIN SODIUM250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6747PACIFIC PHARMACEUTICALS LTDHEALTHCARE LTD.TYZORINTIBEZONIUM IODIDE5MGPACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTANPAKISTANORAL SOLID ORDINARY LOZENGES 1.0X4.0X6.0 LOZENGE STRIP
NDA/MAL/HDP/6748INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDIBUFLAMAR 200IBUPROFEN200MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6749INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDIBUFLAMAR-PIBUPROFEN+PARACETAMOL400MG+500MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6750KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDNYTINNYSTATIN500,000IUKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDAUGANDAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/6751INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDMETCHEK 850METFORMIN850MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6752KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDVITACEEASCORBIC ACID100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6753BLUE CROSS LABARATORIES LIMITEDSTAR PHARMACEUTICALS LTDTUSQ X SYRUPTERBUTALINE+BROMHEXINE+GUAIFENESIN1.25MG+4MG+50MG/5MLBLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6755INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDFLAMARMETHYL NICOTINATE+MEPHENESIN+METHYL SALICYLATE+MENTHOL1%W/W+5%W/W+8%W/W+2%W/WINDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722INDIATOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/6756BETA HEALTHCARE BETA HEALTHCARE UGANDA LIMITEDFEVERIX TOTO SUSPENSIONPARACETAMOL120MG/5MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/6757INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDOSTEOFLAMDICLOFENAC SODIUM50MGINDOCOS REMEDIES LTD-L-14 VERNA INDUSTRIAL AREA VENA GOA-403722INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6758ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDADCO-NAPAMOLPARACETAMOL500MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6759ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDBETAPYNPARACETAMOL+CODEINE PHOSPHATE+DOXYLAMINE+CAFFEINE450 MG+10 MG+5 MG+50 MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS 2.0X9.0 TABLET BLISTER,6.0X9.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER
NDA/MAL/HDP/6760MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDRIFAMPACIN/ ISONIAZID DISPERSIBLE TABLETRIFAMPACIN + ISONIAZID60 MG + 30 MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6761ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDDAWANOL TABLETSPARACETAMOL+ACETYLSALICYLIC ACID+CAFFEINE200MG+300MG+30MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CARTON
NDA/MAL/HDP/6762COSMOS LTDASTRA PHARMA (U) LIMITEDFLUCOLD CAPSULESMULTIINGREDIENTNACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6763ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDCOMPRAL HEADACHE TABLETSPARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS100MG+400MG+130MGADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X48.0X2.0 TABLET STRIP
NDA/MAL/HDP/6765 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDIBUCACH 200IBUPROFEN200MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6766ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDLOCAINE ALIDOCAINE HYDROCHLORIDE+ADRENALINE21.33MG/1.8ML + 0.025MG/1.8MLPHARMA-Q (PTY) LTD -50 COMMANDO ROAD INDUSTRIAL WEST, JOHANNESBURGSOUTH AFRICAPARENTERAL ORDINARY CARTRIDGES 1.0X100.0X1.8 ML CARTRIDGE
NDA/MAL/HDP/6767ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDMEDI-KEEL ABENZOCAINE+CETYLPYRIDINIUM CHLORIDE12MG+1.5MGUNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ? 396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X8.0 LOZENGE BLISTER
NDA/MAL/HDP/6768ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDMEDI-KEEL A BLACKCURRANTBENZOCAINE+CETYLPYRIDINIUM CHLORIDE12MG+1.5MGUNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ? 396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X8.0 LOZENGE BLISTER
NDA/MAL/HDP/6769ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDMEDI-KEEL A HONEY & LEMONBENZOCAINE+CETYLPYRIDINIUM CHLORIDE12MG+1.5MGUNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ? 396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X8.0 LOZENGE BLISTER
NDA/MAL/HDP/6771 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIFLUVIDFLUCONAZOLE150MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY CAPSULES 1.0X4.0 CAPSULE BLISTER
NDA/MAL/HDP/6772ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITEDPIOSAFE 30PIOGLITAZONE HCL30MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6773ARISTO PHARMACEUTICALS PVT LTD NORVIK ENTERPRISES LIMITED ACECLOACECLOFENAC100MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6774KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL FLEMIN EXPECTORANTDIPHENHYDRAMINE HYDROCHLORIDE +AMMONIUM CHLORIDE12.5MG+130MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6775IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYSOLONEPREDNISOLONE ACETATE1%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC SUSPENSIONS 1.0X5.0 ML VIAL
NDA/MAL/HDP/6776LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITED M-FORLIN 500METFORMIN500MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6777KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL FUSIDIC ACIDFUSIDIC ACID2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE,1.0X15.0 G TUBE
NDA/MAL/HDP/6778KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDAXCEL IBUPROFENIBUPROFEN100MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/6780IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYTIMOLTIMOLOL MALEATE0.5%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6781IND-SWIFT LTDTATA UGANDA LIMITEDNETAZOX-500NITAZOXANIDE500MGIND-SWIFT LIMITED-INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6782IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYXOLOLBETAXOLOL HYDROCHLORIDE0.5%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6783ABBVIE (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFORANEISOFLURANE99.9%W/VAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOMUNITED KINGDOMOTHER SYSTEMIC LIQUID INHALATIONS 1.0X250.0 ML BOTTLE
NDA/MAL/HDP/6784IVEE INFUSIONS EPZ LTDASTRA PHARMA (U) LIMITEDIVYZOXANCIPROFLOXACIN HYDROCHLORIDE0.3%W/VIVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBIKENYAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6785IND-SWIFT LTDTATA UGANDA LIMITEDNETAZOX DTNITAZOXANIDE200MGIND-SWIFT LIMITED-INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6787IND-SWIFT LTDTATA UGANDA LIMITEDNETAZOXNITAZOXANIDE100MG/5MLIND-SWIFT LIMITED-INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/6788SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDROYAL VIT GMULTI-INGREDIENTSMULTI-INGREDIENTS SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, S" OF OCTOBER CITY, EGYPT. PO. BOX 43, OCTOBER CITY. POSTAL CODE NO.12566 EGYPTORAL SOLID ORDINARY CAPSULES 1.0X2.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6789STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDDICLOSALDICLOFENAC SODIUM75MG/3MLSTRIDES ARCOLAB LTD. -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUKINDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X5.0X3.0 ML AMPOULE
NDA/MAL/HDP/6790MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIMZEROMEPRAZOLE + DOMPERIDONE20MG + 30MGINVENTIA HEALTHCARE PVT. LTD-FI ? FI /1 ADDITIONAL AMBERNATH, M.I.D.C. AMBERNATH (EAST) ? 421 506, DIST. THANE, INDIA INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/6792JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDPREZISTADARUNAVIR400MGJANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET CONTAINER
NDA/MAL/HDP/6793 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDNESTAMINOPHYLLINE100MGCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/6794HETERO LABS LTD ABACUS PHARMA (AFRICA) LIMITEDZOLIDLINEZOLID600MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/6796SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANCEPH DSCEPHALEXIN125MG/5MLSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6797MARTINDALE PHARMACEUTICALS LTD LABOREX UGANDA LIMITEDPETHIDINE INJECTIONPETHIDINE100MG/2MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/6806F. HOFFMANN- LA ROCHELABOREX UGANDA LIMITEDRECORMONEPOETIN BETA2000 IU/0.3MLROCHE DIAGNOSTICS GMBH MANNHEIM -SANDHOFER STRABE 116, 68305, MANNHEIMGERMANYPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X6.0X0.3 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/6807GLAXOSMITHKLINE LTDERIS LTDAUGMENTIN ESAMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE600MG + 42.9MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6808ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGLYGEN-500METFORMIN HYDROCHLORIDE500MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6810GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDCERVARIXHUMAN PAPILLOMA VIRUS VACCINE (RDNA)TYPE 16 L1 PROTEIN + TYPE 18 L1 PROTEIN + 3-0-DESACYL-4'MONOPHOSPHORYL LIPID A(MPL)GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X10.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE) + A 25 GAUGE NEEDLE
NDA/MAL/HDP/6811DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDCOVALSAR- DENK 160/12.5VALSARTAN + HYDROCHLOROTHIAZIDE160MG +12.5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6812ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDNOFLOXNORFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191UGANDAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/6813DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDCOVALSAR- DENK 320/12.5VALSARTAN + HYDROCHLOROTHIAZIDE320MG +12.5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6814DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDCOVALSAR- DENK 80/12.5VALSARTAN + HYDROCHLOROTHIAZIDE80MG +12.5MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6815ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCROM EYE DROPSSODIUM CROMOGLYCATE2%W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO UGANDAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/6817DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDLETROZOLE DENK 2.5LETROZOLE2.5MGHAUPT PHARMA M?NSTER GMBH-SCHLEEBR?GGENKAMP 15 48159 M?NSTER GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6818SANOFI PASTEURLABOREX UGANDA LIMITEDIMOVAX POLIOPOLIO VIRUS; (MAHONEY) TYPE 1- INACTIVE + (MEF-1) TYPE 2- INACTIVE + (SAUKETT) TYPE 3-INACTIVE40 D + 8D + 32 D ANTIGEN UNITS/ 0.5ML SANOFI PASTEUR-M?RIEUX 69280 MARCY L?ETOILEFRANCEPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL
NDA/MAL/HDP/6820ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABBORI EAR DROPSBORIC ACID1.83%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOTIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/6821LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITEDMAGNESIUM SULPHATE INJECTIONMAGNESIUM SULPHATE50%W/VMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND UNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X10.0 ML AMPOULE
NDA/MAL/HDP/6823LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITEDEPHEDRINE HYDROCHLORIDEEPHEDRINE HYDROCHLORIDE30MG/MLMARTINDALE PHARMACEUTICALS .-ROMFORD ESSEX RM3 8UG UKUNITED KINGDOMPARENTERAL ORDINARY AMPOULES 1.0X2.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/6826MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINC SULFATEZINC SULFATE20MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. ? 431136, MAHARASHTRA STATE, INDIA. INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6832PFIZER LABORATORIES LTDERIS LTDNIMENRIXMENINGOCOCCAL POLYSACCHARIDE SEROGROUPS A, C, W-135 & Y CONJUGATE VACCINE1 DOSE (0.5ML) CONTAINS 5MCG OF POLYSACCHARIDE FOR NEISSERIA MENINGITIDIS SEROGROUPS A,C,W-135 & YGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS 1.0X1.0 DOSE VIAL + 1 PRE-FILLED SYRINGE
NDA/MAL/HDP/6833DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDON.SENTRON-DENK 8MG ODTONDANSETRON8MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/6834GLAXO SMITH KLINE LTDERIS LTDRELVAR ELLIPTA 100/25FLUTICASONE FUROATE + VILANTEROL100MCG + 25MCGGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UKUNITED KINGDOMLUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X1.0 CANNISTER CARTON
NDA/MAL/HDP/6836GLAXO SMITH KLINE LTDERIS LTDRELVAR ELLIPTA 200/25FLUTICASONE FUROATE + VILANTEROL200MCG + 25MCGGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UKUNITED KINGDOMLUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X30.0 DOSE CANNISTER
NDA/MAL/HDP/6837ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEL KITCLARITHROMYCIN + METRONIDAZOLE + PANTOPRAZOLE SODIUM SESQUIHYDRATE250MG + 400MG +40MGTHE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET STRIP
NDA/MAL/HDP/6838TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.MEMENTOR 10MEMANTINE HYDROCHLORIDE10MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-282721INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6840MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.LIPINORMATORVASTATIN CALCIUM TRIHYDRATE20MGMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/6843CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.FYTOBACTCEFOPERAZONE + SULBACTAM0.5 G + 0.5 GCADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATEINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/6844IDA FOUNDATIONJOINT MEDICAL STORE (UPMB - UCMB)BENZOIC ACID + SALICYLIC ACIDBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVIINDIATOPICAL EXTERNAL OINTMENTS 1.0X40.0 G TUBE,1.0X800.0 G CONTAINER
NDA/MAL/HDP/6845CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.FYTOBACT 2GSULBACTAM SODIUM + CEFOPERAZONE SODIUM1G + 1GCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X2.0 G VIAL
NDA/MAL/HDP/6857BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDBRUCIPRO TABLETS CIPROFLOXACIN500MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6859BRAWN LABORATORIES LTDROYAL PHARMA 2011 LTDBRUVEL-500 TABLETSLEVOFLOXACIN HEMIHYDRATE500MGBRAWN LABORATORIES LTD. ADDRESS :13, NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001, HARYANA - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1X10X10 TABLET BLISTER
NDA/MAL/HDP/6862BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDDITS GELDICLOFENAC DIETHYLAMINE1%W/WBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIATOPICAL EXTERNAL GELS AND SOLS 1.0X15.0 G TUBE,1.0X10.0 G TUBE
NDA/MAL/HDP/6865BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDDITS INJECTIONDICLOFENAC SODIUM25MG/MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X3.0 ML AMPOULE
NDA/MAL/HDP/6870BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDHYDROSONE 100MGHYDROCORTISONE SODIUM SUCCINATE100MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X5.0 ML VIAL
NDA/MAL/HDP/6871BRAWN LABORATORIES LTDROYAL PHARMA 2011 LTDVIVAX 100SILDENAFIL CITRATE100MGBRAWN LABORATORIES LTD. ADDRESS :13, NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001, HARYANA - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1X1X4 TABLET BLISTER
NDA/MAL/HDP/6872BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDNETRACORTIL EYE/EAR SUSPENSIONOXYTETRACYCLINE HYDROCHLORIDE +HYDROCORTISONE ACETATE+POLYMYXIN B SULPHATE 10MG+5MG+10000I.UBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAOPHTHALMIC SUSPENSIONS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/6873BRAWN LABORATORIES LTDROYAL PHARMA 2011 LTDROXITHIN TABLETSROXITHROMYCIN150MGBRAWN LABORATORIES LTD. ADDRESS :13, NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001, HARYANA - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1X10X10 TABLET BLISTER
NDA/MAL/HDP/6874BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDCEZIN TABLETSCETIRIZINE HYDROCHLORIDE10MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6875BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDBRUMOX-250 CAPSULESAMOXICILLIN TRIHYDRATE250MGBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL SOLID ORDINARY CAPSULES 10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6876INDOCO REMEDIES LTDTATA UGANDA LTDALERCHEKOLOPATADINE HYDROCHLORIDE0.1%W/WINDOCO REMEDIES LIMITED L-32, 33,34 VERNA INDUSTRIAL ESTATE VERNA, GOA, 403 722 - INDIAINDIAOPHTHALAMIC SOLUTION1X1X5 ML VIAL
NDA/MAL/HDP/6881 ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDASTRALEVOFLOXALEVOFLOXACIN500MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6897BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE GARGLE & MOUTH WASHPOVIDONE IODINE1G/100MLBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI INDUSTRIAL AREA, KARACHI-PAKISTANPAKISTANORAL TOPICAL LIQUIDS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/6914I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDPANZOLE TABLETSPANTOPRAZOLE40MGCORONA REMEDIES PVT LIMITED-VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH ? 173223. INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6921 GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDUFENAC DICLOFENAC SODIUM75MGGUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/6924I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDNAC MRDICLOFENAC POTASSIUM+PARACETAMOL+CHLORZOXAZONE50MG+325MG+250MGCORONA REMEDIES PVT LIMITED-VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH ? 173223. INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6932PSYCHOTROPICS INDIA LTDABACUS PHARMA (AFRICA) LIMITEDVALATE-200SODIUM VALPROATE200 MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6933PSYCHOTROPICS INDIA LTDABACUS PHARMA (AFRICA) LIMITEDVALATE 500 SODIUM VALPROATE BP500MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/6934SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDANASTROZOLE 1 MGANASTROZOLE1MGSALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE 1, 39179 BARLEBEN,GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6935SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDSIMVASTATIN 40 MGSIMVASTATIN40MGSANDOZ GRUP SAGLIK .-GEBZE 2 GOSB IHSAN DEDE CAD. 900. SOK 41480 GEBZE KOCAELITURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6948 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDD3 MUST 60 KCHOLECALCIFEROL60000IUMANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/6970 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDVOMIKIND ORAL SOLUTIONONDANSETRON4MG/5MLMANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESHINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/6974 MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDVOMIKIND-MD 4ONDANSETRON4MGMANKIND PHARMA LIMITED, UNIT-II. -VILLAGE KISHANPURA, P.O JAMNIWALA, PAONTA SAHIB IN H.P.INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6985MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDCOLDRID SYRUPCETIRIZINE DIHYDROCHLORIDE + PHENYLEPHRINE HCL + PARACETAMOL2.5MG + 5MG + 125MGMEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN INDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/6986MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDREPRAZ 20 TABLETSRABEPRAZOLE SODIUM20MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6987MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPORAZ CAPSULESOMEPRAZOLE 20MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES 1.0X10.0X10.0 CAPSULE STRIP
NDA/MAL/HDP/6997HETERO LABS LTD ABACUS PHARMA (AFRICA) LIMITEDEC-PRAM 10ESCITALOPRAM OXALATE10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/6999 CIRON DRUGS & PHARMACEUTICAL PVT LTDROYAL PHARMA 2011 LIMITEDNYSTATIN ORAL SUSPENSIONNYSTATIN100000 UNITS/5MLMEPRO PHARMACEUTICALS LTD-N-118, N-119, N-113, MIDC TARAPUR, BOISAR DIST: THANE-401 506 MAHARASHTRA, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/7004MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDDUOCETZPARACETAMOL+TRAMADOL HYDROCHLORIDE325MG+37.5MGMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED..-515/1 MOO 4, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANGTHAILANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7012MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDMYHEP DVIRDACLATASVIR + SOFOSBUVIR 60MG + 400MG MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON, SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X28.0 TABLET BOTTLE
NDA/MAL/HDP/7013PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAZITHRAA 500AZITHROMYCIN500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/7014PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDACEAAR 100 TABLETACECLOFENAC100MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/7015KOPRAN LIMITEDTATA UGANDA LIMITEDLOKITOMEPRAZOLE20MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7021PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDPINNOFEC PLUSACECLOFENAC+PARACETAMOL100MG+500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7022PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDPINNAFLAM PLUSDICLOFENAC SODIUM+PARACETAMOL50MG+500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7023EXPHAR SA.SURGIPHARM (U) LIMITEDVERZOL ORAL SUSPENSIONALBENDAZOLE200 MG / 5 MLGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X10.0 ML BOTTLE
NDA/MAL/HDP/7024EXPHAR SA.SURGIPHARM (U) LIMITEDMICOZALKETOCONAZOLE2%W/WGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/7029 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDLIPIZAR 20ATORVASTATIN CALCIUM (TRIHYDRATE)20MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7030GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDADOL EXTRAPARACETAMOL+CAFFEINE500MG+65MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY TABLETS 1.0X2.0X12.0 TABLET BLISTER
NDA/MAL/HDP/7035GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDGLYPRIDE 3MGGLIMEPIRIDE3MGGULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.EUNITED ARAB EMIRATESORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7046GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDXEMADERM 0.1% CREAMMOMETASONE FUROATE0.1%W/WGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESTOPICAL EXTERNAL CREAMS 1.0X30.0 G TUBE
NDA/MAL/HDP/7047GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDXEMADERM0.1% OINTMENTMOMETASONE FUROATE0.1%W/WGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS 1.0X30.0 G TUBE
NDA/MAL/HDP/7050GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDPANDERM SKIN OINTMENTNYSTATIN+NEOMYCIN SULFATE+GRAMICIDIN+TRIAMCINOLONE10,000,000I.U+2.5MG+0.25MG+1MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE
NDA/MAL/HDP/7051GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDDEXIPAN CREAMDEXPANTHENOL0.05%W/WGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESTOPICAL EXTERNAL CREAMS 1.0X20.0 G TUBE
NDA/MAL/HDP/7053 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOVID CREAMKETOCONAZOLE2%W/WHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/7055 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDVIREST 400ACICLOVIR400MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIAORAL SOLID ORDINARY TABLETS 5.0X5.0 TABLET BLISTER
NDA/MAL/HDP/7057 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDVIREST CREAM 5%ACICLOVIR5%W/WHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAMALAYSIATOPICAL EXTERNAL CREAMS 1.0X5.0 G TUBE
NDA/MAL/HDP/7063 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDGRISEOFULVIN 500MG FILM-COATED TABLETGRISEOFULVIN500MGHOVID 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/7070 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN 1000 MG FILM-COATED TABLETMETFORMIN HYDROCHLORIDE1000MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIAMALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7071 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFORACORT-200 FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE6MCG + 200MCG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA.INDIALUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/7074 CIPLA LTDQUALITY CHEMICALS LTD - HUMANFORACORT-100FORMETEROL FUMARATE DIHYDRATE + BUDESONIDE 6 MCG+100 MCG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA.INDIALUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/7077 CIPLA LTDQUALITY CHEMICALS LTD - HUMANFORACORT-400FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE6MCG + 400MCG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA.INDIALUNG ADMINISTRATION METERED-DOSE POWDER INHALER 1.0X1.0X120.0 METERED DOSE CANNISTER
NDA/MAL/HDP/7078 ICPA HEALTH PRODUCTS LTDMETRO PHARMACEUTICALS LIMITEDHEXIDINE?CHLORHEXIDINE GLUCONATE0.2 %W/V ICPA HEALTH PRODUCTS LIMITED-286/287, GIDC, ANKLESHWAR-393002. GUJARAT, INDIA. INDIATOPICAL EXTERNAL LIQUIDS 1.0X160.0 ML BOTTLE
NDA/MAL/HDP/7088PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LTD - WILSONPINNOX 200OFLOXACIN200MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7090BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDENDOPROSTCARBOPROST TROMETHAMINE 125MCG/0.5MLBHARAT SERUMS & VACCINES LTD.-PLOT NO. K?27, JAMBIVILI VILLAGE, ANAND NAGAR, ADDITIONAL M.I.D.C., AMBERNATH (EAST)-INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/7091PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAARLEFLOX 500 TABLETSLEVOFLOXACIN HEMIHYDRATE500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7093 PHARCO PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDDECLOPHEN 25 MG INFANTILE SUPPOSITORIESDICLOFENAC SODIUM 25MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTRECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/7096GAMA PHARMACEUTICALS (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDDEXAPHEN SYRUPDEXAMETHASONE + CHLORPHENIRAMINE MALEATE10MG + 40MG/100MLPHARCO 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/7098UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDACEFORCE SPACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG+325MG+15MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7100STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCOMBIART 80/480MGARTEMETHER + LUMEFANTRINE80MG + 480MGSTRIDES SHASUN LIMITED --36/7, SURAGAJAKKANAHALLI, INDLAVADI CROSS, ANEKAL TALUK, BANGALORE ? 562 106 INDIAINDIAORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES 1.0X6.0 SACHET CARTON
NDA/MAL/HDP/7101 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDASTHARENSALBUTAMOL SULPHATE4MGRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7102 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREPRAZINECHLORPROMAZINE HYDROCHLORIDE100MGRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7105CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDTRAMACETAL TABLETSACETAMINOPHEN +TRAMADOL HYDROCHLORIDE 325MG+37.5MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7106 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREVIVEGLUCOSE ANHYDROUS + TRISODIUM CITRATE DIHYDRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE13.5G + 2.9G + 2.6G + 1.5GRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1.0 SACHET CARTON
NDA/MAL/HDP/7111INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDMOFLOREN EDMOXIFLOXACIN HYDROCHLORIDE5MG/MLINDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/7123UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMARTINEZ 10MONTELUKAST SODIUM10MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7124 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITAMIN E 400 MG. VITAMIN E400 MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL SOLID ORDINARY OTHER CAPSULES 1.0X2.0X12.0 CAPSULE BLISTER
NDA/MAL/HDP/7128S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCOTRIKANT-960SULFAMETHOXAZOLE+ TRIMETHOPRIM800MG + 160MGS KANT HEALTHCARE LIMITED. PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7130LIFEPHARM FZEAIVEEN (U) LTD - WILSON ROADHEMOVIT CAPSULESDRIED FERROUS SULPHATE + FOLIC ACID150MG +500MCGESKAYEF BANGLADESH LTD--400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH BANGLADESHORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7136EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAMIKACIN 100 MG / 2MLAMIKACIN SULPHATE100MG/2MLEGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY ? INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPTEGYPTPARENTERAL ORDINARY VIALS 1.0X1.0X2.0 ML VIAL
NDA/MAL/HDP/7139LIFEPHARM FZEAIVEEN (U) LIMITEDCOLDIFED SYRUPPSEUDOEPHEDRINE HYDROCHLORIDE+HYTRIPROLIDINE HYDROCHLORIDE30MG+1.25MG/5MLLIFEPHARMA FZE .-JEBEL ALI -DUBAI UAEUNITED ARAB EMIRATESORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/7146SUNRISE INTERNATIONAL LABS LTDROYAL PHARMA 2011 LIMITEDSUNTACRANITIDINE HYDROCHLORIDE150 MGSUNRISE INTERNATIONAL LABS LTD.-PLOT NO. 100, LANE 5, SECTOR II, PHASE II IDA CHERLAPALLY, HYDERABAD-500 051INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7147AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDBIMATBIMATOPROST0.03% W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAOPHTHALMIC DROPS 1.0X1.0X3.0 ML VIAL
NDA/MAL/HDP/7148SUNRISE INTERNATIONAL LABS LTDROYAL PHARMA 2011 LIMITEDOMEPSUN OMEPRAZOLE20 MGSUNRISE INTERNATIONAL LABS LTD.-PLOT NO. 100, LANE 5, SECTOR II, PHASE II IDA CHERLAPALLY, HYDERABAD-500 051INDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7149AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDOLOPAT ODOLOPATADINE HYDROCHLORIDE0.2% W/VAJANTA PHARMA LIMITED-N-118, 119, MIDC, TARAPUR BOISAR, DIST. THANE 401506, MAHARASHTRA STATE, INDIA INDIAOPHTHALMIC DROPS 1.0X1.0X3.0 ML VIAL
NDA/MAL/HDP/7151AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDAPDROPS DXMOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE SODIUM PHOSPHATE5MG+1MG/MLAJANTA PHARMA LIMITED-N-118, 119, MIDC, TARAPUR BOISAR, DIST. THANE 401506, MAHARASHTRA STATE, INDIA INDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/7153EXIR PHARMACEUTICAL COMPANY.UNEED GLOBAL GROUP LIMITEDTYLOPHEN? ACETAMINOPHEN 120MG/5MLEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANIRANORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/7154ABARIS HEALTHCARE PVT. LTDROYAL PHARMA 2011 LIMITEDCIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDE2MG/MLABARIS HEALTHCARE PVT LTD - -SURVEY NO. 1407-11, VILLAGE RAJPUR, TALUKA KADI DIST. MEHSANA, GUJARAT-382740INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7157 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLINEZOLID TABLETS 600MGLINEZOLID600MG CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BOTTLE,1.0X20.0 TABLET CONTAINER
NDA/MAL/HDP/7162ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDTEXAVIRTENOFOVIR DISOPROXIL FUMARATE 300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7164CIPLA LTDQUALITY CHEMICALS LTDARTEMETHER /LUMEFANTRINE 60MG/360MGARTEMETHER + LUMEFANTRINE60MG + 360MGCIPLA LIMITED - UNIT I, VILLAGE UPPER MALPUR, P.O. BHUD, TEHSIL NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 173205, INDIAINDIAORAL SOLID ORDINARY TABLETS 1X30X6 TABLET BLISTERS
NDA/MAL/HDP/7166CIPLA LTDQUALITY CHEMICALS LTD ARTEMETHER /LUMEFANTRINE 40MG/240MGARTEMETHER + LUMEFANTRINE40MG + 240MGCIPLA LIMITED - UNIT I, VILLAGE UPPER MALPUR, P.O. BHUD, TEHSIL NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 173205, INDIAINDIAORAL SOLID ORDINARY TABLETS 1x30x6 TABLET BLISTERS
NDA/MAL/HDP/7175PSYCHOTROPICS INDIA LTDABACUS PHARMA (AFRICA) LIMITEDTELPIL A 40/5 MGTELMISARTAN + AMLODIPINE BESYLATE40MG + 5MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7189ACULIFE HEALTHCARE SUPER MEDIC LTDMERONIR MEROPENEM SODIUM1000MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*20ML AMPOULE OF WFI
NDA/MAL/HDP/7202NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDVILDAGLIPTINVILDAGLIPTIN50MGNOVARTIS 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 TABLETS 1.0X4.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7209BROOKES PHARMA (PRIVATE) LIMITEDJEET PHARMACEUTICALS LIMITED MINOXIN SOLUTIONMINOXIDIL2%W/VBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900PAKISTANTOPICAL EXTERNAL LIQUIDS 1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/7210STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDARTECAPARTESUNATE100MGSTRIDES SHASUN LIMITED --36/7, SURAGAJAKKANAHALLI, INDLAVADI CROSS, ANEKAL TALUK, BANGALORE ? 562 106 INDIAINDIARECTAL SYSTEMIC CAPSULES 1.0X1.0X2.0 SUPPOSITORY BLISTER,1.0X1.0X6.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/7212PHARMACO DISTRIBUTION (PTY) LTDECHO PHARMACY (U) LIMITEDPHARMALGANPARACETAMOL10MG/MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARATINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7217PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAARPANTO 40 PANTOPRAZOLE40MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7218PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAARTMIN 500METFORMIN500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7219THEON PHARMACEUTICALS LTDAIVEEN (U) LIMITEDTHEOXONE -1 GCEFTRIAXONE 1GTHEON PHARMACEUTICALS LTD.-VILLAGE SAINI MAJRA, TEHSIL NALAGARH DIST, SOLAN- 174101, INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/7227 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDNEMADOL 50TRAMADOL HYDROCHLORIDE 50MG NATIONAL HEALTHCARE PVT. LTD.-(WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPALNEPALORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7228SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDAMOXICILLIN 250MG DISPERSIBLE TABLETS AMOXICILLIN TRIHYDRATE 250 MG SANDOZ GMBH BIOCHEMISTRASSE 10-6250 KUNDL, AUSTRIA AUSTRIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7229PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDAARCIFLOX 500CIPROFLOXACIN500MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7230 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDHISTABLOC 2MLRANITIDINE HYDROCHLORIDE25MG/MLNATIONAL HEALTHCARE PVT. LTD.--WORKS: STERILE BLOCK CHHATAPIPRA-3, BARA, NEPALNEPALPARENTERAL ORDINARY VIALS 1.0X10.0X2.0 ML VIAL
NDA/MAL/HDP/7231 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDLIGNAT 2%LIDOCAINE HYDROCHLORIDE 2% W/V NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY VIALS 1.0X30.0 ML VIAL
NDA/MAL/HDP/7233 NATIONAL HEALTHCARE PVT LTDANDYCO PHARMACY (UGANDA) LTDMIZOVA MIDAZOLAM 1MG/MLNATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA NEPALNEPALPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/7238MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-10NEBIVOLOL HYDROCHLORIDE10MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7241EXPHAR SA.SURGIPHARM (U) LIMITEDGENTASOLGENTAMICIN SULFATE0.3%W/VAHLCON PARENTERAL (I) LTD.--SP-918,BHLWADI (RAJ) INDIA M.LIC.: RAJ 2002INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/7243BAL PHARMA LIMITEDHEALTHCARE LTD.EMTRIMTRIMETHOPRIM + SULPHAMETHOXAZOLE80MG+ 400MG BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7244MANKIND PHARMA LTDTATA UGANDA LTDCEFAKIND-250CEFUROXIME AXETIL250MGCOPMED PHARMACEUTICAL PVT. LTD., UNIT-II PLOT NO.50, GONDPUR INDUSTRIAL AREA, PAONTA SAHIB, DIST. SIRMOUR, HIMACHAL PRADESH-173025 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1X1X10 TABLET BLISTER
NDA/MAL/HDP/7246 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESGAMA PHARMACEUTICALS (U) LIMITEDDESLORATDESLORATIDINE5MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X10.0 TABLET STRIP
NDA/MAL/HDP/7248 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESGAMA PHARMACEUTICALS (U) LIMITEDESOMELODAN 20ESOMEPRAZOLE20MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7249 EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCESGAMA PHARMACEUTICALS (U) LIMITEDESOMELODAN 40ESOMEPRAZOLE MAGNESIUM40MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPTEGYPTORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7255ACULIFE HEALTHCARE SUPER MEDIC LTDNIRIXONECEFTRIAXONE SODIUM 1000MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*1 10ML WFI AMPOULE
NDA/MAL/HDP/7257PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDPAARPIN TABLET PARACETAMOL 650 MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7258GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDDESCOVY 200MG/10MGEMTRICITABINE + TENOFOVIR ALAFENAMIDE200MG/10MGPATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9,ROTTENDORF PHARMA GMBH-OSTENFELDER STRA?E 51-61,59320 ENNIGERLOH,GERMANYCANADAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7263NIPRO MIDDLE EAST FZEROYAL PHARMA 2011 LIMITEDVERMIKIL TABLET ALBENDAZOLE 400MGNIPRO JMI PHARMA LTD.-CHAUDDAGRAM, COMILLA BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X25.0X1.0X2.0 TABLET BLISTER
NDA/MAL/HDP/7264 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDMIOPAN PLUS SUSPENSIONMAGALDRATE+SIMETHICONE540MG + 40MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7266 CIPLA LTD.QUALITY CHEMICALS LTD - HUMANATAZANAVIR SULFATE AND RITONAVIR TABLETS ATAZANAVIR SULFATE + RITONAVIR USP 300 MG + 100 MGCIPLA LTD(PATALGANGA)-CIPLA LIMITED, PLOT NO. A-42 (UNIT II),MIDC,PATALGANGADISTRICT - RAIGAD, MAHARASHTRA,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7269EXPHAR SA.SURGIPHARM (U) LIMITEDFEBRILEX SYRUPPARACETAMOL+DEXTROMETORPHAN HYDROBROMIDE+CHLORPHENAMINE MALEATE125MG+5MG+1MG/5 MLGRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)INDIAORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/7274CIPLAQCILCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDZENTAIR 0.5MGENTECAVIR0.5MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7284?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LTD LIVERCOL 10ROSUVASTATIN CALCIUM10MG?LKO ?LA? SANAYI VE TICARET A. ?.-3. 42050 SEL?UKLU / KONYA TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7286EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTOBRIN OPHTHALMIC OINTMENTTOBRAMYCIN3MG/GEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT EGYPTOPHTHALMIC OINTMENTS 1.0X5.0 G TUBE
NDA/MAL/HDP/7287EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPISTIGMIN 0.05% NEOSTIGMINE METHYLSULPHATE0.05%W/VEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPTEGYPTPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/7288MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKETESSE FILM COATED TABLETSDEXKETOPROFEN TROMETAMOL25MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILAITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7291 PHARCO PHARMACEUTICALSGAMA PHARMACEUTICALS (U) LIMITEDDERMATIN CREAMCLOTRIMAZOLE1%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 1.0X12.0 G TUBE
NDA/MAL/HDP/7293?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LTD ALRINASTDESLORATADINE5MG?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1 SEL?UKLU / KONYATURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7298MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-2.5 NEBIVOLOL HYDROCHLORIDE 2.5 MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7299SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCLOTINEX 60 ENOXAPARIN SODIUM60MG/PRE-FILLED SYRINGESQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/7301HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPACLITERO 300PACLITAXEL6 MG/MLHETERO LABS LIMITED UNIT VI, APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JEDCHERLA (MANDAL) MAHABOOB NAGER (DISTRICT) ANDHRA PRADESH-509 301 INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X50.0 ML VIAL
NDA/MAL/HDP/7304PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD.)ROYAL PHARMA 2011 LTDGABAZUREGABAPENTIN300MGZIM LABORATORIES LTD. B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441 501, DIST. NAGPUR, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1X2X10 TABLET BLISTERS
NDA/MAL/HDP/7305HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPACLITERO 30PACLITAXEL6 MG/MLHETERO LABS LIMITED UNIT VI, APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JEDCHERLA (MANDAL) MAHABOOB NAGER (DISTRICT) ANDHRA PRADESH-509 301 INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/7306HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDPACLITERO 100PACLITAXEL6 MG/MLHETERO LABS LIMITED UNIT VI, APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JEDCHERLA (MANDAL) MAHABOOB NAGER (DISTRICT) ANDHRA PRADESH-509 301 INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X1.0X16.7 ML VIAL
NDA/MAL/HDP/7309SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDBECLOMIN 250 HFA INHALER BECLOMETASONE DIPROPIONATE250 ?CG/PUFFSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESHBANGLADESHLUNG ADMINISTRATION METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/7312MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDBETADINE OINTMENT 5%W/WPOVIDONE IODINE5%W/WG.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIATOPICAL EXTERNAL OINTMENTS 1.0X15.0 G TUBE,1.0X125.0 G TUBE,1.0X250.0 G JAR
NDA/MAL/HDP/7313 PANACEA BIOTEC LTDSTAR PHARMACEUTICALS LTDEASYFIVE-TT (FULLY LIQUID PENTAVALENT VACCINE)DIPHTHERIA TOXOID + TETANUS TOXOID + INACTIVATED W-B, PERTUSSIS + HBSAG + HIB (PRP-TT)30 IU + 60 IU + 4 IU + 10MCG + 10 MCGPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH ? 173 205INDIAPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/7319DROGSAN ?LA?LARI SAN. VE TIC. A.?.BUFFALO HEALTH CARE LTDSIPROSAN 500CIPROFLOXACIN HYDROCHLORIDE500MGDROGSAN ?LA?LARI SAN. VE TIC. A.?.-ESENBOGA MERKEZ MAH CUBUK CAD NO.31 CUBUK ANKARA -TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/7324MEDREICH PLCSURGIPHARM (U) LTD,AMOXICILLIN DISPERSIBLE TABLETS 250MGMOXICILLIN TRIHYDRATE250MGMEDREICH LIMITED, 12TH MILE, OLD MADRAS ROAD, VIRGONAGAR, BANGALORE - 560 049. KARNATAKA, INDIA.INDIADISPERSIBLE TABLET1X10X10, 1X1X10 TABLET BLISTERS
NDA/MAL/HDP/7325DROGSAN ?LA?LARI SAN. VE TIC. A.?.BUFFALO HEALTHCARE LTD DALMAN AQ NASAL SPRAYFLUTICASONE PROPIONATE0.05%W/VDROGSAN ?LA?LARI SAN. VE TIC. A.?. --ESENBO?A MERKEZ MAH. ?UBUK CADDESI NO: 31 06760 ANKARA - TURKEYTURKEYNASAL SYSTEMIC UNIT DOSE AEROSOLS 1.0X1.0X120.0 METERED DOSE BOTTLE
NDA/MAL/HDP/7328DROGSAN ?LA?LARI SAN. VE TIC. A.?.BUFFALO HEALTHCARE LTD CARDIOSAN 10MGAMLODIPINE BESILATE10MGDROGSAN ?LA?LARI SAN. VE TIC. A.?.-ESENBOGA MERKEZ MAH CUBUK CAD NO.31 CUBUK ANKARA -TURKEYTURKEYORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7329DAWA LIMITEDSUPER MEDIC LTDACEPAR- MR PARACETAMOL +ACECLOFENAC+CHLORZOXAZONE 500 MG+100 MG +375 MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7334 IPCA LABORATORIES LTDSURGIPHARM (U) LIMITEDETOVA 400ETODOLAC 400MGIPCA LABORATORIESLIMITED-IPCA LABORATORIES LTD P.O SEJANTA DISTRICT RATLAM 457002 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7335MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDBETADINE 5%POVIDONE IODINE5%W/VG.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIATOPICAL EXTERNAL LIQUIDS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/HDP/7336MODI NUNDIPHARMA PVT LTDSURGIPHARM (U) LIMITEDBETADINE GERMICIDE GARGLE 2% MINTPOVIDONE IODINE2%W/VG.S PHAMBUTOR PVT LTD-G.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIAORAL TOPICAL LIQUIDS 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7337JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDPREZISTA 150 DARUNAVIR150MGJANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X240.0 TABLET BOTTLE
NDA/MAL/HDP/7339AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDADERAN 16 CANDESARTAN CILEXETIL16 MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7342CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ZEALARGY RUPATADINE FUMERATE10 MG CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATEINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7344ACULIFE HEALTHCARE SUPER MEDIC LTDHEPANIR HEPARIN SODIUM 1000IU/ML ACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X5.0 ML VIAL
NDA/MAL/HDP/7346 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREZN TABLETSZINC SULFATE MONOHYDRATE 20MGRENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKAUGANDAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7348MSD (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDISENTRESS 25 MG RALTEGRAVIR POTASSIUM 25MGPATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA,MERCK SHARP & DOHME BV.-WAARDERWEG 39 HAARLEM, - 2031 BN, NETHERLANDS,MSD (PTY) LTD. -117-16TH ROAD, HALFWAY HOUSE, 1685 SOUTH AFRICAUNITED STATESORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/7351TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDTRYFIX CV DSCEFIXIME+CLAVULANIC ACID50MG+31.25MGTWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWARINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7353MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOPHAGE XR 500MGMETFORMIN HYDROCHLORIDE 500MGMERCK KGAA--FRANKFURTER STR. 250 64293 DARMSTADT GERMANY,MERCK SANT? S.A.S.-2 RUE DU PRESSOIR VERT 45400 SEMOY FRANCEGERMANYORAL SOLID RETARD TABLETS 1.0X6.0X15.0 TABLET BLISTER
NDA/MAL/HDP/7355AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDARTEFAN SUSPENSIONARTEMETHER+LUMEFANTRINE180MG+1080MGAJANTA PHARMA LIMITED.-B-41516, MIDC INDUSTRIAL AREA, PAITHAN, AURANGABAD-431 148 DIST: AURANGABAD MAHARASHTRA,INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/7356 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN TABLET 500MGMETFORMIN HYDROCHLORIDE500MGHOVID BERHAD-121, JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIAMALAYSIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X20.0 TABLET BLISTER
NDA/MAL/HDP/7357 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDPAMAGIN-C SYRUPCETIRIZINE HYDROCHLORIDE+DEXTROMETHORPHAN HYDROBROMIDE+ACETAMINOPHEN+PHENYLEPHRINE HYDROCHLORIDE+ZINC GLUCONATE+MENTHOL2.5MG+7.5MG+125MG+5MG+7.5MG+2.5MG/5MLCACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/7359INDCHEMIE HEALTH SPECIALITIES PVT. LTD.TATA UGANDA LIMITEDINDCLAV 625AMOXICILLIN+CLAVULANATE POTASSIUM500MG+125MGINDCHEMIE HEALTH SPECIALITIES PVT LTD-VILLAGE THANA TEHSIL BADDI DIST SOLAN HIMACHAL PRADESH 173 205 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7362RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDTRAM-DOL-50TRAMADOL HYDROCHLORIDE50MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7363INDCHEMIE HEALTH SPECIALITIES PVT. LTD.TATA UGANDA LIMITEDINDCLAV 228AMOXICILLIN+CLAVULANATE POTASSIUM200MG+28MG/5MLINDCHEMIE HEALTH SPECIALITIES PVT. LTD.-VILLAGE & P.O ? THANA, TEHSIL ? BADDI, DIST- SOLAN, HIMACHALINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7364?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LIMITEDMOKSEFEN 400 MGMOXIFLOXACIN HYDROCHLORIDE400MG?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1 SEL?UKLU / KONYATURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/7365AUROCHEM PHAMACEAUTICALS (1) LTD)SUPER MEDIC LTDDOLOACT MRPARACETAMOL+ DICLOFENAC POTASSIUM+CHLORZOXAZONE 500 MG+50 MG+250 MGKARALEX PHARMA-58, PALGHAR TALUKA, INDUSTRIAL CO.-OP. ESTATE LTD.PALGHAR ?INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7366TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDTRYFIXCEFIXIME200MGTWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWARINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET STRIP
NDA/MAL/HDP/7367TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDTRYFIX 100 DSCEFIXIME100MG/5MLTWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWARINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7369TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDXOMOX CV DSAMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE200MG+28.5MG/5MLTWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEEINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7370TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDXOMOX CV 625AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE500MG+125MGTWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/7376TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDXOMOX CV 375AMOXICILLIN+POTASSIUM CLAVULANATE250MG+125MGTWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/7377TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDXOMOX DSAMOXICILLIN TRIHYDRATE125MG/5MLTWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEEINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7378AURONEXT PHARMA PRIVATE LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDERTAPIK ERTAPENEM SODIUM1 GAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/7379TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDTRYDROX 250CEFADROXIL250MGTWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWARINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET STRIP
NDA/MAL/HDP/7380TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDTRYDROX DSCEFADROXIL125MG/5MLTWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWARINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7381MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDBETADINE ANTISEPTIC CREAM 5%POVIDONE-IODINE5%W/WG.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X10.0 G TUBE
NDA/MAL/HDP/7384YURIA PHARM LTDYURIA PHARM EAST AFRICA LIMITEDTIVORTINARGININE HYDROCHLORIDE42MG/MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINEUKRAINEPARENTERAL ORDINARY AMPOULES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7385TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDTRYOXIM DSCEFUROXIME AXETL125MG/5MLTWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWARINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7386TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDTRYLEXIN 125 DSCEFALEXIN MONOHYDRATE125MG/5MLTWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWARINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7388TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDTRYFIX CV 200CEFIXIME+CLAVULANIC ACID200MG+125MGTWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWARINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET STRIP
NDA/MAL/HDP/7396GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDHARVONI SOFOSBUVIR+LEDIPASVIR 400 MG+90 MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADACANADAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X28.0 TABLET BOTTLE
NDA/MAL/HDP/7406ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDARENAADRENALINE0.1% W/V LINCOLN PARENTERAL LTD -11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/7410MEDOPHARM, INDIAPLANET PHARMACEUTICALS UGANDA LTDCOTRIMOXAZOLE TABLETS BP 960 MGTRIMETHOPRIM +SULPHAMETHOXAZOLE 960MGMEDOPHARM --34 B, INDUSTRIAL AREA, MALUR - 563160, KARNATAKA, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/7421PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDGESIC ADL 200IBUPROFEN200MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7422CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAV 625MGAMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM500MG+125MG MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7424MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDZINC SULFATE TABLETS USP 20MGZINC SULFATE MONOHYDRATE 20MGMACLEODS PHARMACEUTICALS LTD - - VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA 174101 INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7431WIN-MEDICARE PVT. LTDSURGIPHARM (U) LTDMOVICOLPOLYETHYLENE GLYCOL + SODIUM CHLORIDE + SODIUM BICARBONATE + POTASSIUM CHLORIDE13.125G + 350.7MG + 178.5MG + 46.6MG /SACHETWIN-MEDICARE PVT. LTD MODIPURAM - 250 110, UTTAR PRADESH, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1X10X13.81G, SACHETS
NDA/MAL/HDP/7441VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTH XLSODIUM HYALURONATE8MG/MLVIRCHOW BIOTECH PVT LTD-SURVEY NO. 172, PART GAGILLAPUR(P) QUTHBULLAPUR(MANDAL), R.R, DISTRICT, TELANGANA STATE, 500043.INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X6.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/7446AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDCIPLUMECIPROFLOXACIN HYDROCHLORIDE 0.3% W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAOPHTHALMIC DROPS 1.0X10.0 ML VIAL
NDA/MAL/HDP/7449CIPLAQCILCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE/ TENOFOVIR DF 300/300MG LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE300MG+300MGCIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7453GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDANTIDIAZOXNITAZOXANIDE 100MG/5MLGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/7469BROOKES PHARMA (PRIVATE) LIMITEDHARLEYS UGANDA LIMITEDECZEMUS 0.03% OINTMENTTACROLIMUS MONOHYDRATE0.03%W/WBROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900PAKISTANTOPICAL EXTERNAL OINTMENTS 1.0X1.0X10.0 G TUBE
NDA/MAL/HDP/7475UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOCLOX 500AMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM250MG+250MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7478SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDSIMVASTATIN 20 MG FILM-COATED TABLETSSIMVASTATIN20MGSANDOZ GRUP SAGLIK -GEBZE 2 GOSB IHSAN DEDE CAD. 900. SOK 41480 GEBZE KOCAELITURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7481ACCORD HEALTH CARE LTDNORVIK ENTERPRISES LIMITEDSILDENAFIL ACCORD 100SILDENAFIL CIRATE100MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/7488ACCORD HEALTH CARE LTDNORVIK ENTERPRISES LIMITEDFINASTERIDE 5MGFINASTERIDE 5MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7490ACCORD HEALTH CARE LTDNORVIK ENTERPRISES LIMITEDSILDENAFIL ACCORD 50SILDENAFIL CITRATE 50MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARATINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/7491DENK PHARMA GMBH & COBENLE CONSULT LIMITEDCIPRO-DENK 750CIPROFLOXACIN HYDROCHLORIDE750MGALLPHAMED PHARBIL ARZNEIMITTEL GMBH. -HILDEBRANDSTRABE 12 37081 GOTTINGENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7504KHANDELWAL LABORATORIES PVT. LTD.SURGIPHARM (U) LTDIMATINATE 400IMATINIB MESYLATE400MGKHANDELWAL LABORATORIES PVT. LTD. PLOT B-1, WAGLE INDUSTRIAL ESTATE, THANE- 400 604. MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY CAPSULES 1X1X10 CAPSULE CONTAINER
NDA/MAL/HDP/7523DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDLEVOFLOX-DENK 5 MG/MLLEVOFLOXACIN HEMIHYDRATE5MG/MLSOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH--INDUSTRIESTR. 3 34212 MELSUNGEN GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML VIAL
NDA/MAL/HDP/7531LINCOLN PHARMACEUTICALS LTDABACUS PARENTERAL DRUGS LIMITEDFRUSO FUROSEMIDE 10MG/ML LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/7533ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDASUNATE 60 ARTESUNATE 60MG LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON + 1*5ML 0.9%W/W SODIUM CHLORIDE SOLUTION AMPOULE + 1*1ML 5.0%W/W SODIUM BICARBONATE SOLUTION AMPOULE
NDA/MAL/HDP/7536PLANET PHARMACEUTICALS UGANDA LTDPLANET PHARMACEUTICALS UGANDA LTDNETVAICAINBUPIVACAINE HYDROCHLORIDE + DEXTROSE5MG + 80MG /MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0X10.0X4.0 ML AMPOULE,1.0X10.0X4.0 ML AMPOULE
NDA/MAL/HDP/7539SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDCOUGH LINCTUSCHLORPHENIRAMINE2MG/5MLSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X1000.0 ML JERRYCAN,1.0X200.0 ML BOTTLE
NDA/MAL/HDP/7541SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDCHLORHEXIDINE SCRUBCHLORHEXIDINE GLUCONATE4%W/VSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X1000.0 ML JERRYCAN
NDA/MAL/HDP/7544SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDGLYCERIN OF BORAXGLYCERINE+BORAX12%W/VSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X22.0 ML BOTTLE
NDA/MAL/HDP/7546SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDHYDROGEN PEROXIDEHYDROGEN PEROXIDE6%W/VSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/7548SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDIODINE TINCTUREIODINE + POTASSIUM IODIDE2.5%W/V+2.5%W/VSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X22.0 ML BOTTLE
NDA/MAL/HDP/7552SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDMAGNESIUM TRISILICATE MIXTUREMAGNESIUM TRISILICATE + LIGHT MAGNESIUM CARBONATE + SODIUM BICARBONATE250MG + 250MG + 250MG/5MLSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/7554SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDPOVIDONE IODINE BPPOVIDONE IODINE10%W/VSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X200.0 ML BOTTLE,1.0X1000.0 ML JERRYCAN
NDA/MAL/HDP/7556SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDSEVASTATCETRIMIDE + CHLORHEXIDINE3%W/V+0.3%W/VSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X1.0 L BOTTLE
NDA/MAL/HDP/7559SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDSURGICAL SPIRITMETHYL SALICYLATE0.5%V/VSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDATOPICAL EXTERNAL SPIRITS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7560SEV PHARMACEUTICALS LTDSEV PHARMACEUTICALS LIMITEDVIOLGENTCRYSTAL VIOLET0.5%W/VSEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X25.0 ML BOTTLE
NDA/MAL/HDP/7569STRIDES SHASUN LIMITED .DELMAW ENTERPRISES LIMITEDARCOMETERARTEMETHER80MG/MLSTRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD BANGALORE 560076 INDIA INDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X6.0 ML AMPOULE,1.0X1.0X8.0 ML AMPOULE
NDA/MAL/HDP/7571 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDNEUROVIT FILM-COATED TABLETTHIAMINE MONONITRATE + PYRIDOXINE HCL + CYANOCOBALAMINE97MG + 50MG + 100MGHOVID 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/7575ACME FORMULATION PVT. LTD.MARIE STOPES UGANDA LIMITEDMEDIPRISTMIFEPRISTONE200MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7594SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDHYDROCHLOROTHIAZIDE 25MG TABLETSHYDROCHLOROTHIAZIDE25MGSALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE 1, 39179 BARLEBEN,GERMANYORAL SOLID ORDINARY TABLETS 1.0X4.0X25.0 TABLET BLISTER
NDA/MAL/HDP/7597CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAVAMOXICILLIN SODIUM + CLAVULANIC ACID1000MG + 200MG MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSPARENTERAL ORDINARY DRY VIALS 1.0X10.0X1.2 G VIAL
NDA/MAL/HDP/7606ANKUR DRUGS AND PHARMA LTDJOINT MEDICAL STORE (UPMB - UCMB)KELVIMOL 500PARACETAMOL 500MGANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST. SOLAN (HP) ? 174 101(INDIA) INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7611FERRING GMBHMACNAUGHTON LIMITEDPABALCARBETOCIN100MCG/MLFERRING GMBH.-11, WITTLANDGERMANYPARENTERAL ORDINARY VIALS 1.0X5.0X1.0 ML VIAL
NDA/MAL/HDP/7612PSYCHTROPICS INDIA LTDABACUS PHARMA (AFRICA) LIMITEDSOTHREX -BRTERBUTALINE SULFATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL 2.5MG+8MG+100MG+5MG/10MLPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7613PSYCHTROPICS INDIA LTDABACUS PHARMA (AFRICA) LIMITEDKETOPIL KETOCONAZOLE2%W/VPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIATOPICAL EXTERNAL LIQUID SOAPS/WASHES 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7617CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG/300 MG /300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600 MG + 300 MG + 300 MGCIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7631ADWIAWIDE SPECTRUM ENTERPRISES (U) LIMITEDAMADOL 100MG SR TABLETTRAMADOL HYDROCHLORIDE100MGADWIA CO. S.A.E-10TH OF RAMADAN CITY, INDUSTRIAL AREA A2, EGYPTEGYPTORAL SOLID RETARD TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7632SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDBISOPROLOL 2.5 MG FILM-COATED TABLETSBISOPROLOL FUMARATE 2.5MGLEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HDP/7634SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDBISOPROLOLBISOPROLOL 5 MG LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X25.0 TABLET BLISTER
NDA/MAL/HDP/7635SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDBISOPROLOL 10MG FILM-COATED TABLETS BISOPROLOL FUMARATE10MGLEK S.A-95 - 010 STRYK?W, PODLIPIE 16, POLAND,SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X25.0 TABLET BLISTER
NDA/MAL/HDP/7649SAKAR HEALTHCARE LIMITEDTATA UGANDA LIMITEDPARABUFEN SUSPENSIONIBUPROFEN + PARACETAMOL(100MG + 162.5MG)/5MLSAKAR HEALTHCARE LIMITED-BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT ? INDIA.INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/7651MSD (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUVIA 25SITAGLIPTIN25MGMSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7652MSD (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUVIA 100SITAGLIPTIN100MGMSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7653MSD (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUVIA 50SITAGLIPTIN50MGMSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7656A.MENARINI INDUSTRIE FARMACEUTICHE RIUNITEPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDSPASMOMENOTILONIUM BROMIDE40MGA.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA CAMPO DI PILE, L?AQUILA (AQ), ITALYITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X15.0 TABLET BLISTER
NDA/MAL/HDP/7660SPECPHARM (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTENEMCOMEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE200MG + 300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7663CIPLAQCILCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDZENTAIRENTECAVIR MONOHYDRATE1.0MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7667SAGA LABORATORIES SUPER MEDIC LTDZIMYCIN 500AZITHROMYCIN DIHYDRATE 500MGSAGA LABORATORIES--SURVEY NO.198/2 & 198/3 CHACHRAWADI VASNA, TAL; SANAND AHMEDABAD 382210.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/7670 IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDICHLOR 50CHLORTHALIDONE50MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7671 IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDICHLOR-25CHLORTHALIDONE25MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7673NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDVALSARTANVALSARTAN80MGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAINSPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7674ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABLEVOXLEVOFLOXACIN HEMIHYDRATE5G/LABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7675NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDVALSARTANVALSARTAN160MGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAINSPAINORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/7681ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEECEL 200CELECOXIB200MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7683GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDDELAREXDESLORATADINE5MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7686EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTGENTGENTAMICIN SULPHATE0.3W/V EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/7688MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOPHAGE 850MG TABLETMETFORMIN HYDROCHLORIDE850MGNKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X300.0 TABLET CONTAINER,1.0X60.0 TABLET CONTAINER,1.0X4.0X15.0 TABLET BLISTER
NDA/MAL/HDP/7689UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDCUFO LOZENGES(LEMON)2, 4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESOL1.2MG + 0.6MGUNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ? 396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER
NDA/MAL/HDP/7692UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDCEFECTRON-S 1.5 GCEFOPERAZONE SODIUM+SULBACTAM SODIUM1000MG + 500MG AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.5 G VIAL + 1*10 ML LDPE AMPOULE OF SWFI
NDA/MAL/HDP/7695UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDCORTUM 500CEFUROXIME AXETIL500MGAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7701VISSCO REHAILITATION AIDS PVT LTDKIMSY MEDS LTDFLUCONAZOLE TABLETS 200 MGFLUCONAZOLE200 MGMYLAN LABORATORIES LIMITED, ?-PLOT NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA AURANGABBAD- 431136 MAHARASTRA STATE, INDIA. ?INDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7706CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDCACEF 200CEFPODOXIME PROXETIL200MGALKEM LABORATORIES LIMITED -VILLAGE- THANA BADDI, YEH NALAGAR, DISTRICT SOLAN, HIMACHAL PRADESH INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/7707MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDZOLIGLIT 15PIOGLITAZONE15MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BLISTER
NDA/MAL/HDP/7708LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDLAMPYKLOX CAPSULESAMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM250MG+250MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA? 444 104 (MS). INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/7709NITIN LIFESCIENCES LTDHEALTHCARE LTD.DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE8MG/2MLNITIN LIFESCIENCES LTD--RAMPUR ROAD PAONTA SAHIB DIST. SIRMOUR (H.P) 173 025INDIAPARENTERAL ORDINARY AMPOULES 1.0X50.0X2.0 ML AMPOULE
NDA/MAL/HDP/7710MYLAN LABORATORIES LIMITED.KIMSY MEDS LTDFLUCONAZOLEFLUCONAZOLE50MGMYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA, AURANGABAD. ? 431136, MAHARASHTRA STATE, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/7711 HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN 850 MG METFORMIN HYDROCHLORIDE850MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA MALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7715JANSSEN-CILAG INTERNATIONAL NVLABOREX UGANDA LIMITEDSIRTUROBEDAQUILINE FUMARATE100MGRECIPHARM PHARMACEUTICALS PVT LTD-34TH KM, TUMKUR ROAD, T-BEGUR, NELAMANGALA TALUK BENGALURU, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X188.0 TABLET BOTTLE
NDA/MAL/HDP/7716CORE ACCESS LIMITEDCORE ACCESS LTD ALRINAST 2.5 MG / 5 ML SYRUPDESLORATIDINE2.5 MG / 5 ML?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1 SEL?UKLU / KONYATURKEYORAL LIQUID ORDINARY SYRUPS 1.0X150.0 ML BOTTLE
NDA/MAL/HDP/7721SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDMAALOX LEMON FLAVORINGALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE175MG + 200MG + 25MG/ 5MLNATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANYGERMANYORAL LIQUID ORDINARY SUSPENSIONS 1.0X250.0 ML BOTTLE,1.0X355.0 ML AMPOULE
NDA/MAL/HDP/7722SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDMAALOX MINT FLAVORINGALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE175MG + 200MG/ 5MLNATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANYGERMANYORAL LIQUID ORDINARY SUSPENSIONS 1.0X355.0 ML BOTTLE,1.0X250.0 ML AMPOULE
NDA/MAL/HDP/7724FERRING GMBHMACNAUGHTON LIMITEDMENOPURHIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU]75 IU + 75 IU/ 4ML VIALFERRING (PTY) LTD-WITTLAND II 24146 KIELGERMANYPARENTERAL ORDINARY DRY VIALS 10.0X4.0 ML VIAL 10*1ML CLEAR COLOURLESS GLASS AMPOULES CONTAINING 9.0MG/ML OF NACL
NDA/MAL/HDP/7726MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR100MG + 25MGMACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/7727SANDOZ KENYA LTDSURGIPHARM (U) LIMITEDBIODROXIL 500MG/5MLCEFADROXIL500MG/5MLSANDOZ GMBH BIOCHEMISTRASSE 10-6250 KUNDL, AUSTRIA AUSTRIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/7728 NORVATIS PHARMA SERVICES INC.SURGIPHARM (U) LIMITEDLINEXLACTOBACILLUS ACIDOPHILUS + BIFIDOBACTERIUM INFANTIS + ENTEROCOCCUS FAECIUM1.2 * 10 TO POWER 7 COLONY FORMING UNITS OF VIABLE LACTIC ACID BACTERIA SPECIESLEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIASLOVENIAORAL SOLID ORDINARY CAPSULES 1.0X2.0X8.0 CAPSULE BLISTER
NDA/MAL/HDP/7735AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDIBUMOL 400PARACETAMOL + IBUPROFEN 325MG + 400MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7740UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMETHICOWEL 1500METHYLCOBALAMIN1500 MCG/MLAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/7745UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDTAZOGARDPIPERACILLIN + TAZOBACTAM4G + 0.5GAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0x4.5 G Vial ,2X10ML LDPE AMPOULES OF WFI
NDA/MAL/HDP/7747UNOSOURCE PHARMA LTD.ESCORTS PHARMACEUTICALS LIMITEDTHERMODOLPARACETAMOL1.0%W/VAKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7751UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNODEX COUGH SYRUPBROMHEXINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + AMMONIUM CHLORIDE8MG + 10MG + 100MGAKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7760ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDOZACE MD 10OLANZAPINE10MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND,PSYCHOTROPICS INDIA LTD PLOT--NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7764ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTELPRESS-H 40/12.5TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7784DAFRA PHARMA GMBHLABOREX UGANDA LIMITEDLORATOLLORATADINE 5MG/5MLNOBEL ILAC DUZCE-SANAYIINVE TICARET A.S SANCAKLAR 81100 DUZCETURKEYORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7828 AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIZTROL 24BETAHISTINE DIHYDROCHLORIDE24MGAUROBINDO PHARMA LIMITED, UNIT ? III-SURVEY NO.:113 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7903MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMELMET-1000SRMETFORMIN HYDROCHLORIDE1000MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID RETARD COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7905NABIQASIM INDUSTRIES (PVT) LTD. JEET PHARMACEUTICALS LIMITEDACEFYLACEFYLINE PIPERAZINE + DIPHENHYDRAMINE HYDROCHLORIDE45MG +8MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS 1.0X120.0 ML BOTTLE
NDA/MAL/HDP/7906AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDIVMOLPARACETAMOL10MG/MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/7907BHARAT SERUMS AND VACCINES LIMITED,GITTOES PHARMACEUTICALS LIMITEDHUCOG 5000 HPCHORIONIC GONADOTROPHIN5000 I.U/ VIALBHARAT SERUMS & VACCINES LIMITED -PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (E) MAHARASHTRA STATE 421501 INDIAPARENTERAL ORDINARY DRY VIALS 1.0X5000.0 I.U VIAL + 1*1ML 0.9%W/V NACL AMBER GLASS AMPOULE
NDA/MAL/HDP/7909SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDLANTUSINSULIN GLARGINE100 UNITS/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY S C VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/7910SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDLANTUSINSULIN GLARGINE100 UNITS/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY CARTRIDGES 1.0X5.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/7911SANOFI-AVENTIS KENYALABOREX UGANDA LIMITEDLANTUS SOLOSTARINSULIN GLARGINE100 UNITS/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY GERMANYPARENTERAL ORDINARY PRE-FILLED PENS 1.0X5.0X3.0 ML PREFILLED PEN
NDA/MAL/HDP/7912UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDGLIMEWEL M-1GLIMEPIRIDE + METFORMIN HYDROCHLORIDE1MG + 500MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/7928MACK BROWN PHARMACEUTICALS PVT LIMITED SHURIK LTDCOLDROP HERBAL COUGH SYRUPMULTINGREDIENTMULTINGREDIENTMETA HERBALS PVT LTD-G-523, G.I.D.C, LODHIKA, VILLAGE METODA, KALAWAD ROAD, DISTRICT RAJKOT, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8007BAYER AGSURGIPHARM (U) LIMITEDADALAT RETARDNIFEDIPINE20MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANYGERMANYORAL SOLID RETARD OTHER COATED TABLETS 6.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8009COSMOS LTD.ASTRA PHARMA (U) LIMITEDGRISO-500GRISEOFULVIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8010COSMOS LTD.ASTRA PHARMA (U) LIMITEDMETROZOLE TABLETSMETRONIDAZOLE200MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/8015SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDD-FENDICLOFENAC SODIUM25MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X3.0 ML AMPOULE
NDA/MAL/HDP/8021CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANLAMIVIR-150 TABLETSLAMIVUDINE150MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8022CIPLA LTD.QUALITY CHEMICALS LTD - HUMANLAMIVUDINE + NEVIRAPINE + ZIDOVUDINELAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG +50MG + 60MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8023DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDAMOXICLAV-DENK 500/62.5AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500 MG + 62.5 MGPENCEF PHARMA GMBH-BRITENBACHSTR ASSE 13 D-13509 BERLINGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X8.0 TABLET BLISTER
NDA/MAL/HDP/8032CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATE/LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE600 MG + 300 MG CIPLA LTD-A-33 & A-37/2/2 MIDC PATALGANGA 410220INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8043DAFRA PHARMA GMBHLABOREX UGANDA LIMITEDRABEZOLRABEPRAZOLE SODIUM20MGB?L?M PHARMACEUTICALS-GOSB 41480 GEBZE-KOCAEL?/TURKETURKEYORAL SOLID ORDINARY TABLETS 1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8061PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDLYRICA 25MGPREGABALIN25 MGPFIZER GMBH ARZEIMITELWORK -MOOSWADALLE 179090, FREIBERG GERMANYGERMANYORAL SOLID ORDINARY CAPSULES 1.0X2.0X14.0 CAPSULE BLISTER
NDA/MAL/HDP/8062PFIZER LABORATORIES (PTY) LTD BELGIUMLABOREX UGANDA LIMITEDPROSTIN E2DINOPROSTONE3MGPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURSBELGIUMVAGINAL TABLETS 1.0X4.0 TABLET STRIP
NDA/MAL/HDP/8063PFIZER LABORATORIES (PTY) LTD ITALYLABOREX UGANDA LIMITEDUNASYN 1.5AMPICILLIN + SULBACTAM1000 MG + 500 MGHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELEITALYPARENTERAL ORDINARY DRY VIALS 1.0X1.0X1.5 G VIAL
NDA/MAL/HDP/8073NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTRILEPTALOXCARBAZEPINE300MGNOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALYITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X50.0 TABLET CONTAINER
NDA/MAL/HDP/8078AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 100/270ARTESUNATE + AMODIAQUINE100 MG + 270 MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBADINDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X6.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/8080KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCEFTONECEFTRIAXONE1GKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION
NDA/MAL/HDP/8082MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDABACAVIR SULFATE + LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE60MG + 30MGMYLAN LABORATORIES LIMITEDD ,-F-4 & F-12,MIDC, MALEGAON,SIRRRRAR, NASHIK -422113 MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8084AGILA SPECIALTIES PRIVATE LIMITEDKIMSY MEDS LTDTAZPENPIPERACILLIN + TAZOBACTAM4+0.5 G/VIALMYLAN LABORATORIES LIMITED(BETA LACTAM DIVISION)-NO. 152/6, 154/16 DORESANIPALYA, BILEKAHALLI, BANNERGHATTA ROAD BANGALORE - 560 076 INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X4.5 G VIAL
NDA/MAL/HDP/8085KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCIPROL-500CIPROFLOXACIN500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8087ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDONDEM INJECTION 4MG/2MLONDANSETRON4MG/2MLALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/8088ALKEM LABORATORIES LIMITED ABACUS PHARMA (AFRICA) LIMITEDONDEM INJECTION 8MG/4MLONDANSETRON8MG/4MLALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X4.0 ML AMPOULE
NDA/MAL/HDP/8089KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM-AMOXYAMOXYCILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER
NDA/MAL/HDP/8091 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEGEL SUSPENSIONALUMINIUM HYDROXIDE+MAGNESIUM TRISILICATE120MG+250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8092LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL 250MGAMOXYCILLIN250MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349 OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA. KENYAORAL SOLID ORDINARY CAPSULES 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8093CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIR-NZIDOVUDINE + LAMIVUDINE + NEVIRAPINE 300MG + 150MG + 200MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8095DENK PHARMA GMB H &CO. KGBENLE CONSULT LIMITEDCOLOSAR-DENK 100/12.5LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE100MG + 12.5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8096ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDBENZALINBENZATHINE BENZYLPENICILLIN SODIUM2.4MEGA/ VIALREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100CHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0 VIAL CARTON
NDA/MAL/HDP/8097SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITIN 5000ERYTHROPOIETIN5000IU/ 0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIAINDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X6.0X0.5 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/8100GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDAMPICLOXAMPICILLIN/ CLOXACILLIN250MG/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/8103UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDWELQUINE 500LEVOFLOXACIN500MGAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8104ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDTELPRESS 40TELMISARTAN40MGPSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8105UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDXERINLEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM5MG + 10MGAKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8106UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDPLENMOXIMOXIFLOXACIN HYDROCHLORIDE0.4%W/VAKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8107UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDWELRAB 20RABEPRAZOLE SODIUM20MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8108MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDORSGLUCOSE ANHYDROUS+TRISODIUM CITRATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE6.75G + 1.45G + 1.3G + 0.75G: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE POSTAL ADDRESS : P.O.BOX 5917, KAMPALA. UGANDAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0X25.0 G SACHET
NDA/MAL/HDP/8109ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDIRON FOLATEFERROUS IRON + FOLIC ACID65MG + 0.4MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV, INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN) INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8110MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDR.B.TONE SYRUPMULTI-INGREDIENTN/AMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X200.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8112MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMOXICLAVAMOXICILLIN + CLAVULANIC ACID156.25MG/5MLMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY POWDERS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8113MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMOXICLAV FORTEAMOXICILLIN + CLAVULANIC ACID312.5MG/5ML MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREACYPRUSORAL SOLID ORDINARY POWDERS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8115MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDLAMIVUDINELAMIVUDINE150MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8116MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE200MG + 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/8118MACLEODS PHARMACEUTICALS LTD NORVIK ENTERPRISES LIMITEDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR200MG + 50MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X120.0 TABLET BOTTLE
NDA/MAL/HDP/8119SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDHALOPERIDOL DECANOATEHALOPERIDOL DECANOATE50MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE
NDA/MAL/HDP/8120SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDABTALPHA-BETA ARTEETHER75MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X3.0X2.0 ML AMPOULE
NDA/MAL/HDP/8121SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDSWISSQUINEQUININE300MG/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/8123CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.MYCIDAC- CMYCOBACTERIUM W (HEAT KILLED) + SODIUM CHLORIDE0.5 *10 TO POWER 9 BACILLI + 0.9%W/VCADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARATINDIAPARENTERAL RETARD I M PRE-FILLED SYRINGES 1.0X0.2 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/8124RENE PHARMACY(R) LTD..RENE PHARMACY LTDCODEINE PHOSPHATE CODEINE PHOSPHATE30 MGCYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015INDIAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE
NDA/MAL/HDP/8125DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDKIMSY MEDS LTDMATADORLEVOFLOXACIN500MGDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD, -NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/8127SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2% W/VSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X30.0 ML VIAL
NDA/MAL/HDP/8128MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDATOREG 10ATORVASTATIN CALCIUM10MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8129MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDATOREG 20ATORVASTATIN CALCIUM20MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD.-SY. N0. 172 & 173,PARK ROAD, DULAPALLY VILLAGEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8130DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDDEGRA 100SILDENAFIL CITRATE100MGDEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8131DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDDEGRASILDENAFIL CITRATE50MGDEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8132MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDZOLIGLIT 30PIOGLITAZONE HYDROCHLORIDE30MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8133MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDMYHEPSOFOSBUVIR400MGMYLAN LABORATORIES LIMITEDD ,-F-4 & F-12,MIDC, MALEGAON,SIRRRRAR, NASHIK -422113 MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X28.0 TABLET BOTTLE
NDA/MAL/HDP/8134MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSALPRAZ 40PANTOPRAZOLE40MGAIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANAINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X7.0 TABLET BLISTER
NDA/MAL/HDP/8135BAL PHARMA LIMITEDSHREEJI PHARMACEUTICALS LIMITEDREGAMOLPARACETAMOL500MG BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8137IDA FOUNDATIONKIMSY MEDS LTDDIAZEPAMDIAZEPAM10MGGLAND PHARMA LIMITED-D. P PALLY NARSAPUR ROAD, HYDERABAD ? 500 043, INDIA INDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/8140SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDFUROSEMIDEFUROSEMIDE40MGSANDOZ PVT LTD.--MIDC IND, AREA KALWE BLOCK VILLAGE DIGHE NAVI MUMBAI 400708INDIAORAL SOLID ORDINARY TABLETS 1.0X4.0X25.0 TABLET BLISTER
NDA/MAL/HDP/8142BAYER EAST AFRICA LTDSURGIPHARM (U) LIMITEDXARELTORIVAROXABAN2.5MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8143NAARI LTDECHO PHARMACY (U) LIMITEDLYDIA POSTPILLEVONORGESTREL1.5MGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/8144NAARI LTDECHO PHARMACY (U) LIMITEDMA KAREMIFEPRISTONE + MISOPROSTOL200MG+ 200MCG NAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHANDINDIAORAL SOLID ORDINARY TABLETS 1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/8145DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR 10MONTELUKAST SODIUM10MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8146DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR JUNIOR 4MONTELUKAST SODIUM4MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8147DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDDENK- AIR JUNIOR 5MONTELUKAST SODIUM 5 MG DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8148SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDFLUCLOXACILLINFLUCLOXACILLIN500MGSPARSH BIO-TECH PVT. LTD.--PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR ? 361006 GUJARAT INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8149GLAXO SMITHKLINE LTDERIS LTDAVODARTDUTASTERIDE0.5MGGLAXOSMITHKLINE PHARMACEUTICALS SA .-GRUNWALDZKA 189 STREET, 60-322 POZNANA POLANDORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8150NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDJAKAVIRUXOLITINIB20MGNOVARTIS PHARMA STEIN AG-CH. 4002 STEIN, SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8151 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGO-C (THANE)VITAMIN C100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/8152NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDJAKAVIRUXOLITINIB15MGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8154 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDAGOGCORTHYDROCORTISONE ACETATE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/8155NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDJAKAVIRUXOLITINIB5MGNOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS 1.0X4.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8156TATA UGANDA LIMITEDGITTOES PHARMACEUTICALS LIMITEDDIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINEDIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE25 LF (? 30 IU)+5.5 LF (? 40 IU)+16 IOU (? 4.0 IU)+12.5MCG+11MCGBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078INDIAPARENTERAL ORDINARY I M VIALS 1.0X48.0X0.5 ML VIAL (1 DOSE VIAL),1.0X24.0X5.0 ML VIAL (10 DOSE VIAL)
NDA/MAL/HDP/8157 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDD LYTE- PLAINANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE + POTASSIUM CHLORIDE13.50G + 2.60G + 2.90G +1.50G/ 1LAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X20.5 G SACHET
NDA/MAL/HDP/8158SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDGLIMEPIRID SANDOZGLIMEPIRIDE3MGLEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATESPOLANDORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8159AUROBINDO PHARMA LIMITED (UNIT III)GITTOES PHARMACEUTICALS LIMITEDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR100MG + 25MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8160FOUNTIL LIFE SCIENCES PVT LTD.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDULGICID (CHERRY FLAVOUR)ALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE200MG+250MG+250MG+250MG+125MG/15MLSTEDMAN PHARMACEUTICALS PVT LTD...-C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORURINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8162BHARAT SERUMS AND VACCINES LTDGITTOES PHARMACEUTICALS LIMITEDHUMOG 75 HPHIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] /150 I.U75 IU + 75 IU/ 150 I.U VIALBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501INDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON + 1*1 ML AMPOULE OF 0.9%W/V NACL
NDA/MAL/HDP/8163MODI-MUNDIPHARMA PVT. LTDSURGIPHARM (U) LTDBETADINE SURGICAL SCRUBPOVIDONE-IODINE7.5%W/WG.S. PHARMBUTOR PVT. LTD., B-172, INDUSTRIAL AREA, BEHROR-301 701, RAJASTHAN, INDIAINDIATOPICAL SOLUTION1X1X50ML, 1X500ML, PET BOTTLE
NDA/MAL/HDP/8164INDOCO REMEDIES LTDTATA UGANDA LIMITEDATM 200AZITHROMYCIN DIHYDRATE200MG/5MLINDOCO REMEDIES LTD, B-20,-B-20 MIDC, WALUJ, AURANGABAB 431136 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/8165UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDCUFO BLACK CURRANT2,4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESOL1.2MG + 0.6MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER
NDA/MAL/HDP/8166UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDCUFO ORANGE2,4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESO1.2MG + 0.6MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER
NDA/MAL/HDP/8167MODI-MUNDIPHARMA PVT. LTDSURGIPHARM (U) LTDBETADINE STANDARDISED MICROBICIDAL SOLUTION 10% W/VPOVIDONE-IODINE10%W/WG.S. PHARMBUTOR PVT. LTD., B-172, INDUSTRIAL AREA, BEHROR-301 701, RAJASTHAN, INDIAINDIATOPICAL SOLUTION1X1X50ML, 1X1X100ML, 1X500ML BOTTLE
NDA/MAL/HDP/8168PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDUNASYN 750MGSULTAMICILLIN TOSYLATE750MGHAUPT PHARMA LATINA S.R.L -STRADA STATALE 156 KM 47,600 04100 BORGO SAN MICHELE LATINA,ITALY.ITALYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X4.0 TABLET STRIP
NDA/MAL/HDP/8169PALASH PHARMA.BSUPER MEDIC LTDZIMYCINAZITHROMYCIN DIHYDRATE200MG /5MLSAGA LABORATORIES SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA, TAL.: SANAND, DIST.: AHMEDABAD 382 210, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1X1X5ML, PET BOTTLE
NDA/MAL/HDP/8170FOUNTIL LIFE SCIENCES PVT LTD.PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDULGICID (PINEAPPLE FLAVOUR)ALGINIC + MAGNESIUM HYDROXIDE +DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE200MG+250MG+250MG+250MG+125MG/15MLSTEDMAN PHARMACEUTICALS PVT LTD...-C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORURINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8171KHANDELWAL LABORATORIES PVT. LTD.SURGIPHARM (U) LTDPLATINEX 50CISPLATIN50MG/50MLKHANDELWAL LABORATORIES PVT. LTD. PLOT B-1, WAGLE INDUSTRIAL ESTATE, THANE- 400 604. MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY VIALS 1X1X50ML, GLASS VIAL
NDA/MAL/HDP/8172ACINO PHARMA AGGOODMAN INTERNATIONAL LTDCOAMOX-ACINO 875AMOXICILLIN + CLAVULANIC ACID875MG + 125 MGLABESFAL LABORATORIES ALMIRO S.A-LAGEDOSANT, SOLVENIASLOVENIAORAL SOLID ORDINARY TABLETS 1.0X3.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8177MEGA LIFESCIENCES (AUSTRALIA) PTY LTDASTRA PHARMA (U) LIMITEDCILZEC PLUSTELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER, AMPOULE AMPOULE
NDA/MAL/HDP/8178 AGOG PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDNYSTAGO TABLETSNYSTATIN500,000I.UAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIAINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8180COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOL TABLETS 500MGPARACETAMOL500MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X50.0X2.0 TABLET STRIP,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/8182STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDSTRICORTHYDROCORTISONE500MGSTRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD BANGALORE 560076 INDIA INDIAPARENTERAL RETARD DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/8183STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDSTRICORT-100HYDROCORTISONE SODIUM SUCCINATE100MGSTRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD BANGALORE 560076 INDIA INDIAPARENTERAL ORDINARY DRY VIALS 1.0X100.0 MG VIAL
NDA/MAL/HDP/8184STRIDES ARCOLAB LIMITEDROYAL PHARMA 2011 LIMITEDTETRACYCLINETETRACYCLINE HYDROCHLORIDE250MGSTRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER
NDA/MAL/HDP/8185STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDINDOMETHACIN CAPSULESINDOMETHACIN25MGSTRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER
NDA/MAL/HDP/8186STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDCELOVANVANCOMYCIN HYDROCHLORIDE500MGSTRIDES ARCOLAB LIMITED .-OPP. 11M BILEKAHALLI, BANNERGINDIAPARENTERAL ORDINARY VIALS 1.0X500.0 G VIAL
NDA/MAL/HDP/8188AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE + ZIDOVUDINE + NEVIRAPINELAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGAUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8189AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULPHATE TABLETSABACAVIR SULPHATE 300MGAUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8190AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLAMIVUDINE TABLETSLAMIVUDINE 150 MGAUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)INDIAORAL SOLID ORDINARY TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8191AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDIDANOSINE DELAYED-RELEASEDIDANOSINE DELAYED-RELEASE400MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIAINDIAORAL SOLID RETARD CAPSULES 1.0X30.0 CAPSULE BOTTLE
NDA/MAL/HDP/8192LINCOLN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDL-KELFINSULPHADOXINE + PYRIMETHAMINE500MG + 25MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/8193MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDECOX 400ETHAMBUTOL400MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. ,MACLEODS PHARMACEUTICALS LTD- -PLOT 25-27, SURVEY NO. 306, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT)- 396210, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/8194MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDSOLONEX-100ISONIAZID100MGMACLEODS PHARMACEUTICALS LTD .-PLOT 1 & 2 MAHIM ROAD NEAR KULDEEP NAGAR, PALGHAR (W) 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/8195MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDRH-COMRIFAMPICIN & ISONIAZID150MG +75MGMACLEODS PHARMACEUTICALS LTD .-PLOT 1 & 2 MAHIM ROAD NEAR KULDEEP NAGAR, PALGHAR (W) 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/8196MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDANTI-THYROXCARBIMAZOLE5MGMACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101,MACLEODS PHARMACEUTICALS LTD .-PLOT 1 & 2 MAHIM ROAD NEAR KULDEEP NAGAR, PALGHAR (W) 401 404 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8197EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDAMIKACINAMIKACIN SULPHATE500MG/2ML EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS 1.0X2.0 ML VIAL
NDA/MAL/HDP/8198MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDXYMEX DROPSMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/8199MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDXYMEX SYRUPMULTIVITAMIN/ DIASTASE/PEPSINMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8200MEDIPHARM INDUSTRIES LTDMEDIPHARM INDUSTRIES (E.A) LTDORS ORANGEGLUCOSE ANHYDROUS + TRISODIUM CITRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE6.75G + 1.45G + 1.3G + 0.75G / SACHETMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDAUGANDAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.4 G SACHET
NDA/MAL/HDP/8201CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCENTROZINECETIRIZINE HYDROCHLORIDE5MG/5MLCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506INDIAORAL LIQUID ORDINARY SYRUPS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/8202MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDISONIAZIDISONIAZID300MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT) - 396210, INDIA. ,OXALIS LABS--VILLAGE THEDA,P.O.LODHIMAJRA ,TEHSIL BADDI,DIST .SOLAN (HIMACHAL PRADESH) - 174101 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER
NDA/MAL/HDP/8204FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDDOPAMINE HCL FRESENIUSDOPAMINE HYDROCHLORIDE200MG/5MLFRESNIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD KORSTEN PORT ELIZABETH 6020SOUTH AFRICAPARENTERAL ORDINARY AMPOULES 1.0X10.0X5.0 ML AMPOULE
NDA/MAL/HDP/8205Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDANLODINAMLODIPINE BESYLATE10MG Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSANMALAYSIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8206BRAWN LABORATORIES LTDROYAL PHARMA 2011 LIMITEDBRULEXINCEFALEXIN MONOHYDRATE125MG/5MLBRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8207NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDZOMETAZOLEDRONIC ACID4MG/5MLNOVARTIS PHARMA STEIN AG ;-SCHAFFHAUSERSTRASSE CH 4332 STEIN-SWITZERLANDSWITZERLANDPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/8208 CIRON DRUGS & PHARMACEUTICAL PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL SODIUM SUCCINATECHLORAMPHENICOL SODIUM SUCCINATE1GCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X25.0X1.0 G VIAL
NDA/MAL/HDP/8209 CIRON DRUGS & PHARMACEUTICAL PVT LTDRENE PHARMACY LTDTHIOPENTAL SODIUM INJECTIONTHIOPENTAL SODIUM 1GM / VIALCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X50.0X1.0 G VIAL
NDA/MAL/HDP/8210CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDHYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BPHYDROCORTISONE100MGCIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506INDIAPARENTERAL ORDINARY DRY VIALS 1.0X50.0X100.0 MG VIAL
NDA/MAL/HDP/8211SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCO-ASTHALIN SYRUPSALBUTAMOL + BROMHEXINE2MG/5ML + 4MG/5MLBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYAKENYAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8212FDC LTDAIVEEN (U) LIMITEDBACTIGEN EYE/EAR DROPSGENTAMICIN0.3%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC VIALS 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL
NDA/MAL/HDP/8213FDC LTDAIVEEN (U) LIMITEDZOCON 200FLUCONAZOLE200MGFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY TABLETS 1.0X5.0X2.0 TABLET BLISTER
NDA/MAL/HDP/8216SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDSEFOTAXCEFOTAXIME SODIUM1GSWISS 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/8217S KAGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDMETFOKANTMETFORMIN HYDROCHLORIDE850MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8218 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDDECLOPHEN 12.5DICLOFENAC SODIUM12.5MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTRECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/8219 PHARCO B PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDDERMATINCLOTRIMAZOLE1%W/VPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT. P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT EGYPTTOPICAL EXTERNAL LIQUIDS 1.0X20.0 ML BOTTLE
NDA/MAL/HDP/8221 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDNEMADOLTRAMADOL HYDROCHLORIDE50MG/ML NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARANEPALPARENTERAL ORDINARY AMPOULES 1.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/8222MICRO LABS LTDLABOREX UGANDA LIMITEDLUBREXSODIUM CARBOXYMETHYL CELLULOSE0.5%W/VMICRO LABS LTD ..NO 113 TO 116, 4TH PHASE, KIADB BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE-560099INDIAOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/8223IRAN MEDICAL GROUP COMPANY UNEED GLOBAL GROUP LIMITEDLORAXIMECEFOTAXIME1000MG/MLEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANIRANPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 MG VIAL
NDA/MAL/HDP/8224EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIGENTGENTAMICIN SULFATE0.3%W/WEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B EGYPT EGYPTOPHTHALMIC OINTMENTS 1.0X5.0 G TUBE
NDA/MAL/HDP/8225LINCOLN PARENTERAL LIMITEDMETRO PHARMACEUTICALS LIMITEDARTELIN 60ARTESUNATE60MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X60.0 MG VIAL + 1*1 ML AMPOULE OF 5.0%W/V SODIUM BICARBONATE INJECTION B.P + 1*5 ML AMPOULE OF 0.9%W/V NACL
NDA/MAL/HDP/8226DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDSALRESSALBUTAMOL SULPHATE120.5MCG/SPRAYDEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYLUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER 1.0X200.0 METERED DOSE CANNISTER
NDA/MAL/HDP/8227HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDALZER 5DONEPEZIL HYDROCHLORIDE5MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8228AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDVITAMIN B-COMPLEX (BEEKO)VITAMINS B1 + B2 + B6 + NIACINAMIDE1MG +1MG +1MG +15MGSTRIDES SHASUN LTD .-PLOT 9-12 DEWAN & SONS INDL AREA VEOOR PALGHARINDIAORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8229CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATE + LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE60MG + 30MGCIPLA LTD-A-33 & A-37/2/2 MIDC PATALGANGA 410220INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8230LIFEPHARM FZEAIVEEN (U) LIMITEDPANALIFEPARACETAMOL500MGLIFE PHARMA FZE --JEBEL ALI FREE ZONE, PLOT NO. MO 0502, P.O. BOX 17404, DUBAI-UAEUNITED ARAB EMIRATESORAL SOLID ORDINARY TABLETS 1.0X2.0X12.0 TABLET BLISTER
NDA/MAL/HDP/8231DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDANASTROZOLE DENKANASTROZOLE1MGHAUPT PHARMA GMBH & CO KG-SCHLEEBRUGGENKAMP 15, 48159 MUNSTER, GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8232GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDMOMATEMOMETASONE FUROATE MONOHYDRATE50MCG/ SPRAYGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA,GLENMARK PHARMACEUTICALS LTD-VILLAGE, KISHANPURA, BADDI, NALAGARH ROAD, INDIAINDIANASAL SYSTEMIC METERED-DOSE LIQUIDS 1.0X120.0 METERED DOSE BOTTLE
NDA/MAL/HDP/8233CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCOLSTIMFILGRASTIM300?G/MLCADILA HEALTHCARE LTD.--PLOT SURVEY NO. 23, 25/P, 37, 40/P, 42 TO 47 SARKHEJ BAVLA N.H NO.8A OPP.RAMDEV MASALA CHANGODAR TAL. SANAND DIST AHMEDABAD 382213INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X1.0 ML PRE- FILLED SYRINGE
NDA/MAL/HDP/8234ABBOT LABORATORIES S.A. (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDINFUVAC 2015INACTIVATED INFLUEZA VACCINE-SURFACE ANTIGEN [A/CALIFORNIA/7/2009(H1N1) PDM09 + A/SWITZERLAND/9715293/2013(H3N2) + B/PHUKET/3073/2013-LIKE STRAINS]15?G + 15?G +15?GABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLSTNETHERLANDSPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)
NDA/MAL/HDP/8235DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + SERRATIOPEPTIDASE + PARACETAMOL100MG + 15MG + 500MGDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8236KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LTDHYDROGEN PEROXIDEHYDROGEN PEROXIDE6%W/VKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDATOPICAL EXTERNAL LIQUIDS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8237GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GOODMAN INTERNATIONAL LTDBCOOLCETYLPYRIDINIUM CHLORIDE + LIDOCAINE HYDROCHLORIDE1MG +1MGGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA STREET RAS AL KHAIMAHUNITED ARAB EMIRATESORAL SOLID ORDINARY LOZENGES 1.0X2.0X9.0 LOZENGE BLISTER
NDA/MAL/HDP/8238MERIDIAN ENTERPRISES PRIVATE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDMETROSUPP 500METRONIDAZOLE500MGMERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1.0X2.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/8239GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDERIS LTDUMBIPRO GELCHLORHEXIDINE 4%W/WGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UKUNITED KINGDOMTOPICAL EXTERNAL GELS AND SOLS 1.0X7.0 SACHET CARTON
NDA/MAL/HDP/8240STRIDES ARCOLAB LIMITEDVEERAM HEALTHCARE (U) LIMITEDEFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE600MG + 200MG + 300MGSTRIDES 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/8241ACINO PHARMA AGGOODMAN INTERNATIONAL LTDCLOPACINCLOPIDOGREL BESILATE75MGACINO PHARMA AG .-BIRSWEG 2 4253 LIESBERG BASEL LANDSWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS 2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8242IDA FOUNDATIONKIMSY MEDS LTDTETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAOPHTHALMIC OINTMENTS 1.0X50.0X5.0 G TUBE
NDA/MAL/HDP/8244MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDHERTRAZ 440TRASTUZUMAB (R-DNA ORIGIN)440MGBIOCON LIMITED-SPECIAL ECONOMIC ZONE, PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIAPARENTERAL ORDINARY DRY VIALS 1.0X440.0 MG VIAL ,1X2X10ML VIALS OF WFI
NDA/MAL/HDP/8245AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDMOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDE0.5%W/VAXA PARENTERAL LIMITED-PLOT NO.936,937&939, VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR (UTTARAKHAND) INDIA.INDIAOPHTHALMIC DROPS 1.0X5.0 ML BOTTLE
NDA/MAL/HDP/8246PHARMACIA S.P.AERIS LTDALDACTONESPIRONOLACTONE25MGPIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND UNITED KINGDOMORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8247SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDE-DOLTRAMADOL 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 1.0X2.0X5.0X2.0 ML AMPOULE
NDA/MAL/HDP/8248CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDCLAVACE SUSPENSIONAMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM457MG/5MLALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8249RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDPANZOL-DPANTOPRAZOLE+DOMPERIDONE20MG + 10MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8250CIPLA LTDQUALITY CHEMICALS LTD - HUMANLUMARTEM DTARTEMETHER+LUMEFANTRINE20MG+120MGCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER
NDA/MAL/HDP/8251HEALTHCARE PHARMACEUTICALS LTDECHO PHARMACY (U) LIMITEDFUROTILCEFUROXIME AXETIL250MGHEALTHCARE PHARMACEUTICALS LTD -RAJENDRAPUR GAZIPURBANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X6.0 TABLET BLISTER
NDA/MAL/HDP/8252FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDPARACETAMOL FRESENIUSPARACETAMOL10MG/MLFRESENIUS KABI AUSTRIA GMBH-AUSTRIA GMBH HAFNERSTRASSEM 36 8055 GRAZAUSTRIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X10.0X50.0 ML VIAL
NDA/MAL/HDP/8253REYOUNG PHARMACEUTICAL CO LTDROYAL PHARMA 2011 LIMITEDDICLOFENAC SODIUMDICLOFENAC SODIUM25MG/MLREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100CHINAPARENTERAL ORDINARY AMPOULES 10.0X10.0X3.0 ML AMPOULE
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NDA/MAL/HDP/8274HETERO LABS LTD ABACUS PHARMA (AFRICA) LIMITEDBICATERO 50BICALUTAMIDE50MGHETERO LABS LTD (UNIT-VI)-"SY.NO. 439, 440 & 458,APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT ANDHRA PRADESH-509301 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
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NDA/MAL/HDP/8278HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDANATEROANASTROZOLE1MGHETERO LABS LTD, UNIT VI, INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
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NDA/MAL/HDP/8281UNIMED INDIAMETAPLUS (U) LIMITEDCO-TRIMOXAZOLE TABLET BPCO-TRIMOXAZOLE480MGUNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/8282SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDBINOZYT 500AZITHROMYCIN500MGSANDOZ SRL LTD-LIVEZENI STREET 7A540472 TARGU MURES ROMANIAROMANIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/8283ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDQUINASQUININE SULPHATE BP300MGASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABADINDIAORAL SOLID ORDINARY COATED TABLETS 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/8285TATA UGANDA LIMITEDTATA UGANDA LIMITEDCUFO LOZENGES(HONEY LEMON) 2,4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESOL1.2MG+ 0.6MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210INDIAORAL SOLID ORDINARY LOZENGES 1.0X2.0X12.0 LOZENGE BLISTER
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NDA/MAL/HDP/8292META PRODUCTS UGANDA LTDMETAPLUS (U) LIMITEDPARACETAMOLPARACETAMOL500MGHEBEI JIHENG (GROUP) PHARMACEUTICAL CO LTD 368-HEBEI JIHENG (GROUP) PHARMACEUTICAL CO LTD 368 JIANSHE ST HENGSHUI CITY HEBEI 053000CHINAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
NDA/MAL/HDP/8297COSMOS LTDASTRA PHARMA (U) LIMITEDISONIAZIDE TABLETSISONIAZID100MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 10.0X10.0 TABLET BLISTER,1000.0 TABLET CONTAINER
NDA/MAL/HDP/8306GILEAD SCIENCES, INC.UNITED HEALTHCARE DISTRIBUTORS LTDSOVALDISOFOSBUVIR400MGPATHEON INC. 2100 SYNTEX COURT MISSISSAUGA, ONTARIO ON L5N 7K9 CANADA GILEAD SCIENCES IRELAND UC IDA BUSINESS AND TECHNOLOGY PARK CARRIGTOHILL, CO. CORK IRELANDCANADA IRELANDORAL SOLID ORDINARY FILM-COATED TABLETS 1X1X28 TABLET BOTTLE
NDA/MAL/HDP/8309INDUS PHARMA PVT LTDHEALTHCARE LTD.SNOLIP 20MGATORVASTATIN200MGINDUS PHARMA (PVT) LTD ,-PLOTS NO. 64, 65, 66 & 67, SECTOR -27, KORANGI INDUSTRIAL AREA, KARACHI - 74900INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/8312CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TRICORT 40 TRIAMCINOLONE ACETONIDE 40MG/MLCADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA ? 387 810, AHMEDABAD, GUJARAT STATE INDIA INDIAPARENTERAL ORDINARY VIALS 1.0X1.0 ML VIAL
NDA/MAL/HDP/8313 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDFULYZAQ DELAYED RELEASE TABLETSCROFELEMER125 MGPATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USAUNITED STATESORAL SOLID RETARD ENTERIC-COATED TABLETS 1.0X60.0 TABLET CONTAINER
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NDA/MAL/HDP/8315JANSSEN-CILAG INTERNATIONAL NVMEDICAL ACCESS (UGANDA) LIMITEDPREZISTA 75DARUNAVIR75MGJANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X480.0 TABLET BOTTLE
NDA/MAL/HDP/8316AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDOLUTEGRAVIR 50 MG/ LAMIVUDINE 300 MG/ TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETSDOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50MG + 300MG + 300MG"AUROBINDO PHARMA LIMITED-UNIT ?VII, SEZ, TSIIC, PLOT NO. SI,S. NO.?S 411/P, 425/P, 434/P, 435/P & 458/P,GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT -509 302 TELANGANA STATE, INDIA" INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8317ACULIFE HEALTHCARE SUPER MEDIC LTDMERONIR 500MEROPENEM 500MGACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL + 1*10ML AMPOULE OF WFI
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NDA/MAL/HDP/8319KOPRAN LIMITEDTATA UGANDA LIMITEDERYKO-250ERYTHROMYCIN STEARATE TABLETS BP 250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER
NDA/MAL/HDP/8320 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDSTACEF 1 GMCEFTRIAXONE SODIUM 1 GMNATIONAL HEALTHCARE PVT. LTD.-(WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPALNEPALPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/8321UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDPROSTER- 200 CAPSULESPROGESTERONE200 MGAKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8322 GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEMONT LMONTELUKAST SODIUM+LEVOCETIRIZINE DIHYDROCHLORIDE10 MG + 5 MGGLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X14.0 TABLET BOTTLE
NDA/MAL/HDP/8324CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDLOOBID TABLETSOFLOXACIN + ORNIDAZOLE 200MG + 500 MG CACHET PHARMACEUTICAL PVT LTD. HIMACHAL-THANA, BADDI, HIMACHAL PRADESH-173 205, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8325PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDUNASYNSULTAMICILLIN250MG/5MLHAUPT PHARMA LATINA S.R.L -STRADA STATALE 156 KM 47,600 04100 BORGO SAN MICHELE LATINA,ITALY.ITALYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X60.0 ML BOTTLE
NDA/MAL/HDP/8326MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 250 DTAMOXICILLIN250MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8327ARYOGEN PHARMED CO.UNEED GLOBAL GROUP LIMITEDZYTUXRITUXIMAB500MG/50MLARYOGEN PHARMED CO. NO. 140, TAJBAKHSH STREET, 24TH KILOMETER TEHRAN-KARAJ MAKHSOUS ROAD, ALBORZ,IRANIRANPARENTERAL ORDINARY INFUSION VIALS/BOTTLES?1.0x1.0x50.0 ML VIAL
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NDA/MAL/HDP/8330RESONANT PHARMACEUTICALSSHREEJI PHARMACEUTICALS LIMITEDCOARTLUMEFANTRINE + ARTEMETHER 480 MG + 80 MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/8331MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTORSINEX-20TORSEMIDE20MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8332DEVA HOLDING A.SSHREEJI PHARMACEUTICALS LIMITEDAZITRO 500 MGAZITHROMYCIN 500MG DEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER
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NDA/MAL/HDP/8338PINNACLE LIFE SCIENCE PVT. LTD.METRO PHARMACEUTICALS LIMITEDACEAAR PACECLOFENAC + PARACETAMOL100MG +325MGPINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)INDIAORAL SOLID ORDINARY TABLETS 1.0X20.0X10.0 TABLET BLISTER
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NDA/MAL/HDP/8341GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDGENVOYAELVITEGRAVIR+COBICISTAT+EMTRICISTABINE+TENOFOVIR ALAFENAMIDE150MG + 150MG + 200MG + 10MGPATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9CANADAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
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NDA/MAL/HDP/8345CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCELZA 500CEFUROXIME AXETIL USP 500 MGALKEM LABORATORIES LTD--PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESHINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8346AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDADERAN 8CANDESARTAN CILEXETIL 8MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8347YICHANGHUMANWELL PHARMACEUTICAL CO., LTD.KAIYUANTANG (U) LIMITEDFENTWELL 0.05MG/MLFENTANYL CITRATE0.05MG/MLYICHANGHUMANWELL PHARMACEUTICAL CO., LTD.-NO.19,DALIAN ROAD, YICHANG DEVELOPING ZONE,HUBEI PROVINCE ,CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X5.0X10.0 ML AMPOULE
NDA/MAL/HDP/8348?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LIMITEDIRBECOR PLUS 300MG/12.5MGIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MG?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1 SEL?UKLU / KONYATURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8349TIL HEALTHCARE PVT LTDKPI HEALTHCARE LIMITEDASTYMIN-C DROPSL-LEUCINE USP + L-ISOLEUCINE USP + L-LYSINE HYDROCHLORIDE USP + L-PHENYLALANINE USP + L-THREONINE USP + L-VALINE USP+ L-TRYPTOPHAN USP + DL-METHIONINE USP + ASCORBIC ACID BP 0.84M+1.43MG+1.84MG+1.18MG+3.66MG+1.00MG+1.00MG+5.00MG+100MGTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIAINDIAORAL LIQUID ORDINARY DROPS 1.0X15.0 ML BOTTLE
NDA/MAL/HDP/8350YICHANGHUMANWELL PHARMACEUTICAL CO., LTD.KAIYUANTANG (U) LIMITEDFENTWELL 0.05MG/MLFENTANYL CITRATE0.05MG/MLYICHANGHUMANWELL PHARMACEUTICAL CO., LTD.-NO.19,DALIAN ROAD, YICHANG DEVELOPING ZONE,HUBEI PROVINCE ,CHINACHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/8351TIL HEALTHCARE PVT LTDKPI HEALTHCARE LIMITEDASTYMIN SYRUPL-LEUCINE+L-ISOLEUCINE+L-LYSINE HYDROCHLORIDE+L-PHENYLALNINE+L-THREONINE+L-METHIONINE+L-TRYPTOPHAN+L-VALINE+THIAMINE HYDROCHLORIDE+RIBOFLAVING HYDROCHLORIDE+NICOTINAMIDE+CALCIUM PANTOTHENATE+CYANOCOBALAMIN+FOLIC ACID+COLECALCIFEROL+ALPHATOCOPHERYLACETATE10.3MG + 5.9MG + 25MG + 5MG + 4.2MG + 9.2MG + 5MG + 6.7MG + 5MG + 1.5MG +25MG + 5MG + 2.5MCG + 0.75MG + 200IU AND 7.5IUTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8353AJANTA PHARMA LIMITED ABACUS PHARMA (AFRICA) LIMITEDNURIFER CAPSULESCARBONYL IRON + FOLIC ACID + VITAMIN B12 + VITAMIN C + ZINC SULFATE MONOHYDRATE100MG+1.5 MG + 15 MCG + 75 MG + 61.8 MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.INDIAORAL SOLID ORDINARY CAPSULES 1.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8354MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDZORUXAZOLEDRONIC ACID5MG/100MLGLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8355AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDONECLAPZ 75CLOPIDOGREL75MGAUROBINDO PHARMA LTD--UNIT VII SEZ PLOT S1 SPECIAL ECONOMIC ZONEINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8356UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLORFACT-DDESLORATIDINE5MG,AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8357FRESENIUS KABI SOUTH AFRICA (PTY) LIMITEDSURGIPHARM (U) LIMITEDFRESENIUS PROPOVEN 1%PROPOFOL1% W/VFRESENIUS KABI AUSTRIA GMBH PLANT GRAZ-HAFNERSTRASSE 36 A-8055 GRAZ AUSTRIA,FRESENIUS KABI AB PLANT UPPSALA-RAPSGATAN 7S-75174 UPPSALA SWEDENAUSTRIAPARENTERAL ORDINARY OTHER INFUSIONS 1.0X10.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL,1.0X10.0X100.0 ML VIAL
NDA/MAL/HDP/8358TIL HEALTHCARE PVT LTDKPI HEALTHCARE LIMITEDASTYMIN FORTEMULTI-INGREDIENTMULTI-INGREDIENTTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X5.0X3.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8359ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDASUNATE 120ARTESUNATE120MG LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS 1.0X120.0 MG VIAL + 1*10 ML SODIUM CHLORIDE IN GLASS AMPOULE + 1*2 ML SODIUM BICARBONATE IN GLASS AMPOULE
NDA/MAL/HDP/8392?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LIMITEDIRBECOR PLUS 150MG/12.5MGIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MG?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1 SEL?UKLU / KONYATURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8393 NATIONAL HEALTHCARE ANDYCO PHARMACY (UGANDA) LTDNACLOR EYE DROPS 10MLCHLORAMPHENICOL0.5% W/VNATIONAL HEALTHCARE PVT. LTD.--WORKS: STERILE BLOCK CHHATAPIPRA-3, BARA, NEPALNEPALOPHTHALMIC DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/8394MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDRIFAMPICIN 75 MG ISONIAZID 50 MG AND PYRAZINAMIDE 150 MG DISPERSIBLE TABLETSRIFAMPICIN + ISONIAZID + PYRAZINAMIDE75MG + 50MG + 150MGMACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMANINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X100.0 TABLET CONTAINER, 1.0X3.0X28.0 TABLET BLISTER
NDA/MAL/HDP/8395MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDRIFAMPICIN 75 MG ISONIAZID 50 MG DISPERSABLE TABLETSRIFAMPICIN + ISONIAZID75MG + 50MGMACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMANINDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X100.0 TABLET CONTAINER,1.0X3.0X28.0 TABLET BLISTER
NDA/MAL/HDP/8396MARIE STOPES INTERNATIONALMARIE STOPES UGANDA LIMITEDBACK-UPLEVONORGESTREL1.5MG ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0 TABLET BLISTER
NDA/MAL/HDP/8401KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKPI HEALTHCARE LIMITEDAZOX-500AZITHROMYCIN DIHYDRATE500MGTHE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY.-UM-AL-AMAD/PLANT ( RAZI ).P.O.BOX 151 UM-AL-AMAD 16197 JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X3.0 TABLET BLISTER
NDA/MAL/HDP/8406HETERO LABS LTD UNIT IXABACUS PHARMA (AFRICA) LIMITEDPIOGEN45PIOGLITAZONE HYDROCHLORIDE45MGHETERO LABS LIMITED .-S.NO.10, I.D.A., GADDAPOTHARAM VILLAGE, JINNARAM MANDAL,MEDAK DISTRICT, ANDHRA PRADESH, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8407INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDTORTAS 20TORSEMIDE20MGINTAS PHARMACEUTICALS LTD -CAMP ROAD, SELAQUI ? 248 197 DEHRADUN (UK)INDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8411LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDRHEUMAC GELDICLOFENAC1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYAKENYATOPICAL EXTERNAL GELS AND SOLS 1.0X20.0 G TUBE
NDA/MAL/HDP/8419ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDVB COMPLEX VIT B1+ VIT B2 +VIT B3 + NICOTINAMIDE+PANTOTHENOL10MG +1MG +1MG +16MG +0.5MGKIVI PHARM CO. LTD .-NO.5 HANGTIAN STREET, DONGSHAN HIGH TECH INDUSTRIAL DEVELOPMENT ZONE,SHALINGZI TOWN, XUANHUA,ZHANGJIAKOU CITY,HEBEI 075100, CHINA * CHINAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE
NDA/MAL/HDP/8424LINCOLN PARENTERAL LIMITEDMETRO PHARMACEUTICALS LIMITEDHAEMRICHFERRIC AMMONIUM CITRATE+ FOLIC ACID+PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE50MG + 0.55MG +2.4MG + 1.2MG +11MG /5MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARATINDIAORAL LIQUID ORDINARY SYRUPS 1.0X90.0 ML BOTTLE
NDA/MAL/HDP/8432 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDDECLOPHENDICLOFENAC SODIUM100MGPHARCO PHARMACEUTICALS-KILO 31 ALEXANDRIA-CAIRO DESERT ROAD AMRIYA ALEXANDRIAEGYPTRECTAL SYSTEMIC ADULT SUPPOSITORIES 1.0X5.0 SUPPOSITORY STRIP
NDA/MAL/HDP/8434DAWA LIMITEDSUPER MEDIC LTDDACINAZOLEMICONAZOLE NITRATE2%W/WDAWA LTD-BABA DOGO ROAD RUARAKA KENYATOPICAL EXTERNAL CREAMS 1.0X15.0 G TUBE
NDA/MAL/HDP/8443BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDEKON-D TABLETSCETIRIZINE10 MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET STRIP,1.0X10.0X12.0 TABLET STRIP
NDA/MAL/HDP/8466CIPLA LIMITEDQUALITY CHEMICALS LTD - HUMANLUMARTEM HS 80ARTEMETHER + LUMEFANTRINE80MG + 480MGCIPLA LIMITED--UNIT 1,VILLAGE UPPER MALPUR, P.O. BHUD, TEHSIL NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 173205, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0X6.0 TABLET BLISTER
NDA/MAL/HDP/8467MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOPHAGE XR 750MGMETFORMIN HYDROCHLORIDE750MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY,MERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADTFRANCEORAL SOLID ORDINARY TABLETS 1.0X4.0X15.0 TABLET BLISTER
NDA/MAL/HDP/8468THEON PHARMACEUTICALS LIMITTEDAIVEEN (U) LIMITEDTHEOMOX-500AMOXICILLIN500 MGTHEON PHARMACEUTICALS LIMITED.- VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8469UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDMETHICOWEL INJECTIONMETHYLCOBALAMIN500MCG/ML AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT III, PLOT NO 2,3,4 &5, SECTOR 6-B, IIE, SIDCUL RANIPUR HARIDWAR-249403 UTTARAKHAND INDIAINDIAPARENTERAL ORDINARY I M AMPOULES 1.0X5.0X1.0 ML AMPOULE
NDA/MAL/HDP/8470LUPIN LIMITEDAIVEEN (U) LIMITEDIXIME 400CEFIXIME400MGLUPIN LIMITED--198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/8471LUPIN LIMITEDAIVEEN (U) LIMITEDIXIME FOR ORAL SUSPENSIONCEFIXIME100MG/5MLLUPIN LIMITED--198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X75.0 ML BOTTLE
NDA/MAL/HDP/8472CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAV 375MGAMOXICILLIN + CLAVULANIC ACID250MG + 125MG MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8473S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDNYSTATIN VAGINAL INSERTSNYSTATIN100000 I.US KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARATINDIAVAGINAL TABLETS 1.0X10.0X10.0 TABLET STRIP
NDA/MAL/HDP/8474GLAXOSMITH KLINE LTDERIS LTDAUGMENTIN SACHETS 1G/125MGAMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE1000MG + 125MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCEFRANCEORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X12.0 SACHET CARTON
NDA/MAL/HDP/8475LINCOLN PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDOROCANMICONAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL TOPICAL GELS AND SOLS 1.0X15.0 G TUBE
NDA/MAL/HDP/8476 AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAURODANZ 8ONDANSETRON HYDROCHLORIDE DIHYDRATE8MGAUROBINDO PHARMA LTD--UNIT-III SURVEY NO. 313 & 314, BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT TELANGANA STATE INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8477WOCKHARDT LTDTATA UGANDA LIMITEDGLARITUS 100IU/MLINSULIN GLARGINE100IU/MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIAINDIAPARENTERAL ORDINARY CARTRIDGES 1.0X3.0 ML CARTRIDGE
NDA/MAL/HDP/8480 SUN PHARMACEUTICAL INDUSTRIES LTDSTAR PHARMACEUTICALS LTDERTIVIX 1MGENTECAVIR MONOHYDRATE1MGSUN PHARMACEUTICALS INDUSTRIES LIMITED--SEZ UNIT 1,A-41,INDUSTRIAL AREA, PHASE VIIIA,S.A.S NAGAR,MOHALI-160071,PUNJAB,INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8481LINCOLN PARENTERAL LIMITEDMETRO PHARMACEUTICALS LIMITEDPARACETAMOL BP INJECTIONPARACETAMOL150MG/MLLINCOLN PARENTERAL LTD -11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARATINDIAPARENTERAL ORDINARY AMPOULES 1.0X10.0X2.0 ML AMPOULE
NDA/MAL/HDP/8483SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDGLIMEPIRID SANDOZ? 2MG TABLETSGLIMEPIRIDE2MGLEK S.A--U1, PODLIPIE 16, 95-0140 STRYKOW POLANDPOLANDORAL SOLID ORDINARY TABLETS 1.0X9.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8484MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAVERNOLCARVEDILOL25MGMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8485CACHET PHARMACEUTICALS PVT LIMITEDASTRA PHARMA (U) LIMITEDTRIAXONCEFIXIME400MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205INDIAORAL SOLID ORDINARY COATED TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8487BAL PHARMA LIMITEDHEALTHCARE LTD.EMTRIM FORTESULFAMETHOXAZOLE + TRIMETHOPRIM 800MG + 160MG BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR UDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8488 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCEFRAZ 200CEFIXIME TRIHYDRATE200MG ZIM LABORATORIES LIMITED-B-21122, MIDC AREA, KALMESHWAR -441 501, DIST. NAGPUR,INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8489SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDT-DOLTRAMADOL HYDROCHLORIDE100 MG / 2 MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY AMPOULES 1.0X2.0 ML AMPOULE
NDA/MAL/HDP/8490ALTHEA PHARMA PVT LTD.JOINT MEDICAL STORE (UPMB - UCMB)SODIUM CHLORIDESODIUM CHLORIDE0.9% W/VALTHEA PHARMA PVT LTD --PLOT NO. 374 SHED NO. E,.ALPHA INDUSTRIAL PARK , ATHIYAWAD DABHEL ,NANI DAMAN (U.T) 396210, INDIAINDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/8491MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCETROTIDE 0.25MGCETRORELIX0.25MGABBOTT BIOLOGICALS B.V VEERWEG -12,NL-8121 AA OLST THE NETHERLANDS,PIERRE FABRE MEDICAMENT -AQUITAINE PHARM INTERNATIONAL SITE 1FRANCEPARENTERAL ORDINARY COMBINATION PACK VIALS 1.0X1.0 VIAL CARTON,1.0X1.0 PREFILLED SYRINGE CARTON
NDA/MAL/HDP/8493GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDDESCOVY 200MG/25MGEMTRICITABINE/TENOFOVIR ALAFENAMIDE200MG + 25 MGPATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9,ROTTENDORF PHARMA GMBH-OSTENFELDER STRA?E 51-61,59320 ENNIGERLOH,GERMANYCANADAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8494KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFOBACTAMCEFOPERAZONE SODIUM+SULBACTAM SODIUM500MG + 500MGKOTRA PHARMA (M) SDN.BHD,-1,2 & 3 JALAN TTC 12 CHENG INDUSTRIAL ESTATE 75250 MELAKAMALAYSIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL
NDA/MAL/HDP/8495CACHET PHARMACEUTICALS PRIVATE LIMITEDASTRA PHARMA (U) LIMITEDCACEF 50CEFPODOXIME PROXETIL USP50MG / 5MLALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA.INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X30.0 ML BOTTLE
NDA/MAL/HDP/8496THEON PHARMACEUTICALS LIMITTEDAIVEEN (U) LIMITEDTHEOXONE-500MGCEFTRIAXONE500MGTHEON PHARMACEUTICALS LIMITED.- VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 MG VIAL
NDA/MAL/HDP/8497TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDSWASTIK PHARMACEUTICAL LTDTRYOXIM 500CEFUROXIME AXETIL500 MGTWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD - -UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE-247668. DIST.-HARIDWAR, UTTAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8498GULF PHARMACEUTICAL INDUSTRIES(JULPHAR)GOODMAN INTERNATIONAL LTDTRIAXONE 0.5GCEFTRIAXONE0.5GGULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.EUNITED ARAB EMIRATESPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON + 5 ML AMPOULE OF WATER FOR INJECTION
NDA/MAL/HDP/8499YELURI FORMULATIONS PVT LTDESCORTS PHARMACEUTICALS LIMITEDSOLOCEF 1000 MGCEFTRIAXONE SODIUM1000MGYELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6 IDA BOLLARAM,MEDAK DIST.502325, TELANGANA,INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/8500AURONEXT PHARMA PRIVATE LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDINEMPLUS 500 IMIPENEM+CILASTATIN 500MG +500MGAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA.INDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 G VIAL
NDA/MAL/HDP/8501MEDREICH PLCLABOREX UGANDA LIMITEDBIOZOLEMETRONIDAZOLE125MG/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 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8502MEDREICH PLCLABOREX UGANDA LIMITEDFLEMINGAMOXICILLIN + POTASSIUM CLAVULANATE400MG/5ML + 57MG/5MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X70.0 ML BOTTLE
NDA/MAL/HDP/8503MEDREICH PLCLABOREX UGANDA LIMITEDNORZOLNORFLOXACIN + TINIDAZOLE400MG + 600MGMEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8504MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLEDVIRLEDIPASVIR + SOFOSBUVIR90MG + 400MG MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON, SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X28.0 TABLET BOTTLE
NDA/MAL/HDP/8522PLANET PHARMACEUTICALS UGANDA LTDPLANET PHARMACEUTICALS UGANDA LTDDAYPENAMMEROPENEM500MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X500.0 MG VIAL
NDA/MAL/HDP/8601DROGSAN ?LA?LARI SAN. VE TIC. A.?.BUFFALO HEALTH CARE LTDCARDIOSAN 5MGAMLODIPINE BESILATE5 MGDROGSAN ?LA?LARI SAN. VE TIC. A.?.-06760 ?UBUK ?ANKARA / TURKEYTURKEYORAL SOLID ORDINARY TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8602MAVID PHARMACEUTICALS LIMITEDMAVID PHARMACEUTICAL INDUSTRIES LIMITEDKOFLIN COUGH FLU LINCTUSCHLOPHENIRAMINE2MGMAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKOUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8603MAVID PHARMACEUTICAL INDUSTRIES LIMITEDMAVID PHARMACEUTICAL INDUSTRIES LIMITEDMAGNESIUM TRISILICATE SUSPENSIONSODIUM BICARBONATE + LIGHT MAGNESIUM CARBONATE + MAGNESIUM 250 MG + 250 MG + 250 MGMAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKOUGANDAORAL LIQUID ORDINARY SUSPENSIONS 1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8604MAVID PHARMACEUTICAL INDUSTRIES LIMITEDMAVID PHARMACEUTICAL INDUSTRIES LIMITEDPYODINEPOVIDINE-IODINE10 %W/VMAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X60.0 ML BOTTLE
NDA/MAL/HDP/8605MAVID PHARMACEUTICAL INDUSTRIES LIMITEDMAVID PHARMACEUTICAL INDUSTRIES LIMITEDHYDROGEN PEROXIDEHYDROGEN PEROXIDE6 %W/VMAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X250.0 ML BOTTLE
NDA/MAL/HDP/8606MAVID PHARMACEUTICAL INDUSTRIES LIMITEDMAVID PHARMACEUTICAL INDUSTRIES LIMITEDDIPHEX COUGH EXPECTORANTDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + AMMONIUM CHLORIDE0.014 MG / 5 ML + 0.057 MG / 5 ML + 0.135 MG / 5 MLMAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKOUGANDAORAL LIQUID ORDINARY SYRUPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8611MAVID PHARMACEUTICAL INDUSTRIES LIMITEDMAVID PHARMACEUTICAL INDUSTRIES LIMITEDSURGICAL SPIRITMULT-INGREDIENTN/AMAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8615MAVID PHARMACEUTICAL INDUSTRIES LIMITEDMAVID PHARMACEUTICAL INDUSTRIES LIMITEDCALAMINE LOTIONCALAMINE + ZINC OXIDE0.75 MG / 5 ML + 0.25 MG / 5 MLMAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKOUGANDATOPICAL EXTERNAL SUSPENSIONS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8617MAVID PHARMACEUTICAL INDUSTRIES LIMITEDMAVID PHARMACEUTICAL INDUSTRIES LIMITEDMAVID'S KEVLONCHLORHEXIDINE GLUCONATE 20% + CETRIMIDE0.015 G / 5 ML +0.15 G / 5 MLMAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKOUGANDATOPICAL EXTERNAL LIQUIDS 1.0X125.0 ML BOTTLE
NDA/MAL/HDP/8637 BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCINAZITHROMYCIN DIHYDRATE40MG/MLBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X15.0 ML BOTTLE
NDA/MAL/HDP/8639MSD (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDISENTRESS 100MGRALTEGRAVIR POTASSIUM100MGPATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA,MERCK SHARP & DOHME BV.-WAARDERWEG 39 HAARLEM, - 2031 BN, NETHERLANDS,MSD (PTY) LTD. -117-16TH ROAD, HALFWAY HOUSE, 1685 SOUTH AFRICAUNITED STATESORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8640UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDCORTUM 250CEFUROXIME AXETIL250MGAKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8641CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TELI HTELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGCADILA PHARMACEUTICALS LIMITED-1389,TRASAD ROAD, DHOLKA-382 225, AHMEDABAD GUJARAT STATE, INDIA.INDIAORAL SOLID ORDINARY LAYERED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8643SWISS PARENTERALS PVT LTDROYAL PHARMA 2011 LIMITEDARTESUNATE 60MGARTESUNATE60MGSWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0X60.0 MG VIAL + 1*1*5ML AMPOULE OF 0.9%W/V NACL + 1*1*1ML AMPOULE OF 5%W/V NAHCO3
NDA/MAL/HDP/8644 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDLOOBID SUSPENSIONOFLOXACIN + ORNIDAZOLE50MG + 125MG / 5MLCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X30.0 ML BOTTLE
NDA/MAL/HDP/8648UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNODEX PLUSTERBUTALINE SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN2.5MG + 8MG + 100MGAKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8649INJECTCARE PARENTERALS PVT. LTDMATRIX (U) LTDCEFCARECEFTRIAXONE SODIUM1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/HDP/8650?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LIMITEDCEFDIA 400MGCEFIXIME TRIHYDRATE400MGNOBEL ?LA? SAN. VE TIC. A.?.-81100 SANCAKLAR, D?ZCE-TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X5.0 TABLET BLISTER
NDA/MAL/HDP/8653PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD)ROYAL PHARMA 2011 LIMITEDLEFLOXIN 500LEVOFLOXACIN HEMIHYDRATE500MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8655MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOPHAGE XR 1000MGMETFORMIN HYDROCHLORIDE1000MGMERCK KGAA--FRANKFURTER STR. 250 64293 DARMSTADT GERMANY,MERCK SANT? S.A.S.-2 RUE DU PRESSOIR VERT 45400 SEMOY FRANCEGERMANYORAL SOLID RETARD TABLETS 1.0X4.0X15.0 TABLET BLISTER
NDA/MAL/HDP/8658SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDMETFORMIN 1000MGMETFORMIN HYDROCHLORIDE1000MGLEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X4.0X15.0 TABLET BLISTER
NDA/MAL/HDP/8659SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDMETFORMIN 500MGMETFORMIN HYDROCHLORIDE500MGLEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW POLANDORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X6.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8660GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDVEMLIDYTENOFOVIR ALAFENAMIDE25MGPATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9CANADAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8661AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDDOLUTEGRAVIR TABLETS 50MGDOLUTEGRAVIR SODIUM50MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8662 RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDAMOXIREN-DSAMOXICILLIN TRIHYDRATE250MG/5MLRENE INDUSTRIES LTD .-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALAUGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8665 CACHET PHARMACEUTICALS PVT LTDASTRA PHARMA (U) LIMITEDPAMAGIN-CCETIRIZINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + ACETAMINOPHEN + PHENYLEPHRINE HYDROCHLORIDE + ZINC GLUCONATE5.0 MG +15 MG + 500 MG + 5 MG + 7.5 MGCACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8679KWALITY AFRO ASIA LIMITEDKWALITY AFRO ASIA LTDK COUGH-DBROMOHEXINE HYDROCHLORIDE + AMMONIUM CHLORIDE + DEXTROMETHORPHAN HYDOBROMIDE + MENTHOL8MG + 10MG + 100MG + 5MGKWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROADUGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8685MSN LABORATORIES PRIVATE LIMITEDGOOD DAY PHARMACY LIMITEDRANCV 500RANOLAZINE500 MGMSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT PIN CODE 502 325 ANDHRA PRADESH, INDIA. INDIAORAL SOLID RETARD FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8686CODAL-SYNTO LTD RENE PHARMACY LTDCODANOLATENOLOL 100 MG MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8688MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDDURART 600DARUNAVIR 600 MGMYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8689MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDDURART 800DARUNAVIR800 MGMYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8690CIPLA LTDQUALITY CHEMICALS LTDARTESUNATE SUPPOSITORIES 100MGARTESUNATE100MGCIPLA LIMITED, PLOT NO. D-7 MIDC INDUSTRIAL AREA, KURKUMBH, DIST: PUNE 413 802, INDIAINDIARECTAL SYSTEMIC SUPPOSITORIES 1X1X2 SUPPOSITORY BLISTER
NDA/MAL/HDP/8691REMEDICA LTDGOODMAN INTERNATIONAL LTDQUETRA 1000LEVETIRACETAM 1000MGREMEDICA LTD.-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE,3056 LIMASSOL CYPRUSCYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8692GOODMAN INTERNATIONAL (U) LTDGOODMAN INTERNATIONAL LTDPARAFUSIVPARACETAMOL10 MG/MLS.M FARMACEUTICI SRL-ZONA INDUSTRIALE, 85050 TITO-POTENZA (PZ) ITALY ITALYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/HDP/8693REMEDICA LTDGOODMAN INTERNATIONAL LTDQUETRA 100MG/MLLEVETIRACETAM 100 MG/MLREMEDICA LTD.-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE,3056 LIMASSOL CYPRUSCYPRUSORAL LIQUID ORDINARY LIQUIDS 1.0X300.0 ML BOTTLE
NDA/MAL/HDP/8696 PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDBABY COLSIMETHICONE40MG/0.6MLPHARCO PHARMACEUTICALS-KILO 31 ALEXANDRIA-CAIRO DESERT ROAD AMRIYA ALEXANDRIAEGYPTORAL LIQUID ORDINARY EMULSIONS 1.0X1.0X15.0 ML BOTTLE
NDA/MAL/HDP/8697CADILA HEALTHCARE LIMITED.ABACUS PHARMA (AFRICA) LIMITEDZYPIRON 20IRON SUCROSE 20MG/MLCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210INDIAPARENTERAL ORDINARY VIALS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/8699REMEDICA LTDGOODMAN INTERNATIONAL LTDACETAZOLAMIDEACETAZOLAMIDE250 MGREMEDICA LTD.-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE,3056 LIMASSOL CYPRUSCYPRUSORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8743CADILA PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ISONIAZIDISONIAZID300 MGCADILA PHARMACEUTICALS LIMITED.-1389, DHOLKA-387810, INDIA OPP.RAJVANSH APARTMENT, SATYA MARG, BODAKDEV, AHMEDABAD ? 380054, GUJARAT, INDIA.INDIAORAL SOLID ORDINARY TABLETS 1.0X24.0X28.0 TABLET BLISTER
NDA/MAL/HDP/8814MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDACRIPTEGADOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE50MG + 300MG + 300MGMYLAN LABORATORIES LIMITEDD ,-PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE-II, SECTOR-III, PITHAMPUR-454775 DIST. DHAR, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8815 ZIM LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDZIMAGRA ? ODS 50SLIDENAFIL CITRATE50 MG ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA, KALMESHWAR ? 441501, DIST. NAGPUR, MAHARASHTRA, INDIAOTHER SYSTEMIC SPECIAL SOLIDS 1.0X1.0X10.0 SACHET CARTON
NDA/MAL/HDP/8816ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABPARAPARACETAMOL1%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAPARENTERAL ORDINARY INFUSION BAGS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8817MEDIPHARM INDUSTRIES (E.A) LTDMEDIPHARM SALES LIMITEDMEDISOLONE-15PREDNISOLONE SODIUM PHOSPHATE15MG/5MLMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDAUGANDAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X5.0 ML BOTTLE
NDA/MAL/HDP/8818AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLEVOTOP-PFLEVOFLOXACIN HEMIHYDRATE1.5%W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAOPHTHALMIC DROPS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/8819 UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLORFACT-D SYRUPDESLORATADINE5MG/5MLAKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIAINDIAORAL LIQUID ORDINARY SYRUPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8820TROIKAA PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDT-DOL P RAPIDTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGTROIKAA PHARMACEUTICALS LTD .-C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8821AUROBINDO PHARMA LTD PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDROFAST 10ROSUVASTATIN CALCIUM10MG"AUROBINDO PHARMA LIMITED-UNIT ?VII, SEZ, TSIIC, PLOT NO. SI,S. NO.?S 411/P, 425/P, 434/P, 435/P & 458/P,GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT -509 302 TELANGANA STATE, INDIA" INDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8822ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDALIDOLIDOCAINE HYDROCHLORIDE2%W/V LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. INDIAPARENTERAL ORDINARY AMPOULES 1.0X1.0X30.0 ML VIAL
NDA/MAL/HDP/8823GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDEPCLUSASOFOSBUVIR + VELPATASIR400MG + 100MGPATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9CANADAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X28.0 TABLET BOTTLE
NDA/MAL/HDP/8824AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEPAFLAMNEPAFENAC0.1% W/VCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIAINDIAOPHTHALMIC SUSPENSIONS 1.0X1.0X5.0 ML VIAL
NDA/MAL/HDP/8825LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLAXALINKLACTULOSE3.35G/5ML LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR, GUJARAT, INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X170.0 ML BOTTLE
NDA/MAL/HDP/8826CIPLA LTD.QUALITY CHEMICALS LTD - HUMANABACAVIR SULFATE AND LAMIVUDINE TABLETS FOR ORAL SUSPENSION 120/60 MGABACAVIR SULFATE + LAMIVUDINE120MG + 60MGCIPLA LIMITED -PLOT NO A ? 33, A ? 2 (UNIT ? I), MIDC PATALGANGA, DISTRICT RAIGAD, 410 220 MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS 1.0X1.0X60.0 TABLET BOTTLE
NDA/MAL/HDP/8827HETERO LABS LTDABACUS PHARMA (AFRICA) LIMITEDSOFGENSOFOSBUVIR400 MGHETERO LABS LIMITED UNIT-VI --APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR DIST -509301, TELANGANA, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X28.0 TABLET BOTTLE
NDA/MAL/HDP/8835RESONANT PHARMACEUTICALSSHREEJI PHARMACEUTICALS LIMITEDTRIO-FAS(KIT)AZITHROMYCIN DIHYDRATE + FLUCONAZOLE + SECNIDAZOLE1000MG + 150MG + 2GACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8914RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPEFLOREN 400PEFLOXACIN MESILATE DIHYDRATE400 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8915UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDATOXIA 120 MGETORICOXIB120 MGUNITED PHARMACEUTICAL MANUFACTURING CO. LTD--P.O. BOX 69 AMMAN 11591 - AL-RAGEEM SAHAB - JORDANJORDANORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X7.0 TABLET BLISTER
NDA/MAL/HDP/8916MACLEODS PHARMACEUTICALS LTD.NORVIK ENTERPRISES LIMITEDTAMSUMAC 0.4TAMSULOSIN HYDROCHLORIDE0.4MGMACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101 INDIA INDIAORAL SOLID RETARD CAPSULES 1.0X1.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8917SVIZERA LABS PRIVATE LTDGITTOES PHARMACEUTICALS LIMITEDSCC-2 LLW TABLETSRIFAMPICIN + ISONIAZID150MG + 75MGSVIZERA LABS PRIVATE LIMITED-PLOT D-16/6 TTC INDUSTRIAL AREA MIDC TURBHE NAVI MUMBAI 400703, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X24.0X28.0 TABLET BLISTER
NDA/MAL/HDP/8918SVIZERA LABS PRIVATE LTDGITTOES PHARMACEUTICALS LIMITEDSCC-3 LLW TABLETSRIFAMPICIN + ISONIAZID + ETHAMBUTOL HYDROCHLORIDE150MG + 75MG + 275MGSVIZERA LABS PRIVATE LIMITED-PLOT D-16/6 TTC INDUSTRIAL AREA MIDC TURBHE NAVI MUMBAI 400703, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X24.0X28.0 TABLET BLISTER
NDA/MAL/HDP/8919SVIZERA LABS PRIVATE LTDGITTOES PHARMACEUTICALS LIMITEDSCC-4 TABLETSRIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL HYDROCHLORIDE150MG + 75MG + 400MG + 275MGSVIZERA LABS PRIVATE LIMITED-PLOT D-16/6 TTC INDUSTRIAL AREA MIDC TURBHE NAVI MUMBAI 400703, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X24.0X28.0 TABLET BLISTER
NDA/MAL/HDP/8920MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCRINONE 8% GELPROGESTERONE90MG/APPLICATORFLEET LABORATORIES LTD 94 RICKMANSWORTH ROAD, WATFORD, HERT, WD18 7JJ, UNITED KINGDOMUNITED KINGDOMVAGINAL GEL1X1X15G APPLICATOR
NDA/MAL/HDP/8921 SUN PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDVESIZEN 5SOLIFENACIN SUCCINATE5 MGSUN PHARMACEUTICALS LTD-,-SEZ UNIT ?I, PLOT NO. A-41, INDUSTRIAL AREA, PHASE VIIIA S.A.S NAGAR MOHALI-160 071 PUNJAB, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8923 SUN PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDVESIZEN 10SOLIFENACIN SUCCINATESUN PHARMACEUTICALS LTD-,-SEZ UNIT ?I, PLOT NO. A-41, INDUSTRIAL AREA, PHASE VIIIA S.A.S NAGAR MOHALI-160 071 PUNJAB, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8925ZIFAM PINNACLE PTY. LTD. BOOTS PHARMACEUTICALS LIMITEDZIFAMET 250METRONIDAZOLE250 MGFREDUN PHARMACEUTICALS LTD --14, 15, 16, ZORABIAN INDUSTRIAL COMPLEX, VILLAGE, VEOOR, PALGHAR (EAST) DIST: THANE ? 401 404 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8926MSN LABORATORIES PRIVATE LIMITEDGOOD DAY PHARMACY LIMITEDGLUSIS 1000 ERMETFORMIN HYDROCHLORIDE1000 MGMSN LABORATORIES PRIVATE LIMITED (FORMULATIONS DIVISION) - -PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, INDIAINDIAORAL SOLID RETARD TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8927BIOLOGICAL E. LTDPILLAR LOGISTICS LIMITEDDIPHTHERIA AND TETANUS VACCINE (ADSORBED REDUCED ANTIGEN(S) CONTENT)DIPHTHERIA TOXOID + TETANUS TOXOID 2 LF ( NOT LESS THAN 2 IU) + 8.8 LF (NOT LESS THAN 20 IU)/ 0.5MLBIOLOGICAL E. LIMITED--PLOT NO.1 SHAPOORJI PALLONJI BIOTECH PARK PHASE II, KOLTHUR VILLAGE, SHAMEERPET, MANDAL, R.R. DISTRICT, ANDRA PRADESH 500078, INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X24.0X1.0X10.0 DOSE VIAL,1.0X48.0X1.0 DOSE VIAL
NDA/MAL/HDP/8928CODAL-SYNTO LTD RENE PHARMACY LTDSYNTOCLAVAMOXICILLIN TRIHYDRATE + CLAVULANIC ACID125MG+31.25MG / 5ML MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUSCYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8929OCTAPHARMA AGPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDALBUNORMHUMAN ALBUMIN20%W/VOCTAPHARMA PRODUKTIONSGESELLSCHAFT DEUTSCHLAND MBH--WOLFGANG-MARGUERRE-ALLEE 1 31832 SPRINGE GERMANYGERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8930RESONANT PHARMACEUTICALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDGASTRISAFE-(KIT)CLARTHROMYCIN + ESOMEPRAZOLE MAGNESIUM DIHYDRATE + TINIDAZOLE5000MG + 40MG + 500MGACME PHARMACEUTICAL PVT. LTD.-ROPAR ROAD NALAGARH, DIST. SOLAN, HIMACHAL PRADESH ? 174101 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X7.0X6.0 TABLET STRIP (2 TABLETS + 2 TABLETS + 2 CAPSULES)
NDA/MAL/HDP/8931CARITAS HEALTHCARE PVT. LTDREDDYS PHARMA LIMITEDSODIUM CHLORIDE INTRAVENOUS INFUSION BPSODIUM CHLORIDE0.9%W/VSICHUAN KELUN PHARMACEUTICAL CO., LTD-SOUTH OF NO.2 ROAD, XINDU SATELLITE CITY INDUSTRIAL DEVELOPMENT ZONE, CHENGDU, SICHUAN PROVINCE 610500, P. R. CHINACHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE
NDA/MAL/HDP/8932S KANT HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPRAZIQUANTELPRAZIQUANTEL600 MGS KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARATINDIAORAL SOLID ORDINARY TABLETS 1.0X25.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8933CIPLA LTDQUALITY CHEMICALS LTD - HUMANQ-TIBSULFAMETHOXAZOLE + TRIMETHOPRIM + ISONIAZID + PYRIDOXINE HYDROCHLORIDE800MG + 160MG + 300MG +25MGCIPLA LIMITED>-A-33, A-37/2/2 & A-2, M.I.D.C, PATALANGA 410 220, DISTRICT RAIGAD, M.S, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/8934ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCYCLO P EYE DROPSCYCLOPENTOLATE HYDROCHLORIDE1.0%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.UGANDAOPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL
NDA/MAL/HDP/8935AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.FECLO GELDICLOFENAC DIETHYLAMMONIUM SALT1%W/WAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTANPAKISTANTOPICAL EXTERNAL EMULSION GELS 1.0X1.0X20.0 G TUBE,1.0X1.0X15.0 G TUBE
NDA/MAL/HDP/8936AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.ESOFOLEESOMEPRAZOLE MAGNESIUM TRIHYDRATE40MGAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTANPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/8937AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.ESOFOLEESOMEPRAZOLE MAGNESIUM TRIHYDRATE20MGAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTANPAKISTANORAL SOLID ORDINARY CAPSULES 1.0X2.0X7.0 CAPSULE BLISTER
NDA/MAL/HDP/8938AL-FAZAL PHARMA INDUSTRIES (PVT.) LTDHEALTHCARE LTD.SULPHASILSILVER SULPHADIAZINE1%W/WAL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTANPAKISTANTOPICAL EXTERNAL CREAMS 1.0X1.0X20.0 G TUBE,1.0X1.0X50.0 G TUBE
NDA/MAL/HDP/8939FREDUN PHARMACEUTICALS LTDMEDICIVE PHARMACEUTICALS LTDFREMOL PLUSPARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE + CAFFEINE (ANHYDROUS)500MG + 10MG + 2MG + 30MMGFREDUN PHARMACEUTICALS LTD --14, 15, 16, ZORABIAN INDUSTRIAL COMPLEX, VILLAGE, VEOOR, PALGHAR (EAST) DIST: THANE ? 401 404 - INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X50.0X1.0X4.0 TABLET BLISTER
NDA/MAL/HDP/8940?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LIMITEDRABIZA 20MGRABEPRAZOLE SODIUM20MG?LKO ?LA? SANAYI VE TICARET A. ?.-3. 42050 SEL?UKLU / KONYA TURKEYTURKEYORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8941?LKO ?LA? SANAYI VE TICARET A. ?.CORE ACCESS LIMITEDLIVERCOL 20MGROSUVASTATIN CALCIUM20MG?LKO ?LA? SANAYI VE TICARET A. ?.-3. 42050 SEL?UKLU / KONYA TURKEYTURKEYORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X14.0 TABLET BLISTER
NDA/MAL/HDP/8944GUILIN PHARMACEUTICALS CO.LTD.STAR PHARMACEUTICALS LTDGAMOK 625MGAMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM500MG + 125MGSINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINACHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8946GUILIN PHARMACEUTICALS CO.LTD.STAR PHARMACEUTICALS LTDGAMOK 0.6GAMOXICILLIN SODIUM + CLAVULANATE POTASSIUM500MG + 100MGSINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X0.6 G VIAL
NDA/MAL/HDP/8947GUILIN PHARMACEUTICALS CO.LTD.STAR PHARMACEUTICALS LTDGAMOK 1.2GAMOXICILLIN SODIUM + CLAVULANATE POTASSIUM1G + 0.2GSINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X10.0X1.2 G VIAL
NDA/MAL/HDP/8948GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).GAMA PHARMACEUTICALS (U) LIMITEDJULMENTIN ESAMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM600 MG / 5 ML + 42.9 MG / 5 MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR) --DIGDAGA, AIRPORT STREET RAS AL KHAIMAH UNITED ARAB EMIRATESINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8949EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDCETAL SUPOSITORIESPARACETAMOL120MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPTEGYPTRECTAL SYSTEMIC SUPPOSITORIES 1.0X1.0X5.0 SUPPOSITORY BLISTER
NDA/MAL/HDP/8950KOTRA PHARMA (M) SDN,BHDUNITED HEALTHCARE DISTRIBUTORS LTDVAXCEL CEFEPIME-1G INJECTIONCEFEPIME HYDROCHLORIDE1 GKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIAMALAYSIAPARENTERAL ORDINARY DRY VIALS 1.0X1.0 VIAL CARTON
NDA/MAL/HDP/8951MATRIX UGANDA LTDMATRIX (U) LTDVOREN ENTERIC MICROEN CAPSULATED CAPSULEDICLOFENAC SODIUM50MGY.S P INDUSTRIES (M) SDN BHD-PLOT NO. 3, 5 & 7, JALAN P/7, SECTION 13, KAWASAN, PERINDUSTRIAN BANDAR BARU BANGI, 43000 KAJANG, SELANGOR DARUL EHSAN, MALAYSIAMALAYSIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/8952THEON PHARMACEUTICALS LTDAIVEEN (U) LIMITEDTHEOFLEX -500CEFALEXIN MONOHYDRATE500 MGTHEON PHARMACEUTICALS LIMITED.- VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/8953JOHNSON &JOHNSON (PTY) LTDERIS LTDBENYLIN CHILDREN'S WET COUGHGUAIFENESIN100MG PER 10MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/HDP/8954JOHNSON &JOHNSON (PTY) LTDERIS LTDBENYLIN WET COUGHGUAIFENESIN200MG PER 10MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICASOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE
NDA/MAL/HDP/8955GULF PHARMACEUTICAL INDUSTRIES(JULPHAR)GOODMAN INTERNATIONAL LTDCEFUZIMECEFUROXIME AXETIL125MG/5MLGULF PHARMACEUTICAL INDUSTRIES (JULPHAR) --DIGDAGA, AIRPORT STREET RAS AL KHAIMAH UNITED ARAB EMIRATESINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X50.0 ML BOTTLE
NDA/MAL/HDP/9051MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDSULFAMETHOXAZOLE/ TRIMETHOPRIM TABLETS USPSULFAMETHOXAZOLE + TRIMETHOPRIM 400MG + 80MGMYLAN LABORATORIES LTD-PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/9052MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDSULFAMETHOXAZOLE/ TRIMETHOPRIM TABLETS USPSULFAMETHOXAZOLE + TRIMETHOPRIM 800MG + 160MGMYLAN LABORATORIES LTD-PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH;INDIAORAL SOLID ORDINARY TABLETS 1.0X1.0X10.0 TABLET BLISTER
NDA/MAL/HDP/9053F. HOFFMANN LA-ROCHELABOREX UGANDA LIMITEDMABTHERA? 100MG/10MLRITUXIMAB100MG/10MLROCHE DIAGNOSTICS GMBH MANNHEIM--SANDHOFER STRASSE 116 -68305 MANNHEIM GERMANY.GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X2.0X10.0 ML VIAL
NDA/MAL/HDP/9054F. HOFFMANN LA-ROCHELABOREX UGANDA LIMITEDMABTHERA? 500MG/50MLRITUXIMAB500MG/50MLROCHE DIAGNOSTICS GMBH MANNHEIM--SANDHOFER STRASSE 116 -68305 MANNHEIM GERMANY.GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X1.0X50.0 ML VIAL
NDA/MAL/HDP/9055MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPYRAZINAMIDE TABLETS BP 150MGPYRAZINAMIDE150MG"MACLEODS PHARMACEUTICALS LTD,--BLOCK N2, VILLAGE THEDA, POST OFFICE LODHIMAJRA, TEHSIL BADDI, DISTRICT SOLAN, HIMACHAL PRADESH ? 174101 INDIA." INDIAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/HDP/9056AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVALSAR-AM 160/5 AMLODIPINE + VALSARTAN5MG + 160MGAUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/9057GUILIN PHARMACEUTICAL CO.LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDD-ARTEPP?DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE60MG + 480MGGUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X6.0 TABLET BLISTER
NDA/MAL/HDP/9058GUILIN PHARMACEUTICAL CO.LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDD-ARTEPP? DISPERSIBLEDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE30MG + 240MGGUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X2.0X3.0 TABLET BLISTER
NDA/MAL/HDP/9059TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTDMETRO PHARMACEUTICALS LIMITEDCLASSMOX DROPSAMOXICILLIN TRIHYDRATE125MG/MLTWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD - -UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE-247668. DIST.-HARIDWAR, UTTAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X10.0 ML BOTTLE
NDA/MAL/HDP/9060UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDRESPIWEL 2RESPERIDONE2 MGAKUMS DRUGS & PHARMACEUTICALS LTD. SITE ADDRESS :19, 20, 21, SEC-6A, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249 403 -INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X10.0X10.0 TABLET BLISTER
NDA/MAL/HDP/9061UNOSOURCE PHARMA LTD.ABACUS PHARMA (AFRICA) LIMITEDUNOROCK KITIBANDRONATE SODIUM MONOHYDRATE AND [CALCIUM CITRATE MALATE + CALCITRIOL][150MG] AND [250MG + 0.25MG]AKUMS DRUGS & PHARMACEUTICALS LTD. SITE ADDRESS :19, 20, 21, SEC-6A, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249 403 -INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0 TABLET BLISTER + 1X30 TABLET BLISER COMBIPACK
NDA/MAL/HDP/9062AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDADERAN 32CANDESARTAN CILEXETIL32 MGAJANTA PHARMA LIMITED B-1-5-6, MIDC AREA PAITHAN, AURANGABAD, 431 148 DIST: AURANGABAD MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/9063LAURUS LABS LTDBEYOND LOGISTICS LTDTENOFOVIR DISOPROXIL FUMARATE TABLETS 300 MGTENOFOVIR DISOPROXIL FUMARATE300 MGLAURUS LABS LIMITED (UNIT II) PLOT NO.: 19,20,&21, WESTERN SECTOR, APSEZ, ATCHUTAPURAM MANDAL, VISAKHAPATNAM DISTRICT, 531 011, ANDRA PRADESH, INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X30.0 TABLET BOTTLE
NDA/MAL/HDP/9064THEON PHARMACEUTICALS LTDAIVEEN (U) LIMITEDTHEOMOX-250AMOXICILLIN TRIHYDRATE250 MGTHEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN HIMACHAL PRADESH - 174 101 - INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/9065THEON PHARMACEUTICALS LTDAIVEEN (U) LIMITEDTHEOFLEX -250CEFALEXIN MONOHYDRATE250 MGTHEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN HIMACHAL PRADESH - 174 101 - INDIAINDIAORAL SOLID ORDINARY CAPSULES 1.0X10.0X10.0 CAPSULE BLISTER
NDA/MAL/HDP/9066THEON PHARMACEUTICALS LTDAIVEEN (U) LIMITEDTHEOFIX-200CEFIXIME TRIHYDRATE200 MGTHEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN HIMACHAL PRADESH - 174 101 - INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X2.0X10.0 TABLET BLISTER
NDA/MAL/HDP/9067MEDISEL (K) LTDAIVEEN (U) LIMITEDBRONCHOWINDOXOFYLLINE400 MGCORONA REMEDIES PVT LTD VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH ? 173223. INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X3.0X10.0 TABLET BLISTER
NDA/MAL/HDP/9068MEDISEL (K) LTDAIVEEN (U) LIMITEDMOXODOC TABLETMOXIFLOXACIN HYDROCHLORIDE400 MGCORONA REMEDIES PVT LTD VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH ? 173223. INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS 1.0X1.0X10.0 TABLET BLISTER

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/VDP/1536NORBROOK KENYA LTDNORBROOK (U) LTDLEVAFAS X-TRALEVAMISOLE +OXYCLOZANIDE 7.5% W/V +15% W/V NORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X5.0 L JERRYCAN,1.0X40.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN
NDA/MAL/VDP/1594NORBROOK KENYA LTDNORBROOK (U) LTDPESTIGONFIPRONIL 100MGNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMTOPICAL EXTERNAL LIQUIDS 1.0X4.02 ML PIPETTE,1.0X1.34 ML PIPETTE,1.0X0.67 ML PIPETTE,1.0X0.5 ML PIPETTE,1.0X2.68 ML PIPETTE
NDA/MAL/VDP/1617HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDEVACIDE OXYCLOZANIDE + LEVAMISOLE HYDROCHLORIDE30MG + 15MG /MLHEBEI YUANZHENG PHARMACEUTICAL CO., LTD -INDUSTRIAL AREA, YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE. P.R. CHINA. CHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X1.0 L CONTAINER
NDA/MAL/VDP/1619DAWA LIMITEDSUPER MEDIC LTDTRIMOXOL-VET ORAL POWDERTRIMETHOPRIM+SULFAMETHOXAZOLE2.0%W/W+10%W/WDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA,MEDISEL KENYA LTD - -LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0X30.0 G SACHET
NDA/MAL/VDP/1621HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDIVERMECTIN IVERMECTIN1%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY S C VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/1644HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDDIMINAZENE PLUSDIMINAZENE DIACETURATE + ANTIPYRINE + VITAMIN B121.05G + 1.31G +1MG/ 2.36GHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAOTHER SYSTEMIC POWDER 1.0X23.6 G SACHET,1.0X2.36 G SACHET
NDA/MAL/VDP/1667INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDINTRAFER 100 B12IRON DEXTRAN + CYANOCOBALAMIN100MG + 0.1MG / MLINTERCHEMIE WERKEN ?DE ADELAAR? EESTI AS-VANAPERE TEE 14, PRINGI 74001 VIIMSI, HARJUMAAESTONIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/2443DAWA LIMITEDSUPER MEDIC LTDDABENDAZOLE 2.5%W/VALBENDAZOLE2.5%W/VDAWA LTD-BABA DOGO ROAD RUARAKA ,MEDISEL KENYA LTD - -LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE,1.0X5000.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/2520INTRACIN PHARMACEUTICALS PVT LTDMTK UGANDA LIMITEDIMIVETIMIDOCARB DIPROPIONATE120MG/MLINTRACIN PHARMACEUTICALS PVT LTD-C-1, B-53, GIDC ESTATE NADAID-387 001(GUJARAT INDIAPARENTERAL ORDINARY VIALS 1.0X40.0 ML BOTTLE
NDA/MAL/VDP/2550VET CENTRE LTDVET CENTRE UGANDA LIMITEDINTERMECTIN SUPER IVERMECTIN + CLORSULON10MG + 100MGINTERCHEMIE WERKEN DE ADELAAR-EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY S C VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/2590LAPROVET S.A.SEVERVICTORY LIMITEDTETRACOLIVITOXYTETRACYCLINE+COLISTIN10G/100G+7MUI/100GLABORATOIRES BIOVE SAS-3 RUE DE LORRAINE, BP 45 62510 ARQUES FRANCEFRANCEORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1000.0 G CONTAINER,1.0X100.0 G SACHET
NDA/MAL/VDP/2623INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDIMOCHEM 120IMIDOCARB DIPROPIONATE120MG/MLINTERCHEMIE WERKEN DE ADELAAR-EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/2626DAWA LIMITED-SUPER MEDIC LTDPET D WORM MEBENDAZOLE + PIPERAZINE CITRATE + PRAZIQUANTEL 110MG + 275MG +25MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY CHEWABLE TABLETS 1.0X10.0X6.0 TABLET BLISTER
NDA/MAL/VDP/2630LABORATORIOS HIPRA S.AERAM UGANDA LIMITEDHIPRAVIAR CLONATTENUATED LIVE NEWCASTLE VIRUS CL/79 CLON10??? - 10???? EID??/ DOSE (0.03ML) LABORATORIOS HIPRA, S.A-AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN SPAINORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X2500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X5000.0 DOSE VIAL
NDA/MAL/VDP/2633LABORATORIOS HIPRA S.AERAM UGANDA LIMITEDHIPRAVIAR B1/H120 LIVE NEWCASTLE DISEASE VIRUS, B1 STRAIN + LIVE AVIAN INFECTIOUS BRONCHITIS VIRUS, MASS H120 STRAINLIVE NEWCASTLE DISEASE VIRUS - 10??? -10??? EID??/DOSE + LIVE AVIAN INFECTIOUS BROCHITIS VIRUS - 10?-10?EID??/DOSELABORATORIOS HIPRA, S.A-AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN SPAINPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/2634LABORATORIES HIPRA SAERAM UGANDA LIMITEDHIPRAGUMBORO CH/80CLONED LIVE INFECTIOUS BURSAL DISEASE VIRUS, CH/80 CLON10??? TCID??/DOSELABORATORIOS HIPRA, S.A-AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN SPAINORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1000.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL
NDA/MAL/VDP/2635LABORATORIOS HIPRA S.AERAM UGANDA LIMITEDHIPRAGUMBORO-GM97 LIVE INFECTIOUS BURSAL DISEASE VIRUS, STRAIN GM9710? - 10? EID??/ DOSELABORATORIOS HIPRA, S.A-AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN SPAINORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL
NDA/MAL/VDP/2637LABORATORIOS HIPRA S.AERAM UGANDA LIMITEDHIPRAVIAR SATTENUATED LIVE NEWCASTLE DISEASE VIRUS, LASOTA STRAIN10??? - 10???EID??/ DOSE (0.03ML)LABORATORIOS HIPRA, S.A-AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN SPAINOTHER SYSTEMIC SPECIAL SOLIDS 1.0X2500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X10.0X500.0 DOSE VIAL
NDA/MAL/VDP/2638LABORATORIOS HIPRA S.AERAM UGANDA LIMITEDHIPRAVIAR CLON/ H120LIVE NEWCASTLE DISEASE VIRUS CL/79 CLON + LIVE INFECTIOUS BRONCHITIS VIRUS, MASS H120 STRAINLIVE NEWCASTLE DISEASE VIRUS, CL/79 - ?10???EID??/DOSE + LIVE INFECTIOUS BROCHITIS VIRUS - ?10?EID??/DOSELABORATORIOS HIPRA, S.A-AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN SPAINORAL LIQUID ORDINARY SUSPENSIONS 1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/2839DAWA LIMITED-SUPER MEDIC LTDEGOCIN 20 %OXYTETRACYCLINE200MG/MLHEBEI YUANZHENG PHARMACEUTICALS CO LTD , -WUQI INTERSECTION SHIZHENG ROAD , SHIJIAZHUANG PROVINCE , CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/2845ALIVIRA ANIMAL HEALTHERAM UGANDA LIMITEDSEMIDIUMISOMETAMIDIUM1000MGALIVIRA ANIMAL HEALTH LIMITED -A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIAINDIAOTHER SYSTEMIC OTHER POWDERS/GRANULES 1.0X10.0X1000.0 MG SACHET
NDA/MAL/VDP/2847CHONGQUING FANGTONG ANIMAL PHARMACEUTICAL CO.LTDNILE SERVICES LTDSTARMECTIN 1%IVERMECTIN10MG/MLCHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO.LTD-BANGIAO INDUSTRIAL PARK,RONGCHANG,CHONGQUING,CHINACHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML BOTTLE
NDA/MAL/VDP/2854VAPCOGOODMAN INTERNATIONAL LTDOXYDONE FORTE 20% LA OXYTETRACYCLINE200MG/MLVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) -KING HUSSEIN STREET AL DHULAIL AREA ZARQA PROVINCE HASHEMITE KINGDOM OF JORDANJORDANPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL
NDA/MAL/VDP/2856VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDVAPCOGENT-10%GENTAMICIN10%W/VVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) -KING HUSSEIN STREET AL DHULAIL AREA ZARQA PROVINCE HASHEMITE KINGDOM OF JORDANJORDANPARENTERAL ORDINARY DRY VIALS 1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL
NDA/MAL/VDP/2866HEBEI YUANZHENG PHARMACEUTICAL CO. LTDEVERVICTORY LIMITEDEVALBEN-2.5ALBENDAZOLE2.5%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5.0 L JERRYCAN
NDA/MAL/VDP/2870ALIVIRA ANIMAL HEALTHERAM UGANDA LIMITEDSEQULEVA PLUS SUSPENSIONLEVAMISOLE + OXYCLOZANIDE75MG/5ML + 150MG/5MLALIVIRA ANIMAL HEALTH LIMITED -A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X120.0 ML CONTAINER,1.0X250.0 ML CONTAINER
NDA/MAL/VDP/2871HEBEI YUANZHENG PHARMACEUTICAL CO. LTDEVERVICTORY LIMITEDEVALBEN-10ALBENDAZOLE10%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAORAL LIQUID ORDINARY LIQUIDS 1.0X500.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5.0 L JERRYCAN,1.0X1000.0 ML CONTAINER
NDA/MAL/VDP/2881NORBROOK KENYA LTDNORBROOK (U) LTDDUODIP 50:5 %CHLORPYRIFOS + CYPERMETHRIN50%W/V + 5%W/VNORBROOK LAB. LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP NORTHERN IRELAND, UKUNITED KINGDOMTOPICAL EXTERNAL LIQUIDS 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X50.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/4157CHONGQING FANGTONG PHARMACEUTICALS CONILE SERVICES LTDMULTISTARVIT( A + D3 + E + B1 + B2 + B6 +B12) + NICOTINAMIDE + PANTOTHENOL15000 IU + 1000 IU + 20MG + 10MG + 5MG + 3MG + 50MG + 35MG + 25MGCHONGQING FANGTONG ANIMAL PHARMACEUTICAL LLTD-BANGIAO INDUSTRIAL PARK RHONGCHANG CHINACHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/4164LAPROVET S.A.S EVERVICTORY LIMITEDTRISULMYCINETRIMETHOPRIM+SULFADIAZINE SODIUM4%W/W+18.68%W/WBIOVE LABORATORY-3, RUE DE LORRAINE, BP 45 62510 ARQUES FRANCEFRANCEORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/4214INTRACIN PHARMACEUTICAL PVT LTDVEERAM HEALTHCARE (U) LIMITEDIROFLOXENROFLOXACIN10%W/VINTRACIN PHARMACEUTICAL PVT LTD -C-1, B-53, G.I.D.C. ESTATE, NADIAD 387 001 [GUJARAT], INDIAINDIAPARENTERAL ORDINARY OTHER VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/4240NORBROOK KENYA LTDNORBROOK (U) LTDALBAFAS 2.5%ALBENDAZOLE25MG/MLNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN
NDA/MAL/VDP/4255ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDTERAZOLE 30%LEVAMISOLE HYDROCHLORIDE 30%W/WASHISH LIFE SCIENCE PVT. LTD.-AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY UNIT DOSE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/4258VAPCOGOODMAN INTERNATIONAL LTDLEVOZAN LEVAMIZOLE HCL +OXYCLOZANIDE30MG/ML+60MG/MLVAPCO-DHULIEL ARA, KING HUSSEIN STREET HALLOBATJORDANORAL LIQUID ORDINARY SUSPENSIONS 1000.0 ML BOTTLE,250.0 ML BOTTLE,100.0 ML BOTTLE,500.0 ML BOTTLE
NDA/MAL/VDP/4262ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDASHIDOX-NDOXYCYCLINE+NEOMYCIN100MG+100MG/GASHISH LIFE SCIENCE PVT. LTD. .-AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/4265ASHISH LIFE SCIENCE PVT. LTDMTK UGANDA LIMITEDASHIALBEN 300ALBENDAZOLE300MGASHISH LIFE SCIENCE PVT. LTD-J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X11.0X5.0 BOLUS BLISTER
NDA/MAL/VDP/4424ALIVIRA ANIMAL HEALTHERAM UGANDA LIMITEDSEQUZENE PLUSDIMINAZENEDIACETURATE,CYANOCOBALAMIN0.5G,0.01GALIVIRA ANIMAL HEALTH LIMITED -A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIAINDIAORAL SOLID ORDINARY GRANULES 1.0X1.0X10.0X23.6 G SACHET,1.0X1.0X10.0X2.36 G SACHET
NDA/MAL/VDP/4427NORBROOK KENYA LTDNORBROOK (U) LTDALBAFAS 10%ALBENDAZOLE10%W/VNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN
NDA/MAL/VDP/4432KELA LABORATORIES N.VNILE SERVICES LTDPHENYLBUTAKEL 20PHENYLBUTAZONE20%W/VKELA NV-SINT-LENARTSEWAG 48 2320 HOOGSTRATEN BELGIUMBELGIUMPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/4433ALIVIRA ANIMAL HEALTHERAM UGANDA LIMITEDSEQUZOLE 10%ALBENDAZOLE10%W/VALIVIRA ANIMAL HEALTH LIMITED -A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1000.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/VDP/4435V.M.D.N.VERAM UGANDA LIMITEDENROVETO-20ENROFLOXACIN200MG/MLVMD NV HOGE MAUW--HOGE MUW 900-B2370, ARENDONKBELGIUMORAL LIQUID ORDINARY LIQUIDS 1.0X1000.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/4437 NORBROOK KENYANORBROOK (U) LTDSYPERTIX 10% ECALPHACYPERMETHRIN10%W/VNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYATOPICAL EXTERNAL EMULSION GELS 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L JERRYCAN,1.0X5.0 L JERRYCAN
NDA/MAL/VDP/4443V.M.D.N.VERAM UGANDA LIMITEDIVERVETO-1IVERMECTIN10MG/MLVMD NV HOGE MAUW-HOGE MUW 900, 2370, ARENDONKBELGIUMPARENTERAL ORDINARY S C VIALS 1.0X1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/4445DAWA LIMITED-SUPER MEDIC LTDFASOVERM DS SUSPENSIONOXYCLOZANIDE + LEVAMISOLE HCL + COBALT SULPHATE6%W/V + 3%W/V + 0.704%W/VDAWA LTD-BABA DOGO ROAD RUARAKA ,MEDISEL KENYA LTD - -LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X5.0 L JERRYCAN,1.0X1.0 L BOTTLE,1.0X150.0 ML BOTTLE,1.0X500.0 ML JERRYCAN
NDA/MAL/VDP/4449COSMOS LTDJOSE DEVELOPMENT LIMITEDCOSVITA MULTIVITAMINN/ACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 10.0X30.0 G SACHET
NDA/MAL/VDP/4452ASHISH LIFE SCIENCE PVT LTDMTK UGANDA LIMITEDASHOXY 20%OXYTETRACYCLINE HYDROCHLORIDE100GASHISH LIFE SCIENCE PVT. LTD. .-AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/4476VMD NV HOGE MAUWERAM UGANDA LIMITEDDOXYVET-50SDOXYCYCLINE500MG/GVMD NV HOGE MAUW-HOGE MUW 900, 2370, ARENDONKBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G BOTTLE
NDA/MAL/VDP/4478ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDASHIALBEN 10%ALBENDAZOLE500MG/5MLASHISH LIFE SCIENCE PVT. LIMITED-J-137, MIDC, TARAPUR, BOISAR, THANE 401 501, MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X250.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/4479HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDYZ-PENSTREPTO 20/20 SUSPENSIONPENICILLIN G/DIHYDROSTREPTOMYCIN SUPHATE200MG/ML+200MG/MLHEBEI YUANZHENG PHARM.CO.LTD-NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINACHINAPARENTERAL ORDINARY DRY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/4494CIPLA LTD.QUALITY CHEMICALS LTD - VETLEVACIPLEVAMISOLE HCL 10%W/WOKASA PHARMA PVT LTD-L-2, ADDITIONAL M.I.D.C. AREA, SATARA SATARA-415004, MAHARASHTRA, INDIAINDIAORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X10.0X100.0 G SACHET
NDA/MAL/VDP/4502ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDASHOXY CHICK FORMULAOXYTETRACYCLINE+ VIT A+ D3 + E + K3 + B2 +B12 + CALCIUM + NICOTINAMIDE6G + 0.4G +0.09MG +0.147MG 72MG + 260MG +200MCG + 465MG +1.2MGASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/4508ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDASHOXY EGG FORMULAOXYTETRACYCLINE HCL + VITAMINS; A + D3 +B2 +B12 + E +K3 + NICOTINAMIDE + CALCIUM PANTOTHENATE6G + 225,000IU + 45000IU + 290MG + 220MCG + 100IU + 80MG + .35G + 465MG /100GASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/4512INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDINTROVITVITAMINS/ AMINO ACIDSMULTI-INGREDIENTINTERCHEMIE WERKEN ?DE ADELAAR? B.V - -METAALWEG 8,5804 CG,VENRAY,HOLLAND NETHERLANDSPARENTERAL ORDINARY DRY VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/4649ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDTOLTRACOXTOLTRAZURIL50MG/MLASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X15.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/4653ASHISH LIFE SCIENCE PVT LTDMTK UGANDA LIMITEDALBECTINALBENDAZOLE+IVERMECTIN3000MG+100MGASHISH LIFE SCIENCE PVT. LTD-J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIAINDIAORAL SOLID ORDINARY OTHER TABLETS 1.0X1.0 BOLUS BLISTER
NDA/MAL/VDP/4659 INTRACINE PHARMACEUTICAL PVT LTDVEERAM HEALTHCARE (U) LIMITEDI- TINIVERMECTIN1% W/VINTRACIN PHARMACEUTICAL PVT LTD -C-1, B-53, G.I.D.C. ESTATE, NADIAD 387 001 [GUJARAT], INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/4664INTRACIN PHARMACEUTICAL PVT LTDVEERAM HEALTHCARE (U) LIMITEDIMOLY 10% OXYTETRACYCLINE10% W/VINTRACIN PHARMACEUTICAL PVT. LTD-C-1 B/53, G.I.D.C ESTATE, NADIAD-387001INDIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/4667VET CENTRE UGANDA LIMITEDVET CENTRE UGANDA LIMITEDPHENYLJECTPHENYLBUTAZONE200MG/MLINTERCHEMIE WERKEN DE ADELAAR-EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/4668MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD.KWEWAYO (U) VET PHARMACY LIMITEDOXYNAL 20 LAOXYTETRACYCLINE200MG/MLMEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD-AL HUSSAN ST. OPPOSITE AL-ASSER SUITE COMPANY INDUSTRIAL CITY IRBID AL- RUMTHA /AL HASSAN INDUSTRIAL CITYJORDANPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/4671NORBROOK KENYA LTDNORBROOK (U) LTDALBAFASALBENDAZOLE2500MGNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL SOLID ORDINARY OTHER TABLETS 1.0X40.0 BOLUS STRIP
NDA/MAL/VDP/4673CHONGQUING FANGTONG ANIMAL PHARMACEUTICAL CO.LTDNILE SERVICES LTDDIMINASTARDIMINAZENE DIACETURATE1.05GCHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUINGCHINAOTHER SYSTEMIC OTHER POWDERS/GRANULES 1.0X10.0X2.36 G SACHET
NDA/MAL/VDP/4676INTERCHEMIE WERKEM DE ADELAAR B.VVET CENTRE UGANDA LIMITEDINTERMECTINIVERMECTIN10MG/MLINTERCHEMIE WERKEN DE ADELAAR-EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY OTHER VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/4689VET CENTRE LTDVET CENTRE UGANDA LIMITEDGENTA 100GENTAMYCIN100MG/ MLINTERCHEMIE WERKEN DE ADELAAR-EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/4691VET CENTRE LTDVET CENTRE UGANDA LIMITEDINTERFLOX ORALENROFLOXACIN100MG/MLINTERCHEMIE WERKEN ?DE ADELAAR? B.V-METAALWEG 8, 5804 CG, VENRAY, HOLLAND ESTONIAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0 L BOTTLE
NDA/MAL/VDP/4699CHONGQUING FANGTONG ANIMAL PHARMACEUTICAL CO.LTDNILE SERVICES LTDTETRASTAR 130OXYTETRACYCLINE13%W/VCHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINACHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/VDP/5637DAWA LIMITEDSUPER MEDIC LTDDASCARNIL WORM POWDERPIPERAZINE CITRATE B.P0.35G/GDAWA LIMITED -BABA DOGO RWARAKA,MEDISEL KENYA LTD - -LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 5.0X30.0 G SACHET
NDA/MAL/VDP/5645NORBROOK LABORATORIES LTDNORBROOK (U) LTDLEVACIDE POULTRYLEVAMISOLE HYDROCHLORIDE7.5%W/VNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN
NDA/MAL/VDP/5646NORBROOK LABORATORIES LTDNORBROOK (U) LTDLEVACIDE WORM DRENCHLEVAMISOLE HYDROCHLORIDE15MG/MLNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0 L JERRYCAN,1.0X2.5 L JERRYCAN,1.0X5.0 L JERRYCAN,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/5649CHONGQUING FANGTONG ANIMAL PHARMACEUTICAL CO.LTDNILE SERVICES LTDALBENDASTAR 10%ALBENDAZOLE10%W/VCHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO., LTD-BANQIAO INDUSTRIAL PARK, RONGCHANG, CHONGQING CHINANON-HUMAN USE LIQUIDS 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X5.0 L JERRYCAN
NDA/MAL/VDP/5651CHONGQUING FANGTONG ANIMAL PHARMACEUTICAL CO.LTDNILE SERVICES LTDALBENDASTAR 2.5%ALBENDAZOLE25MG/MLCHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO., LTD-BANQIAO INDUSTRIAL PARK, RONGCHANG, CHONGQING CHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0 L JERRYCAN
NDA/MAL/VDP/5652NORBROOK LABORATORIES LTDNORBROOK (U) LTDLEVAFAS DIAMONDLEVAMISOLE+OXYCLOZANIDE30G+60GNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL LIQUID ORDINARY LIQUIDS 1.0X5.0 L JERRYCAN,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5653VAPCOGOODMAN INTERNATIONAL LTDPIROPLASMINACETURATE + ANTIPYRINE + VITAMIN B1275 MG + 250 MG + 0.00004 MGVAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)-DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDANJORDANPARENTERAL ORDINARY VIALS 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5654NORBROOK LABORATORIES LTDNORBROOK (U) LTDLEVAFAS FLUKE & WORM DRENCHLEVAMISOLE HCL+OXYCLOZANIDE15G+30GNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X5.0 L JERRYCAN,1.0X1.0 L BOTTLE,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/5657COSMOS LTDJOSE DEVELOPMENT LIMITEDPOLTRICIN CHICK FORMUMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 5.0X25.0 G SACHET
NDA/MAL/VDP/5658KELA LABORATORIES N.VNILE SERVICES LTDALBENDAZOLE 1500MGALBENDAZOLE1500MGKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMORAL SOLID ORDINARY OTHER TABLETS 25.0X4.0 TABLET BLISTER
NDA/MAL/VDP/5659COSMOS LTDJOSE DEVELOPMENT LIMITEDPOLTRICIN MAYAI FORMULAMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 5.0X25.0 G SACHET
NDA/MAL/VDP/5660COSMOS LTDJOSE DEVELOPMENT LIMITEDWORMICID 150 TABLETSLEVAMISOLE HYDROCHLORIDE150MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER
NDA/MAL/VDP/5661INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDALBENOL-100 ORALALBENDAZOLE100MG/MLINTERCHEMIE WERKEN ?DE ADELAAR? B.V-METAALWEG 8, 5804 CG, VENRAY, HOLLAND NETHERLANDSORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/5662COSMOS LTDJOSE DEVELOPMENT LIMITEDWORMICID 1G BOLUSLEVAMISOLE HYDROCHLORIDE1GCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X30.0 BOLUS CARTON
NDA/MAL/VDP/5663COSMOS LTDJOSE DEVELOPMENT LIMITEDWORMICID LIQUID DEWORMERLEVAMISOLE HYDROCHLORIDE1.5W/VCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5664KELA LABORATORIES N.VNILE SERVICES LTDALBENZOLE 10%ALBENDAZOLE10%W/VKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMORAL LIQUID ORDINARY LIQUIDS 1.0X120.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/VDP/5665COSMOS LTDJOSE DEVELOPMENT LIMITEDWORMICID PLUS-OLEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE+CALCIUM SULFATE1.5W/V+3%W/V+0.382%W/VCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X125.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/5668COSMOS LTDJOSE DEVELOPMENT LIMITEDWORMITA SUSPENSIONALBENDAZOLE 2.5%W/VCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5670COSMOS LTDJOSE DEVELOPMENT LIMITEDWORMITA-150 TABLETSALBENDAZOLE150MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY TABLETS 1.0X10.0 TABLET BLISTER
NDA/MAL/VDP/5673VMD NV ERAM UGANDA LIMITEDALBEVETO-10ALBENDAZOLE100MG/MLVMD NV-HOGE MAUW 900-B2370, ARENDOKBELGIUMORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5674KELA LABORATORIES N.VNILE SERVICES LTDDEXA-KEL 02 50MLDEXAMETHASONE0.2%W/VKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/5676VMD NV ERAM UGANDA LIMITEDDIAZIPRIM 48%SULPHADIAZINE + TRIMETHOPRIM400 MG + 80 MGVMD NV HOGE MAUW-HOGE MUW 900, 2370, ARENDONKBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5677LABORATOIRES LAPROVETEVERVICTORY LIMITEDLEVALAPLEVAMISOLE20%W/WLABORATOIRES BIOVE -3 RUE DE LORRAINE BP 45 62510 ARQUESFRANCEORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X10.0X100.0 G SACHET,1.0X1000.0 G SACHET
NDA/MAL/VDP/5680HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDLEVAMISOLELEVAMISOLE75MG/MLHEBEI YUANZHENG PHARMACEUTICALS CO LTD , -NO.13 LIUYUAN ROAD CHANG'AN SECTION SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY I M VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/5681HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDLEVAMISOLELEVAMISOLE100MG/MLHEBEI YUANZHENG PHARMACEUTICALS CO LTD , -NO.13 LIUYUAN ROAD CHANG'AN SECTION SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY I M VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/5682INTRACIN PHARMACEUTICAL PVT LTDVEERAM HEALTHCARE (U) LIMITEDDIMINACINDIMINAZENE ACETERATE7%W/VINTRACIN PHARMACEUTICAL PVT. LTD-C-1 B/53, G.I.D.C ESTATE, NADIAD-387001INDIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5684KELA LABORATORIES N.VNILE SERVICES LTDDIMINAKEL-23.6GDIMINAZENE ACETURATE2.36GKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMOTHER SYSTEMIC POWDER 1.0X23.6 G SACHET,1.0X2.36 G SACHET
NDA/MAL/VDP/5688INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDLIMOXIN-200 LAOXYTETRACYCLINE200MG/MLINTERCHEMIE WERKEN DE ADELAAR-EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5690VET CENTRE LTDVET CENTRE UGANDA LIMITEDMACRALAN-200TYLOSIN200MG/MLINTERCHEMIE WERKEN DE ADELAAR -EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5691ANGLIAN NUTRITION PRODUCTS COMPANYSUPER MEDIC LTDDIMINA-VETDIMINAZENE DIACETURATE + ANTIPYRINE1.05G + 1.31G/ SACHETDAWA LTD-BABA DOGO ROAD RUARAKA KENYAOTHER SYSTEMIC POWDER 10.0X2.36 G SACHET, TABLET AMPOULE
NDA/MAL/VDP/5693VMD NV HOGE MAUWERAM UGANDA LIMITEDDIMINAVETODIMINAZENE/ANTIPYRINE1.05G/1.31GVMD NV HOGE MAUW-HOGE MUW 900, 2370, ARENDONKBELGIUMNON-HUMAN USE SOLUBLE POWDERS 1.0X2.36 G SACHET,1.0X23.6 G SACHET
NDA/MAL/VDP/5695HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDDIMINAZENE DIACETURATEDIMINAZENE DIACETURATE2.36G/ SACHET, 23.6G/ SACHETHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAOTHER SYSTEMIC POWDER 10.0X2.36 G SACHET
NDA/MAL/VDP/5696MEDITEC (U) LIMITEDKWEWAYO (U) VET PHARMACY LIMITEDMILBITRAZAMITRAZ12.5% W/VBAYER (PTY) LTD-5TH AVENUE, VOSTERSKROON, EXT. 3SOUTH AFRICATOPICAL EXTERNAL EMULSIONS 500.0 ML BOTTLE,250.0 ML BOTTLE,100.0 ML BOTTLE,5.0 L JERRYCAN,1.0 L JERRYCAN
NDA/MAL/VDP/5697VMD NV HOGE MAUWERAM UGANDA LIMITEDVMD OLIGOVIT PLUSMULTI-INGREDIENTMULTI-INGREDIENTVMD NV HOGE MAUW--HOGE MUW 900-B2370, ARENDONKBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5699VMD NV ERAM UGANDA LIMITEDVMD SUPERVITAMINS POWDERMULTI-VITAMINMULTI-INGREDIENTVMD NV HOGE MAUW-B2370, ARENDOKBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5700KELA LABORATORIES N.VNILE SERVICES LTDMULTIVITAMINMULTI-INGREDIENTNAKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5701BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDDIPENDIHYDROSTREPTOMYCIN/ BENZYL PENICILLIN200MG/MLCHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUING,BIMEDA CHEMICALS EXPORT LTD.-IRELANDIRELANDNON-HUMAN USE LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5702COSMOS LTDJOSE DEVELOPMENT LIMITEDDISEPTOPRIM BOLUSMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY TABLETS 1.0X4.0X10.0 TABLET STRIP
NDA/MAL/VDP/5703ALFASAN INTERNATIONAL BVNILE SERVICES LTDALFAPORALPHACYPERMETHRIN5%W/VCHIMAC S.A-RUE DE RENORY, 26/2,B-4102 OUGREE BELGIUMBELGIUMTOPICAL EXTERNAL EMULSIONS 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5704AGRAR HOLLAND BVSEKALALA LIMITEDPIPERZINEPIPERAZINE HYDROCHLORIDE1GLABORATORIA SMEETS-FOTOGRAFIELAAN 42 (SITE1 ) NEBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5709KELA LABORATORIES N.VNILE SERVICES LTDPIPERAZINE CITRATE 100%PIPERAZINE CITRATE100 MGKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1000.0 G SACHET,1.0X200.0 G SACHET,1.0X100.0 G SACHET
NDA/MAL/VDP/5711KELA LABORATORIES N.VNILE SERVICES LTDVITAMINS+OLIGOELEMETSMULTI-INGREDIENTMULTI-INGREDIENTKELA LABORATORIES N.V .--ST.LENAARTSEWEG 42320 HOOGSTRTEN BELGIUM BELGIUMPARENTERAL ORDINARY I M VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5717KELA LABORATORIES N.VNILE SERVICES LTDTYLOXAN 20%TYLOSIN TARTRATE20%W/VKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5718KELA LABORATORIES N.VNILE SERVICES LTDPHENOXYL 5%OXYTETRACYCLINE HYDROCHLORIDE50MG/MLKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5719VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDTYLOVAPTYLOSIN200MG/MLVAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)-DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDANJORDANPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5722VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)GOODMAN INTERNATIONAL LTDVAPCODIMIDINESULPHADIMIDINE33%W/VVAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)-DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDANJORDANPARENTERAL ORDINARY VIALS 1.0X1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/5723NORBROOK LABORATORIES LTDNORBROOK (U) LTDDUOFAST INTRAMAMMARY SUSPENSIONTRIMETHOPRIM + SULFADIAZINE40MG+200MG IN 8G SYRINGENORBROOK LABERATORIES LTD -STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOMIRELANDPARENTERAL ORDINARY OTHER INFUSIONS 1.0X8.0 G SYRINGE
NDA/MAL/VDP/5726NORBROOK LABORATORIES LTDNORBROOK (U) LTDDUOTECH DRENCH OXFENDAZOLE+CLOSANTEL25MG/ML + 50MG/MLNORBROOK LABERATORIES LTD -OLD LIMURU RD NAIROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1000.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5000.0 ML CONTAINER,1.0X60.0 ML CONTAINER
NDA/MAL/VDP/5727VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDVAPCOZINAMITRAZ125MG/MLVAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)-DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDANJORDANTOPICAL EXTERNAL EMULSIONS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5730VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDVAZURILTOLTRAZURIL2.5%W/VVAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)-DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDANJORDANORAL LIQUID ORDINARY LIQUIDS 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML JERRYCAN
NDA/MAL/VDP/5731VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDVERMECTINIVERMECTIN1%W/VVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) -AL-HALABAT STREET NO. 5 DHELEIL ZARKA GOVERNERATE, JORDANJORDANPARENTERAL ORDINARY S C VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5732VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDVERMECTIN-PLUSIVERMECTIN+CLORSULON10MG/ML+100MG/MLVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) -KING HUSSEIN STREET AL DHULAIL AREA ZARQA PROVINCE HASHEMITE KINGDOM OF JORDANJORDANPARENTERAL ORDINARY OTHER VIALS 1.0X1.0X100.0 ML VIAL,1.0X1.0X50.0 ML VIAL
NDA/MAL/VDP/5733BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDENDOSPEC 10% ALBENDAZOLE100MG/MLBIMEDA CHEMICALS EXPORT LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQINGCHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0 L BOTTLE,1.0X500.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X5.0 L JERRYCAN
NDA/MAL/VDP/5734VAPCOGOODMAN INTERNATIONAL LTDENROSOL-SENROFLOXACIN10%W/VVAPCO-DHULIEL ARA, KING HUSSEIN STREET HALLOBATJORDANORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X500.0 ML JAR
NDA/MAL/VDP/5735CIPLA LTD..QUALITY CHEMICALS LTD - VETENROVET 10%ENROFLOXACIN100MG/MLMIST AIR HEALTH & HYGIENE-PLOT 3 MIDC, SHIROLI, KOLHAPUR- 416122INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/5736VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDSUPER VITAMINMULTI-INGREDIENTMULTI-INGREDIENTVAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)-DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDANJORDANORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X1.0 L JERRYCAN
NDA/MAL/VDP/5737ALIVIRA ANIMAL HEALTHERAM UGANDA LIMITEDPFBENFENBENDAZOLE2.5%W/VALIVIRA ANIMAL HEALTH LIMITED -A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5738VAPCOGOODMAN INTERNATIONAL LTDERYTHROMYCIN THIOCYANATEERYTHROMYCIN THIOCYANATE20%W/WVAPCO-DHULIEL ARA, KING HUSSEIN STREET HALLOBATJORDANORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5739VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDSULPHAMYCIN-KNEOMYCIN SULPHATE + SULPHAGUANIDINE + SULPHADIMIDINE SODIUM + SULPHATHIAZOLE SODIUM +VITAMIN B2+NICOTINIC ACID+PECTIN16.650G + 50.0G + 50.0G + 50.0G + 3.30G + 16.65G + 5.00G / 1000 GVAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)-DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDANJORDANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1000.0 G SACHET,1.0X100.0 G SACHET
NDA/MAL/VDP/5741INTERVET SA (PTY) LTDERAM UGANDA LIMITEDESTRUMATECLOPROSTENOL SODIUM0.263MG/MLVET PHARMA FRIESOYTHE GMBH-GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0X10.0 ML VIAL
NDA/MAL/VDP/5742INTERCHEMIE WERKEM DE ADELAAR B.VVET CENTRE UGANDA LIMITEDPENSTREP-400DIHYDROSTREPTOMYCIN + PENICILLIN200MG+200MGINTERCHEMIE WERKEN ?DE ADELAAR? B.V-METAALWEG 8, 5804 CG, VENRAY, HOLLAND NETHERLANDSPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5743BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDSUPERMECIVERMECTIN1%W/VCHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUINGCHINAPARENTERAL ORDINARY S C VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/5744KELA LABORATORIES N.VNILE SERVICES LTDPENSTREP-20/20PENICILLIN G PROCAINE+DIHYDROSTREPTOMYCIN SULPHATE200000I.U+200MG/MLKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5746KELA LABORATORIES N.VNILE SERVICES LTDPENSTREP 20/20DIHYDROSTREPTOMYCIN+PROCAINE PENICILLIN200MG+200MGKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/5747BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDSUPERMEC PLUSIVERMECTIN/CLORSULON10MG+100MG/MLCHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUINGCHINAPARENTERAL ORDINARY S C VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5748 LAPROVETEVERVICTORY LIMITEDETHIDIUMHOMIDIUM BROMIDE250MGLAPROVET-2 CHEMIN DE LA MILLETERRE TOURS CEDEXFRANCEORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET BOTTLE,1.0X20.0 TABLET BOTTLE
NDA/MAL/VDP/5749BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDTETROXY CHICK FORMULAMULTI-VITAMINMULTI-INGREDIENTBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X120.0 G SACHET
NDA/MAL/VDP/5750CHONGQING FANGTONG PHARMACEUTICALS CONILE SERVICES LTDPENSTARPENICILLIN G PROCAINE + DIHYDROSTREPTOMYCIN SULPHATE200,000IU/ML + 200MG/MLCHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO.LTD-BANGIAO INDUSTRIAL PARK,RONGCHANG,CHONGQUING,CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/5751BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDTETROXY EGG FORMULAMULTI-VITAMINMULTI-INGREDIENTBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X120.0 G SACHET
NDA/MAL/VDP/5752BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDTETROXY INJECTIONOXYTETRACYCLINE HYDROCHLORIDE100MG/MLCHONGOING FANGTONG ANIMAL PHARMACEUTICALS CO. LTD-BANQIAO INDUSTRIAL PARK, RONGCHANG, CHONGOING, CHINA,BIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/5753NORBROOK LABORATORIES LTDNORBROOK (U) LTDPEN & STREPDIHYDROSTREPTOMYCIN SULPHATE + PENICILLIN G MONOHYDRATE250MG + 250MGNORBROOK LABARATORIES LIMITED-STAION WORKS NEWRY, COUNTY DOWN, BT 356JP NORTHERN IRELAND UKUNITED KINGDOMPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/5754INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDALISERYL WSERYTHROMYCIN + OXYTETRACYCLINE +STREPTOMYCIN + COLISTIN + VITAMINS (A + D3 + B1 + B2 + B6 + B12 + C) + CALCIUM + VIT K3 + NICOTINAMIDE + INOSITOL35MG +50MG + 35MG + 200 0001U + 3000 IU + 1500 IU + 2MG + 2MG + 4MG + 2MG + 10MCG + 20MG + 10MG + 2MG + 20MG +1MGINTERCHEMIE WERKEN ?DE ADELAAR? B.V - -METAALWEG 8,5804 CG,VENRAY,HOLLAND NETHERLANDSORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5755BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDTETROXY LAOXYTETRACYCLINE HYDROCHLORIDE200MG/MLCHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINA,BIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/VDP/5756INTRACIN PHARMACEUTICAL PVT LTD?MTK UGANDA LIMITEDPAVEXPARVAQUONE150MG/MLINTRACIN PHARMACEUTICALS PVT LTD-C-1, B-53, GIDC ESTATE NADAID-387 001(GUJARAT INDIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/5757HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDEVACIDE PLUSOXYCLOZANIDE + LEVAMISOLE HYDROCHLORIDE60MG + 30MG/MLHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5760BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDPARVONPARVAQUONE15OMG/MLBIOVET JOINT STOCK COMPANY -FINISHED DRUG FORMS DEPARTMENT 48 VASIL PETLESHKOV STREET PESHTERA 4550BULGARIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/VDP/5761BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDPARVEXON INJECTIONPARVAQUONE150MG/MLBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELAND,BIOVET JOINT STOCK COMPANY -FINISHED DRUG FORMS DEPARTMENT 48 VASIL PETLESHKOV STREET PESHTERA 4550IRELANDPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5763BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDPARVEXON PLUSPARVAQUONE + FRUSEMIDE150MG + 55MG/MLBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELAND,BIOVET JOINT STOCK COMPANY -FINISHED DRUG FORMS DEPARTMENT 48 VASIL PETLESHKOV STREET PESHTERA 4550IRELANDPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5764JUANCO SPS LTDMTK UGANDA LIMITEDALMATIXAMITRAZ12.5W/VMELEIA AGRO CIENCAS SA-BRAZILBRAZILTOPICAL EXTERNAL EMULSIONS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5765KELA LABORATORIES N.VNILE SERVICES LTDPARVAKELPARVAQUONE150MG/MLKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5769BREMER PHARMA GMBHQUALITY CHEMICALS LTD - VETFERRUM 10% + B12 INJECTIONMULTI-VITAMINMULT-INGREDIENTBREMER PHARMA GMBH .-WERKSTRSSE 42 34414 WARBURG SCHGERMANYPARENTERAL ORDINARY I M VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5775AGRAR HOLLAND BVSEKALALA LIMITEDAMCOXAMPROLIUM HYDROCHLORIDE20%W/WLABORATORIA SMEETS-FOTOGRAFIELAAN 42 (SITE1 ) NEBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5776VAPCOGOODMAN INTERNATIONAL LTDOXYVITAMINOXYTETRACYCLINE HCL+VIT A+VIT D3+VIT E+VIT C+FERROUS SO4+MAGNESIUM SO4+ZINC SO4+COPPER SO4+COBALT CH250G+2,500,000IU+500,000IU+1,000IU+10,000MG+500MG+400MG+150MG+40MG+10MG / 1000GVAPCO-DHULIEL ARA, KING HUSSEIN STREET HALLOBATJORDANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET,1.0X1000.0 G SACHET
NDA/MAL/VDP/5777INTERCHEMIE WERKEM DE ADELAAR B.VVET CENTRE UGANDA LIMITEDFLUCONIX 340NITROXINIL340MG/MLINTERCHEMIE WERKEN DE ADELAAR -EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5778VMD NV ERAM UGANDA LIMITEDOXYVETO 50 S POWDEROXYTETRACYCLINE HCL500MG/GVMD NV-HOGE MAUW 900-B2370, ARENDOKBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET,1.0X250.0 G SACHET,1.0X500.0 G SACHET,1.0X1000.0 G SACHET
NDA/MAL/VDP/5779DAWA LIMITEDSUPER MEDIC LTDAMIDIOSTAT-PLUSAMPROLIUM HCL +SULFAQUINOXALINE SODIUM + VITAMIN K3 + VITAMIN A200MG +150MG +5MG + 15000 IU/ GDAWA LTD-BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY POWDERS 1.0X10.0X30.0 G SACHET
NDA/MAL/VDP/5783ANGLIAN NUTRITION PRODUCTS COMPANYNILE SERVICES LTDAMINO-VITMULTIVITAMINMULTI-INGREDIENTKELA NV-SINT-LENARTSEWAG 48 2320 HOOGSTRATEN BELGIUMBELGIUMORAL LIQUID ORDINARY LIQUIDS 1.0X500.0 ML BOTTLE
NDA/MAL/VDP/5784HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDYZ-PENSTREPTO 20/25 SUSPENSIONPENICILLIN G/DIHYDROSTREPTOMYCIN200MG/ML+250MG/MLHEBEI YUANZHENG PHARMACEUTICAL CO-NO. 13 LIUYUAN ROAD, CHANG?AN SECTION SHIJIAZHUANG CITY, HEBEI PROVINCE CHINA. CHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X250.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5785VMD NV ERAM UGANDA LIMITEDAMINOVIT POWDERMULTIVITAMINMULTI-INGREDIENTVMD NV HOGE MAUW-B2370, ARENDOKBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5787ALFASAN INTERNATIONAL BVNILE SERVICES LTDAMITIXAMITRAZ12.5%W/VCHIMAC S.A-RUE DE RENORY, 26/2,B-4102 OUGREE BELGIUMBELGIUMTOPICAL EXTERNAL EMULSIONS 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5789INTERCHEMIE WERKEM DE ADELAAR B.VVET CENTRE UGANDA LIMITEDOXYTOCIN-10OXYTOCIN10 IU/MLINTERCHEMIE WERKEN DE ADELAAR -EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/5793HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDYZOXYTETRA 30%OXYTETRACYCLINE HCL30%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5794VMD NV HOGE MAUWERAM UGANDA LIMITEDFLUMEQ-50-SFLUMEQUINE500MG/GVMD NV HOGE MAUW--HOGE MUW 900-B2370, ARENDONKBELGIUMORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5795VAPCOGOODMAN INTERNATIONAL LTDOXYTETRACYCLINEOXYTETRACYCLINE25%W/WVAPCO --DHULIEIL PROVINCE, KING HUSSEIN STREET NO. IT 1 IZARKA, JORDANJordanOral Solid Ordinary Powders 1.0x100.0 G Sachet
NDA/MAL/VDP/5796HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDYZOXYTETRA 20%OXYTETRACYCLINE DIHYDRATE20%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X500.0 ML VIAL
NDA/MAL/VDP/5797HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDYZOXYTETRA 12.5%OXYTETRACYCLINE HCL12.5%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X500.0 ML VIAL,1.0X250.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5800HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDYZOXYTETRA 10%OXYTETRACYCLINE HCL10%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL
NDA/MAL/VDP/5804MERIAL SAS ERAM UGANDA LIMITEDFRONTLINE SPRAY FIPRONIL0.25%W/VMERIAL SAS-4 CHEMIN DU CALQUET 31057 TOULOUSE CEDEFRANCETOPICAL EXTERNAL SPRAYS WITHOUT GAS 1.0X500.0 ML CANNISTER,1.0X125.0 ML CANNISTER,1.0X250.0 ML CANNISTER
NDA/MAL/VDP/5806KELA LABORATORIES N.VNILE SERVICES LTDOXY-KEL 10OXYTETRACYCLINE HYDROCHLORIDE100MG/MLKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X500.0 ML VIAL,1.0X250.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5807KELA LABORATORIES N.VNILE SERVICES LTDOXYKEL 20OXYTETRACYCLINE HYDROCHLORIDE200MG/MLKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/5808KELA LABORATORIES N.VNILE SERVICES LTDOXY-KEL 20 WSPOXYTETRACYCLINE HYDROCHLORIDE20 %W/WKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5809BREMER PHARMA GMBHQUALITY CHEMICALS LTD - VETGENTAMASTGENTAMYCIN SULPHATE20MG/GMBREMER PHARMA GMBH .-WERKSTRSSE 42 34414 WARBURG SCHGERMANYPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X7.5 MG PRE- FILLED SYRINGE
NDA/MAL/VDP/5810AGRAR HOLLAND BVSEKALALA LIMITEDVITOXMULTI-INGREDIENTMULTI-INGREDIENTLABORATORIA SMEETS-FOTOGRAFIELAAN 42 (SITE1 ) NEBELGIUMORAL LIQUID RETARD SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5811INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDAMPROLIN-300 WSAMPROLIUM30%W/WINTERCHEMIE WERKEN ?DE ADELAAR? B.V - -METAALWEG 8,5804 CG,VENRAY,HOLLAND NETHERLANDSORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5812BREMER PHARMA GMBHQUALITY CHEMICALS LTD - VETGENTAMICIN 5% INJECTIONGENTAMYCIN SULPHATE50MG/MLBREMER PHARMA GMBH .-WERKSTRSSE 42 34414 WARBURG SCHGERMANYPARENTERAL ORDINARY VIALS 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5813VMD NV ERAM UGANDA LIMITEDAMPROLIUM-20SAMPROLIUM HYDROCHLORIDE200MG/GVMD NV-HOGE MAUW 900-B2370, ARENDOKBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5814AGRAR HOLLAND BVSEKALALA LIMITEDV & E PLUSMULTI-INGREDIENTMULTI-INGREDIENTLABORATORIA SMEETS-FOTOGRAFIELAAN 42 (SITE1 ) NEBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5815LABORATORIES HIPRA SAERAM UGANDA LIMITEDGENTAMOXAMOXYCILLIN + GENTAMICIN150 MG + 40 MGLABORATORIES HIPRA SA-AVDA LASELVA 135-17170, AMESPAINPARENTERAL ORDINARY VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5817AGRAR HOLLAND BVSEKALALA LIMITEDAMPRO-SULAMPROLIUM+SULPHAQUINOXALINE+VITAMIN K3166MG+166MG+20MGLABORATORIA SMEETS-FOTOGRAFIELAAN 42 (SITE1 ) NEBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5818CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO.LTDNILE SERVICES LTDOXYSTAR 10%OXYTETRACYCLINE100MG/MLCHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X500.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/5819ANGLIAN NUTRITION PRODUCTS COMPANYNILE SERVICES LTDANCOBANAMPROLIUM20%W/WKELA NV-SINT-LENARTSEWAG 48 2320 HOOGSTRATEN BELGIUMBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET,1.0X1.0 KG SACHET
NDA/MAL/VDP/5820CHONGQING FANGTONG ANIMAL PHARMACEUTICAL CO.LTDNILE SERVICES LTDOXYSTAR 20%OXYTETRACYCLINE200MG/MLCHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5825VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDVERMIZOLE-FORTEALBENDAZOLE10%W/VVAPCO (VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD)-DHULEIL AREA, KING HUSSEIN STREET, HALLOBAT ROAD, AMMAN, JORDANJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/VDP/5826VMD NV ERAM UGANDA LIMITEDGENTAVETO -5GENTAMYCIN SULPHATE 50MG/MLVMD NV-HOGE MAUW 900-B2370, ARENDOKBELGIUMPARENTERAL ORDINARY VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5827LAPROVET S.A.SEVERVICTORY LIMITEDANTICOXSULFADIMIDINE SODIUM + DIAVERIDINE80%W/W + 8%W/WBIOVE LABORATORY-3, RUE DE LORRAINE, BP 45 62510 ARQUES FRANCEFRANCEORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X10.0X30.0 G SACHET,1.0X10.0X100.0 G SACHET,1.0X1000.0 G CONTAINER
NDA/MAL/VDP/5828ANGLIAN NUTRITION PRODUCTS CO.NILE SERVICES LTDVITALYTEMULTI-INGREDIENTMULTI-INGREDIENTKELA NV-SINT-LENARTSEWAG 48 2320 HOOGSTRATEN BELGIUMBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X30.0 G SACHET,1.0X150.0 G SACHET
NDA/MAL/VDP/5829BREMER PHARMA GMBHQUALITY CHEMICALS LTD - VETAS SUPERMEDMULTI-INGREDIENTN/ABREMER PHARMA GMBH .-WERKSTRSSE 42 34414 WARBURG SCHGERMANYORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5830INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDGLUCORTIN 20DEXAMETHASONE2MG/MLINTERCHEMIE WERKEN DE ADELAAR -EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/5831ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDASAMPROAMPROLIUM20%W/WASHISH LIFESCIENCE PVT LTD-213 LAXMI PLAZA INDUSTRIAL ESTATE NEW LINK RD ANDHERI-(W) MUMBAIINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5832COSMOS LTDJOSE DEVELOPMENT LIMITEDASCAREX WORM POWDERPIPERAZINE CITRATE360MG/GCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X30.0 G SACHET
NDA/MAL/VDP/5833COSMOS LTDJOSE DEVELOPMENT LIMITEDASCATEN-PMULTI-INGREDIENTMULTI-INGREDIENTCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY SOLUBLE POWDERS 10.0X6.0 TABLET BLISTER
NDA/MAL/VDP/5834VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDASCAZINEPIPERAZINE CITRATE360MG/GVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) -KING HUSSEIN STREET AL DHULAIL AREA ZARQA PROVINCE HASHEMITE KINGDOM OF JORDANJORDANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1000.0 G SACHET,1.0X100.0 G SACHET
NDA/MAL/VDP/5835ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDASHIALBEN 2500ALBENDAZOLE2500MGASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X5.0 TABLET BLISTER
NDA/MAL/VDP/5836ASHISH LIFE SCIENCE PVT. LTDMTK UGANDA LIMITEDASHIALBEN 2.5%ALBENDAZOLE2.5%W/VASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/5837SCHERING PLOUGH ANIMAL HEALTHCEE K-BRANDS LIMITEDGRENADE ECCYHALOTRIN5%W/VCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY, NAIROBI KENYATOPICAL EXTERNAL LIQUIDS 1.0X1.0 L BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5.0 L JERRYCAN
NDA/MAL/VDP/5842CIPLA LTDQUALITY CHEMICALS LTD - VETVETPRO 20%W/VAMPROLIUM HYDROCHLORIDE20%W/VOKASA PHARMA, -L-2 ADDITIONAL MIDC AREA SATARA 415004INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5844NORBROOK LABORATORIES LTDNORBROOK (U) LTDNORODINE BOLUSSULPHADIAZINE + TRIMETHOPRIM1G + 200MGNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL SOLID ORDINARY OTHER TABLETS 1.0X50.0 BOLUS CONTAINER,1.0X20.0 BOLUS CONTAINER
NDA/MAL/VDP/5846ASHISH LIFE SCIENCE PVT. LTDMTK UGANDA LIMITEDASHIENRO 10%ENROFLOXACIN100MG/MLASHISH LIFE SCIENCE PVT. LTD-J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5847CIPLA LTDQUALITY CHEMICALS LTD - VETVERMONIL SUSPENSIONLEVAMISOLE+OXYCLOZANIDE3%W/V+6%W/VMIST AIR HEALTH & HYGIENE-PLOT 3 MIDC, SHIROLI, KOLHAPUR- 416122INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1000.0 ML BOTTLE,1.0X125.0 ML BOTTLE
NDA/MAL/VDP/5849NORBROOK LABORATORIES LTDNORBROOK (U) LTDNOROMECTIN INJECTIONIVERMECTIN1%W/VNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMPARENTERAL ORDINARY S C VIALS 1.0X50.0 ML VIAL,1.0X250.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5851NORBROOK LABORATORIES LTDNORBROOK (U) LTDNOROTRAZAMITRAZ12.5%W/VNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYATOPICAL EXTERNAL LIQUIDS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X1.0 L JERRYCAN
NDA/MAL/VDP/5852NORBROOK LABORATORIES LTDNORBROOK (U) LTDNOROTRYPDIMINAZENE DIACETURATE1.05GM/MLNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMPARENTERAL ORDINARY VIALS 1.0X2.36 G VIAL
NDA/MAL/VDP/5853LABORATORIES HIPRA SAERAM UGANDA LIMITEDHIPRALONA ENRO-SNORFLOXACIN20%W/VLABORATORIOS HIPRA, S.A-AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN SPAINORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/5854CIPLA LTDQUALITY CHEMICALS LTD - VETTYLOCIPTYLOSIN TARTRATE200MG/GMEDISPRAY LABORATORIES PVT LTD --L-1/1, L-1/2/2, ADDITIONAL MIDC SATARA 415004INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G CONTAINER
NDA/MAL/VDP/5856ANGLIAN NUTRITION PRODUCTS COMPANYNILE SERVICES LTDOTC PLUSMULTI-INGREDIENTMULTI-INGREDIENTKELA LABORATORIES N.V .--ST.LENAARTSEWEG 42320 HOOGSTRTEN BELGIUM BELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X150.0 G CONTAINER,1.0X1.0 KG CONTAINER
NDA/MAL/VDP/5858CIPLA LTDQUALITY CHEMICALS LTD - VETTRYCIPDIMINAZENE DIACETURATE1.05GMIST AIR HEALTH & HYGIENE-PLOT 3 MIDC, SHIROLI, KOLHAPUR- 416122INDIAPARENTERAL ORDINARY DRY VIALS 1.0X2.36 G VIAL
NDA/MAL/VDP/5859CIPLA LTD.QUALITY CHEMICALS LTD - VETOTC 20%OXYTETRACYCLINE HCL20%W/WMEDISPRAY LABORATORIES PVT LTD --L-1/1, L-1/2/2, ADDITIONAL MIDC SATARA 415004INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5860KELA LABORATORIES N.VNILE SERVICES LTDO.T.C. 20OXYTETRACYCLINE HYDROCHLORIDE20%W/WKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5861BAYER ANIMAL HEALTH (PTY) LTDKWEWAYO (U) VET PHARMACY LIMITEDHI-TETOXYTETRACYCLINE DIHYDRATE120MG/MLPHARMA-Q (PTY) LTD -50 COMMANDO ROAD, INDUSTRIA WESSOUTH AFRICAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/5862BREMER PHARMA GMBHQUALITY CHEMICALS LTD - VETTRIMETHOSULFTRIMETHOPRIM/SULFADIAZINEMULTI-INGREDIENTBREMER PHARMA GMBH .-WERKSTRSSE 42 34414 WARBURG SCHERFEDEGERMANYPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5863NORBROOK LABORATORIES LTDNORBROOK (U) LTDNORODINE 24SULFADIAZINE + TRIMETHOPRIM200MG + 40MGNORBROOK LABARATORIES LIMITED-STAION WORKS NEWRY, COUNTY DOWN, BT 356JP NORTHERN IRELAND UKUNITED KINGDOMPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5865ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDASHPIRAZINEPIPERAZINE CITRATE1000MG/GASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET,1.0X5.0 G SACHET,1.0X25.0 G SACHET
NDA/MAL/VDP/5866BREMER PHARMA GMBHQUALITY CHEMICALS LTD - VETTETRACYCLINE 25%TETRACYCLINE HYDROCHLORIDE50MG/MLBREMER PHARMA GMBH .-WERKSTRSSE 42 34414 WARBURG SCHGERMANYORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5867NORBROOK LABORATORIES LTDNORBROOK (U) LTDNOROCLOX DCCLOXACILLIN BENZATHINE500MGNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X4.5 G SACHET
NDA/MAL/VDP/5868BREMER PHARMA GMBHQUALITY CHEMICALS LTD - VETSYNCHROMATECLOPROSTENOL0.25MG/MLBREMER PHARMA GMBH .-WERKSTRSSE 42 34414 WARBURG SCHGERMANYPARENTERAL ORDINARY VIALS 1.0X20.0 ML BOTTLE
NDA/MAL/VDP/5869NORBROOK LABORATORIES LTDNORBROOK (U) LTDNOROCILLIN LABENZATHINE+PROCAINE PENICILLIN159MG+112MG/MLNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5870BREMER PHARMA GMBHQUALITY CHEMICALS LTD - VETSUPERMED TS TS 1SULFADIAZINE/TRIMETHOPRIM400MG/80MGBREMER PHARMA GMBH .-WERKSTRSSE 42 34414 WARBURG SCHGERMANYORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5871INTERVET SA (PTY) LTDERAM UGANDA LIMITEDIMIZOLIMIDOCARB12%W/VVET PHARMA FRIESOYTHE GMBH-GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X40.0 ML VIAL,1.0X10.0 ML VIAL
NDA/MAL/VDP/5873NORBROOK LABORATORIES LTDNORBROOK (U) LTDNORBROOK MILKING SALVEDICHLOREPHEN/LANOLIN0.55%W/VNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYATOPICAL EXTERNAL CREAMS 1.0X250.0 G CONTAINER,1.0X100.0 G CONTAINER,1.0X500.0 G CONTAINER,1.0X1.0 KG CONTAINER,1.0X2.0 KG CONTAINER
NDA/MAL/VDP/5874ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDASHTYLTYLOSIN20%W/WASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET,1.0X1.0 KG CONTAINER
NDA/MAL/VDP/5877BIMEDA CHEMICAL EXPORTS BIMEDA UGANDA LIMITEDNITRODOXNITROXYNIL ETHYL GLUCAMINE34%W/VCHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINACHINAPARENTERAL ORDINARY S C VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5878ASHISH LIFE SCIENCE PVT LTDMTK UGANDA LIMITEDNILZASH S FORTELEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE30MG/ML+60MG/MLASHISH LIFE SCIENCE PVT. LTD-J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIAINDIAORAL LIQUID ORDINARY LIQUIDS 1.0X500.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/5879ASHISH LIFE SCIENCE PVT. LTDMTK UGANDA LIMITEDASHULPHA 5SULPHADIMIDINE5GASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAORAL SOLID ORDINARY TABLETS 1.0X10.0X5.0 BOLUS BLISTER
NDA/MAL/VDP/5880SCHERING PLOUGH ANIMAL HEALTHCEE K-BRANDS LIMITEDNILZAN BOLUSLEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE1G + 1.4GCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY, NAIROBI KENYAORAL SOLID ORDINARY OTHER TABLETS 1.0X20.0X1.0 TABLET STRIP
NDA/MAL/VDP/5881ASHISH LIFE SCIENCE PVT. LTDMTK UGANDA LIMITEDASTRISUL 480SULPHADIAZINE+TRIMETHOPRIM400MG+80MGASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET,1.0X1000.0 G SACHET
NDA/MAL/VDP/5882SCHERING PLOUGH ANIMAL HEALTHCEE K-BRANDS LIMITEDNILZAN PLUS WITH COBALTLEVAMISOLE HYDROCHLORIDE+ OXYCLOZANIDE15MG+30MGCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY, NAIROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0 L BOTTLE,1.0X5.0 L BOTTLE,1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X150.0 ML BOTTLE
NDA/MAL/VDP/5883NORBROOK LABORATORIES LTDNORBROOK (U) LTDAVAVITE VITAMIN SUPPLEMENTMULTIVITAMINMULTI-INGREDIENTNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL LIQUID ORDINARY LIQUIDS 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5884HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDMULTIVITAMIN INJECTIONVIT A + VIT B2 +VIT B6 + VIT B12 +VIT D315,000 IU + 10MG +3MG +60 MCG + 7500 IUHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5885INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDINTERTRIMSULFAMETHOXAZOLE + TRIMETHOPRIM200MG + 40MG/MLINTERCHEMIE WERKEN DE ADELAAR -EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5886LABORATORIOS HIPRA S.AERAM UGANDA LIMITEDAVISAN SECUREINACTIVATED SALMONELLA ENTERITIDIS PT-4 FAGOTYPE MAT + INACTIVATED SALMONELLA TYPHIMURIUM, DT-4 FAGOTYPE MATINACTIVATED SALMONELLA ENTERITIDIS ? 1/13 + INACTIVATED SALMONELLA TYPHIMURIUM ? 1/40LABORATORIOS HIPRA, S.A-AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN SPAINPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/5887HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDMULTIVITAMIN INJECTIONVITAMIN A + B1 + B2 +B6 +B12 + D3 + E + DEXPANTHENOL + FOLIC15,000 IU + 10MG + 5MG +3MG + 25MCG + 1000IU +20MG + 25MGHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5888NORBROOK LABORATORIES LTDNORBROOK (U) LTDMULTIVITAMIN INJECTIONMULTIVITAMINMULTI-INGREDIENTNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMPARENTERAL ORDINARY VIALS 1.0X50.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5889CHONGQUING FANGTONG ANIMAL PHARMACEUTICAL CO.LTDNILE SERVICES LTDBACLEANSULFAMONOMETHOXINE SODIUM + TRIMETHOPRIM50MG +10MG /MLCHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5890BAYER EAST AFRICA LTDKWEWAYO (U) VET PHARMACY LIMITEDBAYCOXTOLTRAZURIL2.5 % W/WBAYER AG-D-51368 LEVERKUSEN GERMANYGERMANYORAL LIQUID ORDINARY LIQUIDS 1.0X25.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5891ASHISH LIFE SCIENCE PVT LTDMTK UGANDA LIMITEDMURTRYPDIMINAZENE DIACETURATE + PHENAZONE1.05G + 1.31G /2.36GASHISH LIFE SCIENCE PVT. LTD.-AT: J-137, MIDC, TARAPUR, BOISAR 401501, DIST. THANE, MAHARASHTRA, INDIA INDIANON-HUMAN USE POWDERS 1.0X10.0X2.36 G SACHET
NDA/MAL/VDP/5893NORBROOK LABORATORIES LTDNORBROOK (U) LTDINTRADINESULPHADIMIDINE333MG/MLNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML VIAL
NDA/MAL/VDP/5895BAYER ANIMAL HEALTH (PTY) LTDKWEWAYO (U) VET PHARMACY LIMITEDBAYTICOL2%FLUMETHRIN2 % W/VBAYER (PTY) LTD-5TH AVENUE, VOSTERSKROON, EXT. 3SOUTH AFRICATOPICAL EXTERNAL EMULSIONS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/5896NORBROOK LABORATORIES LTDNORBROOK (U) LTDINTRADINE POULTRY SULPHADIMIDINE SODIUM33.3%W/VNORBROOK LABERATORIES LTD -OLD LIMURU RD NAIROBI KENYAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/5897KELA LABORATORIES N.VNILE SERVICES LTDNEOXYVITALOXYTETRACYCLINE+NEOMYCIN+VITAMINSMULTI-INGREDIENTKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 100.0 G SACHET
NDA/MAL/VDP/5898BIMEDA CHEMICAL EXPORTS BIMEDA UGANDA LIMITEDMULTIVITAMIN INJECTIONMULTIVITAMINMULTI-INGREDIENTBIMEDA CHEMICALS EXPORT LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQINGCHINAPARENTERAL ORDINARY I M VIALS 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/VDP/5899BAYER ANIMAL HEALTH (PTY) LTDKWEWAYO (U) VET PHARMACY LIMITEDBAYTICOL POUR-ONFLUMETHRIN1 % W/VBAYER (PTY) LTD-5TH AVENUE, VOSTERSKROON, EXT. 3SOUTH AFRICATOPICAL EXTERNAL LIQUIDS 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5900NORBROOK LABORATORIES LTDNORBROOK (U) LTDOPTICLOX EYE OINTMENTCLOXACILLIN BENZATHINE835MG/5GNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMNON-HUMAN USE PASTES 1.0X5.0 G PRE- FILLED SYRINGE
NDA/MAL/VDP/5904INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDINTROVIT A+ WSVITAMINS A + D3 + E + B1 + B2 + B6 + B12 +C) + CA + VIT K3 + NICOTINAMIDE + FOLATE + BIOTIN + CL + FESO4 +MNSO4 + ZNSO4 + NACL20000 IU + 6000 IU + 60MG + 6MG +12MG +8MG +60 MCG + 20MG + 20MG +4MG + 80MG +2MG + 300MCG + 5MG + 12MG + 12MG +12MG + 12MG + 100MGINTERCHEMIE WERKEN ?DE ADELAAR? B.V-METAALWEG 8, 5804 CG, VENRAY, ? HOLLAND NETHERLANDSORAL SOLID ORDINARY POWDERS 1.0X100.0 SACHET CARTON
NDA/MAL/VDP/5905CIPLA LTDQUALITY CHEMICALS LTD - VETBENVET 10%W/VALBENDAZOLE USP10%W/VMIST AIR HEALTH & HYGIENE-PLOT 3 MIDC, SHIROLI, KOLHAPUR- 416122INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML BOTTLE,1.0X125.0 ML BOTTLE,1.0X1.0 L JERRYCAN
NDA/MAL/VDP/5906CIPLA LTDQUALITY CHEMICALS LTD - VETBENVET 2.5%W/VALBENDAZOLE USP2.5%W/VMIST AIR HEALTH & HYGIENE-PLOT 3 MIDC, SHIROLI, KOLHAPUR- 416122INDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0 L JERRYCAN,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5907VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD(VAPCO)GOODMAN INTERNATIONAL LTDBENZATELALBENDAZOLE+CLOSANTEL25MG+50MG/MLVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) -DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML JERRYCAN
NDA/MAL/VDP/5910NORBROOK LABORATORIES LTDNORBROOK (U) LTDBETAMOXAMOXYCILLIN TRIHYDRATE150MG/MLNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5911NORBROOK LABORATORIES LTDNORBROOK (U) LTDBETAMOX 200MGAMOXYCILLIN TRIHYDRATE200MGNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDORAL SOLID ORDINARY TABLETS 1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER
NDA/MAL/VDP/5912NORBROOK LABORATORIES LTDNORBROOK (U) LTDBETAMOX LAAMOXYCILLIN TRIHYDRATE150MG/MLNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5913BIMEDA CHEMICAL EXPORTS BIMEDA UGANDA LIMITEDBILOSINTYLOSIN TARTRATE200MG/MLCHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUINGCHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5915BIMEDA UGANDA LIMITEDBIMEDA UGANDA LIMITEDBIMATRAZAMITRAZ12.5% W/VBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDTOPICAL EXTERNAL LIQUIDS 1.0X1.0 L CONTAINER,1.0X100.0 ML CONTAINER,1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER
NDA/MAL/VDP/5916BIMEDA CHEMICAL EXPORTS BIMEDA UGANDA LIMITEDBIMECTIN DSIVERMECTIN2%W/WCHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUINGCHINAPARENTERAL ORDINARY S C VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/5917BIMEDA UGANDA LIMITEDBIMEDA UGANDA LIMITEDBIMECTIN INJECTIONIVERMECTIN10MG/MLBIMEDA CHEMICALS EXPORT LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING,CHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUINGCHINAPARENTERAL ORDINARY S C VIALS 1.0X500.0 ML VIAL,1.0X50.0 ML VIAL,1.0X20.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5918BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDBIMECTIN PLUSIVERMECTIN+CLORSULON10MG/ML+100MG/MLCHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUINGCHINAPARENTERAL ORDINARY S C VIALS 1.0X50.0 ML VIAL,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML VIAL
NDA/MAL/VDP/5919BIMEDA UGANDA LIMITEDBIMEDA UGANDA LIMITEDBIMOXYL LA INJECTIONAMOXYCILLIN TRIHYDRATE150MG/MLBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/5921ANGLIAN NUTRITION PRODUCTS COMPANYNILE SERVICES LTDIVERMECTIN 10 PLUSIVERMECTIN + CLORSULIN1.05MG/10MG/MLKELA NV-SINT-LENARTSEWAG 48 2320 HOOGSTRATEN BELGIUMBELGIUMPARENTERAL ORDINARY S C VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/5922BREMER PHARMA GMBHQUALITY CHEMICALS LTD - VETPIPERAZINE CITRATEPIPERAZINE CITRATE100GMBREMER PHARMA GMBH .-WERKSTRSSE 42 34414 WARBURG SCHGERMANYORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5925KELA LABORATORIES N.VNILE SERVICES LTDKELAMECTIN 1%IVERMECTIN1%W/VKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/5927KELA LABORATORIES N.VNILE SERVICES LTDKELAMIDIUMISOMETAMIDIUM CHLORIDE500MG/1000GKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMOTHER SYSTEMIC OTHER POWDERS/GRANULES 1.0X10.0X1.96 G SACHET
NDA/MAL/VDP/5928NORBROOK LABORATORIES LTDNORBROOK (U) LTDLIFE AID EXTRAMINERAL SUPPLEMENTMULTI-INGREDIENTNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5930KELA LABORATORIES N.VNILE SERVICES LTDKOMBITIM 240SULFAMETHOXAZOLE+TRIMETHOPRIM24%W/VKELA LABORATORIES N.V .-ST.LENAARTSEWEG 48, BELGIUMPARENTERAL ORDINARY VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5931ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDTRYPASHISHISOMETAMIDIUM HYDROCHLORIDE1G/SACHETASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAOTHER SYSTEMIC OTHER POWDERS/GRANULES 1.0X1.0 G SACHET
NDA/MAL/VDP/5932NORBROOK LABORATORIES LTDNORBROOK (U) LTDMULTIJECT IMMNEOMYCIN SULPHATE + PREDNISOLONE PROCAINE PENICILLIN G MONOHYDRATE20MG + 2MGNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X5.0 G PRE- FILLED SYRINGE
NDA/MAL/VDP/5933ASHISH LIFE SCIENCE PVT. LTD.MTK UGANDA LIMITEDTRYPASHISH 250ISOMETAMIDIUM HYDROCHLORIDE250MGASHISH LIFE SCIENCE PVT. LIMITED. -J-137, MIDC, TARAPUR, BOISAR, THANE, INDIAINDIAPARENTERAL ORDINARY DRY VIALS 1.0X250.0 MG VIAL + 25ML LDPE BOTTLE OF WFI
NDA/MAL/VDP/5934NORBROOK LABORATORIES LTDNORBROOK (U) LTDLIGNOCAINE+ADRENALINELIGNOCAINE+ADRENALINE20MG+ 0.023MG/MLNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5935NORBROOK LABORATORIESNORBROOK (U) LTDLACTACLOXAMPICILLIN + CLOXACILLIN SODIUM75 MG + 200 MGNORBROOK LABERATORIES LTD -STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOMIRELANDPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X5.0 G PRE- FILLED SYRINGE
NDA/MAL/VDP/5936BIMEDA CHEMICAL EXPORTS BIMEDA UGANDA LIMITEDMULTIMASTNEOMYCIN SULPHATE + OXYTETRACYCLINE HYDROCHLORIDE + PREDNISOLONE + PROCAINE PENICILLIN MONOHYDRATE250MG + 50MG + 10MG + 100MGBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDPARENTERAL ORDINARY I M PRE-FILLED SYRINGES 1.0X4.5 G PRE- FILLED SYRINGE
NDA/MAL/VDP/5937CEVA SANTE ANIMALE MTK UGANDA LIMITEDVECTOCIDDELTAMETHRIN50G/LCEVA SANTE ANIMALE TUNISIA-91 RUE DE CAMBODGE, DUBOSVILLE 1009, TUNISIATUNISIATOPICAL EXTERNAL LIQUIDS 1.0X100.0 ML CANNISTER,1.0X1000.0 ML CANNISTER,1.0X20.0 ML CONTAINER
NDA/MAL/VDP/5939CEVA SANTE ANIMALE MTK UGANDA LIMITEDVERIBENDIAMINAZENE DIACETURATE + CYANOCOBALAMIN + HYDROXOCOBALAMIN1.05 G + 0.6 MG + 2.4 MGCEVA SANTE ANIMALE .-ZI-TRES LE BOIS 22600-LOUDEAC & LA BALLASTIERE 33501 LIBOURNE CEDEXFRANCEOTHER SYSTEMIC POWDER 1.0X10.0X2.36 G SACHET,1.0X10.0X23.6 G SACHET
NDA/MAL/VDP/5940NORBROOK LABORATORIESNORBROOK (U) LTDLEVACIDELEVAMISOLE HCL7.5%W/VNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDORAL LIQUID ORDINARY LIQUIDS 1.0X1.0 L BOTTLE
NDA/MAL/VDP/5941NORBROOK LABORATORIES LTDNORBROOK (U) LTDLEVACIDE INJECTIONLEVAMISOLE HYDROCHLORIDE75MG/MLNORBROOK LABERATORIES LTD -STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOMIRELANDPARENTERAL ORDINARY VIALS 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5942INTERCHEMIE WERKEM DE ADELAAR B.VVET CENTRE UGANDA LIMITEDNEMOVIT WS (EGG FORMULA)OXYTETRACYCLINE + NEOMYCIN + VITAMINS( A + D3 + E + B1 + B2 + B6 + B12 +C) + CALCIUM + VIT K3 + NICOTINAMIDE + FOLATE + METHIONINE + LYSINE60MG + 40MG + 7500 I.U + 1500I.U + 5MG + 1MG + 2MG + 7.5MCG + 25MG + 7.5MG + 5MG + 15MG + 30MG +0.3MG +30MG +50MGINTERCHEMIE WERKENS DE ADELAAR B.V-METAALWEG 8, 5804 VENARY, NETHERLANDSNETHERLANDSORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5944BAYER ANIMAL HEALTH (PTY) LTDKWEWAYO (U) VET PHARMACY LIMITEDSECTA INSECTICIDAL SHAMPOOCYPERMETHRIN + PIPERONYL720MG/L + 3280MG/LBAYER ANIMAL HEALTH (PTY) LTD-16 WILLOWTON ROAD PIETERMARITZBURGSOUTH AFRICATOPICAL EXTERNAL LIQUIDS 1.0X250.0 ML BOTTLE
NDA/MAL/VDP/5945CEVA SANTE ANIMALE MTK UGANDA LIMITEDVERIBENDIAMINAZENE DIACETURATE445MG/GCEVA SANTE ANIMALE .-ZI-TRES LE BOIS 22600-LOUDEAC & LA BALLASTIERE 33501 LIBOURNE CEDEXFRANCEOTHER SYSTEMIC SPECIAL SOLIDS 1.0X2.36 G SACHET
NDA/MAL/VDP/5948CEVA SANTE ANIMALE MTK UGANDA LIMITEDVERIDIUMISOMETAMIDIUM HCL125MG,1GCEVA SANTE ANIMALE .-ZI-TRES LE BOIS 22600-LOUDEAC & LA BALLASTIERE 33501 LIBOURNE CEDEXFRANCEOTHER SYSTEMIC POWDER 1.0X10.0X125.0 MG SACHET,1.0X10.0X1.0 G SACHET
NDA/MAL/VDP/5949CEVA SANTE ANIMALE MTK UGANDA LIMITEDVIGOSINECARNITINE HYDROCHLORIDE50MG/MLSANOFI SANTE NUTRITION ANIMALE-98767 LIBOURNE , FRANCEFRANCEORAL LIQUID ORDINARY LIQUIDS 1.0X250.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5950LABORATORIOS HIPRA S.AERAM UGANDA LIMITEDBRONIPRA 1ATTENUATED LIVE INFECTIOUS BRONCHITIS VIRUS , STRAIN H120 ?10? EID??/DOSE (0.03ML) LABORATORIOS HIPRA, S.A-AVDA LA SELVA, 135, 17170 AMER (GIRONA) SPAIN SPAINORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X5000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/5951ALIVIRA ANIMAL HEALTHERAM UGANDA LIMITEDSEQUZOLEALBENDAZOLE2.5%W/VALIVIRA ANIMAL HEALTH LIMITED -A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/5952CEVA SANTE ANIMALE MTK UGANDA LIMITEDVETACOX SSODIUM SULFADIMIDINE+DIAVERIDINE80G+8G/100GSANOFI SANTE NUTRITION ANIMALE-98767 LIBOURNE , FRANCEFRANCEORAL SOLID ORDINARY POWDERS 1.0X25.0 G SACHET,1.0X100.0 G SACHET
NDA/MAL/VDP/5953ALIVIRA ANIMAL HEALTHERAM UGANDA LIMITEDSEQUZENEDIMINAZENE DIACETURATE / PHENAZONE1.05G + 1.31G PER 2.36GALIVIRA ANIMAL HEALTH LIMITED -A-68 ADDITIONAL AMBERNATH MIDC INDUSTRIAL AREA AMBERNATH (E) INDIAINDIAOTHER SYSTEMIC OTHER POWDERS/GRANULES 1.0X10.0X23.6 G SACHET,1.0X10.0X2.36 G SACHET
NDA/MAL/VDP/5954MTK UGANDA LIMITEDMTK UGANDA LIMITEDVETPEN 20/25PROCAINE PENICILLIN/DIHYDROSTREPTOMYCIN200000 I.U/250000 I.USHANGHAI GONGYIN VETERINARY MEDICINES PLANT-NO. 298 HUANCHENG EAST ROAD, FENGXAIN TOWN, SHANGHAI CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/5955MTK UGANDA LIMITEDMTK UGANDA LIMITEDVETMYCIN 20%OXYTETRACYCLINE200MG/MLSHANGHAI GONGYIN VETERINARY MEDICINES PLANT-NO. 298 HUANCHENG EAST ROAD, FENGXAIN TOWN, SHANGHAI CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/5957LABORATORIES HIPRA SAERAM UGANDA LIMITEDVERMIPRAZOL-10ALBENDAZOLE10%W/VLABORATORIES HIPRA SA-AVDA LASELVA 135-17170, AMESPAINORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/5959NORBROOK LABORATORIES LTDNORBROOK (U) LTDBOVACLOX DCAMPICILLIN + CLOXACILLIN250 MG + 500 MGNORBROOK LABARATORIES LIMITED-STAION WORKS NEWRY, COUNTY DOWN, BT 356JP NORTHERN IRELAND UKIRELANDPARENTERAL ORDINARY PRE-FILLED SYRINGES 1.0X4.5 G PRE- FILLED SYRINGE
NDA/MAL/VDP/5960MEDITEC (U) LIMITEDKWEWAYO (U) VET PHARMACY LIMITEDBOVITRAZAMITRAZ 12.5 % W/VBAYER (PTY) LTD-5TH AVENUE, VOSTERSKROON, EXT. 3SOUTH AFRICATOPICAL EXTERNAL EMULSIONS 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5961INTRACIN PHARMACEUTICALS PVT LTDVEERAM HEALTHCARE (U) LIMITEDBUPACINBUPARVAQUONE50MG/MLINTRACIN PHARMACEUTICAL PVT LTD -C-1, B-53, G.I.D.C. ESTATE, NADIAD 387 001 [GUJARAT], INDIAINDIAPARENTERAL ORDINARY VIALS 1.0X50.0 ML BOTTLE
NDA/MAL/VDP/5962INTERVET SA (PTY) LTDERAM UGANDA LIMITEDTAKTICAMITRAZ125G/LCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY, NAIROBI KENYATOPICAL EXTERNAL LIQUIDS 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X5.0 L JERRYCAN,1.0X20.0 L JERRYCAN,1.0X1.0 L BOTTLE,1.0X40.0 ML BOTTLE,1.0X500.0 ML JAR
NDA/MAL/VDP/5965DAWA LIMITEDSUPER MEDIC LTDBUPALEXBUPARVAQUONE50MG/MLCHONGQING FANGTONG ANIMAL PHARMACEUTICAL COMPANY LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQUINGCHINAPARENTERAL ORDINARY VIALS 1.0X40.0 ML VIAL
NDA/MAL/VDP/5967NORBROOK KENYA LTDNORBROOK (U) LTDBUPANOR INJECTIONBUPARVAQUONE50MG/MLNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKUNITED KINGDOMPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL,1.0X50.0 ML BOTTLE
NDA/MAL/VDP/5968UNIVET LTDBIMEDA UGANDA LIMITEDTRAMAZOLEALBENDAZOLE10%W/VMEDISEL KENYA LIMITED-PLOT NO. LR. NO. 4953/1209, GENERAL KAGO ROAD, P.O.BOX 540-00100, THIKA-KENYAIRELANDORAL LIQUID ORDINARY SUSPENSIONS 1.0X5.0 L JERRYCAN,1.0X2.5 L JERRYCAN,1.0X120.0 ML BOTTLE,1.0X1.0 L JERRYCAN
NDA/MAL/VDP/5969BIMEDA CHEMICAL EXPORTS LTDBIMEDA UGANDA LIMITEDBUPARVEXBUPARVAQUONE50MG/MLBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELAND,BIOVET JOINT STOCK COMPANY -FINISHED DRUG FORMS DEPARTMENT 48 VASIL PETLESHKOV STREET PESHTERA 4550BULGARIAPARENTERAL ORDINARY VIALS 1.0X20.0 ML BOTTLE,1.0X40.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/VDP/5970INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDBUTACHEM-50BUPARVAQUONE50MG/MLINTERCHEMIE WERKEN DE ADELAAR-EESTI AS VANAPERE TEE 14 PRINGI 74001 VIIMSI HARJUMAAESTONIAPARENTERAL ORDINARY VIALS 2.0X50.0 ML VIAL
NDA/MAL/VDP/5971ZOETIS BELGIUM SAERAM UGANDA LIMITEDSUPONA AEROSOLMULTI-INGREDIENTMULTI-INGREDIENTIPANEMA INDUSTRIA DE PRODUCTS VETERINARIOS LTD, RA-BRAZILBRAZILTOPICAL EXTERNAL PRESSURISED AEROSOLS 1.0X385.0 ML CANNISTER
NDA/MAL/VDP/5972KELA LABORATORIES N.VNILE SERVICES LTDBUTAKELBUPARVAQUONE5%W/VKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMPARENTERAL ORDINARY VIALS 1.0X30.0 ML BOTTLE,1.0X50.0 ML BOTTLE
NDA/MAL/VDP/5973INTERVET SA (PTY) LTDERAM UGANDA LIMITEDBUTALEXBUPARVAQUONE5%W/VVET PHARMA-FRIESOYTHE SEDELSBERGE 26169,GERMANYGERMANYPARENTERAL ORDINARY VIALS 1.0X40.0 ML VIAL,1.0X20.0 ML VIAL
NDA/MAL/VDP/5974ZOETIS BELGIUM SAERAM UGANDA LIMITEDSUPONA EXTRACHLORPHENVINPHOS1000GWYETH LEDERLE S.P.A-VIA F.GORGONE ZONEITALYTOPICAL EXTERNAL EMULSIONS 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5975CEVA SANTE ANIMALE MTK UGANDA LIMITEDBUTALINEBUPARVAQUONE50MG/MLCEVA SANTE ANIMALE-10 AVENUE DE LA BALLASTIERE 33500 LIBOURNE FRANCEFRANCEPARENTERAL ORDINARY VIALS 1.0X20.0 ML VIAL,1.0X40.0 ML VIAL
NDA/MAL/VDP/5976MERIAL SAS ERAM UGANDA LIMITEDTRODAX 34%NITROXYNIL34%W/VMERIAL SAS-4 CHEMIN DU CALQUET 31057 TOULOUSE CEDEFRANCEPARENTERAL ORDINARY S C VIALS 1.0X250.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/5977CHONGQUING FANGTONG ANIMAL PHARMACEUTICAL CO.LTDNILE SERVICES LTDBUTARSTARBUPARVAQUONE50 MG/MLCHONGQING FANGTONG ANIMAL PHARMACEUTICALS CO. LTD-CHONGQING FANGTONG ANIMAL PHARMACEUTICALS CO. BANQIAO INDUSTRIAL PARK, RONGCHANG, CHONGQING CHINA CHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X30.0 ML VIAL
NDA/MAL/VDP/5978MTK UGANDA LIMITEDMTK UGANDA LIMITEDBUTELBUPARVAQUONE50MG/MLSHANGHAI GONGYIN VETERINARY MEDICINES PLANT-NO. 298 HUANCHENG EAST ROAD, FENGXAIN TOWN, SHANGHAI CHINACHINAPARENTERAL ORDINARY VIALS 1.0X40.0 ML BOTTLE
NDA/MAL/VDP/5979MERIAL SAS ERAM UGANDA LIMITEDTRYPADIMDIMINAZENE DIACETURATE/ANTIPYRINE2.36GMERIAL SAS-4 CHEMIN DU CALQUET 31057 TOULOUSE CEDEFRANCEOTHER SYSTEMIC SPECIAL SOLIDS 1.0X2.36 G VIAL
NDA/MAL/VDP/5980MERIAL SAS ERAM UGANDA LIMITEDTRYPAMIDIUM/SAMORINISOMETAMIDIUM HYDROCHLORIDE100%W/WMERIAL SAS-4 CHEMIN DU CALQUET 31057 TOULOUSE CEDEFRANCEPARENTERAL ORDINARY DRY VIALS 1.0X1.0 G VIAL,1.0X125.0 MG VIAL
NDA/MAL/VDP/5981BIMEDA CHEMICAL EXPORTS LTDBIMEDA UGANDA LIMITEDBUVONAL INJECTIONBUPARVAQUONE50MG/MLBIMEDA CHEMICALS EXPORT LTD .-OF BIOVET JSC LOCATED AT 48, VASIL PETLESHKOV STREET, PESHTERA 4550, BULGARIABULGARIAPARENTERAL ORDINARY VIALS 1.0X40.0 ML VIAL,1.0X20.0 ML VIAL
NDA/MAL/VDP/5982ZOETIS BELGIUM SAERAM UGANDA LIMITEDPROTAIDCHLORFENVINPHOS+ALPHACYPERMETHRIN30%W/V+3%W/VZOETIS MANUFACTURING ITALIA S.R.L.,-VIA FRANCO GORGONE S.N.C., 95121 CATANIA, ITALYITALYTOPICAL EXTERNAL LIQUIDS 1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5983NORBROOK LABORATORIES LTDNORBROOK (U) LTDCALCIJECTBORIC ACID+CALCIUM GLUBIONATE6.84G+33.3GNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X400.0 ML BOTTLE
NDA/MAL/VDP/5984ZOETIS BELGIUM SAERAM UGANDA LIMITEDRENEGADE 50 SPRAYALPHACYPERMETHRIN50MG/MLWYETH LEDERLE S.P.A-VIA F.GORGONE ZONEITALYTOPICAL EXTERNAL EMULSIONS 1.0X200.0 ML CONTAINER, 1.0X100.0 ML CONTAINER, 1.0X250.0 ML CONTAINER,1.0X1.0 L CONTAINER
NDA/MAL/VDP/5986COSMOS LTDJOSE DEVELOPMENT LIMITEDS-DIME 16% SOLUTIONSULPHADIMIDINE16%W/VCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL LIQUID ORDINARY LIQUIDS 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/5987COSMOS LTDJOSE DEVELOPMENT LIMITEDS-DIME 5G BOLUSSULPHADIMIDINE5GCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY OTHER TABLETS 1.0X10.0X10.0 BOLUS BLISTER,1.0X10.0 BOLUS BLISTER
NDA/MAL/VDP/5988NORBROOK LABORATORIES LTDNORBROOK (U) LTDCALCIJECT LVCALCIUM GLUCONATE+BORIC ACID388.5MG/ML+73.4MG/MLNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/5997AGRAR HOLLAND BVSEKALALA LIMITEDAGDOXYTYLDOXYCYCLINE+TYLOSIN20G+15G/100GLABORATORIA SMEETS.-FOTOGRATIELAAN 42, AND NEERLANDWEG 24, 2610 WILRIJK ANTWERPEN, BELGIUMBELGIUMORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/5998VAPCOGOODMAN INTERNATIONAL LTDCHOLIVIT-AMMULTI-INGREDIENTN/AVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) -DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET,1.0X500.0 G SACHET,1.0X1000.0 G CONTAINER,1.0X5.0 KG CONTAINER
NDA/MAL/VDP/5999AGRAR HOLLAND BVSEKALALA LIMITEDAGROXY 20%OXYTETRACYCLINE HYDROCHLORIDE20%W/WLABORATORIA SMEETS-FOTOGRAFIELAAN 42 (SITE1 ) NEBELGIUMORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET,1.0X1.0 KG SACHET
NDA/MAL/VDP/6001COOPER (U) LTDMTK UGANDA LIMITEDVETMYCIN 10%OXYTETRACYCLINE100MG/MLSHANGHAI GONGYIN VETERINARY MEDICINES PLANT-NO. 298 HUANCHENG EAST ROAD, FENGXAIN TOWN, SHANGHAI CHINACHINAPARENTERAL ORDINARY VIALS 1.0X1.0X250.0 ML VIAL,1.0X1.0X100.0 ML VIAL
NDA/MAL/VDP/6003NORBROOK LABORATORIES LTDNORBROOK (U) LTDCLOSAMECTINIVERMECTIN+CLOSANTEL5MG/ML+125MG/MLNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY S C VIALS 1.0X20.0 ML VIAL,1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/6004BIMEDA CHEMICAL EXPORT BIMEDA UGANDA LIMITEDDELTAGUARD POURDELTAMETHRIN1%W/VBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDTOPICAL EXTERNAL EMULSIONS 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/6007CIPLA LTDQUALITY CHEMICALS LTD - VETCOBACTSULFAMETHAZINE+TRIMETHOPRIM200MG+40MGMEDISPRAY LABORATORIES PVT LTD-L-1/1, L-1/2/2, ADDITIONAL MIDC SATARAINDIAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/6008COSMOS LTDJOSE DEVELOPMENT LIMITEDCOCCID GRANULESAMPROLIUM HYDROCHLORIDE20%W/WCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBIKENYAORAL SOLID ORDINARY GRANULES 10.0X30.0 G SACHET
NDA/MAL/VDP/6010VMD NV HOGE MAUWERAM UGANDA LIMITEDCOLIVETO-4800COLISTINE SULPHATE4.8 MILLION I.U/GVMD NV HOGE MAUW-HOGE MUW 900, 2370, ARENDONKBELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G CONTAINER
NDA/MAL/VDP/6011NORBROOK LABORATORIES LTDNORBROOK (U) LTDCOLVASONE INJECTIONDEXAMETHASONE SODIUM PHOSPHATE0.2%W/VNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/6012KELA LABORATORIES N.VNILE SERVICES LTDCOMBI-KEL40 L.APROCAINE PENICILLIN+ DIHYDROSTRPTOMYCIN + BENZATHINE PENICILLIN120000I.U+80,000I.U+200MGKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X250.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/6014COOPER KENYA LTDCEE K-BRANDS LIMITEDCOOPER'S NEW MILKING SALVEDICLOROPHEN/LANOLIN0.55 % W/W / 2.00%W/WCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY, NAIROBI KENYATOPICAL EXTERNAL CREAMS 1.0X100.0 G CONTAINER,1.0X250.0 G CONTAINER,1.0X400.0 G CONTAINER,1.0X1.0 KG CONTAINER,1.0X2.0 KG CONTAINER
NDA/MAL/VDP/6015MTK UGANDA LIMITEDMTK UGANDA LIMITEDVETVITVIT A + D3 +E + NICOTINAMIDE + THIAMINE + PYRIDOXINE + RIBOFLAVINE + D PANTHENOL + B12 + D-BIOTIN + CALCIUM2000I.U + 2000I.U +4MG + 10MG + 10MG + 5MG +1MG +1MG + 10MCG +10MCG + 10MGSHANGHAI GONGYIN VETERINARY MEDICINES PLANT-NO. 298 HUANCHENG EAST ROAD, FENGXAIN TOWN, SHANGHAI CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/6017ANGLIAN NUTRITION PRODUCTS CO.NILE SERVICES LTDCTC 20%CHLORTETRACYCLINE HYDROCHLORIDE20%W/VKELA LABORATORIES N.V .--ST.LENAARTSEWEG 42320 HOOGSTRTEN BELGIUM BELGIUMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X150.0 G CONTAINER
NDA/MAL/VDP/6018NORBROOK LABORATORIES LTDNORBROOK (U) LTDALAMYCIN 10OXYTETRACYCLINE HYDROCHLORIDE10%W/VNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL
NDA/MAL/VDP/6019NORBROOK LABORATORIES LTDNORBROOK (U) LTDALAMYCIN AEROSOLOXYTETRACYCLINE HYDROCHLORIDE3.6%W/WNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDNON-HUMAN USE SPRAYS WITHOUT GAS 1.0X140.0 G CANNISTER
NDA/MAL/VDP/6020NORBROOK LABORATORIES LTDNORBROOK (U) LTDALAMYCIN CHICK FORMULAOXYTETRACYCLINE/ VITAMINSMULTI-INGREDIENTNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X125.0 G SACHET,1.0X25.0 G SACHET,1.0X250.0 G SACHET
NDA/MAL/VDP/6021NORBROOK LABORATORIES LTDNORBROOK (U) LTDALAMYCIN EGG FORMULAMULTI-INGREDIENTN/ANORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X500.0 G SACHET,1.0X125.0 G SACHET,1.0X250.0 G SACHET,1.0X25.0 G SACHET,1.0X1.0 KG SACHET
NDA/MAL/VDP/6022NORBROOK LABORATORIES LTDNORBROOK (U) LTDALAMYCIN LA 20OXYTETRACYCLINE HYDROCHLORIDE20%W/VNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/6023NORBROOK LABORATORIES LTDNORBROOK (U) LTDALAMYCIN LA 300OXYTETRACYCLINE HYDROCHLORIDE30%W/VNORBROOK LABORATORIES LTD-STATION WORKS, NEWRY, COUNTRY DOWN, BT35 6JP, NORTHERN IRELAND-UKIRELANDPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/6024NORBROOK LABORATORIES LTDNORBROOK (U) LTDALBAFASALBENDAZOLE600MGNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL SOLID ORDINARY OTHER TABLETS 1.0X20.0 BOLUS STRIP
NDA/MAL/VDP/6026BAYER ANIMAL HEALTH (PTY) LTDKWEWAYO (U) VET PHARMACY LIMITEDCURAMYCINOXYTETRACYCLINE DIHYDRATE123MG/MLPHARMA-Q (PTY) LTD -50 COMMANDO ROAD, INDUSTRIA WESSOUTH AFRICAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/6027BIMEDA CHEMICAL EXPORTS BIMEDA UGANDA LIMITEDCYPERGUARDCYPERMETHRIN10%W/VBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDTOPICAL EXTERNAL EMULSIONS 1.0X250.0 ML BOTTLE,1.0X400.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/6028VETERTNARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDCYPERMETHRIN-10 ECCYPERMETHRIN10%W/VVAPCO.-DHULIEIL ARA, KING HUSSEIN STREET 120/ZARKA HALLOBATJORDANTOPICAL EXTERNAL EMULSIONS 1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE
NDA/MAL/VDP/6029DAWA LIMITEDSUPER MEDIC LTDDABENDAZOLE 10%ALBENDAZOLE10%W/VDAWA LTD-BABA DOGO ROAD RUARAKA ,MEDISEL KENYA LTD - -LR NO : 4953 / 1209, GENERAL KAGO ROAD, P.O. BOX 5401000, THIKA - KENYAKENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X40.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X5.0 L JERRYCAN
NDA/MAL/VDP/6083INTERCHEMIE WERKEM DE ADELAAR B.VVET CENTRE UGANDA LIMITEDLIMOXIN-400 WSOXYTETRACYCLINE HYDROCHLORIDE400MG/GINTERCHEMIE WERKEN ?DE ADELAAR? B.V - -METAALWEG 8,5804 CG,VENRAY,HOLLAND NETHERLANDSORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/6084VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)GOODMAN INTERNATIONAL LTDVAPCOTRIM BOLUSTRIMETHOPRIM + SULFADIAZINE200MG + 1000MGVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)-DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANORAL SOLID ORDINARY TABLETS 1.0X10.0X5.0 BOLUS BLISTER
NDA/MAL/VDP/6087THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDTECTINIVERMECTIN1%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/6089VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDFLUMEVAPFLUMEQUINE200MG/MLVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)-DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/6091VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDVITAMIN E-SVITAMIN E+SODIUM SELENITE100I.U+2MG/MLVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)-DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/6100VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)GOODMAN INTERNATIONAL LTDVITAMIN AD3EVITAMIN A+VITAMIN D3+VITAMIN E100,000I.U+25,000I.U+100I.UVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)-DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/6254CIPLA LTDQUALITY CHEMICALS LTD - VETIVOCIPIVERMECTIN0.08%W/V MISTAIR HEALTH & HYGIENE PVT LTD-PLOT PLOT NO.3 MIDC SHIROLI KOLHAPUR 416 122INDIAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0 L BOTTLE
NDA/MAL/VDP/6255COOPER K-BRANDS LTDCEE K-BRANDS LIMITEDNEFLUKALBENDAZOLE10%W/VCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY, NAIROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X125.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/6258HEBEI YUANZHENG PHARMACEUTICAL CO., LTD ERAM UGANDA LIMITEDOXYTET-10%OXYTETRACYCLINE HYDROCHLORIDE10%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X500.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/6260HEBEI YUANZHENG PHARMACEUTICAL CO LTDERAM UGANDA LIMITEDOXYTET-30%OXYTETRACYCLINE HYDROCHLORIDE30%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/6262VET CENTRE UGANDA LIMITEDVET CENTRE UGANDA LIMITEDINTROMIDIUMISOMETAMIDIUM HYDROCHLORIDE1G/SACHETINTERCHEMIE WERKEN ?DE ADELAAR? B.V-METAALWEG 8, 5804 CG, VENRAY, ? HOLLAND NETHERLANDSOTHER SYSTEMIC OTHER POWDERS/GRANULES 1.0X10.0X1.0 G SACHET
NDA/MAL/VDP/6263INTRACIN PHARMACEUTICAL PVT LTDMTK UGANDA LIMITEDT-DAXNITROXYNIL340MG/MLINTRACIN PHARMACEUTICAL PVT. LTD-C-1 B/53, G.I.D.C ESTATE, NADIAD-387001INDIAPARENTERAL ORDINARY S C VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/6265VET CENTRE UGANDA LIMITEDVET CENTRE UGANDA LIMITEDINTERZAN GOLD ORALLEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE30MG+60MG/MLINTERCHIEME WENKEN "DE ADELAAR" B.V.-HORSTERWEG 26A 5811 AC CASTENERY HOLLANDNETHERLANDSORAL LIQUID ORDINARY SUSPENSIONS 1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/6822CEVA SANTE ANIMALE MTK UGANDA LIMITEDPRID DELTAPROGESTERONE1.55GCEVA SANTE ANIMALE .-ZI TRES LE BIOS 22600 LOUDEACFRANCEVAGINAL INTRA UTERINE DEVICES 1.0X10.0 DEVICE CARTON
NDA/MAL/VDP/6824KELA LABORATORIES N.VNILE SERVICES LTDALBENDAZOLE 10%ALBENDAZOLE100MG/MLKELA LABORATORIES N.V-ST.LENAARTSEWEG 48, B-2320BELGIUMORAL LIQUID ORDINARY OTHER LIQUIDS 1.0X500.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/6827NORBROOK LABORATORIES LTDNORBROOK (U) LTDHEXASOLLAOXYTETRACYCLINE+FLUNIXIN300MG+20MGNORBROOK LABERATORIES LTD -STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOMUNITED KINGDOMPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/6835QUALITY CHEMICALS LTDQUALITY CHEMICALS LTD - VETECOTIK DIP AND SPRAYAMITRAZ12.5%W/VCEVA ANIMAL HEALTH S.A, (PTY) LTD-NO. 8 MIFA INDUSTRIAL PARK, 399 GEORGE ROAD, RANDJESPARK, MIDRAND,MONTAJAT VETERINARY PHARMACEUTICAL CO. LTD (AGROCHEMICALS DIVISION)-STREET 20, 2ND INDUSTRIAL CITY P.O BOX 4248 DAMMAN 31491 SAUDI ARABIASOUTH AFRICATOPICAL EXTERNAL EMULSIONS 1.0X250.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE
NDA/MAL/VDP/6839AGRAR HOLLAND BVSEKALALA LIMITEDAGLEVA 20LEVAMISOLE HYDROCHLORIDE200MGLABORATORIA SMEETS NV.-FOTOGRAFIELAAN 42 B-2610 ANTWERPEN-WILRIJK BELGIUMORAL LIQUID ORDINARY UNIT DOSE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/6849BIMEDA UGANDA LIMITEDBIMEDA UGANDA LIMITEDTETROXY 12.5%OXYTETRACYCLINE125MG/MLCHONGQING FANGTONG ANIMAL-BANGQIAO INDUSTRIAL PARKCHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/6851BIMEDA UGANDA LIMITEDBIMEDA UGANDA LIMITEDTETROXY 30%OXYTETRACYCLINE300MG/MLCHONGGING FANGTONG ANIMAL PHARMACEUTICAL CO. LTD-BANQIAO INDUSTRIAL PARK RONGCHANG CHONGQING CHINACHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/6888MERIAL SAS ERAM UGANDA LIMITEDNOVIDIUMHOMIDIUM CHLORIDE250MGMERIAL SAS-4 CHEMIN DU CALQUET 31057 TOULOUSE CEDEFRANCEORAL SOLID ORDINARY SOLUBLE TABLETS 100.0 TABLET CONTAINER
NDA/MAL/VDP/6889HEBEI YUANZHENG PHARMACEUTICAL CO. LTDERAM UGANDA LIMITEDOXYTET- 12.5%OXYTETRACYCLINE HYDROCHLORIDE12.5%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X250.0 ML VIAL,1.0X500.0 ML VIAL
NDA/MAL/VDP/6892THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDBUTEXBUPARVAQUONE5%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY VIALS 1.0X40.0 ML VIAL
NDA/MAL/VDP/6893THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDOXYTETRAVET 20%OXYTETRACYCLINE20%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/6894THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.GLOBAL VET (U) LIMITEDPRIMOVETSULPHADIAZINE + TRIMETHOPRIM400MG + 80MGTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/6896ELYS CHEMICAL INDUSTRIES LTDGLOBAL VET (U) LIMITEDERYTHRATEERYTHROMYCIN THIOCYANATE350MG/GTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET,1.0X500.0 G SACHET
NDA/MAL/VDP/6899THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.GLOBAL VET (U) LIMITEDOXYTETRAVET 30%OXYTETRACYCLINE30%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/6900THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.GLOBAL VET (U) LIMITEDDEXAROIDEDEXAMETHASONE SODIUM PHOSPHATE4MG/MLTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML BOTTLE
NDA/MAL/VDP/6902THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.GLOBAL VET (U) LIMITEDERYTHRATE 20%ERYTHROMYCIN THIOCYANATE20%W/WTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/6903THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.GLOBAL VET (U) LIMITEDGENTYLOTYLOSIN TARTRATE + GENTAMICIN SULPHATE250MG + 100MG/GTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/6904THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.GLOBAL VET (U) LIMITEDOXYTETRAVET 50%OXYTETRACYCLINE HYDROCHLORIDE50%W/WTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/6906THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.GLOBAL VET (U) LIMITEDIVOSANIVERMECTIN + CLOSANTEL-NA5MG +125MG /MLTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/6908THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.GLOBAL VET (U) LIMITEDTECTIN SUPERIVERMECTIN + CLORSULON10MG + 100MG/ MLTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/7032HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LTDBUPARVANORBUPARVAQUONE5 % W/VHEBEI HOPE HARMONY PHARMACEUTICAL CO. LTD-INDUSTRIAL AREA, YUANSHI TOWN, SHIJIAZHUANG CITY, HEBEI PROVINCE CHINACHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML BOTTLE,1.0X20.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/7034HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LTD IVANORIVERMECTIN1% W/V HEBEI KEXING PHARMACEUTICALS CO. LTD --NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA.CHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/7045HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-DOXYTYLOSINTYLOSIN + DOXYCYCLINE 200MG + 200MG HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/7059BAODING SUNLIGHT HERB MEDICAMENT CO., LTDBD PHARMACEUTICALS LTDLEVA & CLOZALEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE30MG/ML + 60MG/ML BAODING SUNLIGHT HERB MEDICAMENT CO., LTD-NO.76 NORTH TUANJIE ROAD QINGYUAN, BAODING CITYCHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0 ML BOTTLE,1.0X500.0 ML AMPOULE
NDA/MAL/VDP/7060BAODING SUNLIGHT HERB MEDICAMENT CO., LTDBD PHARMACEUTICALS LTDIVER PLUS IVERMECTIN + CLORSULON 10MG/ML +100MG/MLBAODING SUNLIGHT HERB MEDICAMENT CO.LTD-NO.76 NORTH TUANJIE ROAD QINGYUAN BAODING CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY S C VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7061BAODING SUNLIGHT HERB MEDICAMENT CO., LTDBD PHARMACEUTICALS LTDOXY-100 OXYTETRACYCLINE 100MG/MLBAODING SUNLIGHT HERB MEDICAMENT CO., LTD-NO. 76 NORTH TUANJIE ROAD QINGYUAN, BAODING CITY, HEBEI PROVINCE, P. R. CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7265HEBEI KEXING PHARMACEUTICAL CO., LTD.JUBAILI AGROTEC LTDV-MULTINORVITAMINS (A+D3 + E+ B12 + C + B1 + B6 +B2 ) + NIACINAMIDE + D-PANTHENOL + D- BIOTIN3000 I.U + 2000 I.U + 4MG + 10MCG + 1 MG + 10MG + 5MG + 1MG + 12.5MG + 10MG + 10MCG HEBEI KEXING PHARMACEUTICALS CO. LTD --NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA.CHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/7276HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-OXYOXYTETRACYCLINE HCL 100MG/ML HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/7279HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-OXYLAOXYTETRACYCLINE200MG/ML HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/7280HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITED KX-OXYLA 30%OXYTETRACYCLINE 300MG/ML HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/7281HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-IVERMECIVERMECTIN10MG/ML HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE
NDA/MAL/VDP/7282HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-IVERCLO IVERMECTIN+ CLORSULON 10MG/ML + 100MG/ML HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/7285HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITED DEXANORDEXAMETHASONE SODIUM PHOSPHATE 4MG/ML HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X50.0 ML BOTTLE
NDA/MAL/VDP/7397VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD(VAPCO)GOODMAN INTERNATIONAL LTDVAPCOTRIM POWDERTRIMETHOPRIM + SULPHADIAZINE NA80MG/1GM+400MG/1GMVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) -DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X500.0 G SACHET,1.0X100.0 G SACHET,1.0X250.0 G SACHET,1.0X1.0 KG SACHET
NDA/MAL/VDP/7398EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDEAGLE TYLOSIN 200 INJECTIONTYLOSIN TARTRATE200MG/ML EAGLE VET TECH CO. LTD-235-34, CHUSA-RO, SHINAM-MYUN, YESAN-GUN, CHUNGCHEONGNAM- DO, KOREA SOUTH KOREAPARENTERAL ORDINARY I M VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7399EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDOXYVET-10%OXYTETRACYCLINE HYDROCHLORIDE100MG/MLEAGLE VET TECH CO LTD--256-46 DUGOK-RI SHNAM-MYEON YESAN-GUN CHUNGNAMSOUTH KOREAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7400EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDOXYVET-LA INJECTIONOXYTETRACYCLINE DIHYDRATE200MG/MLEAGLE VET TECH CO LTD--256-46 DUGOK-RI SHNAM-MYEON YESAN-GUN CHUNGNAMSOUTH KOREAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7402DAWA LIMITEDSUPER MEDIC LTDDAWAFER INJECTABLE SOLUTIONIRON DEXTRAN100G/MLHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY I M VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7532LAPROVET ?HUNGERARY PHARMACEUTICALS LTD EVERVICTORY LIMITEDAVI IBD INTER LIVE INFECTIOUS BURSAL DISEASE VACCINE - STRAIN LIBDV ?10? TCID??/DOSE.LAPROVET HUNGARY .-BUDAPEST 1107, HOROG U 32-34 HUNGARY HUNGARYPARENTERAL ORDINARY VIALS 1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/7537LABORATOIRES LAPROVETULTRAVETIS UGANDA LIMITEDINOMAZENEDIMINAZENE DIACETURATE1.05G/SACHETCEVA SANTE ANIMALE ZONE INDUSTRIELLE-TRES LE BOIS 22600 LOUDEACFRANCEOTHER SYSTEMIC POWDER 1.0X10.0X23.6 G SACHET,2.0X10.0X2.36 G SACHET
NDA/MAL/VDP/7540LABORATOIRES LAPROVETULTRAVETIS UGANDA LIMITEDSECURIDIUMISOMETAMIDIUM CHLORHYDRATE125MG /SACHETCEVA SANTE ANIMALE ZONE INDUSTRIELLE-TRES LE BOIS 22600 LOUDEACFRANCEOTHER SYSTEMIC OTHER POWDERS/GRANULES 1.0X10.0X6.2 G SACHET,1.0X10.0X775.0 MG SACHET
NDA/MAL/VDP/7542LABORATOIRES LAPROVETULTRAVETIS UGANDA LIMITEDSURVIDIMDIMINAZENE DIACETURATE + VIT B12 + VIT B610.5G + 10MG + 50MG/ SACHETCEVA SANTE ANIMALE ZONE INDUSTRIELLE-TRES LE BOIS 22600 LOUDEACFRANCEOTHER SYSTEMIC OTHER POWDERS/GRANULES 2.0X10.0X23.6 G SACHET,1.0X10.0X2.36 G SACHET
NDA/MAL/VDP/7543HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDAVIAN INFECTIOUS BRONCHITIS VACCINELIVE AVIAN INFECTIOUS BRONCHITIS VACCINE (MILD MASS TYPE STRAIN) ?10???EID??/DOSE. HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X200.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/7545HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDINFECTIOUS BURSAL DISEASE, NEWCASTLE DISEASE , AVIAN INFECTIOUS BRONCHITIS AND AVIAN REOVIRUS VACCINE, INACTIVATEDINFECTIOUS BURSAL DISEASE (STANDARD TYPE 1 STRAIN, VARIANT DELAWARE 1084A STRAIN, & MAY LAND STRAIN); NEWCASTLE DISEASE (LASOTA STRAIN); AVIAN INFECTIOUS BRONCHITIS (MASS &ARK TYPE STRAINS) AND AVIAN REOVIRUS ( 1133 & 1733 STRAINS) MULTIPLE STRAINS/ DOSE HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE VIAL (500ML)
NDA/MAL/VDP/7547HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDINFECTIOUS BURSAL DISEASE, NEWCASTLE DISEASE AND AVIAN INFECTIOUS BRONCHITIS VACCINE, INACTIVATED.INFECTIOUS BURSAL DISEASE (STANDARD TYPE 1 STRAIN); NEWCASTLE DISEASE (LASOTA STRAIN) AND AVIAN INFECTIOUS BRONCHITIS (MASS TYPE STRAIN)INFECTIOUS BURSAL DISEASE VIRUS - ?10???TCID??/DOSE; NEW CASTLE DISEASE VIRUS - ?10?EID??/DOSE AND AVAIN INFECTIOUS BROCHITIS VIRUS - ?10???EID??/DOSE HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE VIAL (500ML)
NDA/MAL/VDP/7549LAPROVET S.A.SEVERVICTORY LIMITEDDICLACOXDICLAZURIL1G/100MLBIOVE LABORATORY-3, RUE DE LORRAINE, BP 45 62510 ARQUES FRANCEFRANCEORAL LIQUID ORDINARY LIQUIDS 1.0X1.0 L BOTTLE
NDA/MAL/VDP/7550HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDEVAMIDIUMISOMETAMIDIUM1G/ SACHET & 125MG SACHETHEBEI YUANZHENG PHARM.CO.LTD-NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINACHINAOTHER SYSTEMIC POWDER 1.0X10.0X1.0 G SACHET,10.0X1.0X125.0 MG SACHET
NDA/MAL/VDP/7551HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDFOWL POX VACCINE, LIVEFOWL POX VACCINE (FOWL POX STRAIN) ?10? TCID??FP VIRUS/DOSE. HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/7553HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDINFECTIOUS BURSAL DISEASE VACCINEINFECTIOUS BURSAL DISEASE VACCINE, LIVE (INTERMEDIATE STRAIN)?10? EID??IBD VIRUS/DOSE. HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE VIAL,1.0X200.0 DOSE VIAL,1.0X500.0 DOSE VIAL
NDA/MAL/VDP/7555HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDINFECTIOUS BURSAL DISEASE VACCINEINFECTIOUS BURSAL DISEASE VACCINE ,LIVE (INTERMEDIATE INVASIVE STRAIN)?10? EID??IBD VIRUS/DOSE. HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X200.0 DOSE VIAL,1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/7557HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDINFECTIOUS BURSAL DISEASE VACCINE INACTIVATEDINFECTIOUS BURSAL DISEASE VACCINE , INACTIVATED (STANDARD TYPE 1 STRAIN) ?10???TCID??IBD VIRUS/DOSE HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE VIAL (500ML)
NDA/MAL/VDP/7558HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDINFECTIOUS CORYZA INACTIVATED VACCINEINFECTIOUS CORYZA VACCINE, INACTIVATED (HAEMOPHILUS PARAGALLINARUM SEROTYPES A, B & C) ?10?CFU/DOSE HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE VIAL (500ML)
NDA/MAL/VDP/7561HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDMAREK'S DISEASE VACCINEMAREK'S DISEASE VACCINE, LIVE (HVT FC126 STRAIN)?10? PFU/DOSE HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY DRY VIALS 1.0X500.0 DOSE VIAL,1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/7572HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDNEWCASTLE & AVIAN INFECTIOUS BRONCHITIS VACCINENEWCASTLE DISEASE & AVIAN INFECTIOUS BRONCHITIS VACCINE, LIVE (B1 & MILD MASS TYPE STRAINS)NEW CASTLE DISEASE VIRUS - ?10?EID??/DOSE & AVAIN INFECTIOUS BROCHITIS VIRUS - ?10???EID??/DOSE. HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X200.0 DOSE VIAL,1.0X1000.0 DOSE VIAL,1.0X500.0 DOSE VIAL
NDA/MAL/VDP/7574HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDNEWCASTLE & AVIAN INFECTIOUS BRONCHITIS VACCINENEWCASTLE DISEASE & AVIAN INFECTIOUS BRONCHITIS VACCINE , LIVE (LASOTA + MASS TYPE STRAINS)NEW CASTLE DISEASE VIRUS - ?10?EID??/DOSE & AVAIN INFECTIOUS BROCHITIS VIRUS - ?10???EID??/DOSE. HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE VIAL,1.0X500.0 DOSE VIAL
NDA/MAL/VDP/7576HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDNEWCASTLE DISEASE VACCINENEWCASTLE DISEASE VACCINE , LIVE (LASOTA STRAIN) ?10?EID??ND VIRUS/DOSE HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE VIAL,1.0X500.0 DOSE VIAL
NDA/MAL/VDP/7577HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDNEWCASTLE DISEASE VACCINENEWCASTLE DISEASE , VACCINE (B1 STRAIN) ?10?EID??ND VIRUS/DOSE HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X500.0 DOSE VIAL,1.0X200.0 DOSE VIAL,1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/7578INTRACIN PHARMACEUTICAL PVT LTD?VEERAM HEALTHCARE (U) LIMITEDCLOTIN FORTEIVERMECTIN + CLORSULON10MG +100MG/MLINTRACIN PHARMACEUTICAL PVT. LTD-C-1 B/53, G.I.D.C ESTATE, NADIAD-387001INDIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7579HESTER BIOSCIENCES LTDEVERVICTORY LIMITEDNEWCASTLE DISEASE VACCINE INACTIVATEDNEWCASTLE DISEASE VACCINE, INACTIVATED (LASOTA STRAIN) ?10???EID??ND VIRUS/DOSE HESTER BIOSCIENCES LIMITED-MERDA ADRAJ, TALUKA;KADI, DISTRICT: MEHSANA- 382 721, GUJARATINDIAPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE VIAL (500ML)
NDA/MAL/VDP/7580BAYER ANIMAL HEALTH (PTY) LTDKWEWAYO (U) VET PHARMACY LIMITEDDOXYMYCINDOXYCYCLINE +SODIUM SULPHACETAMIDE0.5G +2.5GBAYER ANIMAL HEALTH (PTY) LTD .-16 WILLOWTON ROAD PIETERMARITZBURG 3201SOUTH AFRICAORAL SOLID ORDINARY POWDERS 1.0X50.0 G SACHET
NDA/MAL/VDP/7581HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDNITROXYNIL-34NITROXYNIL34%W/VHEBEI YUANZHENG PHARM.CO.LTD-NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINACHINAPARENTERAL ORDINARY S C VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/7582MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD.KWEWAYO (U) VET PHARMACY LIMITEDZANIDE SUPER LEVAMISOLE HYDROCHLORIDE+OXYCLOZANIDE30MG+60MG/MLMEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS AND VETERINARY PRODUCTS LTD-AL HUSSAN ST. OPPOSITE AL-ASSER SUITE COMPANY INDUSTRIAL CITY IRBID AL- RUMTHA /AL HASSAN INDUSTRIAL CITYJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0 L BOTTLE
NDA/MAL/VDP/7583LAPROVET S.A.SULTRAVETIS UGANDA LIMITEDPARVAJECTBUPARVAQUONE5G/100MLCEVA SANTE ANIMALE-10 AVENUE DE LA BALLASTIERE 33500 LIBOURNE FRANCEFRANCEPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/7584HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDPARVAQUONE -15PARVAQUONE150MG/MLHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/7585LAPROVET S.A.SEVERVICTORY LIMITEDCOLIDOX FORTECOLISTIN SULPHATE + DOXYCYCLINE HYCLATE75M IU + 20G/ 100GBIOVE LABORATORY-3, RUE DE LORRAINE, BP 45 62510 ARQUES FRANCEFRANCEORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/7654BAODING SUNLIGHT HERB MEDICAMENT CO., LTDBD PHARMACEUTICALS LTDALBEN-100ALBENDAZOLE10%W/VBAODING SUNLIGHT HERB MEDICAMENT CO.LTD-NO.76 NORTH TUANJIE ROAD QINGYUAN BAODING CITY HEBEI PROVINCECHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X120.0 ML CONTAINER,1.0X5000.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X500.0 ML CONTAINER
NDA/MAL/VDP/7658BAODING SUNLIGHT HERB MEDICAMENT CO., LTDBD PHARMACEUTICALS LTDALBEN-25ALBENDAZOLE2.5%W/VBAODING SUNLIGHT HERB MEDICAMENT CO., LTD-NO. 76 NORTH TUANJIE ROAD QINGYUAN, BAODING CITY, HEBEI PROVINCE, P. R. CHINACHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML CONTAINER,1.0X120.0 ML CONTAINER,1.0X5000.0 ML CONTAINER,1.0X1000.0 ML CONTAINER
NDA/MAL/VDP/7661BAODING SUNLIGHT HERB MEDICAMENT CO., LTDBD PHARMACEUTICALS LTDALBEN & IVER ORALALBENDAZOLE+ IVERMECTIN2.5%W/V + 0.1%W/VBAODING SUNLIGHT HERB MEDICAMENT CO., LTD-NO. 76 NORTH TUANJIE ROAD QINGYUAN, BAODING CITY, HEBEI PROVINCE, P. R. CHINACHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0 ML CONTAINER
NDA/MAL/VDP/7665MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD.KWEWAYO (U) VET PHARMACY LIMITEDBOVARBUPARVAQUONE50MG/MLHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/7668NORBROOK KENYA LTDNORBROOK (U) LTDCEFENILCEFTIOFUR SODIUM50MG/MLNORBROOK LABERATORIES LTD -STATION WORKS NEWRY COUNTY DOWN BT 35 6JP NORTHERN IRELAND UNITED KINGDOMUNITED KINGDOMPARENTERAL ORDINARY DRY VIALS 1.0X30.0 ML VIAL + 1*20 ML VIAL WFI
NDA/MAL/VDP/7669DAWA LIMITEDSUPER MEDIC LTDDEXAJETDEXAMETHASONE SODIUM PHOSPHATE2MG/MLHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7672EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDDEXAPOWERDEXAMETHASONE2MG/MLEAGLE VET TECH CO. LTD.-235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DOSOUTH KOREAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL
NDA/MAL/VDP/7676HEBEI KEXING PHARMACEUTICAL CO., LTD.JUBAILI AGROTEC LTDIVANOR PLUSIVERMECTIN + CLOSANTEL SODIUM1%W/V + 10%W/V HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/7677HEBEI KEXING PHARMACEUTICAL CO., LTD.JUBAILI AGROTEC LTDSULFANORSULFADIMIDINE SODIUM333MG/ML HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/7679HEBEI KEXING PHARMACEUTICAL CO., LTD.JUBAILI AGROTEC LTDTYLONOR 20TYLOSIN TARTRATE20%W/V HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/7680HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDTYLOSIN 20%TYLOSIN20%W/VHEBEI YUANZHENG PHARM.CO.LTD-NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7684EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDOCCTAN-DOXYTETRACYCLINE HYDROCHLORIDE + VIT ( A + D3 +E + K3 +B2 + B6 + B12)+CALCIUM PANTOTHENATE + NIACINAMIDE60G +2,250,000 I.U + 450,000IU + 660IU + 880MG + 3000MG + 2000MG +2200?G +4650MG + 14000MG/KGEAGLE VET TECH CO. LTD.-235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DOSOUTH KOREAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X500.0 G SACHET,1.0X100.0 G SACHET
NDA/MAL/VDP/7685EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDNEW-PACPRIMTRIMETHOPRIM + SULFAMETHOXAZOLE40G+200G/KGEAGLE VET TECH CO. LTD.-235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DOSOUTH KOREAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET,1.0X500.0 G SACHET
NDA/MAL/VDP/7690INTERCHIEME WENKEN "DE ADELAAR" B.VVET CENTRE UGANDA LIMITEDTRYPONILDIMINAZENE ACETURATE + PHENAZONE1.05G +1.31G/ 2.36GINTERCHEMIE WERKEN ?DE ADELAAR? B.V-METAALWEG 8, 5804 CG, VENRAY, HOLLAND NETHERLANDSORAL SOLID ORDINARY GRANULES 1.0X10.0X2.36 G SACHET
NDA/MAL/VDP/7691DAWA LIMITEDSUPER MEDIC LTDVETGENTAGENTAMICIN SULPHATE10%W/VHEBEI YUANZHENG PHARM.CO.LTD-NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7693INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE - RUSHERELIMOXIN 25 SPRAYOXYTETRACYCLINE HYDROCHLORIDE25MG/MLINTERCHEMIE WERKEN ?DE ADELAAR? B.V-METAALWEG 8, 5804 CG, VENRAY, HOLLAND NETHERLANDSTOPICAL EXTERNAL PRESSURISED AEROSOLS 1.0X200.0 ML CANNISTER
NDA/MAL/VDP/7694INTERCHEMIE WENKEN "DE ADELAAR" B.V.VET CENTRE UGANDA LIMITEDLIMOXIN-100OXYTETRACYCLINE10%V/VINTERCHIEME WENKEN "DE ADELAAR" B.V.-HORSTERWEG 26A 5811 AC CASTENERY HOLLANDNETHERLANDSPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7696INTERVET SA (PTY) LTD.CEE K-BRANDS LIMITEDNILZAN SUPERLEVAMISOLE HYDROCHLORIDE + OXYCLOZANIDE + COBALT SULPHATE HEPTAHYDRATE + SODIUM SELENATE3.0%W/V + 6.0%W/V + 0.764%W/V+ 0.0766%W/VCOOPER K. BRANDS LTD -P.O. BOX 40596 00100 NAIROBI,KENYA. ON KAPTAGAT ROAD, OFF WAIYAKI WAY, NAIROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS 1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/7697BAODING SUNLIGHT HERB MEDICAMENT CO., LTDBD PHARMACEUTICALS LTDPEN-STREPPENICILLIN G PROCAINE + DIHYROSTREPTOMYCIN SULFATE200,000 IU + 200MG/MLBAODING SUNLIGHT HERB MEDICAMENT CO., LTD-NO. 76 NORTH TUANJIE ROAD QINGYUAN, BAODING CITY, HEBEI PROVINCE, P. R. CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/7698VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) GOODMAN INTERNATIONAL LTDLEVOZAN BOLUSLEVAMISOLE + OXYCLOZANIDE1000MG +1400MGVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)-DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANORAL SOLID ORDINARY OTHER COATED TABLETS 1.0X10.0X5.0 BOLUS BLISTER
NDA/MAL/VDP/7700HEBEI YUANZHENG PHARMACEUTICAL CO LTDERAM UGANDA LIMITEDOXYTET- 20%OXYTETRACYCLINE HYDROCHLORIDE20%W/VHEBEI YUANZHENG PHARM.CO.LTD-NO. 16 LIUYUAN ROAD, CHANGAN DISTRICT SHIJIAZHUANG CITY, HEBEI PROVINCE CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X500.0 ML VIAL
NDA/MAL/VDP/8033COSMOS LTDJOSE DEVELOPMENT LIMITEDWORMICID PLUS - O BOLUSMULTI-INGREDIENTN/ACOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREAKENYAORAL SOLID ORDINARY OTHER SPECIAL FORMS 1.0X2.0X15.0 BOLUS STRIP
NDA/MAL/VDP/8179CEVA SANTE ANIMALE MTK UGANDA LIMITEDENZAPROST INJECTIONDINOPROST5MG/MLCEVA SANTE ANIMALE-10 AVENUE DE LA BALLASTIERE 33500 LIBOURNE FRANCEFRANCEPARENTERAL ORDINARY VIALS 1.0X30.0 ML VIAL
NDA/MAL/VDP/8181UNIVET LTDBIMEDA UGANDA LIMITEDCURAFLUKEFENBENDAZOLE+RAFOXANIDE5%W/V+5%W/VMEDISEL KENYA LIMITED-PLOT NO. LR. NO. 4953/1209, GENERAL KAGO ROAD, P.O.BOX 540-00100, THIKA-KENYA.IRELANDORAL LIQUID ORDINARY LIQUIDS 1.0X1.0 L JERRYCAN
NDA/MAL/VDP/8214LAPROVET S.A.S EVERVICTORY LIMITEDOXYTETRACYCLINEOXYTETRACYCLINE50%W/WLABOTOIRES BIOVE-3 RUE DE LORRAINE F-6251O ARQUESFRANCEORAL SOLID ORDINARY POWDERS 1.0X10.0X100.0 G SACHET,1.0X1.0 KG SACHET
NDA/MAL/VDP/8256HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LIMITEDALBENOR 2500ALBENDAZOLE2500MGHEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCECHINAORAL SOLID ORDINARY OTHER TABLETS 1.0X20.0 BOLUS BLISTER
NDA/MAL/VDP/8258EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDALBENDA 10% SOLALBENDAZOLE100G/1LEAGLE VET TECH CO. LTD.-235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DOSOUTH KOREAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0 L CONTAINER
NDA/MAL/VDP/8259EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDENPROTILENROFLOXACIN100G/LEAGLE VET TECH CO. LTD.-235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DOSOUTH KOREAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/8260HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LIMITEDTETRANOR 10OXYTETRACYCLINE HYDROCHLORIDE10%W/VHEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X250.0 ML VIAL,1.0X500.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/8261HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LIMITEDP-STREPNORPROCAINE PENICILLIN + DIHYDROSTREPTOMYCIN SULPHATE200MG + 250MG/MLHEBEI HOPE HARMONY PHARMACEUTICAL CO.,LTD -INDUSTRY AREA,YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINACHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/8262BAODING SUNLIGHT HERB MEDICAMENT CO.LTDBD PHARMACEUTICALS LTDMULTIVITVITAMINS [ A + D3 +E +B1 + B2 + B6 +B12 + C ] + D-PANTHENOL + NICOTINAMIDE + D-BIOTIN3000I.U + 2000I.U +4MG + 10MG +1MG +5MG +10MCG + 1MG + 10MG + 12.5MG + 10MCGBAODING SUNLIGHT HERB MEDICAMENT CO., LTD-NO. 76 NORTH TUANJIE ROAD QINGYUAN, BAODING CITY, HEBEI PROVINCE, P. R. CHINACHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8263 CADILA HEALTHCARE LIMITEDQUALITY CHEMICALS LTD - HUMANBREMA BATRYNIL VETDIMINAZENE ACETURATE7%W/VINTRACIN PHARMACEUTICAL PVT LTD-C-1, B -53, G.I.D.C ESTATE, NADIAD ? 387001 GUJARAT, INDIA.,INDIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8265MCI SANTE ANIMALEERAM UGANDA LIMITEDLYOPOX+PPRLIVE ATTENUATED SHEEP POX VIRUS STRAIN ROMANIA + LIVE ATTENUATED PESTE DES PETITIS RUMINANTS STRAIN NIGERIA 75SHEEP POX VIRUS - ?10??? TCID??/DOSE & PPR VIRUS - ?10??? TCID?? /DOSE.MCI SANTE ANIMALE -LOT NO.157 ZONE INDUSTRIELLE SUD OUEST 28810MOROCCOPARENTERAL ORDINARY DRY VIALS 1.0X100.0 DOSE VIAL + 50ML VIAL OF STERILE DILUENT(SALINE SOLUTION IN WFI)
NDA/MAL/VDP/8267HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-ALBENDAZOLEALBENDAZOLE10%W/V HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/8268GOODMAN INTERNATIONAL LTDGOODMAN INTERNATIONAL LTDOXYTETRACYCLINE HYDROCHLORIDEOXYTETRACYCLINE HYDROCHLORIDE50%W/WVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)-DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET,1.0X250.0 G SACHET,1.0X500.0 G SACHET,1.0X1.0 KG SACHET
NDA/MAL/VDP/8269HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LIMITEDALBENOR 2.5%ALBENDAZOLE2.5%W/VHEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCECHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X5.0 L CONTAINER
NDA/MAL/VDP/8270HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LIMITEDTETRANOR 20 L.AOXYTETRACYCLINE DIHYDRATE20%W/VHEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X250.0 ML VIAL,1.0X100.0 ML VIAL,1.0X500.0 ML VIAL
NDA/MAL/VDP/8271HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LIMITEDTETRANOR 30 L.AOXYTETRACYCLINE HYDROCHLORIDE30%W/VHEBEI HARMONY PHARMACEUTICAL CO. LTD- INDUSTRIAL ZOO YUANSHI TOWN SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/8272EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDBUPAQUONEBUPARVAQUONE50MG/MLEAGLE VET TECH CO LTD--256-46 DUGOK-RI SHNAM-MYEON YESAN-GUN CHUNGNAMSOUTH KOREAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL
NDA/MAL/VDP/8273EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDTYLOSIN 200TYLOSIN TARTRATE200MG/MLEAGLE VET TECH CO LTD--256-46 DUGOK-RI SHNAM-MYEON YESAN-GUN CHUNGNAMSOUTH KOREAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8280ROTAM AGRO CHEMICALS LTDULTRAVETIS UGANDA LIMITEDTIXFIXAMITRAZ12.5%W/VSHANDONG LUXI ANIMAL MEDICINE SHARE CO.,LTD-NO.5 WAIHUANXI ROAD,QIHE COUNTY,SHANDONGCHINATOPICAL EXTERNAL EMULSIONS 1.0X40.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X20.0 L JERRYCAN,1.0X5.0 L JERRYCAN,1.0X200.0 L CONTAINER
NDA/MAL/VDP/8286FARMVIC LTDCOSWAY PHARMACEUTICALS LIMITEDVITAMIN AD3E-SVITAMIN A PALMITATE + CHOLECALCIFEROL + TOCOPHERYL ACETATE50,000 IU + 25,000 IU + 20MGVETERINASKI ZAVOD SUBOTICA -SOLID PHARMACEUTICAL MANUFACTURING PLANT, SRPSKA CRNJA,PARTZANSKA BB, SRPSKA CRNJA REPUBLIC OF SERBIASERBIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/8298NORBROOK LABORATORIESNORBROOK (U) LTDNOROMECTIN ORAL DRENCHIVERMECTIN0.08%W/VNORBROOK KENYA LTD-OLD KIMURU RD- KARURIKENYAORAL LIQUID ORDINARY LIQUIDS 1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE,2.5 L JERRYCAN,1.0X1.0 L JERRYCAN,1.0X5000.0 ML JERRYCAN
NDA/MAL/VDP/8360FATRO S.P.AGLOBAL VET (U) LIMITEDVAIOL-VACLIVE ATTENUATED AVIAN FOWLPOX VIRUS, HP-2 STRAIN-2?10?EID??/DOSEFATRO S.P.A-VIA MOLINO EMILI 2, MACLODIO (BS, ITALY)ITALYORAL LIQUID ORDINARY DROPS 1.0X10.0X1000.0 DOSE VIAL
NDA/MAL/VDP/8361HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LIMITEDFLOXINORENROFLOXACIN200MG/MLHEBEI HOPE HARMONY PHARMACEUTICAL CO. LTD- -NO.114 CHANGSHENG TREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINACHINAORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/8362FATRO S.P.AGLOBAL VET (U) LIMITEDS.E.T-VACINACTIVATED CULTURE OF SALMONELLA ENTERITIDIS + INACTIVATED CULTURE OF SALMONELLA TYPHIMURIUM1,000,000,000CFU/DOSE + 1,000,000,000CFU/DOSEFATRO S.P.A-VIA MOLINO EMILI 2, MACLODIO (BS, ITALY),FATRO S.P.A.-VIA EMILIA 285, OZZANO EMILIA (BO, ITALY) ITALYPARENTERAL ORDINARY VIALS 1.0X500.0 DOSE VIAL (250ML),1.0X1000.0 DOSE VIAL (500ML)
NDA/MAL/VDP/8363CEVA SANTE ANIMALE MTK UGANDA LIMITEDVERYLDIMINAZENE DIACETURATE + LEVAMISOLE1.05G+1.5G,10.5G+15GCEVA SANTE ANIMALE ZONE INDUSTRIELLE-TRES LE BOIS 22600 LOUDEACFRANCENON-HUMAN USE GRANULES 1.0X10.0X49.0 G SACHET,1.0X10.0X4.9 G SACHET
NDA/MAL/VDP/8364FATRO S.P.AGLOBAL VET (U) LIMITEDBIO?VAC ND?IBHITCHNER B1 STRAIN + MASSACHUSETTS H-120 HITCHNER B1 STRAIN - ?10??? EID??/DOSE+ MASSACHUSETTS H-120 - ?10??? EID??/DOSE FATRO S.P.A-FATRO S.P.A VIA MOLINO EMILI, 225030 MACLODIO (BS) ITALYITALYORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/8365LAPROVET S.A.S ULTRAVETIS UGANDA LIMITEDSANIMIXDIMINAZENE DIACETURATE + LEVIMISOLE,DIMINAZENE DIACETURATE + LEVIMISOLE1.05G + 1.5G,10.5G + 15GCEVA SANTE ANIMALE ZONE INDUSTRIELLE-TRES LE BOIS 22600 LOUDEACFRANCEPARENTERAL ORDINARY OTHER INFUSIONS 1.0X10.0X4.9 G SACHET,1.0X10.0X49.0 G SACHET
NDA/MAL/VDP/8366EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDCOLLIE- AMAMPICILLIN TRIHYDRATE + COLLISTIN SULPHATE100G + 25,000,000IUEAGLE VET TECH CO. LTD.-235-34, CHUSA-RO, SHINAM MYUN, YESAN-KUN, CHUNGCHONGNAM-DOSOUTH KOREAORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET,1.0X500.0 G SACHET
NDA/MAL/VDP/8367BIMEDA AMEABIMEDA UGANDA LTDV.H. + H-120 COMBINED VACCINE, NEWCASTLE DISEASENEWCASTLE DISEASE VIRUS (V.H STRAIN) + INFECTIOUS BRONCHITIS VIRUS (H-120 STRAIN)NOT LESS THAN 10^6.0 EID50 + NOT LESS THAN 10^3.5 EID50 PER DOSEABIC BIOLOGICAL LABORATORIES LTD. 3 HAMELACHA ST. WEST INDUSTRIAL ZONE, BEIT SHEMESH, ISRAELISRAELORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1X500, 1X1000 DOSES VIAL
NDA/MAL/VDP/8368FATRO S.P.AGLOBAL VET (U) LIMITEDIBA-VACLIVE ATTENUATED VIRUS OR GUMBORO DISEASE, 1/65PV STRAIN?10?EID??/DOSEFATRO S.P.A-VIA MOLINO EMILI 2, MACLODIO (BS, ITALY)ITALYORAL LIQUID ORDINARY SUSPENSIONS 1.0X1000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL,1.0X10.0X1000.0 DOSE VIAL,1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL
NDA/MAL/VDP/8369HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-OXYWSPOXYTETRACYCLINE25 % W/W HEBEI KEXING PHARMACEUTICALS CO. LTD-NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA. CHINAORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/8370FATRO S.P.AGLOBAL VET (U) LIMITEDBI-VAC 1?AVIAN INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS H120 STRAIN VACCINE(FREEZE DRIED )?10?EID??/DOSEFATRO S.P.A-VIA MOLINO EMILI 2, MACLODIO (BS, ITALY)ITALYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X10.0X1000.0 DOSE VIAL,1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL
NDA/MAL/VDP/8371FATRO S.P.AGLOBAL VET (U) LIMITEDBIO-VAC LA SOTANEWCASTLE DISEASE VIRUS (STRAIN LA SOTA)10^6.5 EID50/DOSEFATRO S.P.A-VIA MOLINO EMILI 2, MACLODIO (BS, ITALY)ITALYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X1.0X1000.0 DOSE VIAL,1.0X1.0X2500.0 DOSE VIAL,1.0X1.0X500.0 DOSE VIAL,1.0X10.0X1000.0 DOSE VIAL,1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL
NDA/MAL/VDP/8372FATRO S.P.AGLOBAL VET (U) LIMITEDBIO-MAREK HVTFREEZE DRIED FC 126 STRAIN OF HERPES VIRUS OF TURKEY (HVT) 1500 PLAQUE FORMING UNITS/ DOSEFATRO S.P.A-VIA MOLINO EMILI 2, MACLODIO (BS, ITALY)ITALYPARENTERAL ORDINARY DRY VIALS 1.0X1000.0 DOSE VIAL,1.0X2000.0 DOSE VIAL
NDA/MAL/VDP/8374BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDND+IB+VP2INACTIVATED, NEWCASTLE DISEASE VIRUS (V.H STRAIN) + INACTIVATED, INFECTIOUS BRONCHITIS VIRUS (M41 STRAIN) + INFECTIOUS BURSAL DISEASE VIRUS (ISRAELI STRAIN VP2 PROTEIN)INACTIVATED, ND VIRUS (V.H STRAIN) ?10???EID??/DOSE + INACTIVATED, IB VIRUS (M41 STRAIN) ?10???EID??/DOSE + IBD VIRUS, VP2 PROTEIN - 25 ?G/DOSABIC BIOLOGICAL LABORATORIES-WESTERN INDUSTRIAL ZONE BEIT SHEMESH, 99100 ISRAELISRAELPARENTERAL ORDINARY I M VIALS 1.0X10.0X1000.0 DOSE BOTTLE (500ML)
NDA/MAL/VDP/8375BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDIC- QUADRO INACTIVATED VACCINEINFECTIOUS CORYZA (AVIBACTERIUM PARAGALLINARUM) VACCINE, INACTIVATED221 STRAIN -10???CFU/DOSE, SPROSS STRAIN - 10???CFU/DOSE - MODESTO STRAIN - 10???CFU/DOSE & AKKO STRAIN - 10???CFU/DOSE.ABIC BIOLOGICAL LABORATORIES-WESTERN INDUSTRIAL ZONE BEIT SHEMESH, 99100 ISRAELISRAELPARENTERAL ORDINARY VIALS 1.0X1000.0 DOSE BOTTLE (300ML),1.0X2000.0 DOSE BOTTLE (600ML)
NDA/MAL/VDP/8376BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDNECTIV FORTEINACTIVATED, NEWCASTLE DISEASE VIRUS (V.H STRAIN?10???EID??/DOSE 90.1 ML)ABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAELISRAELPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X5000.0 DOSE BOTTLE (500ML)
NDA/MAL/VDP/8377BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDV.H. LIVE VACCINEND VIRUS, LIVE (V.H. STRAIN)ND VIRUS, V.H STRAIN (LYOPHILIZED) ?10? EID??/DOSEABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAELISRAELORAL LIQUID ORDINARY DROPS 1.0X1000.0 DOSE VIAL
NDA/MAL/VDP/8378BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDTABIC IB VAR VACCINEAVIAN INFECTIOUS BRONCHITIS VACCINE, LIVE (233A STRAIN)IB VIRUS (233A STRAIN) ?10???EID??/DOSEABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAELISRAELORAL SOLID ORDINARY SOLUBLE TABLETS 1.0X1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X1.0X10.0 TABLET BLISTER (5000 DOSES),1.0X1.0X10.0 TABLET BLISTER (10,000 DOSES)
NDA/MAL/VDP/8380BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDTABIC V.H. LIVE VIRUS VACCINELIVE ATTENUATED NEWCASTLE DISEASE VIRUS, V.H. STRAIN 10? - 10???EID??/DOSEABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAELISRAELORAL SOLID ORDINARY EFFERVESCENT TABLETS 1.0X1.0X10.0 TABLET BLISTER (100 DOSES),1.0X1.0X10.0 TABLET BLISTER (500 DOSES),1.0X1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X1.0X10.0 TABLET BLISTER (5000 DOSES),1.0X1.0X10.
NDA/MAL/VDP/8381BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDTABIC MB LIVE VIRUS VACCINEINFECTIOUS BURSAL DISEASE (IBD) VACCINE, LIVE (M.B STRAIN)INFECTIOUS BURSAL DISEASE VIRUS,M.B STRAIN : 10??? - 10???EID??/DOSEABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAELISRAELORAL SOLID ORDINARY EFFERVESCENT TABLETS 1.0X1.0X10.0 TABLET BLISTER (500 DOSES),1.0X1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X1.0X10.0 TABLET BLISTER (5000 DOSES)
NDA/MAL/VDP/8382VETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO)GOODMAN INTERNATIONAL LTDOXYDONE-500OXYTETRACYCLINE HYDROCHLORIDE500MGVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING CO.LTD (VAPCO) DHULAIL PROVINCE, KING HUSSEIN STREET, NO 120/ZARKA-JORDANJORDANORAL SOLID ORDINARY TABLETS 1X5X10 TABLET BLISTERS
NDA/MAL/VDP/8383BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDTABIC H-120 VACCINEAVIAN INFECTIOUS BRONCHITIS VACCINE, LIVE (H-120 STRAIN)?10???EID??/DOSEABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAELISRAELORAL SOLID ORDINARY EFFERVESCENT TABLETS 1.0X10.0 TABLET BLISTER (1000 DOSES),1.0X10.0 TABLET BLISTER (2000 DOSES),1.0X10.0 TABLET BLISTER (2500 DOSES),1.0X10.0 TABLET BLISTER (5000 DOSES),1.0X10.0 TABLET BLISTER (10,000 DOSES)
NDA/MAL/VDP/8384BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDSALMABICINACTIVATED SALMONELLA ENTERITIDIS (C8, B3) AND SALMONELLA TYPHIMURIUM [2(+4)] STRAINSS. ENTERITIDIS (PT C8 - 1X10? CFU/DOSE & PT B3 - 1X10? CFU/DOSE)+ S. TYPHIMURIUM - PT 2(4+) -1X10? CFU/DOSE ABIC BIOLOGICAL LABORATORIES-WESTERN INDUSTRIAL ZONE BEIT SHEMESH, 99100 ISRAELISRAELPARENTERAL ORDINARY S C VIALS 1.0X500.0 DOSE BOTTLE (250ML),1.0X1000.0 DOSE BOTTLE (500ML)
NDA/MAL/VDP/8387FATRO S.P.AGLOBAL VET (U) LIMITEDBI-VAC 2?ATTENUATED AVIAN INFECTIOUS BRONCHITIS VIRUS, MASSACHUSETTS H-52 STRAIN?10?EID??/DOSEFATRO S.P.A-VIA MOLINO EMILI 2, MACLODIO (BS, ITALY)ITALYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS 1.0X10.0X1000.0 DOSE VIAL,1.0X10.0X2500.0 DOSE VIAL,1.0X10.0X5000.0 DOSE VIAL
NDA/MAL/VDP/8388 CIPLA LTDQUALITY CHEMICALS LTD - HUMANCIPDEX INJECTIONDEXAMETHASONE SODIUM PHOSPHATE4.4 MG/ML CIPLA LTD UNIT I-VILLAGE UPPER MALPUR, P.O. BHUD, TEHSIL NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 173205, INDIA INDIAPARENTERAL ORDINARY VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/8389MCI SANTE ANIMALEERAM UGANDA LIMITEDAVIVAX ND I-2 LYOPHILISELIVE AVIRULENT NEWCASTLE VIRUS, STRAIN ND 1-2STRAIN ND 1-2 - ?10?EID??/DOSEMCI SANTE ANIMALE-LOT NO.157 ZONE INDUSTRIELLE SUD OUEST MOHAMMEDIAMAROC 28810MOROCCOPARENTERAL ORDINARY DRY VIALS 1.0X100.0 DOSE VIAL
NDA/MAL/VDP/8390MCI SANTE ANIMALEERAM UGANDA LIMITEDAVIVAX ND I-2 LIQUIDLIVE AVIRULENT NEWCASTLE VIRUS, STRAIN ND 1-2STRAIN ND 1-2 - ?10?EID??/DOSEMCI SANTE ANIMALE-LOT NO.157 ZONE INDUSTRIELLE SUD OUEST MOHAMMEDIAMAROC 28810MOROCCOPARENTERAL ORDINARY VIALS 1.0X500.0 DOSE VIAL
NDA/MAL/VDP/8391EAGLE VET TECH CO., LTDEAGLEVET UGANDA LIMITEDVITAPOWERMULTI-VITAMINMULTI-INGREDIENTEAGLE VET TECH CO. LTD.-35-34, CHUSA-RO, SHINAM-MYEON, YESAN-GUN, CHUNGCHEONGNAM-DO, KOREASOUTH KOREAPARENTERAL ORDINARY I M VIALS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/8397HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-OXYOXYTETRACYCLINE12.5% W/V HEBEI KEXING PHARMACEUTICALS CO. LTD --NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA.CHINAPARENTERAL ORDINARY VIALS 1.0X500.0 ML VIAL,1.0X100.0 ML VIAL,1.0X250.0 ML VIAL
NDA/MAL/VDP/8398HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LIMITEDALBENOR 300ALBENDAZOLE300MGHEBEI HOPE HARMONY PHARMACEUTICAL CO.,LTD -INDUSTRY AREA,YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINACHINAORAL SOLID ORDINARY TABLETS 1.0X5.0X10.0 TABLET BLISTER
NDA/MAL/VDP/8399BIMEDA CHEMICAL EXPORTS BIMEDA UGANDA LIMITEDAMINOVITALMULTIVITAMINMULTI-INGREDIENTBIMEDA CHEMICALS EXPORT LIMITED-BROOM HILL ROAD, TALLAGHT, DUBLIN 24, IRELANDIRELANDORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/8400HEBEI HOPE HARMONY PHARMACEUTICAL CO., LTD JUBAILI AGROTEC LIMITEDALBENOR 10ALBENDAZOLE100MG/MLHEBEI HOPE HARMONY PHARMACEUTICAL CO.,LTD -INDUSTRY AREA,YUANSHI COUNTY, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINACHINAORAL LIQUID ORDINARY SUSPENSIONS 1.0X1000.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN
NDA/MAL/VDP/8402MELO GROUP AFRICA LIMITEDMELO PHARMACEUTICALS LIMITEDENROTRIL-100ENROFLOXACIN100MGPHARMACEUTICAL AND VETERINARY MATERIAL JSC (HANVET)-NO.88, TRUONG CHINH ROAD, DONG DA, HANOI, VIETNAM.VIETNAMORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/8414MELO GROUP AFRICA LIMITEDMELO PHARMACEUTICALS LIMITEDHANMECTIN-100IVERMECTIN10MG/MLPHARMACEUTICAL AND VETERINARY MATERIAL JSC (HANVET)-NO.88, TRUONG CHINH ROAD, DONG DA, HANOI, VIETNAM.VIETNAMPARENTERAL ORDINARY I M VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8435BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDBRONCHIN INACTIVATED NDV, V.H. STRAIN + INACTIVATED IBV, M-41 STRAIN INACTIVATED NDV, V.H. STRAIN ?10???EID??/DOSE + INACTIVATED IBV, M-41 STRAIN?10???EID??/DOSEABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAELISRAELOTHER SYSTEMIC LIQUIDS 1.0X1000.0 DOSE BOTTLE (500ML)
NDA/MAL/VDP/8478MELO GROUP AFRICA LIMITEDMELO PHARMACEUTICALS LIMITEDHANEGG-PLUSOXYTETRACYCLINE HCL+NEOMYCIN (AS SULFATE)+VITAMIN A+VITAMIN D3+VITAMIN K3+VITAMIN B1+VITAMIN B2+VITAMIN B6+VITAMIN B12+NICOTINAMIDE+CA PANTOTHENATE+FOLIC ACID+VITAMIN C+METHIONINE+LYSINE10 G + 4MG + 750 000 IU + 150 000 IU + 250 MG + 100MG + 200MG + 200MG + 750MG + 1500MG + 750MG + 30MG + 2500MG + 3MG + 5MGPHARMACEUTICAL AND VETERINARY MATERIAL JSC (HANVET)-PHO NOI A INDUSTRIAL ZONE HUNG,YEN PROVINCE, VIETNAMVIETNAMORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X1.0 KG SACHET
NDA/MAL/VDP/8479HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-IRONDEXIRON DEXTRAN10%W/V HEBEI KEXING PHARMACEUTICALS CO. LTD --NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA.CHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8482HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-GENTAMYGENTAMYCIN SULPHATE10%W/V HEBEI KEXING PHARMACEUTICALS CO. LTD --NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA.CHINAPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8486HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX - TYLOSINTYLOSIN TARTRATE20 % W/V HEBEI KEXING PHARMACEUTICALS CO. LTD --NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA.CHINAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES 1.0X100.0 ML BOTTLE
NDA/MAL/VDP/8492BIMEDA AMEA LIMITEDBIMEDA UGANDA LIMITEDMB (GUMBORO) VACCINELIVE ATTENUATED IBD VIRUS M.B.10??? - 10???EID??/DOSEABIC BIOLOGICAL LABORATORIES LTD-P.O.B. 489, WESTERN INDUSTRIAL ZONE BEIT SHEMESH,99100 ISRAELISRAELORAL LIQUID ORDINARY LIQUIDS 1.0X1000.0 DOSE VIAL,1.0X2000.0 DOSE VIAL,1.0X2500.0 DOSE VIAL,1.0X5000.0 DOSE VIAL
NDA/MAL/VDP/8532THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDTYLORATETYLOSIN20%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY VIALS 1.0X1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL
NDA/MAL/VDP/8533THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDOXYTETRAVET 25%OXYTETRACYCLINE25%W/WTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL SOLID ORDINARY POWDERS 1.0X100.0 G SACHET,1.0X500.0 G SACHET,1.0X1.0 KG SACHET
NDA/MAL/VDP/8534THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDAMPROCIDIAAMPROLIUM60%W/WTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET
NDA/MAL/VDP/8535THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDMULTIVITAMIN INJVITAMINS A + D3 +E + B1 + B2 +B6 + B12 + NICOTINAMIDE + PANTOTHENOL15,000IU + 1000IU + 20MG + 10MG + 5MG + 3MG + 50MCG + 35MG + 25MGTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8536THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDGENTAVETGENTAMICIN5%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/8537THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDENROCUREENROFLOXACIN10%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1.0 L BOTTLE
NDA/MAL/VDP/8568MERIALERAM UGANDA LIMITEDBIORAL H120 NEOH120 STRAIN OF AVIAN INFECTIOUS BRONCHITIS VIRUSAT LEAST 3.7 LOG TO THE BASE 10 OF EID50MERIAL LABORATOIRE-PORTE DES ALPES?RUE DE L? AVIATION 69800 SAINT PRIEST FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0X10.0X200.0 DOSE BOTTLE
NDA/MAL/VDP/8663: LAPROVET S.A.S EVERVICTORY LIMITEDINOMIDIUM?ISOMETAMIDIUM CHLORIDE HYDROCHLORIDE1 GCEVA SANTE ANIMALE - -Z.I. TRES LE BOIS, B.P. 372, 22603 LOUDEAC CEDEX, FRANCEFRANCEOTHER SYSTEMIC POWDER 1.0X10.0 SACHET CARTON
NDA/MAL/VDP/8664HEBEI KEXING PHARMACEUTICAL CO., LTD.NANDINI PHARMACEUTICALS LIMITEDKX-TOLTRATOLTRAZURIL2.5% W/V HEBEI KEXING PHARMACEUTICALS CO. LTD --NO.114 CHANGSHENG STREET, LUQUAN DEVELOPMENT ZONE, SHIJIAZHUANG CITY, HEBEI, CHINA.CHINAORAL LIQUID ORDINARY LIQUIDS 1.0X1.0X100.0 ML BOTTLE
NDA/MAL/VDP/8700MELO GROUP AFRICA LIMITEDMELO PHARMACEUTICALS LIMITEDTYLOSIN-200TYLOSIN TARTRATE200 MG/MLPHARMACEUTICAL AND VETERINARY MATERIAL JSC (HANVET)-PHO NOI A INDUSTRIAL ZONE HUNG,YEN PROVINCE, VIETNAMVIETNAMPARENTERAL ORDINARY VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8701HEBEI YUANZHENG PHARMACEUTICAL CO LTDEVERVICTORY LIMITEDBUPARVAQUONE-5BUPARVAQUONE INJECTION5%W/VHEBEI YUANZHENG PHARMACEUTICAL CO LTD--NO.16 LIUYUAN ROAD,CHANG'AN DISTRICT SHIJIAZHUANG CITY HEBEI PROVINCECHINAPARENTERAL ORDINARY VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/8702THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDIMICARBIMIDOCARB12%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY VIALS 1.0X40.0 ML BOTTLE
NDA/MAL/VDP/8703THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDPIPERAMENTICPIPERAZINE36%W/WTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET,1.0X500.0 G SACHET,1.0X1.0 KG SACHET
NDA/MAL/VDP/8704THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDPEN DH STREPPROCAINE PENICILLIN +DIHYDROSTREPTOMYCIN200MG/ML + 200MG/MLTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL RETARD VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8705THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDOXYTETRAVET 10%OXYTETRACYCLINE10%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY I M VIALS 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL
NDA/MAL/VDP/8706THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDALBEVET 2.5%ALBENDAZOLE2.5%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE
NDA/MAL/VDP/8707THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDHEXAVET LAFLUNIXIN + OXYTETRACYCLINE20MG + 300MG /MLTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANPARENTERAL ORDINARY I M VIALS 1.0X100.0 ML VIAL
NDA/MAL/VDP/8708THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDOXYTETRAVETOXYTETRACYCLINE HYDROCHLORIDE5G/200MLTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANTOPICAL EXTERNAL PRESSURISED AEROSOLS 1.0X200.0 ML CANNISTER
NDA/MAL/VDP/8744THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. COGLOBAL VET (U) LIMITEDALBEVET ALBENDAZOLE10%W/VTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL LIQUID ORDINARY SUSPENSIONS 1.0X1.0 L BOTTLE,1.0X500.0 ML BOTTLE,1.0X5.0 L BOTTLE
NDA/MAL/VDP/8745THE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.GLOBAL VET (U) LIMITEDANTICOXDICLAZURIL10MG/MLTHE ARAB PESTICIDES AND VETERINARY DRUGS MFG. CO.-AL HASSAN INDUSTRIAL ESTATE ?IRBIDJORDANORAL LIQUID ORDINARY LIQUIDS 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE
NDA/MAL/VDP/8922MCI SANTE ANIMALEERAM UGANDA LIMITEDAZADIMDIMINAZENE DIACETURATE TETRAHYDRATE + ANTIPYRINE1.05G + 1.31G MCI SANTE ANIMALE LOT-LOT 157, Z.I. SUD-OUEST B.P, 28 810 MOHAMMEDIA ?MOROCCOMOROCCOPARENTERAL ORDINARY DRY VIALS 1.0X10.0X2.36 G VIAL
NDA/MAL/VDP/8924MCI SANTE ANIMALEERAM UGANDA LIMITEDPARANTHIC 10%OXFENDAZOLE10% W/VMCI SANTE ANIMALE LOT-LOT 157, Z.I. SUD-OUEST B.P, 28 810 MOHAMMEDIA ?MOROCCOMOROCCOORAL LIQUID ORDINARY SUSPENSIONS 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER,1.0X1000.0 ML CONTAINER,1.0X2500.0 ML CONTAINER,1.0X5000.0 ML CONTAINER
NDA/MAL/VDP/8942CEVA SANTE ANIMALE MTK UGANDA LIMITEDCYSTORELINGONADORELIN (GNRH) DIACETATE TETRAHYDRATE50MCG/MLCEVA SANTE ANIMALE-10 AVENUE DE LA BALLASTIERE 33500 LIBOURNE FRANCEFRANCEPARENTERAL ORDINARY VIALS 1.0X1.0X120.0 ML VIAL
NDA/MAL/VDP/8945LAPROVET S.A.S GOODMAN INTERNATIONAL LTD - VETVITAMIN E-SVITAMIN E + SODIUM SELENITE20IU + 2MG / GVETERINARY AND AGRICULTURAL PRODUCTS MANUFACTURING COMPANY LTD (VAPCO ) -KING HUSSEIN STREET AL DHULAIL AREA ZARQA PROVINCE HASHEMITE KINGDOM OF JORDANJORDANORAL LIQUID ORDINARY SOLUBLE POWDERS 1.0X100.0 G SACHET

S/n Manufacturer Drug Name RegNo Dosage Form Pack Sizes Licence Holder Ctryofmake ltr
1AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780TEEMAC A4THA212POWDER40GMS AND 18GMSAIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH,UGANDAAIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH,
2AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780MONITEEMAC BA4THA213POWDER18GMS AND 32 GMSAIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH,UGANDAAIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH,
3AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780TEEMONI B4THA214POWDER50GMS & 35GMSAIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH,UGANDAAIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH,
4AIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH, ACHOLI BURS S/TY PADER DISTRICT 0775 919547/0780TEEBUOTHA215POWDER15GMS & 6GMSAIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH,UGANDAAIDS SURVIVAL POINT OJARA ALFRED ADULA EAST VILLAGE WIGWENG PARISH,
5ALOESHA ORGANIC NATURAL HEALTH PRODUCTS LTD P.O.BOX 7876 PLOT 17, TULA ROAD, KIYANJA ZONE, MPERERWE, KAMPALA, UGANDA 0704356951/0776290548SACCO SYRUPTHA389SYRUP1*110ML PET AMBER BOTTLEALOESHA ORGANIC NATURAL HEALTH PRODUCTS LTDUGANDAALOESHA ORGANIC NATURAL HEALTH PRODUCTS LTD
6ALOESHA ORGANIC NATURAL HEALTH PRODUCTS, TULA ROAD,KIYANJA ZONE, MPEREWE P.O.BOX 7876 KAMPALA,PLOT 17 0752940747/0414692983REVITALTHA390SOLUTION1*720ML HDPE BOTTLEALOESHA ORGANIC NATURAL HEALTH PRODUCTS, TULA ROAD,KIYANJA ZONE, MPEREWEUGANDAALOESHA ORGANIC NATURAL HEALTH PRODUCTS, TULA ROAD,KIYANJA ZONE, MPEREWE
7AL-SHIFFA HEALTH CARE JAMADA A.LUBEGIO MBALE-KUMI RD 0752635115BAYAN HERBAL SYRUPTHA331SYRUP50ML AMBER PLASTIC BOTTLEAL-SHIFFA HEALTH CARE JAMADA A.LUBEGIO MBALE-KUMI RD 0752635115UGANDAAL-SHIFFA HEALTH CARE JAMADA A.LUBEGIO MBALE-KUMI RD 0752635115
8AMANS HERBALISTS DR.KIMBUGWE MICHEAL AMANS LUNGUJJA-KOSOVO, KAMPALA +256782361761/ +256753361761 EMAIL: AMANSMICHEAL@GMAIL.COMSTILE HERBAL SOLUTIONTHA198LIQUID1*500ML PET BOTTLEAMANS HERBALISTS DR.KIMBUGWE MICHEAL AMANS LUNGUJJA-KOSOVO, KAMPALAUGANDAAMANS HERBALISTS DR.KIMBUGWE MICHEAL AMANS LUNGUJJA-KOSOVO, KAMPALA
9ASM ORGANICS CO LTD NAMASUBA TRADING CENTRE, UNICAREHERBS@YAHOO.COM 0703062799USHA HERBAL ULCER SYRUPTHA419LIQUID500MLS PET BOTTLEASM ORGANICS CO LTD NAMASUBA TRADING CENTRE, UNICAREHERBS@YAHOO.COM 0703062799UGANDAASM ORGANICS CO LTD NAMASUBA TRADING CENTRE, UNICAREHERBS@YAHOO.COM 0703062799
10BESI UGANDA LIMITED P.O.BOX 24692,BUKOTO KLA, UG. 0772-KIRUNGI AYI AYITHA410OINTMENT20GMS HDPE JARBESI UGANDA LIMITED P.O.BOX 24692,BUKOTO KLA, UG. 0772-UGANDABESI UGANDA LIMITED P.O.BOX 24692,BUKOTO KLA, UG. 0772-
11BESI UGANDA LIMITED P.O.BOX 24692,BUKOTO KLA, UG. 0772-475090/0702475090KIRUNGI HERBAL MOUTHWASHTHA411LIQUID50ML HDPE BOTTLEBESI UGANDA LIMITED P.O.BOX 24692,BUKOTO KLA, UG. 0772-475090/0702475090UGANDABESI UGANDA LIMITED P.O.BOX 24692,BUKOTO KLA, UG. 0772-475090/0702475090
12BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882BIGGI HERBAL COUGH SYRUPTHA295SYRUP100ML &200ML PET BOTTLEBIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882UGANDABIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882
13BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882BIGGI ULCER HERBAL MEDICINETHA296SYRUP100ML &200ML PET BOTTLEBIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882UGANDABIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882
14BIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882BIGGI HERBAL MALARIA SYRUPTHA297SYRUP100ML &200ML PET BOTTLEBIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882UGANDABIGGI HERBAL RESEARCH CLINIC MS. NYILAK HELLEN 0772484882/0705484882
15CREST NATURAL HEALTH CENTRE A.K PLAZA OPPOSITE ALOYSIUS COMPLEX KALERWE, ,Dr.Lutwaama George TEL: 0770 704 880/ 0750 185 580PROST TINCTURETHA229/01/16SOLUTION1*20ML HDPECREST NATURAL HEALTH CENTREUGANDACREST NATURAL HEALTH CENTRE
16DAMA MEDICINAL HERBS SEROMA SHOPPERS STOP PLAZA P.O.BOX 25216,KAMPALA,UGANDA TEL:0772-774338DAMALEO VERA TABLETSTHA291TABLETS1*5*10 ALU-PVC BLISTERSDAMA MEDICINAL HERBS SEROMA SHOPPERS STOP PLAZA P.O.BOX 25216,KAMPALA,UGANDA TEL:0772-774338UGANDADAMA MEDICINAL HERBS SEROMA SHOPPERS STOP PLAZA P.O.BOX 25216,KAMPALA,UGANDA TEL:0772-774338
17DAMA MEDICINAL HERBS. SEROMA SHOPPERS STOP PLAZA 1ST FLOOR, ROOM A/F/11 P.O.BOX 25216 KLA,UG 0758684274/0772684274 SADAKA2003@YAHOO.COMDAMA TOOTH GELTHA405GEL1*50ML TUBEDAMA MEDICINAL HERBS.UGANDADAMA MEDICINAL HERBS. SEROMA SHOPPERS STOP PLAZA 1ST FLOOR, ROOM A/F/11 P.O.BOX 25216 KLA,UG
18DOCTOR?S CHOICE LTD P.O.BOX 314,JINJA, EMAIL:INFO@DOCTORSCHOICE.AFRICAREPLENISH+THA407CAPSULES1*90 IN AN HDPE BOTTLE AND 1*3*10 BLISTERSDOCTOR?S CHOICE LTD P.O.BOX 314,JINJA, EMAIL:INFO@DOCTORSCHOICE.AFRICAUGANDADOCTOR?S CHOICE LTD P.O.BOX 314,JINJA, EMAIL:INFO@DOCTORSCHOICE.AFRICA
19EXLUSIVE (U) LTD PLOT NO: 15/17,1ST INDUSTRIAL AREA P.O.BOX 27264, KLA, UG. 0772-460299.CLEDARI HERBAL HYDRO GELTHA415OINTMENT200GMS AND 50GMSEXLUSIVE (U) LTD PLOT NO: 15/17,1ST INDUSTRIAL AREA P.O.BOX 27264, KLA, UG. 0772-460299.UGANDAEXLUSIVE (U) LTD PLOT NO: 15/17,1ST INDUSTRIAL AREA P.O.BOX 27264, KLA, UG. 0772-460299.
20GABOGOLA AGENCIES,P.O.BOX 33828 K'LA,KYENGERA,MASAKA ROAD,TEL:0772 532353,EMAIL:GABOGOLAAGENCIES@GMAIL.COMGABOGOLA SYRUPTHA292SYRUP300ML GLASS BOTTLEGABOGOLA AGENCIES,P.O.BOX 33828 K'LA,KYENGERA,MASAKA ROADUGANDAGABOGOLA AGENCIES,P.O.BOX 33828 K'LA,KYENGERA,MASAKA ROAD
21Green Pharmacy 11 Pokino Luzige Road Kirumba A Masaka,Tel: 0779 829914AGNUS CACTUSTHA206ORAL SOLUTION1*100ML AMBER PET BOTTLEGREEN PHARMACYUGANDAGREEN PHARMACY
22Green Pharmacy 11 Pokino Luzige Road Kirumba A Masaka,Tel: 0779 829914blood cleanser and detoxifierTHA211ORAL LIQUID100ML PET BOTTLEGREEN PHARMACYUGANDAGREEN PHARMACY
23GREEN PHARMACY 11 POKINO LUZIGE ROAD, KIRUMBA ?A? MASAKA Tel: 0779 829914AMBER PAIN STOPTHA210OINTMENT50GRAMSGREEN PHARMACYUGANDAGREEN PHARMACY
24GREEN PHARMACY 11 POKINO LUZIGE ROAD, KIRUMBA ?A? MASAKA,Tel:0779 829914CALENDULATHA207OINTMENT50GRAMSGREEN PHARMACYUGANDAGREEN PHARMACY
25GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 0700 3134484HEG HERBAL COUGH MIXTURETHA368LIQUID200MLGWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALAUGANDAGWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA
26GWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 07003134448HEG HERBAL ULCER SOLUTIONTHA369SOLUTION500ML IN AN HDPE BOTTLEGWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 07003134448UGANDAGWOWONYA EGGERE HERBAL SERVICES LIMITED MASSAJJA BUSABALA ROAD KAMPALA 0782742742/ 07003134448
27GWOWONYA EGGERE HERBAL SERVICES 0704578355 EZEESHADIA@GMAIL.COM P. O. BOX 30982 KAMPALA UGANDAHEG HERBAL MOUTHWASHTHA354SOLUTION200ML PET BOTTLEGWOWONYA EGGERE HERBAL SERVICESUGANDAGWOWONYA EGGERE HERBAL SERVICES
28HEALTH LIVING HERBAL RESEARCH LTD ,P.O.BOX 30612,KAMPALA UGANDA,TEL: +256 414 255665/+256 754 280718FOCUS HERBAL COUGH SYRUPTHA427LIQUID100MLHEALTH LIVING HERBAL RESEARCH ,P.O.BOX 30612,KAMPALA UGANDA,TEL: +256 414 255665/+256 754 280718UGANDAHEALTH LIVING HERBAL RESEARCH ,P.O.BOX 30612,KAMPALA UGANDA,TEL: +256 414 255665/+256 754 280718
29HERBS FOR YOU, SEETA, MUKONO, 0774 607 012/0704 910492MABIRA HERBAL TEA SPICETHA384POWDER100GMS IN A TRANSPARENT PLASTIC JARHERBS FOR YOU, SEETA, MUKONO, 0774 607 012/0704 910492UGANDAHERBS FOR YOU, SEETA, MUKONO, 0774 607 012/0704 910492
30JOYVA UGANDA LTD, PARK ENKADE MALL, SHOP NO.K70,1ST FLOOR 0755 878 779 0712 878 779JOYVA COUGH MIXTURETHA450LIQUID200 ML PET BOTTLEJOYVA UGANDA LTD, PARK ENKADE MALL, SHOP NO.K70,1ST FLOORUGANDAJOYVA UGANDA LTD, PARK ENKADE MALL, SHOP NO.K70,1ST FLOOR
31KIPO NATURAL PRODUCTS LTD UGANDA NATETE FACTORY ZONE P.O.BOX 25562, KAMPALA 0782351873/0753-807748KIPO HERBAL SKIN OINTMENTTHA018OINTMENT100GKIPO NATURAL PRODUCTS LTD UGANDA NATETE FACTORY ZONEUGANDAKIPO NATURAL PRODUCTS LTD UGANDA NATETE FACTORY ZONE
32MARTIN HERBAL CLINICS BUNDIBUGYO TOWN NEAR BAWILHA 0785067249POMADATTHA398OINTMENT1*50G HDPE JARMARTIN HERBAL CLINICS BUNDIBUGYO TOWN NEAR BAWILHA 0785067249UGANDAMARTIN HERBAL CLINICS BUNDIBUGYO TOWN NEAR BAWILHA 0785067249
33MATIA SSEBUTEMBA HERBAL REMEDIES,P.O.BOX 163,MITYANA TEL: 0772457800/0774178748MATIA SSETUTEMBA HERBAL REMEDIESTHA271LIQUID5 L HDPE CANMATIA SSEBUTEMBA HERBAL REMEDIES,P.O.BOX 163,MITYANA TEL: 0772457800/0774178748UGANDAMATIA SSEBUTEMBA HERBAL REMEDIES,P.O.BOX 163,MITYANA TEL: 0772457800/0774178748
34MICHELLE PICKERING, BLOCK 217,PLOT 936 OFF NAJERA ROAD,BALINTIMA ZONE,KIWATULE,KAMPALAMALARIDTHA301SYRUP1*60ML PET BOTTLEMICHELLE PICKERING, BLOCK 217,PLOT 936 OFF NAJERA ROAD,BALINTIMA ZONE,KIWATULE,KAMPALAUGANDAMICHELLE PICKERING, BLOCK 217,PLOT 936 OFF NAJERA ROAD,BALINTIMA ZONE,KIWATULE,KAMPALA
35MULUMBA MATHIAS O705196769/0776196769 NSANGI, MASAKA ROAD, WAKISO DISTRICTMAMULA COUGH MIXTURETHA333LIQUID400ML BOTTLEMULUMBA MATHIAS O705196769/0776196769 NSANGI, MASAKA ROAD, WAKISO DISTRICTUGANDAMULUMBA MATHIAS O705196769/0776196769 NSANGI, MASAKA ROAD, WAKISO DISTRICT
36MUWEBWA HERBAL MEDICINES P. O. BOX 813, MASAKA KIJJABUWEMI +256772661259MUWEBWA INTESTINAL CLEANSERTHA378POWDER1*10G SACCHETMUWEBWA HERBAL MEDICINES P. O. BOX 813, MASAKA KIJJABUWEMI +256772661259UGANDAMUWEBWA HERBAL MEDICINES P. O. BOX 813, MASAKA KIJJABUWEMI +256772661259
37MUWEBWA HERBAL MEDICINES P.O BOX 813, MASAKA 0772-661259/0704 910091KWESIIMA COUGH MIXTURETHA183SUSPENSION1*200ML PET BOTTLMUWEBWA HERBAL MEDICINES P.O BOX 813, MASAKA 0772-661259/0704 910091UGANDAMUWEBWA HERBAL MEDICINES P.O BOX 813, MASAKA 0772-661259/0704 910091
38MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COMMUWEREZA HERBAL COUGH REMEDIESTHA377SYRUP1*200ML IN AN HDPE BOTTLEMUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COMUGANDAMUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COM
39MUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COMREZA LIN FOR ULCERTHA383SYRUP200ML AND 500ML IN HDPE BOTTLESMUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COMUGANDAMUWEREZA HERBAL CO.LTD,LUGOBA, KAWEMPE,KAZO, 0785 295072/0757 608582 MUWEREZAARAFAH@GMAIL.COM
40NAKAGWA HENRICA,KISAASI,KAMPALA,Tel 0700 665917/0782 007752PALANS COUGH MIXTURETHA197SYRUP1*100ML,PET BOTTLENAKAGWA HENRICA,KISAASI,KAMPALAUGANDANAKAGWA HENRICA,KISAASI,KAMPALA
41Nana Herbal Products (U) Ltd Mengo Hill Road, Kampala-UgandaNANA HERBAL MOUTHWASHTHA 346SPRAY60ML BOTTLENana Herbal Products (U) Ltd Mengo Hill Road, Kampala-UgandaUGANDANana Herbal Products (U) Ltd Mengo Hill Road, Kampala-Uganda
42NSIMYE HERBAL MEDICINE RESEARCHERS,KIKUUBO ZONE IV,KANYANYA PARISH,KAWEMPE DIV,TEL: 0782 457 919/0708 457 919KABUUTI HERBAL SYRUPHDA129/02/16SYRUP1*100ML HDPE BOTTLENSIMYE HERBAL MEDICINE RESEARCHERSUGANDANSIMYE HERBAL MEDICINE RESEARCHERS
43PIPAX LTD,PLOT 20 BUZIGA RING ROAD KAMPALA, MR.EGUMAH PIE,TEL:0754 618691DERMACOLTHA289ORAL SUSPENSION100ML AMBER PET BOTTLEPIPAX LTDUGANDAPIPAX LTD
44ROPERFREE BRAND PRODUCTS,P.O.BOX 21336,KAMPALA,UGANDA,TEL:+256 770838356/+256 772 421235, ROPERFREE@JKASUMBAS.COMROPER FREE MOSQUITO REPELLENTTHA342EMULSION1*100 ML & 1* 60 ML HDPE BOTTLEROPERFREE BRAND PRODUCTS,P.O.BOX 21336,KAMPALA,UGANDAUGANDAROPERFREE BRAND PRODUCTS,P.O.BOX 21336,KAMPALA,UGANDA
45ROPERFREE, KAMPALA (U) P.O.BOX 21336, KAMPALA, UGANDA. TEL:+256772489739, +256773782977 EMAIL: ROPERFREE@KASUMBAS.COMROPER FREE AROMETHERAPHYTHA449LIQUID60ML &100 ML HDPE BOTTLEROPERFREE, KAMPALA (U) P.O.BOX 21336, KAMPALA, UGANDA.UGANDAROPERFREE, KAMPALA (U) P.O.BOX 21336, KAMPALA, UGANDA.
46RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION SABAGABO-MAKINDYE MUNICIPALITY WAKISO DISTRICT 0779071321/0704510148TESOCOKO ?B?THA366POWDER1*100G IN A CLEAR PET JARRUBARAMIRA EMMANUEL BWESIGYE KATOOGO-UGANDARUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION
47RUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION SABAGABO-MAKINDYE MUNICIPALITY WAKISO DISTRICT 0779071321/0704510148TESOCOKO ?G?THA367POWDER1*100G IN A CLEAR PET JARRUBARAMIRA EMMANUEL BWESIGYE KATOOGO-UGANDARUBARAMIRA EMMANUEL BWESIGYE KATOOGO- KANAABA CELL,NDEJJE DIVISION
48RWEHIDI HERBAL CLINIC KAMAIBA UPPER, KASESE.0785374627 HERBALISTSWITHOUTBORDERUG2017@GMAIL.COMHIBISC HERBAL MIXTURETHA399SOLUTION1*500ML HDPE BOTTLERWEHIDI HERBAL CLINIC KAMAIBA UPPER, KASESE.0785374627 HERBALISTSWITHOUTBORDERUG2017@GMAIL.COMUGANDARWEHIDI HERBAL CLINIC KAMAIBA UPPER, KASESE.0785374627 HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM
49RWEHIDI HERBAL CLINIC KAMALHA ANNAH KABALE CELL, BUNDIBUGYODEFENDER TONICTHA347POWDER1*100G BOTTLERWEHIDI HERBAL CLINIC KAMALHA ANNAH KABALE CELL, BUNDIBUGYOUGANDARWEHIDI HERBAL CLINIC KAMALHA ANNAH KABALE CELL, BUNDIBUGYO
50RWEHIDI HERBAL CLINIC,KABALE CELL, BUNDIBUGYO HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM 0785374627RWEHIDI DETOXERTHA400SOLUTION1*500MLS IN A PET BOTTLERWEHIDI HERBAL CLINIC,KABALE CELL, BUNDIBUGYO HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM 0785374627UGANDARWEHIDI HERBAL CLINIC,KABALE CELL, BUNDIBUGYO HERBALISTSWITHOUTBORDERUG2017@GMAIL.COM 0785374627
51SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA,TEL: 0414 271 214SAMONA HERBAL SOAPHDA094SOAP100GM & 120GMSAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALAUGANDASAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA
52SAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA,TEL: 0414 271 214SAMONA HERBAL JELLYHDA095OINTMENT50GM,100GM,150GM,250GM,& 500GMSAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALAUGANDASAMONA PRODUCTS LIMITED P.O BOX 70447 KAMPALA
53SENAT ORGANICS INTERNATIONAL RUBAGA, KAMPALA +256-775-199-750/ +256-703-830-538RENA ULCER SOLUTIONTHA387SOLUTION1*500ML PET BOTTLESENAT ORGANICS INTERNATIONAL RUBAGA, KAMPALAUGANDASENAT ORGANICS INTERNATIONAL RUBAGA, KAMPALA
54SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181MUCURA HERBAL MEDICINETHA371SYRUP1*250ML IN AN HDPE BOTTLESEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITANUGANDASEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN
55SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181WAMPEMBE SYRUPTHA372SYRUP1*250ML IN AN HDPE BOTTLESEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITANUGANDASEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN
56SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181GANYANA HERBAL MEDICINETHA373SYRUP1*250ML IN AN HDPE BOTTLESEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITANUGANDASEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN
57SEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN 0781020108/0703528181MWAMBALA HERBAL MEDICINETHA374SYRUP1*250ML IN AN HDPE BOTTLESEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITANUGANDASEREEYI HERBAL RESEARCH AND RUQUYA CLINIC LWEZA-KAJJANSI; ENTEBBE ROAD NEAR GOOD SAMARITAN
58SMCU HERBAL RESEARCH CENTRE,KUNGU,BUWAATE,KIRA MUNICIPALITY 0773219404/0705005896BURN MASTER LTHA426OINTMENT250G PET JARSMCU HERBAL RESEARCH CENTRE,KUNGU,DUWAATE,KIRA MUNICIPALITYUGANDASMCU HERBAL RESEARCH CENTRE,KUNGU,DUWAATE,KIRA MUNICIPALITY
59SSEKALALA ARAFAT GANYANA HERBAL GROUP. KYENGERA NABAZIZA OFF MASAKA ROAD TEL.0785996266 0754899471.KATS MANTOPSTHA451LIQUID1*750ML PET BOTTLESSEKALALA ARAFAT GANYANA HERBAL GROUP. KYENGERA NABAZIZA OFF MASAKA ROADUGANDASSEKALALA ARAFAT GANYANA HERBAL GROUP. KYENGERA NABAZIZA OFF MASAKA ROAD
60SSEKALALA ARAFAT GANYANA HERBAL GROUP. KYENGERA NABAZIZA OFF MASAKA ROAD TEL.0785996266 0754899471.VIGOR MEN PLUSTHA452LIQUID1*750ML PET BOTTLESSEKALALA ARAFAT GANYANA HERBAL GROUP. KYENGERA NABAZIZA OFF MASAKA ROADUGANDASSEKALALA ARAFAT GANYANA HERBAL GROUP. KYENGERA NABAZIZA OFF MASAKA ROAD
61TALEMWA GODFREY KKATALEMWA BROTHERS GROUP KALAGI MUKONO UGANDA 0703678484/ 0774464843KKATALEMWA HERBAL COUGH MIXTURETHA382LIQUID*200ML WHITE PET BOTTLE AND 1*100ML WHITE PET BOTTLE.TALEMWA GODFREY KKATALEMWA BROTHERS GROUP KALAGI MUKONO UGANDAUGANDATALEMWA GODFREY KKATALEMWA BROTHERS GROUP KALAGI MUKONO UGANDA
62TAYEBWA HEALTH PRODUCTS LTD KASHASHA CELL ? ITOJO PARISH RUHAMA SUBCOUNTY, NTUNGAMO DISTRICT 0772-927206TAYEBWA HERBAL COUGH SYRUPTHA364SYRUP1*100ML AMBER PET BOTTLETAYEBWA HEALTH PRODUCTS LTDUGANDATAYEBWA HEALTH PRODUCTS LTD
63YECO ORGANIC MANAGEMENT LTD KYEBANDO KATALE ZONE GAYAZA ROAD, Tel: +256 705 454951YECO COUGH DOCTORTHA247SYRUP1*120ML HDPE AMBER BOTTLEYECO ORGANIC MANAGEMENT LTD KYEBANDO KATALE ZONE GAYAZA ROADUGANDAYECO ORGANIC MANAGEMENT LTD KYEBANDO KATALE ZONE GAYAZA ROAD
64ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD KAMWOKYA KAMPALA 0750 802618 zurimedicine@gmail.comTypho-CurumTHA355SYRUP1*60ml Amber PET bottleZURI HOMEOPATHICSUGANDAZURI HOMEOPATHICS
65ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD KAMWOKYA KAMPALA 0750 802618 ZURIMEDICINE@GMAIL.COMN?ZURI DEWORMERTHA385SOLUTION60ML AND 100ML PET BOTTLEZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROADUGANDAZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD
66ZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD KAMWOKYA KAMPALA 0750 802618 ZURIMEDICINE@GMAIL.COMGUT REPLENISHERTHA386SOLUTION100ML PET BOTTLEZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROADUGANDAZURI HOMEOPATHICS, MICHELLE PICKERING 724/5 MAWANDA ROAD