Drug Register (January 2022)
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/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HHP/3115MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER11/7/2018
2NDA/MAL/HHP/5500CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDAPTIZOOOM SYRUPCHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2000
3NDA/MAL/HHP/5502HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDGASEXHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN'S SAMPLE)7/1/2000
4NDA/MAL/HHP/5503ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAMODEX OINTMENTPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G JAR7/1/2000
5NDA/MAL/HHP/5505VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDAMPUCARE HERBAL OILPLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X50.0 ML BOTTLE7/1/2008
6NDA/MAL/HHP/5517HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDMENTATHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X50.0 TABLET CONTAINER7/1/2004
7NDA/MAL/HHP/5518MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER7/1/2007
8NDA/MAL/HHP/5519AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDAPDYL-H, HERBAL COUGH SYRUPSAVERA PHARMACEUTICALS PVT LTD --H-39 & 40, M.I.D.C, WALUJ, AURANGABAD, INDIA. AJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2004
9NDA/MAL/HHP/5527HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDKOFLETHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2000
10NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY POWDERS1.0X10.0X765.0 MG SACHET7/1/2009
11NDA/MAL/HHP/5530HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDLIV.52 TABLETSHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE7/1/2000
12NDA/MAL/HHP/5531HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIAINDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/2000
13NDA/MAL/HHP/5532MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATI INDIANASAL TOPICAL LIQUID INHALATIONS1.0X12.0X1.0 G ROD7/1/2009
14NDA/MAL/HHP/5533HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDRUMALAYAHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X25.0 TABLET CONTAINER (PHYSICIAN SAMPLE)7/1/2000
15NDA/MAL/HHP/5536ABACUS PHARMA LTDJEET PHARMACEUTICALS LIMITEDMENTHO PLUS PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI INDIANASAL TOPICAL OINTMENTS1.0X24.0X3.5 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 BOTTLE7/1/2004
16NDA/MAL/HHP/5538HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDSEPTILINHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER7/1/2000
17NDA/MAL/HHP/5546CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDPAEDRITONE SYRUPCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
18NDA/MAL/HHP/5547MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTD-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X35.0X2.0 LOZENGE STRIP7/1/2001
19NDA/MAL/HHP/5549HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDBONISAN LIQUIDHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2000
20NDA/MAL/HHP/5550CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDGUM TONE GELCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL TOPICAL GELS AND SOLS1.0X50.0 G TUBE7/1/2015
21NDA/MAL/HHP/5553ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL DOUBLE ACTION HERBAL COUGH LOZENGESLEAMARK HEALTHCAREPVT LTD-SARKHEJ-BAVLA HIGHWAY MATODA AHMEDABADINDIAORAL SOLID ORDINARY LOZENGES1.0X10.0X2.0 LOZENGE STRIP,1.0X50.0X2.0 LOZENGE STRIP7/1/2009
22NDA/MAL/HHP/5557BETA HEALTH CARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDNEW BETA GRIPE WATERSYDLER 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,KENYA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2014
23NDA/MAL/HHP/5559MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X12.0 G TUBE7/1/2001
24NDA/MAL/HHP/5561MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDCOLDDROP MEDICATED COUGH DROPSMEHTA HERBALS PVT LTD-AMRUTMANTHAN HOUSE, SADAR,RAJKOT,GUJARAT - 360 001,INDIA, RAJKOT, GUJARAT 360001, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X1.0X100.0 LOZENGE CARTON7/1/2009
25NDA/MAL/HHP/5563HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDCYSTONEHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER7/1/2001
26NDA/MAL/HHP/5565ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDENTEX TOOTHACEPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL LIQUIDS1.0X5.0 ML BOTTLE7/1/2000
27NDA/MAL/HHP/5570PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDSITCOMPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2013
28NDA/MAL/HHP/5571ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDRAGON LIQUID BALMAMRUTANJAN HEALTH CARE LIMITED-PLOT NO 37,38&39, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR VILLAGE, THIRUPORUR TALUK, KANCHEEPURAM DISTRICT 603110, INDIA INDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER7/1/2004
29NDA/MAL/HHP/5572CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDVIGOMAX FORTE CHARAK PHARMA PVT LTD-JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER7/1/2011
30NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2009
31NDA/MAL/HHP/5576MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDNO SCAR CREAMMETHA UNANI PHARMACY-METHA UNANI PHARMACY G-524 LODHIKA, G.I.D.C METODA INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2007
32NDA/MAL/HHP/5583HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDEVECAREHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER7/1/2001
33NDA/MAL/HHP/5587CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDMANOLL SYRUP CHARAK PHARMA PVT LTD-JAURASI ROAD,PAUTI VILLAGE,G.T ROAD,SAMALKHA-132 101 INDIA CHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X250.0 MG BOTTLE7/1/2016
34NDA/MAL/HHP/5588CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (HONEY LEMON FLAVOUR)CHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X3.0X4.0 LOZENGE STRIP7/1/2014
35NDA/MAL/HHP/5593ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDSYDLER GRIPE WATERSYDLER REMEDIES PVT LTD -M-190, M.I.D.C, WALUJ, AURANGABAD 431 136 (M.S), INDIA.

INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2010
36NDA/MAL/HHP/5597CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDTOOCHE DROPSCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAORAL TOPICAL DROPS1.0X10.0 ML BOTTLE7/1/2014
37NDA/MAL/HHP/5618MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDVYBRANTVITAL CARE-INDIAINDIAORAL SOLID ORDINARY CAPSULES5.0X10.0 CAPSULE BLISTER7/1/2000
38NDA/MAL/HHP/5623UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(FRUITY FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2005
39NDA/MAL/HHP/5629UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(ORANGE FLAVOUR)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2005
40NDA/MAL/HHP/5630UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH REMEDYUNIQUE PHARMACEUTICAL LABORATORIES --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2000
41NDA/MAL/HHP/5631UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(LEMON)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
42NDA/MAL/HHP/6848CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL (MINT)LEAMARK HEALTHCARE PVT LTD-SARKHEJ BAVLA HIGHWAY,MATODA 382213 AHMEDABAD GUJARAT INDIAORAL SOLID ORDINARY LOZENGES1.0X3.0X4.0 LOZENGE BLISTER7/1/2016
43NDA/MAL/HHP/6850WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.BENZIM NATURAL SYRUP 120MLWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE12/3/2016
44NDA/MAL/HHP/6852WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.DE-FLU SYRUP 120MLWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE12/3/2016
45NDA/MAL/HHP/6853WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.LIV-LONG TABLETWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2016
46NDA/MAL/HHP/6863KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES (HONEY & LEMON FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER12/1/2016
47NDA/MAL/HHP/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDMANIX HERBAL CAPSULESTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2015
48NDA/MAL/HHP/7931DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTDGAMA PHARMACEUTICALS (U) LIMITEDLIBLAB SYRUPDAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD,-NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN. JORDANORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2012
49NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2015
50NDA/MAL/HHP/7936SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGILOBA 60 CAPSULESQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X5.0X6.0 CAPSULE BLISTER7/1/2013
51NDA/MAL/HHP/7937GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSENSUR OILGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI INDIATOPICAL EXTERNAL LIQUIDS1.0X10.0 ML VIAL7/1/2015
52NDA/MAL/HHP/7938SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSILYBIN 140SQUARE HERBAL AND NUTRACEUTICALS LTD -48 MOHAKHALI COMERCIAL AREA, DHAKA-1212 BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
53NDA/MAL/HHP/7939SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGINTEXSQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X5.0X6.0 CAPSULE STRIP7/1/2014
54NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR LOTIONGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIATOPICAL EXTERNAL OTHER CREAMS1.0X50.0 ML BOTTLE7/1/2015
55NDA/MAL/HHP/7942MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA FORTDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY
THAILANDORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2016
56NDA/MAL/HHP/7947UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(HONEY LEMON)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
57NDA/MAL/HHP/7950UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(RASPBERRY)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
58NDA/MAL/HHP/7954UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES(PINEAPPLE)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
59NDA/MAL/HHP/7955KREMOINT PHARMA PVT.LTDPLANET PHARMACEUTICALS UGANDA LTDDICLODAY ROLL-ONKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA INDIATOPICAL EXTERNAL EMULSIONS1.0X50.0 ML BOTTLE12/3/2016
60NDA/MAL/HHP/7958KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(GINGER FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER12/1/2016
61NDA/MAL/HHP/7960KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES(ORANGE FLAVOUR)KREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER12/1/2016
62NDA/MAL/HHP/7961KREMOINT PHARMA PVT.LTDGOOD DAY PHARMACY LIMITEDKOFFENGES LOZENGES MINTKREMOINT PHARMA PVT LTD - -RAGHAV ESTATE, K.S.S.I.D.C. INDUSTRIAL ESTATE AREA, SHIGGAON ROAD, SAVANUR 581118, DIST: HAVERI, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE BLISTER,1.0X10.0X6.0 LOZENGE BLISTER12/1/2016
63NDA/MAL/HHP/7962GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDKREMOINT BABY CARE GRIPE WATERKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE7/1/2015
64NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDREDDYS PHARMA LIMITEDKIDFLAMEBHARGAVA PHYTOLAB PVT LTD-B-92, SECTOR – 2 , NOIDA – 201301, U.P. ( INDIA) INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER7/1/2015
65NDA/MAL/HHP/7974WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.APPERIZE SYRUP 120MLWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE
66NDA/MAL/HHP/8071EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOOVE MASSAGE CREAMEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTTOPICAL EXTERNAL LOTIONS1.0X1.0X40.0 G TUBE7/1/2017
67NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDPOSTORALBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER7/1/2017
68NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICAJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABADINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2017
69NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLET CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE9/20/2017
70NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE2/2/2018
71NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDALKA 5 SYRUPCHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE2/2/2018
72NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE2/2/2018
73NDA/MAL/HHP/8509CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDEVANOVA CAPSULE CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER11/29/2017
74NDA/MAL/HHP/8510BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDFRICKS COUGH SYRUPBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE3/6/2018
75NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDTHUNDER-MBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2017
76NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDREDDYS PHARMA LIMITEDMENIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X20.0 TABLET BLISTER7/1/2016
77NDA/MAL/HHP/8552AMRUTANJAN HEALTHCARE LIMITEABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BALMAMRUTANJAN 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, INDIA
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78NDA/MAL/HHP/8553RAZA INTERNATIONALWIDE SPECTRUM ENTERPRISES (U) LIMITEDHONEY CUREOZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANY?-SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET.
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JORDANTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X15.0 G TUBE7/13/2017
79NDA/MAL/HHP/8556MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-500TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER11/10/2017
80NDA/MAL/HHP/8902WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.DE-TUZ SYRUPWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2018
81NDA/MAL/HHP/9087HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDEPITIZEHIMONT LABORATORIES PVT LIMITED-17-KM FEROZEPUR ROAD LAHORE
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82NDA/MAL/HHP/9088HIMOT LABORATORIES PVT LIMITEDBOOTS PHARMACEUTICALS LIMITEDPASMOLEX DROPSHIMOT LABORATORIES PVT LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY DROPS1.0X120.0 ML BOTTLE7/1/2015
83NDA/MAL/HHP/9090I_CARE PHARMA LIMITEDAIVEEN (U) LIMITEDFATNILEWEST COAST PHARMACEUTICAL WORKS LTD-1143,MELDI ESTATE,NR PRASANG PARTY PLOT,GOTA, AHMEDEBAD INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X4.0X15.0 CAPSULE BLISTER1/28/2019
84NDA/MAL/HHP/9091UNOSOURCE PHARMA LTDESCORTS PHARMACEUTICALS LIMITEDKOFCLEAN SYRUP (HERBAL COUGH SYRUP)MAXCURE NUTRAVEDICS LTD -PLOT NO.13 SEC-6A IIE,SIDCUL,RANIPUR,HARIDWAR-249 403, UTTRAKHAND INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/28/2019
85NDA/MAL/HHP/9093BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDCOFTA EXTRA SYRUPBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE3/22/2019
86NDA/MAL/HHP/9094BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETASIL HERBAL COUGH SYSRUPBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROADKENYAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE3/22/2019
87NDA/MAL/HHP/9095WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.X-TREMEWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER4/23/2019
88NDA/MAL/HHP/9096HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDCOFCIDHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/24/2019
89NDA/MAL/HHP/9097HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDFLUCIDHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/24/2019
90NDA/MAL/HHP/9098HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDCARIPEPTIC SYRUPHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTANPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
91NDA/MAL/HHP/9099HINUCONBOOTS PHARMACEUTICALS LIMITEDCRAN MAX PRO SACHETHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON5/31/2019
92NDA/MAL/HHP/9100HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SACHETHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON5/31/2019
93NDA/MAL/HHP/9101HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
94NDA/MAL/HHP/9102HINUCONBOOTS PHARMACEUTICALS LIMITEDEPTI SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
95NDA/MAL/HHP/9103HINUCONBOOTS PHARMACEUTICALS LIMITEDHILGAS SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
96NDA/MAL/HHP/9104HINUCONBOOTS PHARMACEUTICALS LIMITEDCOLOREST DROPSHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY DROPS1.0X30.0 ML BOTTLE5/31/2019
97NDA/MAL/HHP/9105HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA CAPSULESHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER5/31/2019
98NDA/MAL/HHP/9115NZEN ENTERPRISEHEALTHCARE LTD.DO-MO CAPSULES ABARIS HEALTHCARE PVT. LTD-SURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0X10.0 CAPSULE BLISTER7/16/2019
99NDA/MAL/HHP/9121HINUCONBOOTS PHARMACEUTICALS LIMITEDHILGAS INSTANT SACHETHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON3/11/2020
100NDA/MAL/HHP/9122HINUCONBOOTS PHARMACEUTICALS LIMITEDCOFERB DROPSHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY DROPS1.0X20.0 ML BOTTLE3/11/2020
101NDA/MAL/HHP/9123HINUCONBOOTS PHARMACEUTICALS LIMITEDCOFERB PLUS SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/11/2020
102NDA/MAL/HHP/9125HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA SACHETHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON3/11/2020
103NDA/MAL/HHP/9126HINUCONBOOTS PHARMACEUTICALS LIMITEDCRANMAX AQUA SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/11/2020
104NDA/MAL/HHP/9127HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO JARHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X175.0 G JAR3/11/2020
105NDA/MAL/HHP/9128HINUCONBOOTS PHARMACEUTICALS LIMITEDELFERB SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/11/2020
106NDA/MAL/HHP/9179CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDADDYZOA CAPSULESCHARAK PHARMA PVT. LTD,-PLOT NO. 371, SAYLI RAKHOLI ROAD, SILVASSA-396 230, D.T. OF DADRA & NAGAR HAVELI. INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER1/29/2020
107NDA/MAL/HHP/9182NZEN ENTERPRISEHEALTHCARE LTD.HERBICUFASIAN LIFECARE PVT.LTD-MANJUSAR,SAVLI,VADODARA,GUJARAT, INDIA PLOT NO. 3 & 3/A,SHAH INDUSTRIAL PARK-2,NEAR LAMPDAPURA CROSSING,AT&PO INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE3/11/2020
108NDA/MAL/HHP/9185HEALTHCARE LTD.HEALTHCARE LTD.GINSEMAX-FZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X2.0X15.0 CAPSULE BLISTER5/22/2020
109NDA/MAL/HHP/9254UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDZECUF HERBAL COUGH LOZENGES-STRAWBERRY FLAVOURUNIQUE PHARMACEUTICAL LABORATORIES ;-SURVEY NO. 101/2 & 102/1, DAMAN INDUSTRIAL ESTATE, KAPAIYA, DAMAN 396210 INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/18/2020
110NDA/MAL/HHP/9330ECHO PHARMACYECHO PHARMACY (U) LIMITEDHEMOZEL CREAMALFA MANUFACTURING LLC-4701 NW. 77 AVENUE,MIAMI,FL 33166 UNITED STATESTOPICAL EXTERNAL CREAMS1.0X40.0 G TUBE8/7/2020
111NDA/MAL/HHP/9332MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA IVY SYRUPMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND THAILANDORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE8/31/2020
112NDA/MAL/HHP/9333MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA MOUTH SPRAYMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND THAILANDORAL TOPICAL SPRAYS WITHOUT GAS1.0X10.0 ML BOTTLE8/31/2020
113NDA/MAL/HHP/9484RUSAN PHARMA LTDNORVIK ENTERPRISES LIMITEDISPAHUSK ORANGERUSAN PHARMA LTD'-PLOT NO. 59 - 65, SECTOR II, KANDLA SPECIAL - ECONOMIC ZONE, GANDHIDHAM INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0X3.5 G SACHET1/27/2021
114NDA/MAL/HHP/9485AL-HIKMA FZCO VISION TOWERGOODMAN INTERNATIONAL LTDLOZATY - PEPPERMINTMEKSMAR NATURAL AND HEALTHY PRODUCTS PRODUCTION AND MARKETING LTD.CO-1333. STREET NO: 27 06370 IVEDIK O.S,B / ANKARA- TURKEY TURKEYORAL SOLID ORDINARY LOZENGES1.0X24.0 LOZENGE BLISTER1/27/2021
115NDA/MAL/HHP/9486AL-HIKMA FZCO VISION TOWERGOODMAN INTERNATIONAL LTDLOZATY- GINGERMEKSMAR NATURAL AND HEALTHY PRODUCTS PRODUCTION AND MARKETING LTD.CO-1333. STREET NO: 27 06370 IVEDIK O.S,B / ANKARA- TURKEY TURKEYORAL SOLID ORDINARY LOZENGES1.0X24.0 LOZENGE CARTON1/27/2021
116NDA/MAL/HHP/9487AL-HIKMA FZCO VISION TOWERGOODMAN INTERNATIONAL LTDLOZATY - ORANGEMEKSMAR NATURAL AND HEALTHY PRODUCTS PRODUCTION AND MARKETING LTD.CO-1333. STREET NO: 27 06370 IVEDIK O.S,B / ANKARA- TURKEY TURKEYORAL SOLID ORDINARY LOZENGES1.0X24.0 LOZENGE CARTON1/27/2021
117NDA/MAL/HHP/9488AL-HIKMA FZCO VISION TOWERGOODMAN INTERNATIONAL LTDLOZATY- HONEY AND LEMONMEKSMAR NATURAL AND HEALTHY PRODUCTS PRODUCTION AND MARKETING LTD.CO-1333. STREET NO: 27 06370 IVEDIK O.S,B / ANKARA- TURKEY TURKEYORAL SOLID ORDINARY LOZENGES1.0X24.0 LOZENGE CARTON1/27/2021
118NDA/MAL/HHP/9489KALBE INTERNATIONAL PTE LTDABACUS PHARMA (AFRICA) LIMITEDWOOD'S HERBAL COUGH SYRUPPT.KALBE FARMA TBK-JL.M.H.THAMRIN BLOK A3-1, KAWASAN INDUSTRI DELTA SILIKON,LIPPO CIKARANG,BEKASI- INDONESIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE2/9/2021
119NDA/MAL/HHP/9558HEALTHCARE LTD.HEALTHCARE LTD.DR.ZEE HERBAL VAPOREXZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIANASAL TOPICAL OINTMENTS1.0X25.0 G JAR3/1/2021
120NDA/MAL/HHP/9559SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL MOUTH ULCER GELSYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL TOPICAL GELS AND SOLS1.0X10.0 G TUBE3/1/2021
121NDA/MAL/HHP/9568BHARGAVA PHYTOLAB PVT LTDSHREEJI CARE LIMITEDJAGUAR POWERBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL LIQUID ORDINARY OTHER LIQUIDS1.0X10.0 G BOTTLE3/5/2021
122NDA/MAL/HHP/9569CHEMICURE LABORATORIES PVT. LTD.GOOD DAY PHARMACY LIMITEDVYPOGERMCHEMICURE LABORATORIES PVT. LTD-325, CHARAK MARG, UDAIPUR -313001 INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TIN,1.0X12.0X18.0 G TIN3/18/2021
123NDA/MAL/HHP/9570GAYATRI AYUPHARMA PRIVATE LIMITEDSONA PHARMACEUTICALS LIMITEDBIO-SLIM ACTIVEGAYATRI AYUPHARMA PRIVATE LIMITED-234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) INDIAORAL SOLID ORDINARY CAPSULES1.0X6.0X10.0 CAPSULE BLISTER3/22/2021
124NDA/MAL/HHP/9571BHARGAVA PHYTOLAB PVT LTDSONA PHARMACEUTICALS LIMITEDHERO LIQUID BALMBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIATOPICAL EXTERNAL LIQUIDS1.0X10.0 ML BOTTLE4/15/2021
125NDA/MAL/HHP/9680SOUTH INDIA RESEARCH INSTITUTE PVT. LTD -VEERAM HEALTHCARE (U) LIMITEDTTK GRIPE WATERSOUTH INDIA RESEARCH INSTITUTE PVT.LTD-SIRINAGAR, VIJAYAWADA – 520 007. INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X130.0 ML BOTTLE6/17/2021
126NDA/MAL/HHP/9693SYDLER REMEDIES PVT LTD M-190ABACUS PHARMA (AFRICA) LIMITEDEAZOL COUGH SYRUPSYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/19/2021
127NDA/MAL/HHP/9694GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDTHROWCUF SYRUPKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/22/2021
128NDA/MAL/HHP/9700GRIFFON BIOMETRIX PVT.LTDMETRO PHARMACEUTICALS LIMITEDTOTO GRIPE WATERKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT INDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE8/27/2021
129NDA/MAL/HHP/9701GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDTHROWCUF PLUS SYRUPKESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE8/27/2021
130NDA/MAL/HHP/9702GRIFFON BIOMETRIX PVT.LTDMETRO PHARMACEUTICALS LIMITEDGRIFFON STRONG BALMRAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 INDIATOPICAL EXTERNAL OINTMENTS1.0X9.0 ML BOTTLE8/27/2021
131NDA/MAL/HHP/9703GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDCURODEX OINTMENTRAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G BOTTLE8/27/2021
132NDA/MAL/HHP/9704GRIFFON BIOMETRIX PVT.LTDABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL INHALERRAJESH PHARMACEUTICALS-7, DESHVALI,CHANDLODIYA ROAD,AHMEDABAD, GUJARAT 382 481 INDIANASAL TOPICAL LIQUID INHALATIONS1.0X0.5 ML INHALER8/27/2021
133NDA/MAL/HHP/9705PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDCALMIRELAX™LABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER9/3/2021
134NDA/MAL/HHP/9706PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDCALMIDORMIN™LABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER9/3/2021
135NDA/MAL/HHP/9707PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDDESIROLXLABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER9/3/2021
136NDA/MAL/HHP/9708PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDFREESPIRAX™LABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY TABLETS1.0X15.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER9/3/2021
137NDA/MAL/HHP/9709HINUCONBOOTS PHARMACEUTICALS LIMITEDLIV LIV CAPSULESHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER9/2/2021
138NDA/MAL/HHP/9710PHARMA BAVARIA INTERNATIONAL GMBH -GOODMAN INTERNATIONAL LTDHEPARESIST™XLLABO PHYTOPHAR NV-HANDELSTRAAT 19, 8020 OOSTKAMP, BELGIUM/BELGIQUE - BELGIUM BELGIUMORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER10/7/2021
139NDA/MAL/HHP/9711MEGA LIFESCIENCES PUBLIC COMPANY LTDABACUS PHARMA (AFRICA) LIMITEDGINSOMINMEGA LIFESCIENCES PUBLIC CO. LTD-PLANT 1; 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND THAILANDORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER10/7/2021
140NDA/MAL/HHP/9833ZEE LABORATORIES LIMITEDHEALTHCARE LTD.OSTEOCURE GELZEE LABORATORIES LTD-BEHIND 47, INDUSTRIAL AREA, PAONTA SAHIB-173025 DISTT. SIRMOUR HIMACHAL PRADESH INDIATOPICAL EXTERNAL GELS AND SOLS1.0X100.0 G TUBE10/26/2021
141NDA/MAL/HHP/9923GAYATRI AYUPHARMA PRIVATE LIMITEDVIDA AFRICA LTDCHARCO-PLUSGAYATRI AYUPHARMA PRIVATE LIMITED-234/2/2, PATEL ESTATE, NIKOL ROAD, AHMEDABAD: 382 350, GUJARAT (INDIA) INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER12/21/2021
NDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
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
|
KENYA |OILS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2016
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGGENERIC NAME OF DRUGSTRENGTH OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE 
1NDA/MAL/HDP/0007GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2013
2NDA/MAL/HDP/0013MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDIMPLANON NXTETONOGESTREL68MGN.V. ORGANON-KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLAND | NETHERLANDS |PARENTERAL RETARD IMPLANTS1.0X68.0 MG IMPLANT7/1/2015
3NDA/MAL/HDP/0016REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
4NDA/MAL/HDP/0017SWISS PARENTERALS LTDSHREEJI CARE LIMITEDS-HYDROHYDROCORTISONE100MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X10.0X7.5 ML VIAL7/1/2011
5NDA/MAL/HDP/0021SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDQUINSQUININE DIHYDROCHLORIDE300MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE7/1/2013
6NDA/MAL/HDP/0022GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2009
7NDA/MAL/HDP/0024KOPRAN LIMITEDTATA UGANDA LIMITEDAMPICLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
8NDA/MAL/HDP/0030UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRADMINTRAMADOL HYDROCHLORIDE50MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
|
INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE7/1/2015
9NDA/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 PRADESH |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL7/1/2015
10NDA/MAL/HDP/0045GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL CAPLETSPARACETAMOL500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
11NDA/MAL/HDP/0051H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY | DENMARK |PARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/2015
12NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT |TOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2014
13NDA/MAL/HDP/0053H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK |PARENTERAL RETARD AMPOULES1.0X1.0 ML AMPOULE7/1/2015
14NDA/MAL/HDP/0054GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDFUNGOALCLOTRIMAZOLE1%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
15NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK |PARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/2015
16NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPSDICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA | TROIKAA PHARMACEUTICALS LTD-BLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATE | INDIA |TOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE7/1/2015
17NDA/MAL/HDP/0058ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDWATER FOR INJECTION B.P.WATER FOR INJECTIONN/AACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE7/1/1997
18NDA/MAL/HDP/0059NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
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PAKISTAN |TOPICAL EXTERNAL CREAMS1.0X40.0 G TUBE + 1 APPLICATOR7/1/2006
19NDA/MAL/HDP/0060MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 300 IU/0,5 ML (22 µG/0,5 ML)FOLLITROPIN ALFA22 µG/0,5 MLMERCK SERONO S.A -SUCCURSALE D'AUBONNE, ZONE INDUSTRIELLE DE L'OURIETTAZ, 1170 AUBONNE, SWITZERLAND | MERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | ITALY | SWITZERLAND |PARENTERAL ORDINARY PRE-FILLED PENS1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION7/1/2015
20NDA/MAL/HDP/0063HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATE + LAMIVUDINEABACAVIR SULFATE + LAMIVUDINE600MG + 300MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
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INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2015
21NDA/MAL/HDP/0064MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 450 IU/ IE 0,75 ML (33 µG)FOLLITROPIN ALFA33µG/ 0.7MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND | MERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | SWITZERLAND |PARENTERAL ORDINARY CARTRIDGES1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION7/1/2015
22NDA/MAL/HDP/0069PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN10MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER7/1/1999
23NDA/MAL/HDP/0070PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN20MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/1999
24NDA/MAL/HDP/0088GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC2.7MG+0.52MG+0.58MG+0.30MG+20MG PER 200ML,6.75MG+1.30MG+1.45MG+0.75MG+20MG PER 500ML SACHET,13.5MG+2.60MG+2.90MG+1.50MG+20MG PER 1000ML SACHETAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY COMBINATION PACK POWDERS/GRANULES4.0X500.0 ML SACHET + 1*10 BLISTERS,10.0X200.0 ML SACHET + 1*10 BLISTERS,2.0X1000.0 ML SACHET + 1*10 BLISTERS7/1/2015
25NDA/MAL/HDP/0097MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
26NDA/MAL/HDP/0098MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
27NDA/MAL/HDP/0101GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULESTETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/1998
28NDA/MAL/HDP/0102MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2014
29NDA/MAL/HDP/0103MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
30NDA/MAL/HDP/0104MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2014
31NDA/MAL/HDP/0105GITTOES PHARMACEUTICALS 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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1998
32NDA/MAL/HDP/0107NVS KENYA LTDSURGIPHARM (U) LIMITEDASUNRADEFERASIROX400MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE |SWITZERLAND |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X5.0X6.0 TABLET BLISTER7/1/2015
33NDA/MAL/HDP/0110MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
34NDA/MAL/HDP/0111MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
35NDA/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 SPAIN | SWITZERLAND |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2007
36NDA/MAL/HDP/0114MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY 4MONTELUKAST SODIUM4MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
37NDA/MAL/HDP/0116MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
38NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED -BABA DOGO RWARAKA |KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
39NDA/MAL/HDP/0121SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDPEDZINCZINC SULPHATE20MG BETA HEALTH CARE INTERNATIONAL LIMITED/-PLOT NO. LR 209/ 6534 MOGADISHU ROAD, KENYA | TANZANIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2015
40NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2015
41NDA/MAL/HDP/0125DAWA LIMITEDSUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/2013
42NDA/MAL/HDP/0127DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
43NDA/MAL/HDP/0128DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
44NDA/MAL/HDP/0135SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDHEMOVIT SYRUPIRON + FOLIC ACID + PYRIDOXINE + CYANOCOBALAMIN + ZINC200MG + 1.5MG + 0.5MG + 50 MCG + 2.33MGBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD |TANZANIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2013
45NDA/MAL/HDP/0139DAWA LIMITED-SUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2014
46NDA/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 AREA | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/1998
47NDA/MAL/HDP/0152DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 150IRBESARTAN150MG DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
48NDA/MAL/HDP/0153DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 300IRBESARTAN300MGDELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
49NDA/MAL/HDP/0155TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ASTHATOR 10MONTELUKAST SODIUM10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
50NDA/MAL/HDP/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
51NDA/MAL/HDP/0162RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
52NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENARENPROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2015
53NDA/MAL/HDP/0165TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 5OLANZAPINE ORODISPERSIBLE TABLETS5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
54NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2015
55NDA/MAL/HDP/0168MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
56NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSEN | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
57NDA/MAL/HDP/0182MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAY 40FEBUXOSTAT40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
58NDA/MAL/HDP/0186WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBBC SPRAYBENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE1.5%W/V+0.15%W/V+0.0413%W/VAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT |ORAL TOPICAL SPRAYS WITHOUT GAS1.0X25.0 ML BOTTLE7/1/2014
59NDA/MAL/HDP/0187AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON TABLETTRANEXAMIC ACID500 MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
60NDA/MAL/HDP/0191MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 228.5AMOXICILLIN + CLAVULANATE200 MG + 28.5 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU |INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2013
61NDA/MAL/HDP/0193MEDOPHARM, INDIAPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET STRIP7/1/2013
62NDA/MAL/HDP/0196CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND ZIDOVUDINE TABLETSLAMIVUDINE/ZIDOVUDINE150MG/300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | UGANDA |ORAL SOLID ORDINARY OTHER COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2013
63NDA/MAL/HDP/0203GLAXOSMITHLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUX | FRANCE |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2015
64NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOM | GLAXOSMITHKLINE PHARMACEUTICALS SA-GRUNWALDZKA 189 STREET, 60-322 POZNANA | UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2015
65NDA/MAL/HDP/0205MACLEODS PHARMACEUTICALS LTDS LTDVITACARE LIMITEDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2013
66NDA/MAL/HDP/0207MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATELAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300MG +300MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 | MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/10/2013
67NDA/MAL/HDP/0209HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLHETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE7/1/2013
68NDA/MAL/HDP/0210MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN140MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2011
69NDA/MAL/HDP/0212MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN1G/100MLMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT |ORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE7/1/2012
70NDA/MAL/HDP/0218PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDTENOL-100ATENOLOL100MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
71NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
72NDA/MAL/HDP/0230STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCOMBIARTARTHEMETHER + LUMEFANTRINE20MG +120MGSTRIDES PHARMA SCIENCE LIMITED (STRIDES SHASUN)-KRS GARDENS, PLOT 36/7 SURAGAJKKANAHALLI, INDLAWADI CROSS, ANKAL TALUK, BANGALORE SOUTH - 562106, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER7/1/2013
73NDA/MAL/HDP/0232TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.BRANTALOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
74NDA/MAL/HDP/0233MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCEFIMED 400CEFIXIME TRIHYDRATE400MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
75NDA/MAL/HDP/0234MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCEFIMED 200CEFIXIME TRIHYDRATE200MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X8.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
76NDA/MAL/HDP/0235MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 500CEFUROXIME AXETIL500MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP7/1/2014
77NDA/MAL/HDP/0244SAKAR HEALTHCARE PVT LTDROYAL PHARMA 2011 LIMITEDHYOCINHYOSCINE BUTYLBROMIDE20MG/MLSAKAR HEALTHCARE PVT LTD-BLOCK NO. 10-13, NR. M.N DESAI PETRO PUMP, SARKHEJ-BAVLA ROAD, CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT | INDIA |PARENTERAL ORDINARY AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2013
78NDA/MAL/HDP/0245CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 4GLIMEPIRIDE4MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
79NDA/MAL/HDP/0248IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE40 MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
|
INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
80NDA/MAL/HDP/0250ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKONDICLOFENAC1%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER7/1/2013
81NDA/MAL/HDP/0252LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-40ATORVASTATIN40MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
82NDA/MAL/HDP/0253ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTENLOW-5AMLODIPINE BESYLATE5MGLINCO N PHARMACEUTICALS LIMITED-TRIMUL ESTATE KHATRAJ KALOL GUJARAT INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
83NDA/MAL/HDP/0254MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 5BISOPROLOL HEMIFUMARATE5MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
84NDA/MAL/HDP/0266ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2.400.000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON7/1/2001
85NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
86NDA/MAL/HDP/0270HETERO LABS LTDAIVEEN (U) LIMITEDLEVIN 500MGLEVOFLOXACIN HEMIHYDRATE500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2001
87NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBETTTETANUS VACCNE ADSORBED40 I.UBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA |PARENTERAL ORDINARY AMPOULES1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)7/1/2001
88NDA/MAL/HDP/0275GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE CONSUMER HEALTHCARE S.A (PTY) LIMITED-39 HAWKINS AVENUE, EPPING INDUSTRIA 1, 7460, CAPE TOWN, SOUTH AFRICA | SOUTH AFRICA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER7/1/2011
89NDA/MAL/HDP/0276MICRO LABS LTDLABOREX UGANDA LIMITEDMELANOV 80GLICLAZIDE80MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
90NDA/MAL/HDP/0278COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 100MGCHLORPROMAZINE HYDROCHLORIDE100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/1998
91NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2013
92NDA/MAL/HDP/0287GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDPOWER HEATMETHYL SALICYLATE15%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE,1.0X30.0 G TUBE1/7/2013
93NDA/MAL/HDP/0290LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDNATOAMEBENDAZOLE100MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
94NDA/MAL/HDP/0293HETERO LABS LTDAIVEEN (U) LIMITEDDARUNAVIRDARUNAVIR600 MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2014
95NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
96NDA/MAL/HDP/0298SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDSEFIXI-50 DRY SYRUPCEFIXIME50MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X60.0 ML BOTTLE7/1/2013
97NDA/MAL/HDP/0301HETERO LABS LTDAIVEEN (U) LIMITEDMONAST 10MONTELUKAST SODIUM10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
98NDA/MAL/HDP/0303HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2014
99NDA/MAL/HDP/0307HETERO DRUGS LTDAIVEEN (U) LIMITEDLAMIVUDINE ORAL SOLUTIONLAMIVUDINE10MG/MLHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA | INDIA |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X240.0 ML CONTAINER7/1/2013
100NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND |UNITED KINGDOM |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2013
101NDA/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-361006 | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2013
102NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA -BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844 | UNITED KINGDOM |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2013
103NDA/MAL/HDP/0317YURIA PHARM LTD-UKRAINEPHARMA VILLE LIMITEDCIPROFLOXACIN-UFCIPROFLOXACIN2MG/MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE | UKRAINE |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
104NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULINSALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
105NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
106NDA/MAL/HDP/0322MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2009
107NDA/MAL/HDP/0327GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR 8LORNOXICAM8MGGLENMARK PHARMACEUTICAL LIMITED;--VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
108NDA/MAL/HDP/0335GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDNEOMYCIN SULPHATE CREAM USPNEOMYCIN SULPHATE CREAM USP0.5%WWKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE7/1/2013
109NDA/MAL/HDP/0337IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *500AZITHROMYCIN500MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER7/1/2014
110NDA/MAL/HDP/0339IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *250AZITHROMYCIN250MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER7/1/2014
111NDA/MAL/HDP/0340GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDSONADAYCLOBETASOL-17-BUTYRATE + GENTAMYCIN SULPHATE + MICONAZOLE NITRATE0.05%W/W+0.1%W/W+2%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
112NDA/MAL/HDP/0341IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 40TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2014
113NDA/MAL/HDP/0342IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 80TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2014
114NDA/MAL/HDP/0343GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDWHITFIELD'S OINTMENT B.PBENZOIC ACID + SALICYLIC ACID6% W/W + 3% W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2013
115NDA/MAL/HDP/0349SWISS PARENTERALS PVT LTDSHREEJI CARE LIMITEDCLAXY 1.2 GCOAMOXICLAV1.2GSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL7/1/2013
116NDA/MAL/HDP/0350RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
117NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER7/1/2014
118NDA/MAL/HDP/0354KOPRAN LIMITEDTATA UGANDA LIMITEDLEVOKOPLEVOFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2013
119NDA/MAL/HDP/0355SWISS PARENTERALS LTDSHREEJI CARE LIMITEDBICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2015
120NDA/MAL/HDP/0356DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 50OLEVOFLOXACIN HEMIHYDRATE500MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2014
121NDA/MAL/HDP/0358SWISS PARENTERALS LTDSHREEJI CARE LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY I M VIALS1.0X1.0 G VIAL7/1/2014
122NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE | SWEDEN |ORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON7/1/2001
123NDA/MAL/HDP/0362SWISS PARENTERALS LTDSHREEJI CARE LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2015
124NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER7/1/2014
125NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDMEDVIN PHARMA LIMITEDAGYCIN 500AZITHROMYCIN500MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER7/1/2014
126NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2010
127NDA/MAL/HDP/0372UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLEZYNCETLEVOCETIRIZINE5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

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INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER,5.0X2.0X10.0 TABLET BLISTER7/1/2009
128NDA/MAL/HDP/0373MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDTEMELINCETIRIZINE HYDROCHLORIDE10MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
129NDA/MAL/HDP/0375MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDFENAMON SRNIFEDIPINE20MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
130NDA/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) 18113 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
131NDA/MAL/HDP/0380MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAVERNOLCARVEDILOL6.25NGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
132NDA/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 ELIZABETH | SOUTH AFRICA |PARENTERAL ORDINARY VIALS1.0X10.0X10.0 ML VIAL7/1/2014
133NDA/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 ELIZABETH | SOUTH AFRICA |PARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BAG7/1/2014
134NDA/MAL/HDP/0386EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-80ENOXAPARIN SODIUM80MG/ 0.8MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 |INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 ML PRE- FILLED SYRINGE7/1/2014
135NDA/MAL/HDP/0388KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE STRIP,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/1997
136NDA/MAL/HDP/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IVPARACETAMOL1000MG/100MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2014
137NDA/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) 18113 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X3.0X10.0 TABLET BLISTER7/1/2013
138NDA/MAL/HDP/0400CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDIBSOL 1.2MESALAMINE DELAYED RELEASE1.2GMCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
139NDA/MAL/HDP/0403NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDSUPRIDOLTRAMADOL HYDROCHLORIDE50MG/MLNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA | INDIA |PARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2013
140NDA/MAL/HDP/0406NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDEVATOCINOXYTOCIN10 I.U./ MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2015
141NDA/MAL/HDP/0407NEON LABARATORIES LTD.NORVIK ENTERPRISES 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, MAHARASHTRA | INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2013
142NDA/MAL/HDP/0408MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDALGIC - PACECLOFENAC + PARACETAMOL100 MG + 500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
143NDA/MAL/HDP/0409NEON LABARATORIES LTD.NORVIK ENTERPRISES 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, MAHARASHTRA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2013
144NDA/MAL/HDP/0410MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 20ROSUVASTATIN CALCIUM20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
145NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLAND |FINLAND |PARENTERAL RETARD IMPLANTS1.0X10.0X1.0X2.0X75.0 MG IMPLANT7/1/2003
146NDA/MAL/HDP/0413NEON LABARATORIES LTD.NORVIK ENTERPRISES 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, MAHARASHTRA | INDIA |PARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2013
147NDA/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 140506 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
148NDA/MAL/HDP/0418ASTRA ZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA |UNITED STATES |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2013
149NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA |UNITED STATES |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
150NDA/MAL/HDP/0422GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
151NDA/MAL/HDP/0423GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2013
152NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/1998
153NDA/MAL/HDP/0427MICRO LABS LTDLABOREX UGANDA LIMITEDAMLOZAAR -HLOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE50MG + 5MG + 12.5MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
154NDA/MAL/HDP/0428MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2013
155NDA/MAL/HDP/0429ARISTO PHARMACEUTICALS PVT LTDNORVIK 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. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
156NDA/MAL/HDP/0430ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO ACECLO PLUSACECLOFENAC+PARACETAMOL100MG+500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER7/1/2013
157NDA/MAL/HDP/0433PT SAMBE FARMAMEDVIN PHARMA LIMITEDPROANES MCT/LCTPROPOFOL1%W/VPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY I V AMPOULES1.0X5.0X20.0 ML AMPOULE7/1/2014
158NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDPROHIBINGASTRO-RESISTANT OMEPRAZOLE CAPSULES BP 2020 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP7/1/2010
159NDA/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 ELIZABETH | SOUTH AFRICA |PARENTERAL ORDINARY VIALS1.0X10.0X20.0 ML VIAL7/1/2015
160NDA/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 ELIZABETH | SOUTH AFRICA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2014
161NDA/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 ELIZABETH | SOUTH AFRICA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2015
162NDA/MAL/HDP/0442PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDZIK-ZAK-50SILDENAFIL CITRATE 50MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/2014
163NDA/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 ELIZABETH | SOUTH AFRICA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2015
164NDA/MAL/HDP/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE500 MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2014
165NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDMETROLEBMETRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
166NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X15.0 ML BOTTLE7/1/2009
167NDA/MAL/HDP/0463GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHENPHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2011
168NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL SOLID ORDINARY TABLETS50.0X2.0 TABLET STRIP7/1/1997
169NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD | NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA-AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | DENMARK |PARENTERAL ORDINARY DRY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN7/1/2014
170NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD | NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA-AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | DENMARK |PARENTERAL ORDINARY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN7/1/2014
171NDA/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, INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 ML VIAL,1.0X0.5 ML VIAL7/1/2015
172NDA/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
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X25.0X4.0 TABLET BLISTER7/1/2015
173NDA/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
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
174NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDAZILEB-500AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X3.0 TABLET BLISTER7/1/2014
175NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER7/1/2014
176NDA/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.
|
KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
177NDA/MAL/HDP/0499NVS KENYA LTDSURGIPHARM (U) LIMITEDBANEOCIN OINTMENTBACITRACIN ZINC+NEOMYCIN SULPHATE250I.U + 5000I.ULEK PHARMACEUTICALS DD-VEROVSKOVA 57, SI-1526 LJUBLJANA | MERCK KGAA & CO.-HOSSLGASSE 20 9800 SPITTAL DRAU/ AUSTRIA | AUSTRIA | SLOVENIA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/2014
178NDA/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, INDIA | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
179NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET STRIP7/1/2004
180NDA/MAL/HDP/0521ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDPAN 40PANTOPRAZOLE SODIUM40MGALKEM LABORATORIES LTD .- VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESH | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2014
181NDA/MAL/HDP/0522MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDVAZORTAN 50LOSARTAN POTASSIUM50MGMEDLEY PHARMACEUTICALS LTD -PLOT NO. 18 AND 19, SURVEY NO. 378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM
, DAMAN-396 210, INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
182NDA/MAL/HDP/0526LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDAMILEB- 25AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
183NDA/MAL/HDP/0538MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
184NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
185NDA/MAL/HDP/0542DAWA LIMITEDSUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKA |KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
186NDA/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 HOUSING |JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
187NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
188NDA/MAL/HDP/0547NAARI LTDUNITED HEALTHCARE DISTRIBUTORS LTDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0 TABLET BLISTER (COMBIPACK),1.0X3.0X4.0 TABLET BLISTER7/1/2013
189NDA/MAL/HDP/0548UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICASTMONTELUKAST5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITY |JORDAN |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
190NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2014
191NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
|
INDIA |PARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL (5 DOSE VIAL)7/1/2013
192NDA/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 SECURITY |JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
193NDA/MAL/HDP/0563IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDEZO 40ESOMEPRAZOLE MAGNESIUM40MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA |ORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
194NDA/MAL/HDP/0566SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTIL SUSPENSIONCEFUROXIME AXETIL125MG/5MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X1.0X50.0 ML BOTTLE7/1/2013
195NDA/MAL/HDP/0569ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCELLRIDIN LINCTUSPHOLCODINE10MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL LIQUID ORDINARY SYRUPS1.0X90.0 ML BOTTLE7/1/2014
196NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN250IUBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
|
INDIA |PARENTERAL ORDINARY I M VIALS1.0X1.0X2.0 ML VIAL (1 DOSE VIAL)7/1/2013
197NDA/MAL/HDP/0571ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL KAOPECLIGHT KAOLIN + PECTIN (CITRUS)1G + 20MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE7/1/2015
198NDA/MAL/HDP/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM |OPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/2010
199NDA/MAL/HDP/0573ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL PARACETAMOL-250PARACETAMOL250MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2014
200NDA/MAL/HDP/0574IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE TABLETS 100/270ARTESUNATE AND AMODIAQUINE100MG+270MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER7/1/2013
201NDA/MAL/HDP/0576GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY | GERMANY |ORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER7/1/2015
202NDA/MAL/HDP/0580KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPMULTINGREDIENTMULTINGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
203NDA/MAL/HDP/0582ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDACECLO SERAACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG + 500MG + 15MGARISTO PHARMACEUTICALS PVT LTD-VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2015
204NDA/MAL/HDP/0584ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 1GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE1MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
205NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDNISOLONE ACETATE1%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI €“ 625 020 TAMIL NADU, INDIA | INDIA |OPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE7/1/2013
206NDA/MAL/HDP/0589ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 2GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE2MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
207NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA | INDIA |OPHTHALMIC LIQUIDS1.0X10.0 ML CONTAINER7/1/2013
208NDA/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 PRADESH |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP7/1/2014
209NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2015
210NDA/MAL/HDP/0596MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP1/7/2011
211NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2003
212NDA/MAL/HDP/0599MICRO LABS LIMITEDLABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
213NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
214NDA/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 INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/1999
215NDA/MAL/HDP/0604DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTD-MBARARATRIMOXOLCO-TRIMOXAZOLE480MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | DAWA LIMITED -16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
216NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
217NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
218NDA/MAL/HDP/0611GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDGALCIPRO 500CIPROFLOXACIN HYDROCHLORIDE500MGGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
219NDA/MAL/HDP/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID125MG/5ML + 31.25MG/5MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1998
220NDA/MAL/HDP/0622PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDTENOL-50ATENOLOL50MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
221NDA/MAL/HDP/0626KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCARDIPAC-10AMLODIPINE BESILATE10MGKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0X10.0 TABLET BLISTER7/1/2015
222NDA/MAL/HDP/0627KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAMOXIKIDAMOXICILLIN TRIHYDRATE125MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2015
223NDA/MAL/HDP/0630CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEO LORIDINDESLORATADINE5MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2011
224NDA/MAL/HDP/0634MEDLEY PHARMACEUTICALSMEDVIN 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 INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2014
225NDA/MAL/HDP/0635GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2009
226NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
227NDA/MAL/HDP/0639NEM LABORATORIES (PVT) LTDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
228NDA/MAL/HDP/0654NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER7/1/2013
229NDA/MAL/HDP/0657NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER7/1/2013
230NDA/MAL/HDP/0658NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER7/1/2013
231NDA/MAL/HDP/0665HETERO LABS LTDAIVEEN (U) LIMITEDIRBIS 150IRBESARTAN150MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
232NDA/MAL/HDP/0666HETERO LABS LTDAIVEEN (U) LIMITEDIRBIS-H 300IRBESARTAN300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2013
233NDA/MAL/HDP/0667ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXEL MICONAZOLEMICONAZOLE NITRATE2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/2013
234NDA/MAL/HDP/0669ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXEL FUNGICORT CREAMMICONAZOLE NITRATE + HYDROCORTISONE2% W/W + 1% W/WKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/2013
235NDA/MAL/HDP/0670GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER7/1/2014
236NDA/MAL/HDP/0672GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONOR TABLETSNORFLOXACIN400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/2013
237NDA/MAL/HDP/0674GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2013
238NDA/MAL/HDP/0675ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
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MALAYSIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
239NDA/MAL/HDP/0677GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
240NDA/MAL/HDP/0678ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL HYDROCORTISONE CREAMHYDROCORTISONE1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/2014
241NDA/MAL/HDP/0679GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2013
242NDA/MAL/HDP/0681EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALGENNOVA BIOPHARMACEUTICALS LIMITED-BLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI7/1/2013
243NDA/MAL/HDP/0685FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN |PARENTERAL RETARD I M AMPOULES1.0X5.0X4.0 ML AMPOULE7/1/2015
244NDA/MAL/HDP/0687FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN |ORAL LIQUID ORDINARY LIQUIDS1.0X6.0X10.0 ML SACHET7/1/2015
245NDA/MAL/HDP/0688GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
246NDA/MAL/HDP/0689GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
247NDA/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 140506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/2014
248NDA/MAL/HDP/0691MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
249NDA/MAL/HDP/0692DAWA LIMITEDSUPER MEDIC LTDDAWACLOX -250CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKA |KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2015
250NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2014
251NDA/MAL/HDP/0694GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON7/1/2013
252NDA/MAL/HDP/0696BYANSI SERVICES LIMITEDAIVEEN (U) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2014
253NDA/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 NAIROBI | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/2003
254NDA/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 382210 | INDIA |PARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)7/1/2015
255NDA/MAL/HDP/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL,1.0X100.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL7/1/2014
256NDA/MAL/HDP/0703GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDDICLODAY 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 421 506 |INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE7/1/2013
257NDA/MAL/HDP/0704HETERO LABS LTD UNIT IXAIVEEN (U) 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.P | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER7/1/2013
258NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2011
259NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
260NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
261NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE100MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCE |FRANCE |ORAL LIQUID ORDINARY SUSPENSIONS1.0X20.0 ML BOTTLE7/1/1997
262NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | GERMANY |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2015
263NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | GERMANY |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2015
264NDA/MAL/HDP/0716LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-1GLIMEPIRIDE+METFORMIN HYDROCHLORIDE1MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2014
265NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER7/1/2014
266NDA/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 INDIA | INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.4 ML PRE- FILLED SYRINGE7/1/2011
267NDA/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, INDIA | INDIA |ORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE7/1/2013
268NDA/MAL/HDP/0721MISSION PHARMAMETRO PHARMACEUTICALS LIMITEDARH-AARTEMETHER80MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |PARENTERAL ORDINARY I M AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE7/1/2014
269NDA/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. | INDIA |OPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/2014
270NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE50MGTROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND |INDIA |ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2014
271NDA/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 140506 |INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X225.0 ML BOTTLE7/1/2013
272NDA/MAL/HDP/0728IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 25/67.5ARTESUNATE+AMODIAQUINE25MG+67.5MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
273NDA/MAL/HDP/0731IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 50/135ARTESUNATE + AMODIAQUINE50/135MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
274NDA/MAL/HDP/0733CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYNACACECLOFENAC100MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
275NDA/MAL/HDP/0734AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDOMMED -20OMEPRAZOLE20MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/2015
276NDA/MAL/HDP/0736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMABRON 50TRAMADOL HYDROCHLORIDE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
277NDA/MAL/HDP/0737SANOFI AVENTISSURGIPHARM (U) LIMITEDTAXOTERE 80MGDOCETAXEL TRIHYDRATE80MG/4MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
|
GERMANY |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X4.0 ML VIAL7/1/2014
278NDA/MAL/HDP/0740MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCOTRIMCO-TRIMOXAZOLE960MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X17.0X6.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
279NDA/MAL/HDP/0741MEDOCHEMIE LTDSHREEJI PHARMACEUTICALS LIMITEDMEDOCIPRINCIPROFLOXACIN500MG MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
280NDA/MAL/HDP/0746COSMOS LTDASTRA PHARMA (U) LIMITEDDTS-Z KITTABLET-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
|
KENYA |ORAL LIQUID ORDINARY UNIT DOSE POWDERS1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER7/1/2013
281NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER7/1/2013
282NDA/MAL/HDP/0749AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 1000MEROPENEM1000MGAURONEXT PHARMA PVT LTD.-A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADI | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2014
283NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER7/1/2013
284NDA/MAL/HDP/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
285NDA/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. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2014
286NDA/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 GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
287NDA/MAL/HDP/0757CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 150TOLPERISONE150MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
288NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2011
289NDA/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. | INDIA |OPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/1999
290NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
291NDA/MAL/HDP/0774CADILA PHARMACEUTICALS LIMITEDPLANET PHARMACEUTICALS UGANDA LTDNODONNEBIVOLOL10MGCADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER7/1/2012
292NDA/MAL/HDP/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 75PREGABALIN75MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
293NDA/MAL/HDP/0776FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL TABLETSPARACETAMOL TABLETS500MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1999
294NDA/MAL/HDP/0780CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDATORVA TABLETSATORVASTATIN10MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X1.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2001
295NDA/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.P | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER7/1/2013
296NDA/MAL/HDP/0784COSMOS LTDASTRA PHARMA (U) LIMITEDHEMOSANFERROUS FUMERATE300MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
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KENYA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
297NDA/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.P | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
298NDA/MAL/HDP/0794REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.AMYGYDEXTOBRAMYCIN/DEXAMETHASONE3MG+1MG/MLREMINGTON PHARMACEUTICALS (PVT) LTD-18KM, MULTAN ROAD, LAHORE 53800, PAKISTAN | PAKISTAN |OPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/2014
299NDA/MAL/HDP/0795GITTOES PHARMACEUTICALS LIMITEDGITTOES 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) | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
300NDA/MAL/HDP/0796HETERO LABS LTDAIVEEN (U) LIMITEDAMLOSIN 5AMLODIPINE BESILATE5MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
301NDA/MAL/HDP/0798HETERO LABS LTDAIVEEN (U) LIMITEDAMLOSIN 10AMLODIPINE BESILATE10MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
302NDA/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 SPAIN | SWITZERLAND |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2015
303NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
304NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2GLIMEPIRIDE2MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING |GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
305NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3GLIMEPIRIDE3MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING |GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
306NDA/MAL/HDP/0822ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X0.5 G VIAL,1.0X100.0X0.5 G VIAL,1.0X10.0X0.5 G VIAL7/1/2014
307NDA/MAL/HDP/0823CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTRAP TABLETSTRAMADOL HCL + PARACETAMOL37.5MG+325MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
308NDA/MAL/HDP/0824I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLINCLOXACILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2013
309NDA/MAL/HDP/0826I CARE PHARMA LIMITEDVITACARE LTDAMOXYCILLINAMOXYCILLIN250MG MEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2013
310NDA/MAL/HDP/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER7/1/2015
311NDA/MAL/HDP/0831I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN CAPSULESAMPICILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA | CHINA |ORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2013
312NDA/MAL/HDP/0832MERCKUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER7/1/2015
313NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARAT |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2013
314NDA/MAL/HDP/0835GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
315NDA/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
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2012
316NDA/MAL/HDP/0841MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDETHOMIDETHIONAMIDE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
317NDA/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
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X2.0 TABLET BLISTER7/1/2013
318NDA/MAL/HDP/0843MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCOXERINCYCLOSERINE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/2013
319NDA/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
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X10.0 TABLET BLISTER,1.0X5.0X1.0X10.0 TABLET BLISTER7/1/2013
320NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
321NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2014
322NDA/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
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2012
323NDA/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
|
INDIA |LUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2013
324NDA/MAL/HDP/0855HETERO LABS LTDAIVEEN (U) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
325NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |VAGINAL TABLETS1.0X6.0 PESSARY STRIP7/1/2000
326NDA/MAL/HDP/0864HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM40 MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
327NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLIDLINEZOLID2MG/MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
328NDA/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-INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X2.0X6.0X2.0 ML VIAL7/1/2013
329NDA/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-INDIA | INDIA |PARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE7/1/2013
330NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2010
331NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN10I.U/MLSAKAR HEALTH CARE PVT LTD-10/13 CHONGODAR SARKHEJ BAVLA ROAD DIST AHEMABAD 382213 GUJARATI | NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
332NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
333NDA/MAL/HDP/0877LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDANTAGIT DS GEL MINT FLAVOURDRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X170.0 ML BOTTLE7/1/2007
334NDA/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
|
KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTERNULL
335NDA/MAL/HDP/0882MERCKUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/2.5MGMETFORMIN + GLIBENCLAMIDE500MG + 2.5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY |FRANCE |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER7/1/2012
336NDA/MAL/HDP/0883MERCKUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/5MGMETFORMIN + GLIBENCLAMIDE500MG + 5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY |FRANCE |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER7/1/2012
337NDA/MAL/HDP/0894HETERO LABS LTDAIVEEN (U) LIMITEDGIAGRA 100SILDENAFIL CITRATE100MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER7/1/2014
338NDA/MAL/HDP/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTHSODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0 ML PRE- FILLED SYRINGE7/1/2015
339NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2015
340NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML VIAL WFI7/1/2013
341NDA/MAL/HDP/0902GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SRNIFEDIPINE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
342NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2015
343NDA/MAL/HDP/0911VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHEALACERECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B100MCG/GVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2015
344NDA/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 PRADESH | INDIA |PARENTERAL ORDINARY VIALS1.0X3.0 ML VIAL,1.0X3.0 ML PREFILLED PEN7/1/2015
345NDA/MAL/HDP/0915NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET STRIP7/1/2014
346NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X5.0X4.0 ML VIAL7/1/2012
347NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP7/1/2004
348NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
349NDA/MAL/HDP/0934CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDODIMONT 4MONTELUKAST4MGCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210 |INDIA |ORAL SOLID ORDINARY CHEWABLE COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
350NDA/MAL/HDP/0938FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 20MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS20MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER7/1/2013
351NDA/MAL/HDP/0939LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARHALPHA -BETA ARTEETHER150MG /2MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X3.0X2.0 ML AMPOULE7/1/2012
352NDA/MAL/HDP/0940FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 40MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS40MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER7/1/2013
353NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X15.0 ML BOTTLE7/1/2013
354NDA/MAL/HDP/0942LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH FORTEALPHA -BETA ARTEETHER225MG/ 3MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X3.0X3.0 ML AMPOULE7/1/2012
355NDA/MAL/HDP/0948COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINA SYRUP 5MG/5MLLORATADINE5MG/5MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE7/1/2013
356NDA/MAL/HDP/0952NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDEFECTALCEFTRIAXONE1GNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2013
357NDA/MAL/HDP/0953NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL7/1/2013
358NDA/MAL/HDP/0954NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL RETARD OTHER VIALS1.0X20.0 ML VIAL7/1/2013
359NDA/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 INDIA |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2012
360NDA/MAL/HDP/0959AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DISPERSIBLE 20/120ARTEMETHER + LUMEFANTRINE20MG + 120MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER7/1/2013
361NDA/MAL/HDP/0963AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMODARTESUNATE+AMODIAQUINE50MG+135MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD |INDIA |ORAL SOLID ORDINARY LAYERED TABLETS1.0X3.0 TABLET BLISTER7/1/2013
362NDA/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 AURANGABAD |INDIA |ORAL SOLID ORDINARY LAYERED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
363NDA/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, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2005
364NDA/MAL/HDP/0986EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
365NDA/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, EGYPT | EGYPT |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
366NDA/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, EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
367NDA/MAL/HDP/0999EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID600MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
368NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE7/1/2012
369NDA/MAL/HDP/1001EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
370NDA/MAL/HDP/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
371NDA/MAL/HDP/1007COSMOS LTDASTRA PHARMA (U) LIMITEDZINCOS DISPERSIBLE TABLETS 20MGZINC SULPHATE20MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
|
KENYA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
372NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2012
373NDA/MAL/HDP/1011COSMOS LTDASTRA PHARMA (U) LIMITEDDABORAL SYRUPAMINOSIDINE125MG/5MLCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
|
KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2012
374NDA/MAL/HDP/1012NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDLOX 2%LIDOCAINE2% W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL ORDINARY OTHER VIALS1.0X50.0 ML VIAL,1.0X20.0 ML VIAL7/1/2013
375NDA/MAL/HDP/1013NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDTHIOSOLTHIOPENTAL SODIUM500MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0X20.0 ML VIAL7/1/2013
376NDA/MAL/HDP/1017ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCLOXAMPICILLIN/CLOXACILLIN125MG/125MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
|
KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2015
377NDA/MAL/HDP/1018KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM CHLORCHLORAMPHENICOL250MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA |ORAL SOLID ORDINARY CAPSULES100.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER7/1/1997
378NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID RETARD LAYERED TABLETS1.0X10.0X1.0X12.0 TABLET BLISTER7/1/2012
379NDA/MAL/HDP/1022EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES -WIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
380NDA/MAL/HDP/1030LABORATORIOS SALVAT SALABOREX UGANDA LIMITEDMALACURDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGCIRON DRUGS AND PHARMACEUTICALS PRIVATE LIMITED-PLOT NO. 35-37, 43-45, CFC-B, DEWAN UDHYOG NAGAR, ALIYALI, PALGHAR – 401404, MAHARASHTRA, INDIA.INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X12.0 TABLET BLISTER7/1/2014
381NDA/MAL/HDP/1031EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOXIFLOXMOXIFLOXACIN400MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X1.0X5.0 TABLET BLISTER7/1/2013
382NDA/MAL/HDP/1032EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDARTHFREE 20LEFLUNOMIDE20MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
383NDA/MAL/HDP/1033PLEX LIFE PROVIDERPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYNAMOGENGLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE3MG +1GFAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA | SPAIN |ORAL LIQUID ORDINARY LIQUIDS1.0X20.0X10.0 ML SACHET7/1/2015
384NDA/MAL/HDP/1035GUILIN PHARMACEUTICAL CO.LTDTRIDEM PHARMA UGANDA LIMITEDG-CIPROXCIPROFLOXACIN500MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
385NDA/MAL/HDP/1042ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 80/12.5TELMISARTAN +HYDROCHLOROTHIAZIDE80MG +12.5 MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP7/1/2013
386NDA/MAL/HDP/1044UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDANGINET 80MGVALSARTAN80MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
387NDA/MAL/HDP/1047UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 180MGFEXOFENADINE180MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER7/1/2013
388NDA/MAL/HDP/1048UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 120MGFEXOFENADINE120MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER7/1/2013
389NDA/MAL/HDP/1049GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2012
390NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE10MGINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
| INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER7/1/2013
391NDA/MAL/HDP/1052GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMICLOGENMICONAZOLE NITRATE+CLOBETASOLE PROPIONATE+GENTAMICIN SULPHATE2.0%W/W+0.05%W/W+0.1W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
392NDA/MAL/HDP/1053GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN-125 DTAMOXICILLIN125MGMILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI) | INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
393NDA/MAL/HDP/1054GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2011
394NDA/MAL/HDP/1056GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-N OINTMENTBETAMETHASONE + NEOMYCIN0.1%W/W + 0.5% W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE7/1/2013
395NDA/MAL/HDP/1061SHOSAAN ASIC PACIFICRENE PHARMACY LTDBISACODYL TABLETSBISACODYL5MGNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
396NDA/MAL/HDP/1062VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDVANCONEX-CPVANCOMYCIN500MGVENUS REMEDIES LIMITED-UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP
PHASE I BHATOLI BADDI (HP) 173205
INDIA |
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON7/1/2013
397NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |RECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER7/1/2007
398NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN+PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2010
399NDA/MAL/HDP/1069CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDK-ONE INJECTIONPHYTOMENADIONE10MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X1.0 ML AMPOULE7/1/2014
400NDA/MAL/HDP/1071UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 160/25MGVALSARTAN + HYDROCHLOROTHIAZIDE160 MG + 25 MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
401NDA/MAL/HDP/1072UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 80/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .-57 UBAYBIN MUAATH STREET AL RAGEEM-SAHAB, AMMAN, JORDAN | JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
402NDA/MAL/HDP/1076UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICAST 4MGMONTELUKAST SODIUM4MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
403NDA/MAL/HDP/1078MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2013
404NDA/MAL/HDP/1079GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUININE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2000
405NDA/MAL/HDP/1080ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 250 TABLETSCEFUROXIME AXETIL250MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2009
406NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
407NDA/MAL/HDP/1083GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCHOCOFER SYRUPIRON + FOLIC ACID50MG + 0.5MG /5MLGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
|
INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2013
408NDA/MAL/HDP/1084DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE4MGDAWA LTD-BABA DOGO ROAD RUARAKA |KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
409NDA/MAL/HDP/1085AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDDICLOGEN 1% GELDICLOFENAC GEL BP1%W/WAGIO PHARMACEUTICALS LTD .-A-82, MIDC, BHOSARI, PUNE-411026 | INDIA |TOPICAL EXTERNAL OTHER GELS/SOLS1.0X20.0 G TUBE,1.0X30.0 G TUBE7/1/2013
410NDA/MAL/HDP/1086SHOSAAN ASIC PACIFICRENE PHARMACY LTDSYNOGEN TABLETSDIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE50MG +250MG + 750MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
411NDA/MAL/HDP/1087GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2013
412NDA/MAL/HDP/1088GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDRESTUMCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL7/1/2015
413NDA/MAL/HDP/1093STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE+TENOFOVIR DISOPROXIL FUMARATE200MG+300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
414NDA/MAL/HDP/1094MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-100CEFIXIME100MG/5MLMICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
415NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2012
416NDA/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 PRADESH |INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2012
417NDA/MAL/HDP/1100GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X5.0 G TUBENULL
418NDA/MAL/HDP/1103GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
419NDA/MAL/HDP/1106EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER7/1/2013
420NDA/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, INDIA | INDIA |PARENTERAL ORDINARY I M VIALS1.0X25.0X5.0 ML VIAL (10 DOSES),1.0X10.0X0.5 ML VIAL (1 DOSE)7/1/2005
421NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2014
422NDA/MAL/HDP/1111DAWA LIMITEDSUPER MEDIC LTDFAST-ACT GELDICLOFENAC 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 RUARAKA | KENYA |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE7/1/2013
423NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE7/1/1997
424NDA/MAL/HDP/1114SHOSAAN ASIC PACIFICRENE PHARMACY LTDTRANGEL ULTRADICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN10MG/80MG/60MG/0.15MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA |
INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER7/1/2012
425NDA/MAL/HDP/1117SHOSAAN ASIC PACIFICRENE PHARMACY LTDTETRACYCLINE EYE OINTMENT USP 1%TETRACYCLINE1%W/WNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA |
INDIA |OPHTHALMIC OINTMENTS1.0X20.0X3.5 G TUBE7/1/2013
426NDA/MAL/HDP/1123GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPARPARACETAMOL500 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2012
427NDA/MAL/HDP/1124GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |TOPICAL EXTERNAL LIQUIDS1.0X1.0X500.0 ML BOTTLE7/1/2013
428NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT |INDIA |ORAL SOLID ORDINARY COMBINATION PACK TABLETS1.0X4.0 TABLET BLISTER7/1/2013
429NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2012
430NDA/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, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2012
431NDA/MAL/HDP/1136GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL EMULSIONS1.0X1.0X100.0 ML BOTTLE7/1/2013
432NDA/MAL/HDP/1138GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |TOPICAL EXTERNAL LOTIONS1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2013
433NDA/MAL/HDP/1139GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
434NDA/MAL/HDP/1140GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
435NDA/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-INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2012
436NDA/MAL/HDP/1142GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
437NDA/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
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
438NDA/MAL/HDP/1148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 10MONTELUKAST10MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2012
439NDA/MAL/HDP/1154SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITED-INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.

|
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X30.0 ML VIAL7/1/2012
440NDA/MAL/HDP/1155TRIVENI FORMULATIONS LIMITEDSUPER MEDIC LTDDOXYCYCLINEDOXYCYCLINE100TRIVENI FORMULATION LTD-PLOT NO.52,53,54,63,62,64, ALEAP INDUSTRIAL ESTATE SURAMPALI,
AP-INDIA – 521212
|
INDIA |ORAL SOLID ORDINARY CAPSULES CAPSULE BLISTER, AMPOULE AMPOULE7/1/2012
441NDA/MAL/HDP/1158TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRAMADOLTRAMADOL50MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2012
442NDA/MAL/HDP/1163SHOSAAN ASIC PACIFICRENE PHARMACY LTDFRUSEMIDEFUROSEMIDE40MGNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
443NDA/MAL/HDP/1164TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDPIROXICAMPIROXICAM20MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
444NDA/MAL/HDP/1166PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
445NDA/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. | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2010
446NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2009
447NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE5MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X3.0X10.0 TABLET BLISTER7/1/2013
448NDA/MAL/HDP/1170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO MEGANEURONMETHYLCOBALAMIN500MCGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA |PARENTERAL ORDINARY I M AMPOULES1.0X1.0 ML AMPOULE7/1/2013
449NDA/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. | INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL,1.0X30.0 ML VIAL7/1/2010
450NDA/MAL/HDP/1178HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
451NDA/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).ITALY | SWITZERLAND |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON7/1/2015
452NDA/MAL/HDP/1182TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 5MONTELUKAST SODIUM5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
453NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
454NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
455NDA/MAL/HDP/1186DAWA LIMITEDSUPER MEDIC LTDDACOF EXPECTORANTDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL14.0MG + 135.0MG + 57.0MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
456NDA/MAL/HDP/1189ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDDICLOMAX-75DICLOFENAC SODIUM75MG/ML REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE7/1/2013
457NDA/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 -HP | INDIA |PARENTERAL ORDINARY VIALS1.0X1.0X30.0 ML VIAL7/1/2009
458NDA/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 MAHARASTRA |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2008
459NDA/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 KILBRIDE |UNITED KINGDOM |TOPICAL EXTERNAL OTHER GELS/SOLS1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER7/1/2013
460NDA/MAL/HDP/1208ARISTO PHARMACEUTICALS PVT LTDNORVIK 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 PRADESH |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2011
461NDA/MAL/HDP/1209MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER1/7/2011
462NDA/MAL/HDP/1211ASTRA ZENECAMACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2011
463NDA/MAL/HDP/1212GUILIN PHARMACEUTICALS CO.LTDTRIDEM PHARMA UGANDA LIMITEDGLINTHERARTEMETHER80MG/MLGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI | CHINA |PARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE7/1/2011
464NDA/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, SPAIN | SPAIN |ORAL SOLID ORDINARY CAPSULES1.0X2.0X15.0 CAPSULE BLISTER7/1/2015
465NDA/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 INDIA |INDIA |VAGINAL SUPPOSITORIES1.0X10.0 TABLET BLISTER7/1/2013
466NDA/MAL/HDP/1219DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
467NDA/MAL/HDP/1220BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONARTARTEMETHER + LUMEFANTRINE180 MG + 1080 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BLISTER7/1/2008
468NDA/MAL/HDP/1226AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDSALBUTAMOLSALBUTAMOL4MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2005
469NDA/MAL/HDP/1230MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDLOXAMPAMPICILLIN + CLOXACILLIN250 MG + 250 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
470NDA/MAL/HDP/1231NORVIK ENTERPRISES LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125AMOXYCILLIN125MG/5MLMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU |INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
471NDA/MAL/HDP/1234MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDBISACODYL TABLETS BPBISACODYL5MGMACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
|
INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2007
472NDA/MAL/HDP/1242GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
473NDA/MAL/HDP/1243DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 250LEVOFLOXACIN HEMIHYDRATE250MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
474NDA/MAL/HDP/1244GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR SRLORNOXICAM16MGGLENMARK PHARMACEUTICALS LTD .-VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
475NDA/MAL/HDP/1245GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDFLEXILOR P8LORNOXICAM + PARACETAMOL8MG + 500MGGLENMARK PHARMACEUTICALS LTD .-VILLAGE KISHANPURA, BADDI-NALAGARH ROAD, TEHSIL BADDI, DISTRICT SOLAN HP 173205 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
476NDA/MAL/HDP/1247GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER7/1/2012
477NDA/MAL/HDP/1250STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDSTRIMOL EXTRAPARACETAMOL+CAFFEINE500MG+30MGSTRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAWADICROSS ANEKAL TALUK BANYALURE-562106 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET BLISTER7/1/2014
478NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2013
479NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER7/1/1998
480NDA/MAL/HDP/1255CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGAD |INDIA |ORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1997
481NDA/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 403 526 |INDIA |OPHTHALMIC OINTMENTS1.0X5.0 G TUBE,1.0X3.5 G TUBE7/1/2000
482NDA/MAL/HDP/1265GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2008
483NDA/MAL/HDP/1275REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 10 F.C TABLETSNIFEDIPINE10MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1997
484NDA/MAL/HDP/1278SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI |CHINA |ORAL SOLID ORDINARY TABLETS1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X25.0X1.0X9.0 TABLET BLISTER7/1/2013
485NDA/MAL/HDP/1285SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANFUR-750CEFUROXIME750MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL7/1/2012
486NDA/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. | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2014
487NDA/MAL/HDP/1288PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITAMINAT SYRUPVITAMIN B COMPLEXMULT-INGREDIENTPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
|
EGYPT |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/1998
488NDA/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. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
489NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300IOPROMIDE300MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |PARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL,1.0X100.0 ML VIAL7/1/2012
490NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |PARENTERAL ORDINARY VIALS1.0X100.0 ML VIAL,1.0X50.0 ML VIAL7/1/2012
491NDA/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. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL,1.0X50.0X1.0 VIAL CARTON7/1/2012
492NDA/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.
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
493NDA/MAL/HDP/1303MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFIBRALFINOFIBRATE200MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
494NDA/MAL/HDP/1304MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN2MG + 500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
495NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
496NDA/MAL/HDP/1312BLISS 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 INDIA |INDIA |RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER7/1/2007
497NDA/MAL/HDP/1319REMEDICA LTDGOODMAN INTERNATIONAL LTDZESTAVAL 200 F.C TABLETSALBENDAZOLE200MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS50.0X2.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER7/1/1997
498NDA/MAL/HDP/1324MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X1.0X18.0 ML BOTTLE7/1/2005
499NDA/MAL/HDP/1325MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2016
500NDA/MAL/HDP/1328GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN20MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART |BELGIUM |PARENTERAL ORDINARY VIALS1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE)7/1/1997
501NDA/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, PAKISTAN | PAKISTAN |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/1997
502NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2012
503NDA/MAL/HDP/1341AUROLABSWASTIK PHARMACEUTICAL LTDG-FLOXGATIFLOXACIN SESQUIHYDRATE0.3%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA | INDIA |OPHTHALMIC LIQUIDS1.0X5.0 ML VIAL7/1/2016
504NDA/MAL/HDP/1347MICRO LABS LIMITEDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
505NDA/MAL/HDP/1348TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 500SODIUM VALPROATE (CONTROLLED RELEASE)500MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2009
506NDA/MAL/HDP/1351MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDATORINATORVASTATIN CALCIUM20MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
507NDA/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 INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
508NDA/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 KACHIGAM | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2015
509NDA/MAL/HDP/1359KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENAC-100 SRDICLOFENAC SODIUM100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA |UGANDA |ORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2016
510NDA/MAL/HDP/1361SWISS PARENTERALS LTDSHREEJI CARE LIMITEDFALCI CAREARTESUNATE120MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE7/1/2016
511NDA/MAL/HDP/1362MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN + CLAVULANATE875 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X6.0 TABLET STRIP7/1/2013
512NDA/MAL/HDP/1366F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDHERCEPTIN 440MGTRASTUZUMAB440MGF. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGST |SWITZERLAND |PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X440.0 MG VIAL ,2OML VIAL OF SOLVENT7/1/2016
513NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKA |KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2013
514NDA/MAL/HDP/1372AXA PARENTERALS LTDVITACARE LIMITEDRLLACTIC ACID + SODIUM HYDROXIDE + SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE(0.24 + 0.115 + 0.6 + 0.04 + 0.027)G/100MLAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2014
515NDA/MAL/HDP/1377OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDWATER FOR INJECTIONWATER FOR INJECTIONN/AOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0 ML AMPOULE7/1/2014
516NDA/MAL/HDP/1384CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE AND ZIDOVUDINE TABLETSLAMIVUDINE + ZIDOVUDINE30MG + 60MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
517NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X1.0X5.0X10.0 CAPSULE STRIP7/1/2004
518NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
519NDA/MAL/HDP/1392ASTRA ZENECAMACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON7/1/1997
520NDA/MAL/HDP/1393SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANFURCEFUROXIME500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
521NDA/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. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X15.0 ML VIAL7/1/2010
522NDA/MAL/HDP/1399CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDASTHALINSALBUTAMOL100MCG/DOSECIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH | INDIA |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2010
523NDA/MAL/HDP/1400MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
(EAST), DISTRICT THANE, 421 0506, DIST. THANE,
MAHARASHTRA, INDIA.
|
INDIA |ORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER7/1/2015
524NDA/MAL/HDP/1402MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 1000METFORMIN HYDROCHLORIDE1000MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
(EAST), DISTRICT THANE, 421 0506, DIST. THANE,
MAHARASHTRA, INDIA.
|
INDIA |ORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER7/1/2015
525NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCEBAY DRY SYRUPCEFIXIME TRIHYDRATE50MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
526NDA/MAL/HDP/1409SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN200MG/5MLNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X15.0 ML BOTTLE7/1/2007
527NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
528NDA/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,KENYA | KENYA |ORAL TOPICAL LIQUIDS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2014
529NDA/MAL/HDP/1415ASTRA ZENECAMACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE
|
SWEDEN |ORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2011
530NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2001
531NDA/MAL/HDP/1418SHOSAAN ASIC PACIFICRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
532NDA/MAL/HDP/1419GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOPRIL 10LISINOPRIL10MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2005
533NDA/MAL/HDP/1423SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXYCILLIN + POTASSIUM CLAVULANATE500MG+125MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET BLISTER7/1/2016
534NDA/MAL/HDP/1427GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENA-50ATENOLOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
535NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |PARENTERAL ORDINARY VIALS1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL7/1/1997
536NDA/MAL/HDP/1436MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 10BISOPROLOL HEMIFUMARATE10MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
537NDA/MAL/HDP/1441AXA PARENTERALS LTDVITACARE LIMITEDSODIUM CHLORIDESODIUM CHLORIDE0.9%W/VAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2014
538NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL7/1/2003
539NDA/MAL/HDP/1446RENE 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, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2015
540NDA/MAL/HDP/1447EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITONA PLUSVITAMINS + MINERALSMULTI-INGREDIENTEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA |EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER7/1/2014
541NDA/MAL/HDP/1450GLAXOSMITHKLINE LIMITED LIKONIUNITED HEALTHCARE DISTRIBUTORS LTDVOLTAREN EMULGEL 1%DICLOFENAC DIETHYLAMMONIUM1%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND | SWITZERLAND |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X50.0 G TUBE7/1/1997
542NDA/MAL/HDP/1451NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN INJECTIONDICLOFENAC25MG/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. |SWITZERLAND |PARENTERAL ORDINARY AMPOULES1.0X3.0 ML AMPOULE7/1/1997
543NDA/MAL/HDP/1454RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPAINEXPARACETAMOL + ASPIRIN + CAFFEINE500MG + 400MG + 50 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP7/1/2003
544NDA/MAL/HDP/1457NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2006
545NDA/MAL/HDP/1459NVS KENYA LTDSURGIPHARM (U) LIMITEDTASIGNA 200NILOTINIB200MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND |ORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER7/1/2014
546NDA/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. | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE7/1/2015
547NDA/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. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
548NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID 20OMEPRAZOLE20MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/1998
549NDA/MAL/HDP/1474GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC GELDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE7/1/2016
550NDA/MAL/HDP/1476GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDSEPTOLSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE1%W/W + 0.20W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2016
551NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2001
552NDA/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) | FRANCE |PARENTERAL ORDINARY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE,1.0X10.0X10.0 DOSE VIAL + 1*10*10 DOSE AMPOULE OF NS7/1/1997
553NDA/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 HOUSING |JORDAN |RECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER7/1/2011
554NDA/MAL/HDP/1488DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAU | GERMANY |RECTAL SYSTEMIC ADULT SUPPOSITORIES10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP7/1/2000
555NDA/MAL/HDP/1492DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY. | GERMANY |PARENTERAL ORDINARY AMPOULES1.0X10.0X3.0 ML AMPOULE7/1/1998
556NDA/MAL/HDP/1493AUROBINDO PHARMA LTD UNIT VIIGITTOES PHARMACEUTICALS LIMITEDKOACT 1000AMOXICILLIN/CLAVULANATE POTASSIUM875MG/125MGAUROBINDO PHARMA LIMITED, UNIT III-SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA |ORAL SOLID RETARD TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2007
557NDA/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, SPAIN | SPAIN |TOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/2013
558NDA/MAL/HDP/1495WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPELOX-400PEFLOXACIN400MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP7/1/1997
559NDA/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, KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE7/1/1997
560NDA/MAL/HDP/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN |CHINA |PARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE7/1/2005
561NDA/MAL/HDP/1500MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA | NETHERLANDS |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2008
562NDA/MAL/HDP/1503MEDICAL UNION PHARMACUITICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT CREAMHYDROCORTISONE+CINCHOCAINE0.5%W/W + 0.5%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT |EGYPT |TOPICAL EXTERNAL OTHER CREAMS1.0X20.0 G TUBE7/1/2003
563NDA/MAL/HDP/1505GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALERSALMETEROL/ FLUTICASONE PROPIONATE25/50 MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX |
FRANCE |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON7/1/2007
564NDA/MAL/HDP/1506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 2000RECOMBINANT HUMAN ERYTHROPOIETIN2000 IUWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE7/1/2011
565NDA/MAL/HDP/1508DAWA LIMITED-SUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2009
566NDA/MAL/HDP/1509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDFEVEREXPARACETAMOL500MGBETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100, | KENYA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
567NDA/MAL/HDP/1516WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL PTRAMADOL/ PARACETAMOL37.5MG/ 325MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
568NDA/MAL/HDP/1517SHOSAAN ASIC PACIFICRENE PHARMACY LTDVEST MENTAMU BALMCOMPOUND METHYLSALICYLATEMULTI INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1998
569NDA/MAL/HDP/1525CIPLA LIMITED.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDBENDEXALBENDAZOLE20MG/5MLCIPLA LTD ,,-PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454775 | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2007
570NDA/MAL/HDP/1526FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B675MG + 75MG + 37MG + 37MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2015
571NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER7/1/2007
572NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1997
573NDA/MAL/HDP/1532BF BIOSCIENCES LTDHARLEYS UGANDA LIMITEDNOVAPRESSINTERLIPRESSIN1MG/VIALBF BIOSCIENCES LTD. -RAIWIND,PAKISTAN | PAKISTAN |PARENTERAL ORDINARY VIALS1.0X1.0 MG VIAL7/1/2014
574NDA/MAL/HDP/1533OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITED5DGLUCOSE50G/LOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2007
575NDA/MAL/HDP/1535ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFORTIWIN-4FORTIFIED PROCAINE PENICILLIN SODIUM4 M.UINJECT CARE PARENTERALS PVT LTD-PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X4.0 MU VIAL,1.0X100.0X4.0 MU VIAL,1.0X10.0X4.0 MU VIAL7/1/2011
576NDA/MAL/HDP/1538ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLE SUSPENSIONALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
|
KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2003
577NDA/MAL/HDP/1544GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
578NDA/MAL/HDP/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD-UNIT II, VILLAGE BHATAULI KALAN, BADDI SOLAN (HP) 173205 | UNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X5.0X2.0X10.0 CAPSULE BLISTER7/1/1999
579NDA/MAL/HDP/1549REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.PREDNICOL EYE DROPSPREDNISOLONE/CHLORAMPHENICOL5MG/2MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN |OPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/1999
580NDA/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) 18113 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2004
581NDA/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) 18113 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2004
582NDA/MAL/HDP/1554ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL CETIRIZINECETIRIZINE DIHYDROCHLORIDE5MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2010
583NDA/MAL/HDP/1555GALENTIC PHARMA LTDVITACARE LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
|
INDIA |TOPICAL EXTERNAL LIQUIDS1.0X500.0 ML BOTTLE7/1/2008
584NDA/MAL/HDP/1556VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDVOMISTATONDASENTRON2MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2014
585NDA/MAL/HDP/1557GLAXOSMITHKLINEUNITED HEALTHCARE DISTRIBUTORS 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 RIXENSART |BELGIUM |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE)7/1/2010
586NDA/MAL/HDP/1559LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDOLOMOLPARACETAMOL500MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X1.0X10.0 TABLET BLISTER7/1/2003
587NDA/MAL/HDP/1561LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDNEOVAGNYSTATIN10000IULINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
|
INDIA |VAGINAL TABLETS1.0X14.0 PESSARY STRIP7/1/2004
588NDA/MAL/HDP/1563GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN125MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE | FRANCE |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
589NDA/MAL/HDP/1566GITTOES PHARMACEUTICALS 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 INDIA | NULL |ORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2009
590NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDRHOCLONEMONOCLONAL ANTI-D IMMUNOGLOBULIN300MCGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
|
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X2.0 ML VIAL (1 DOSE VIAL)7/1/2013
591NDA/MAL/HDP/1572SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDROSUVAS 20ROSUVASTATIN20MGSUN PHARMACEUTICAL INDUSTRIES LIMITED (FORMERLY RANBAXY LABORATORIES LIMITED)-VILLAGE GANGUWALA. PAONTA SAHIB DISTRICT SIRMOUR - 173025 (H.P), INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2011
592NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER7/1/2003
593NDA/MAL/HDP/1579PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID100MG/MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE7/1/2011
594NDA/MAL/HDP/1581MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPANTOTABPANTOPRAZOLE40MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2006
595NDA/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 INDIA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
596NDA/MAL/HDP/1585WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDUDIHEP FORTEURSODEOXYCHOLIC ACID300MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2010
597NDA/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 INDIA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE7/1/1997
598NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA |INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE7/1/1997
599NDA/MAL/HDP/1598GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
600NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2005
601NDA/MAL/HDP/1616GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZINCETIRIZINE5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2011
602NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |VAGINAL GELS AND SOLS1.0X30.0 G TUBE7/1/2004
603NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
604NDA/MAL/HDP/1631AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO PHARMA LTD, UNIT III -SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2007
605NDA/MAL/HDP/1632: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM 1.2GAMOXICILLIN SODIUM + CLAVULANATE POTASSIUM1000MG +200MGALKEM LABORATORIES LTD .,.-VILLAGE THANA BADDI DIST-SOLAN TEHSIL NALAGARH HIMACHAL PRADESH 173205 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON + 1 AMPOULE OF WFI7/1/2005
606NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X1.0 G VIAL7/1/1997
607NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/2005
608NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRA WITH OPTIZORBPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | GRANULES INDIA LIMITED-SY. NO. 160/A, 161/E, 162 & 174/A GAGILLAPUR VILLAGE, DUNDIGAL-GANDIMAISAMMA MANDAL, MEDCHAL - MALKHAJGIRI DISTRICT - 500043 TELENGANA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON7/1/2003
609NDA/MAL/HDP/1642UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDEUCHLOR-1000CHLORAMPHENICOL SODIUM SUCCINNATE B.P1GUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA |PARENTERAL ORDINARY VIALS1.0X1.0 G VIAL7/1/2004
610NDA/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,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER7/1/2002
611NDA/MAL/HDP/1650NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL CR 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | ITALY |ORAL SOLID RETARD TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2006
612NDA/MAL/HDP/1652TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 300SODIUM VALPROATE300MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2009
613NDA/MAL/HDP/1656AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDAZIGYL-500AZITHROMYCIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER7/1/2015
614NDA/MAL/HDP/1660GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP7/1/2005
615NDA/MAL/HDP/1661ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIA 100/25LOPINAVIR/ RITONAVIR100MG/25MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2007
616NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE7/1/2003
617NDA/MAL/HDP/1665GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN CAPSULESAMOXICILLIN TRIHYDRATE250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1998
618NDA/MAL/HDP/1673GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN250MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE | GLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER7/1/2005
619NDA/MAL/HDP/1676KOPRAN LIMITEDTATA UGANDA LIMITEDCLOXIN-250CLOXACILLIN250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
620NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDCIPROLEBCIPROFLOXACIN500MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
621NDA/MAL/HDP/1680SHOSAAN ASIC PACIFICRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
622NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2005
623NDA/MAL/HDP/1685LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKONAZOLKETOCONAZOLE200MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
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INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER, 1.0X3.0X10.0 TABLET BLISTER7/1/2005
624NDA/MAL/HDP/1689SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDOMESKOMEPRAZOLE20MGS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/2010
625NDA/MAL/HDP/1690PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE1MG/MLPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2004
626NDA/MAL/HDP/1691WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN500MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT |EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER7/1/2011
627NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE7/1/2007
628NDA/MAL/HDP/1693PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDOPTIMAL (0.05%) CREAMTRETINOIN USP0.5MG/1GPHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN | JORDAN |TOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE7/1/2005
629NDA/MAL/HDP/1697PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
630NDA/MAL/HDP/1701KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFORMINMETFORMIN HYDROCHLORIDE500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
631NDA/MAL/HDP/1702PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDDELORCLOBETASOL PROPIONATE0.05%W/WPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |TOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2005
632NDA/MAL/HDP/1704DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM ILAC SAN. VE. TIC. A.S.-CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 | TURKEY |ORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2011
633NDA/MAL/HDP/1708LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDDENTAMOLACETAMINOPHEN500MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
|
KENYA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1997
634NDA/MAL/HDP/1709REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDLUCIN CREAMHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/1997
635NDA/MAL/HDP/1711KOPRAN LIMITEDTATA UGANDA LIMITEDAMYN-250AMOXYCILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
636NDA/MAL/HDP/1713MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLUMITERARTEMETHER + LUMEFANTRINE20 MG + 120 MGMACLEODS PHARMACEUTICALS LTD -BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X8.0 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 BLISTER7/1/2007
637NDA/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 SALAAM | TANZANIA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2011
638NDA/MAL/HDP/1716ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRMIN 5SMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA | INDIA |PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
639NDA/MAL/HDP/1719ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRMIN 10 PLUSMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
640NDA/MAL/HDP/1723USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT MULTIVITAMIN DROPSMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA |ORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE7/1/2000
641NDA/MAL/HDP/1724GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK | UNITED KINGDOM |NASAL TOPICAL SPRAYS WITHOUT GAS1.0X120.0 METERED DOSE CANNISTER7/1/2009
642NDA/MAL/HDP/1725REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL CREAM 1%CLOTRIMAZOLE1%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
643NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046 |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP7/1/2007
644NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2008
645NDA/MAL/HDP/1731REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDMEDIVEN-S OINTMENTBETAMETHASONE VALERATE + SALICYLIC ACID0.05%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
646NDA/MAL/HDP/1732MICRO LABS LTDLABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1999
647NDA/MAL/HDP/1734KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMOMINTCOMPOUND MAGNESIUM TRISILICATE500MGTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA | INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER7/1/1997
648NDA/MAL/HDP/1739MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMELOXMELOXICAM15MG MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2009
649NDA/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, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
650NDA/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, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
651NDA/MAL/HDP/1748GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER7/1/2011
652NDA/MAL/HDP/1749LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVITAMIN B COMPLEXVITAMIN B COMPLEXN/ALINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARAT | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2005
653NDA/MAL/HDP/1750AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIFLOXNORFLOXACIN0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
654NDA/MAL/HDP/1751AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIFUCINFUSIDIC ACID1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X5.0 ML AMPOULE7/1/2005
655NDA/MAL/HDP/1754AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIMOLTIMOLOL MALEATE0.5%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X5.0 ML VIAL7/1/2005
656NDA/MAL/HDP/1756AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICROM 2%SODIUM CROMOGLYCATE2%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
657NDA/MAL/HDP/1758AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICORTPREDNISOLONE ACETATE0.12%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
658NDA/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, JORDAN | JORDAN |OTIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
659NDA/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 411057 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/1/2014
660NDA/MAL/HDP/1762AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPITROPINATROPINE1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
661NDA/MAL/HDP/1763LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDASPIRIN TABLETS BPACETYL SALICYLIC ACID300MGLABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBI |KENYA |ORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1997
662NDA/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 AFRICA |ORAL LIQUID ORDINARY LIQUIDS1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER7/1/2006
663NDA/MAL/HDP/1765UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDRILIF PLUSACECLOFENAC + PARACETAMOL100MG + 500MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
664NDA/MAL/HDP/1766RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOLDEASE CAPSULESPARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE400MG+30MG+4MG+30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2005
665NDA/MAL/HDP/1767EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES -WIDE SPECTRUM ENTERPRISES (U) LIMITEDPROSTETROLALFUZOSIN HYDROCHLORIDE10MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
666NDA/MAL/HDP/1769GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN10MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART |BELGIUM |PARENTERAL ORDINARY VIALS1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE)7/1/1997
667NDA/MAL/HDP/1772SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDGESTID TABLETSCOMPOUND MAGNESIUM TRISILICATE385MGSUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET BLISTER7/1/2000
668NDA/MAL/HDP/1773MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2005
669NDA/MAL/HDP/1777CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNUZAC 20FLUOXETINE20MGCIPLA LTD ..-PLOT NO. 910 & 15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH 454775 | CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2003
670NDA/MAL/HDP/1778PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCONCIL 500MG CAPSULESAMOXYCILLIN TRIHYDRATE500MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
|
EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/1998
671NDA/MAL/HDP/1779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SOLUTIONPOVIDONE IODINE10.0G/100MLBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN |
PAKISTAN |TOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE7/1/2006
672NDA/MAL/HDP/1782GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
673NDA/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, KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE7/1/1997
674NDA/MAL/HDP/1784MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAZICURE-500AZITHROMYCIN500MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2005
675NDA/MAL/HDP/1785BETA HEALTHCARE UGANDA LIMITEDBETA 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,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER7/1/1997
676NDA/MAL/HDP/1786GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2001
677NDA/MAL/HDP/1790REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM TABLETCO-TRIMOXAZOLE480MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1997
678NDA/MAL/HDP/1795KOPRAN LIMITEDTATA UGANDA LIMITEDAMPIK-250AMPICILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
679NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER7/1/2006
680NDA/MAL/HDP/1797KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDAMPICILLIN+CLOXACILLINAMPICILLIN + CLOXACILLIN250 MG + 250 MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X10.0X500.0 MG VIAL7/1/2010
681NDA/MAL/HDP/1798INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDCARDITAS RETARDNIFEDIPINE20MG
| INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA |
INDIA |ORAL SOLID RETARD FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/1997
682NDA/MAL/HDP/1799INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSECZOL DSSECNIDAZOLE1GMINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
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INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2001
683NDA/MAL/HDP/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE10MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2009
684NDA/MAL/HDP/1801LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI |KENYA |VAGINAL TABLETS1.0X1.0X6.0 PESSARY STRIP7/1/1997
685NDA/MAL/HDP/1804TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LISTRILLISINOPRIL5MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2001
686NDA/MAL/HDP/1807GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMPICLOX NEONATAL DROPSAMPICILLIN + CLOXACILLIN60 MG / 0.6 ML + 30 MG / 0.6 MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X8.0 ML BOTTLE7/1/1997
687NDA/MAL/HDP/1809GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
688NDA/MAL/HDP/1810GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRITRIFLUOPERAZINE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2010
689NDA/MAL/HDP/1811CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIR TABLETSZIDOVUDINE+ LAMIVUDINE300MG + 150MG CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | UGANDAORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE7/1/2001
690NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |TOPICAL EXTERNAL OTHER OINTMENTS1.0X15.0 G TUBE7/1/2003
691NDA/MAL/HDP/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/1998
692NDA/MAL/HDP/1825RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCOLDEASE SYRUPPARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+2MG+15MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2005
693NDA/MAL/HDP/1827REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL SUSPENSIONALBENDAZOLE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2006
694NDA/MAL/HDP/1840REMEDICA LTDGOODMAN INTERNATIONAL LTDOVA-MITCLOMIPHENE50MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2011
695NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
696NDA/MAL/HDP/1842KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDSUGAQUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDA |UGANDA |ORAL SOLID ORDINARY OTHER COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2002
697NDA/MAL/HDP/1843USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058
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INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
698NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDTRIDEM PHARMA UGANDA LIMITEDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
699NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDANTAGIT 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. | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X170.0 ML BOTTLE7/1/2013
700NDA/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, KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
701NDA/MAL/HDP/1853MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDAERIUS ORAL SOLUTIONDESLORATADINE0.5MG/MLSCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG | BELGIUM |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X150.0 ML BOTTLE7/1/2007
702NDA/MAL/HDP/1854ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDFUROSEMIDE INJECTIONFUROSEMIDE10MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE7/1/2004
703NDA/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 AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
704NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDTRIDEM PHARMA UGANDA LIMITEDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM400MG /80MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
705NDA/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. | EGYPT |ORAL TOPICAL GELS AND SOLS1.0X15.0 G TUBE7/1/2004
706NDA/MAL/HDP/1864NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDPATANOLOLOPATADINE HYDROCHLORIDE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM |OPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/2009
707NDA/MAL/HDP/1877RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMINT-O-COOLDRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE120MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2007
708NDA/MAL/HDP/1879SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPENIVPHENOXYMETHYL PENICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
709NDA/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-361006 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2004
710NDA/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.
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INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2004
711NDA/MAL/HDP/1882SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2004
712NDA/MAL/HDP/1887KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOLPARACETAMOL500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
713NDA/MAL/HDP/1889KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PREDSOLPREDNISOLONE5MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON7/1/1997
714NDA/MAL/HDP/1891MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLEVOMAC 500LEVOFLOXACIN500MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER7/1/2005
715NDA/MAL/HDP/1892MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLEVOMAC 250LEVOFLOXACIN250MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER7/1/2012
716NDA/MAL/HDP/1895GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2007
717NDA/MAL/HDP/1898WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDZAPACID - 30LANSOPRAZOLE30MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
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INDIA |ORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER7/1/2001
718NDA/MAL/HDP/1900GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOM 20OMEPRAZOLE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP7/1/2007
719NDA/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 STATE |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
720NDA/MAL/HDP/1902KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMODIUMLOPERAMIDE HYDROCHLORIDE2MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
721NDA/MAL/HDP/1911COSMOS LTDASTRA PHARMA (U) LIMITEDCODEINE PHOSPHATE TABLETS BP 30CODEINE PHOSPHATE30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
722NDA/MAL/HDP/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2008
723NDA/MAL/HDP/1914RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCHLORPHENIRAMINECHLORPHENIRAMINE4MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2003
724NDA/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 ,D | INDIA |TOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/1999
725NDA/MAL/HDP/1920STRIDES ARCOLAB LTDROYAL PHARMA 2011 LIMITEDASCORBIC ACID TABLETASCORBIC ACID100MG STRIDES ARCO LAB LTD-K.R.S GARDENS SURAGAJAKKANAHALLI,INDLAWADI CROSS ANEKAL TALUK,BANGALORE | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
726NDA/MAL/HDP/1924ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL7/1/2013
727NDA/MAL/HDP/1927REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDINTAPLEX TABLETVITAMIN B COMPOUNDN/AREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER
728NDA/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, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
729NDA/MAL/HDP/1929CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
730NDA/MAL/HDP/1931ASTRAZENECAMACNAUGHTON LIMITEDZOLADEX LAGOSERELIN ACETATE10.8MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM |PARENTERAL RETARD PRE-FILLED SYRINGES1.0X10.8 MG IMPLANT7/1/2010
731NDA/MAL/HDP/1937AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ600MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2005
732NDA/MAL/HDP/1938YURIA-PHARM LTDPHARMA VILLE LIMITEDINFULGANPARACETAMOL10MG/MLYURIA-PHARM LLC MANUFACTURING SITE NO. 1-108, KOBZARSKA STREET, CHERKASY, 18030 | UKRAINE |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE7/1/2013
733NDA/MAL/HDP/1940REMEDICA LTDGOODMAN INTERNATIONAL LTDCLOXACILLIN CAPSULESCLOXACILLIN SODIUM250MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL | CYPRUS |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER7/1/2001
734NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL7/1/2005
735NDA/MAL/HDP/1942RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDAMCLORENAMPICILLIN + CLOXACILLIN250 MG + 250 MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER7/1/2009
736NDA/MAL/HDP/1943MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDNITROCONTIN 2.6NITROGLYCERIN (CONTROLLED RELEASE)2.6MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA |ORAL SOLID RETARD TABLETS1.0X25.0 TABLET CONTAINER7/1/2009
737NDA/MAL/HDP/1946WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDSOLUDOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
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INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS10.0X10.0 TABLET STRIP7/1/1998
738NDA/MAL/HDP/1948PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYDRATE500MGHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | ITALYORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER7/1/1998
739NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDVITACARE LIMITEDTRENAXA 500TRANEXAMIC ACID500MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X6.0 TABLET BLISTER7/1/2011
740NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCLOPI 75CLOPIDOGREL75MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP7/1/2006
741NDA/MAL/HDP/1954: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDRAPEED-20RABEPRAZOLE20MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP7/1/2011
742NDA/MAL/HDP/1956MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN250MGMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2006
743NDA/MAL/HDP/1958MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN125MG/5MLMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
|
INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2005
744NDA/MAL/HDP/1959MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDBETRIM 480CO-TRIMOXAZOLE480MGMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
745NDA/MAL/HDP/1960KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENACDICLOFENAC SODIUM50MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2003
746NDA/MAL/HDP/1963MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOFENAC GELDICLOFENAC1%W/WMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
|
INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X35.0 G TUBE7/1/2006
747NDA/MAL/HDP/1964MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLONEXCLOTRIMAZOLE1%W/WMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
|
INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2007
748NDA/MAL/HDP/1966MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPARACINPARACETAMOL500MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
749NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMACCETIRIZINE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
750NDA/MAL/HDP/1971GITTOES PHARMACEUTICALS 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,INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
751NDA/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-INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2013
752NDA/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
|
INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
753NDA/MAL/HDP/1977UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLOSAR-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
754NDA/MAL/HDP/1984ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDCIALISTADALAFIL20MGLILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRID | SPAIN |ORAL SOLID ORDINARY TABLETS2.0X2.0 TABLET BLISTER7/1/2004
755NDA/MAL/HDP/1988KUNMING PHARMACEUTICALS CORPSUPER PHARMACEUTICALS LIMITEDARTEMEDINE INJECTIONARTEMETHER80MG/MLKUNMING PHARMACEUTICAL CORP.-QIGONGLI, WEST SURBURB, KUNMING 650106 - YUNNAM PROVINCE, P.R. CHINA | CHINA |PARENTERAL ORDINARY I M AMPOULES1.0X8.0X1.0 ML AMPOULE7/1/1999
756NDA/MAL/HDP/1989FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDDERMOFIXSERTACONAZOLE NITRATE2%W/WFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2014
757NDA/MAL/HDP/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X2.0 TABLET BLISTER7/1/2005
758NDA/MAL/HDP/1997GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENA-100ATENOLOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X1000.0 TABLET JAR (WITH STATEMENT "FOR HOSPITAL USE ONLY".)7/1/2011
759NDA/MAL/HDP/1999TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CARBATOL 200CARBAMAZEPINE200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER7/1/2000
760NDA/MAL/HDP/2000TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CALCIGARD RETARDNIFEDIPINE(SR)20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA |ORAL SOLID RETARD TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER7/1/2000
761NDA/MAL/HDP/2005AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA-100SILDENAFIL CITRATE100MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2005
762NDA/MAL/HDP/2007GITTOES PHARMACEUTICALS 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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2001
763NDA/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 ,D | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2004
764NDA/MAL/HDP/2009COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN200MG/5MLCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
765NDA/MAL/HDP/2012GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID -B- LOTIONCLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE1%W/V + 0.025%W/VGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |TOPICAL EXTERNAL LOTIONS1.0X15.0 ML BOTTLE7/1/2004
766NDA/MAL/HDP/2014SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCANI-MAKSCLOTRIMAZOLE1%W/W S KANT HEALTHCARE LTD-1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE7/1/2009
767NDA/MAL/HDP/2016GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID CREAMCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
768NDA/MAL/HDP/2018CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDORAXIN SYRUPCYPROHEPTADINE+TRICHOLINE CITRATE2MG+275MGCENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
769NDA/MAL/HDP/2019GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOHALHALOPERIDOL10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
770NDA/MAL/HDP/2020KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDQUINEQUININE SULPHATE300MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER7/1/1997
771NDA/MAL/HDP/2021PHARCO 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
|
EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X12.0X2.0 CAPSULE BLISTER7/1/2000
772NDA/MAL/HDP/2022MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTORACTINCYPROHEPTADINE2MG/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1997
773NDA/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.) | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
774NDA/MAL/HDP/2025REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDFERRO-B COMPLEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
775NDA/MAL/HDP/2026BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 10MGAMLODIPINE BESYLATE10MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN |
PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2009
776NDA/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 HOUSING |JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
777NDA/MAL/HDP/2031GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZID TABLETSISONIAZID100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
778NDA/MAL/HDP/2033MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-50LOSARTAN POTASSIUM50MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2009
779NDA/MAL/HDP/2035KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDNEOSIDARSULPHADOXINE + PYRIMETHAMINE500MG + 25MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER7/1/2004
780NDA/MAL/HDP/2036ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN REGULARHUMAN INSULIN100IUELI LILLY & COMPANY-LILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221 | LILLY FRANCE SA-FRANCE | FRANCE |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE7/1/1998
781NDA/MAL/HDP/2040AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0X12.0 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,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER7/1/2006
782NDA/MAL/HDP/2042SHOSAAN ASIC PACIFICRENE PHARMACY LTDBURNCURESILVER SULFADIAZINE1%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
783NDA/MAL/HDP/2043COSMOS LTDASTRA PHARMA (U) LIMITEDDIASTOP TABLETSATTAPULGITE/ ALUMINIUM HYDROXIDEN/ACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP7/1/1998
784NDA/MAL/HDP/2046COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINALORATADINE10MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
785NDA/MAL/HDP/2047MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDRITONAVIRRITONAVIR100MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE7/1/2011
786NDA/MAL/HDP/2049WOCKHARDT LTDSTAR PHARMACEUTICALS LTDKEFSTAR-500CEFUROXIME AXETIL500MGSANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET STRIP,1.0X1.0X10.0 TABLET BLISTER7/1/2005
787NDA/MAL/HDP/2053EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-5AMLODIPINE BESILATE5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2005
788NDA/MAL/HDP/2055SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE120MGGUILIN PHARMACEUTICAL CO. LTD.-NO. 43 QILIDIAN ROAD, GUILIN 541004 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X120.0 MG VIAL + 1 *2 ML AMPOULE OF 5% SODIUM BICARBONATE SOLUTION + 1*10 ML AMPOULE OF 0.9% SODIUM CHLORIDE7/1/2011
789NDA/MAL/HDP/2056WOCKHARDT LTDSTAR PHARMACEUTICALS LTDBRO-ZEDEXTERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL1.25MG+ 4 MG+50 MG+2.5 MG/5 MLWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
790NDA/MAL/HDP/2058MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDQUININE SULPHATEQUININE SULPHATE300MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2006
791NDA/MAL/HDP/2062SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN PAEDIATRIC SYRUPDEXTROMETHORPHAN HYDROBROMIDE BP + CHLORPHENIRAMINE MALEATE BP + AMMONIUM CHLORIDE BP + PSEUDOEPHEDRINE HYDROCHLORIDE BP(5MG + 2MG + 50MG + 10MG)/ 5MLBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD |TANZANIA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2006
792NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL.0.15MG / 0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X1.0X28.0 TABLET BLISTER7/1/1997
793NDA/MAL/HDP/2066REMEDICA LTDGOODMAN INTERNATIONAL LTDMETHOTREXATEMETHOTREXATE2.5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
794NDA/MAL/HDP/2067UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDZYNCETCETIRIZINE DIHYDROCHLORIDE10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X5.0X10.0 TABLET BLISTER7/1/1999
795NDA/MAL/HDP/2068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDDOMADOLTRAMADOL HYDROCHLORIDE50MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1999
796NDA/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. | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2010
797NDA/MAL/HDP/2070BAYER PHARMA AGSURGIPHARM (U) LIMITEDMIRENALEVONORGESTREL52MGBAYER OY-PANSIONATE 47 20210 TURKU FINLAND |FINLAND |PARENTERAL RETARD IMPLANTS1.0X1.0 IMPLANT CARTON7/1/2009
798NDA/MAL/HDP/2071CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR DRY SYRUPCEFALEXIN125MG/5MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2000
799NDA/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, INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 DOSE VIAL + 0.5ML AMPOULE OF STERILE WATER FOR INJECTION,1.0X10.0 DOSE VIAL + 5ML AMPOULE OF STERILE WATER FOR INJECTION7/1/1997
800NDA/MAL/HDP/2074GITTOES PHARMACEUTICALS 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,INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
801NDA/MAL/HDP/2075GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPREDPREDNISOLONE5MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2006
802NDA/MAL/HDP/2076GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMIDEFUROSEMIDE40MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2006
803NDA/MAL/HDP/2077ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2007
804NDA/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 500078 | INDIA |PARENTERAL ORDINARY VIALS1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL)7/1/2015
805NDA/MAL/HDP/2087ABBVIE LOGISTICS BVMEDICAL ACCESS (UGANDA) LIMITEDNORVIRRITONAVIR100MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
806NDA/MAL/HDP/2090RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCIPRORENCIPROFLOXACIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
807NDA/MAL/HDP/2091KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCAMSTONCLOTRIMAZOLE1%W/WKPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDA |UGANDA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2001
808NDA/MAL/HDP/2093CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TRIGAN-D TABLETPARACETAMOL + DICYCLOMINE500MG + 20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP7/1/1999
809NDA/MAL/HDP/2094MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT-750LEVOFLOXACIN HEMIHYDRATE750MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
810NDA/MAL/HDP/2095GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2010
811NDA/MAL/HDP/2098GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO QUININEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2006
812NDA/MAL/HDP/2101COSMOS LTDASTRA PHARMA (U) LIMITEDCARDISPRINACETYL SALICYLIC ACID75MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
813NDA/MAL/HDP/2102MEDREICH PLCSURGIPHARM (U) LIMITEDFLEMING 625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2006
814NDA/MAL/HDP/2103MEDREICH PLCSURGIPHARM (U) LIMITEDFLEMING 1000 TABAMOXYCILLIN + CLAVULANATE POTASSIUM875 MG + 125 MGMEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2006
815NDA/MAL/HDP/2104MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE/NEVIRAPINE /ZIDOVUDINE DISPERSIBLE TABLETSLAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG + 50MG + 60MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET BOTTLE7/1/2009
816NDA/MAL/HDP/2111HETERO LABS LTDAIVEEN (U) 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 PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2011
817NDA/MAL/HDP/2112MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR200MG + 50MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2008
818NDA/MAL/HDP/2116MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAMLOVAS-10AMLODIPINE BESILATE10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET STRIP7/1/2005
819NDA/MAL/HDP/2122ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYMOLPARACETAMOL120MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
820NDA/MAL/HDP/2125CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDBECLATE 100BECLOMETASONE100MCG/DOSECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |NASAL SYSTEMIC METERED-DOSE LIQUIDS1.0X200.0 METERED DOSE CANNISTER7/1/2009
821NDA/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),INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2010
822NDA/MAL/HDP/2133NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPIDHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE | NOVO NORDISK PRODUCTION SAS-45 AVENUE D’ORLEANS, 28000 CHARTRES, FRANCE | DENMARK |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/1997
823NDA/MAL/HDP/2136MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT SUPOSITORYHYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN5MG + 5MG +10MG +10MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT |EGYPT |TOPICAL EXTERNAL SUPPOSITORIES1.0X6.0 SUPPOSITORY STRIP7/1/2003
824NDA/MAL/HDP/2141CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDINFLAZONEMULTIINGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2005
825NDA/MAL/HDP/2144EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICOTILTENOXICAM20MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA |EGYPT |PARENTERAL ORDINARY VIALS1.0X3.0 VIAL CARTON + 1*3*2ML WFI AMPOULE7/1/2014
826NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |PARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/1997
827NDA/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 USA | UNITED STATES |PARENTERAL ORDINARY S C VIALS1.0X4.0 ML VIAL,1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE7/1/1999
828NDA/MAL/HDP/2151USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 850METFORMIN850MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
829NDA/MAL/HDP/2154ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYNASEGLIPIZIDE5MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
830NDA/MAL/HDP/2156ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRPID 10 INTRAVENOUS FAT EMULSIONSOYA OIL10%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2011
831NDA/MAL/HDP/2158ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRPIDINTRAVENOUS FAT EMULSION20%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
832NDA/MAL/HDP/2160EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDACEM-500CLARITHROMYCIN500MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2005
833NDA/MAL/HDP/2161REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX CREAMACICLOVIR5%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/1997
834NDA/MAL/HDP/2165RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2014
835NDA/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. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2011
836NDA/MAL/HDP/2173GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVO-500LEVOFLOXACIN500MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X5.0 TABLET BLISTER7/1/2003
837NDA/MAL/HDP/2175CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLADONPARACETAMOL500MGCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE €“II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH | INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP7/1/2005
838NDA/MAL/HDP/2176INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDRISPITAS-2RISPERIDONE2MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2011
839NDA/MAL/HDP/2181KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PHENPHENOXYMETHYLPENICILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,250.0 TABLET CONTAINER7/1/1997
840NDA/MAL/HDP/2185GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDROTARIXLIVE ATTENUATED RIX4414 STRAIN OF HUMAN ROTAVIRUS OF THE G1P[8] TYPENOT LESS THAN 10? CCID?? OF THE RIX4414 STRAINGLAXOSMITHKLINE AUSTRALIA.-GLAXOSMITHKLINE AUSTRALIA, 1061 MOUNTAIN HIGHWAY, BORONIA, VICTORIA, 3155 AUSTRALIA | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM |ORAL LIQUID ORDINARY LIQUIDS1.0X1.5 ML TUBE (1 DOSE),1.0X50.0X1.5 ML TUBE (1 DOSE),1.0X7.5 ML TUBE (5-DOSE) FOR GAVI/UNICEF SUPPLY ONLY7/1/2013
841NDA/MAL/HDP/2186ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL DIPHENHYDRAMINE PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE7MG+67.5MG/5MLKOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
|
MALAYSIA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2008
842NDA/MAL/HDP/2189ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL BETAMETHASONEBETAMETHASONE0.1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/2008
843NDA/MAL/HDP/2191LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN250MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI |KENYA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
844NDA/MAL/HDP/2197LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
|
KENYA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/1997
845NDA/MAL/HDP/2199MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 50MCGLEVOTHYROXINE SODIUM50MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER1/7/2013
846NDA/MAL/HDP/2208ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL CEPHALEXINCEPHALEXIN MONOHYDRATE500MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2010
847NDA/MAL/HDP/2211GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDBENZYL BENZOATEBENZYL BENZOATE25%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
|
INDIA |TOPICAL EXTERNAL EMULSIONS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE7/1/2005
848NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081 |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
849NDA/MAL/HDP/2214ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDGENTAMICIN INJECTIONGENTAMICIN SULPHATE40MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | SCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE7/1/1997
850NDA/MAL/HDP/2216GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOCLOPRAMIDEMETOCLOPRAMIDE5MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2005
851NDA/MAL/HDP/2217GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMINOPHYLINEAMINOPHYLLINE20MGNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X50.0X10.0 ML AMPOULE7/1/2005
852NDA/MAL/HDP/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER,1.0X2.0X15.0 TABLET BLISTER7/1/1997
853NDA/MAL/HDP/2220CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 5AMLODIPINE BESYLATE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER7/1/2003
854NDA/MAL/HDP/2226WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ GRANULESL-ORNITHINE-L-ASPARTATE3G/5GWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA |ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X10.0X5.0 G SACHET7/1/2004
855NDA/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 HOUSING |JORDAN |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
856NDA/MAL/HDP/2235WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-NINSULIN HUMAN(RECOMBINANT DNA ORIGIN)100IU/MLWOCKHARDT-WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA | INDIA |PARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL7/1/2006
857NDA/MAL/HDP/2236NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | ITALY |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/1997
858NDA/MAL/HDP/2237WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-30/70INSULIN HUMAN(RECOMBINANT DNA ORIGIN)100I.U/MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X3.0 ML VIAL7/1/2006
859NDA/MAL/HDP/2239NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL ORAL SUSPENSIONCARBAMAZEPINE20MG/MLDELPHARMA HUNINGUE S.A.S-26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCE | FRANCE |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2006
860NDA/MAL/HDP/2242REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX 200 TABLETSACYCLOVIR200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/1997
861NDA/MAL/HDP/2248GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDTETRACYCLINE OPHTHALMICTETRACYCLINE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA | INDIA |OPHTHALMIC OINTMENTS1.0X3.5 G TUBE,1.0X5.0 G TUBE7/1/2004
862NDA/MAL/HDP/2249WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-RINSULIN100MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA |PARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL7/1/2006
863NDA/MAL/HDP/2254MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDBURN CUR CREAMACRIFLAVINE/THYMOLN/ATORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1998
864NDA/MAL/HDP/2256GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN 457MG/5MLAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MG / 5 MLGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE | UNITED KINGDOM |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X70.0 ML BOTTLE7/1/2010
865NDA/MAL/HDP/2258MYLAN LABORATORIES LIMITED (OTL)KIMSY 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 ZONE | QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA. |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE,1.0X1.0X30.0 TABLET BOTTLE7/1/2009
866NDA/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, AHMADABAD | INDIA |PARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE7/1/2001
867NDA/MAL/HDP/2265HETERO DRUGS LTDAIVEEN (U) 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 PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2010
868NDA/MAL/HDP/2267MYLAN LABORATORIES LIMITED (OTL)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 MAHARASTRA | QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA. |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2007
869NDA/MAL/HDP/2269DAWA LIMITEDSUPER MEDIC LTDDAWAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
870NDA/MAL/HDP/2271IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDARTEMETHER 20MG/LUMEFANTRINE 120MGARTEMETHER + LUMEFANTRINE20MG + 120MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X6.0 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,1.0X30.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X10.0X4.0X6.0 TABLET BLISTER7/1/2010
871NDA/MAL/HDP/2272AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLARANTA -500CLARITHROMYCIN500MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X2.0X10.0 TABLET BLISTER7/1/2005
872NDA/MAL/HDP/2280REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.BETADROP-NBETAMETHASONE + NEOMYCIN0.1 %W/V + 0.5 %W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN |OPHTHALMIC DROPS1.0X7.5 ML VIAL7/1/1999
873NDA/MAL/HDP/2281SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDLUMFORTLORATADINE10MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
874NDA/MAL/HDP/2282GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROPANPROPRANOLOL40MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
875NDA/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, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)7/1/1997
876NDA/MAL/HDP/2287GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON7/1/1997
877NDA/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, INDIA |
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2008
878NDA/MAL/HDP/2292MEDREICH PLCSURGIPHARM (U) LIMITEDFLEMING 1200AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE1000MG + 200MGNATCO PHARMA LTD-VIJAYAPUR, NORTH NAGARIJUNA SAGA,INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X5.0X20.0 ML VIAL7/1/2007
879NDA/MAL/HDP/2293GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIOCONTIOCONAZOLE1%W/WGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2005
880NDA/MAL/HDP/2295DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 10ROSUVASTATIN CALCIUM10MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
881NDA/MAL/HDP/2297DAWA LIMITEDSUPER MEDIC LTDSABULIN SYRUPSALBUTAMOL SULPHATE2MG/5MLDAWA LIMITED -BABA DOGO RWARAKA |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2008
882NDA/MAL/HDP/2298MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
883NDA/MAL/HDP/2299DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 20ROSUVASTATIN CALCIUM20MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
884NDA/MAL/HDP/2303MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
885NDA/MAL/HDP/2304MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 10/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE10 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
886NDA/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 GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
887NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X35.0 TABLET BLISTER7/1/2010
888NDA/MAL/HDP/2312REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER7/1/2006
889NDA/MAL/HDP/2313REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 375AMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER7/1/2006
890NDA/MAL/HDP/2314MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDRABEMAC-20RABEPRAZOLE SODIUM20MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2005
891NDA/MAL/HDP/2315MICRO LABS LTDLABOREX 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 560 099 | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2006
892NDA/MAL/HDP/2318MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE-4GLIMEPIRIDE4MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2006
893NDA/MAL/HDP/2319COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOLPARACETAMOL120MG/5MLCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1998
894NDA/MAL/HDP/2320GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDERO-125 DRY SYRUPERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2006
895NDA/MAL/HDP/2322EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTREFLUCANFLUCONAZOLE150MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA |EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X2.0X1.0 CAPSULE STRIP7/1/2007
896NDA/MAL/HDP/2324SWISS PARENTERALS LTDSHREEJI CARE LIMITEDSWISSCLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X7.5 ML VIAL7/1/2011
897NDA/MAL/HDP/2326EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDSYLATE-500ETAMSYLATE50MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X6.0 TABLET STRIP7/1/2004
898NDA/MAL/HDP/2330NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCOARTEMARTEMETHER + LUMEFANTRINE20MG + 120MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND | NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY | SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X24.0 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,1.0X4.0X6.0 TABLET BLISTER7/1/2005
899NDA/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, INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)7/1/1997
900NDA/MAL/HDP/2334SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES MUMPS & RUBELLAMEASLES VIRUS+MUMPS VIRUS+RUBELLA VIRUSNLT 1000 CCID50+NLT 5000 CCID50 +NLT1000 CCID50SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT7/1/1997
901NDA/MAL/HDP/2335GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2001
902NDA/MAL/HDP/2338GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE | FRANCE |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE7/1/2003
903NDA/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. PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER7/1/2007
904NDA/MAL/HDP/2342AUROBINDO PHARMA LTD UNIT VIIPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGAUROBINDO PHARMA LIMITED, UNIT III-SURVEY NO. 313 & 314, BACHUPALLY (MANDAL), MEDCHAL - MALKAJGIRI (DISTRICT) - 500090 TELENGANA (STATE) | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2007
905NDA/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, INDIA | INDIA |PARENTERAL ORDINARY I M VIALS1.0X10.0X10.0 ML VIAL (10 DOSE VIAL),1.0X50.0X1.0 ML VIAL (1 DOSE VIAL)7/1/2005
906NDA/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, NAIROBI | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X1.0X12.0 CAPSULE BLISTER7/1/2007
907NDA/MAL/HDP/2353ASTRA ZENECAMACNAUGHTON LIMITEDNEXIUMESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE)10MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN |ORAL SOLID ORDINARY GRANULES1.0X28.0 SACHET CARTON7/1/2013
908NDA/MAL/HDP/2354STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2006
909NDA/MAL/HDP/2356GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININEQUININE DIHYDROCHLORIDE600MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2005
910NDA/MAL/HDP/2357ACINO PHARMA AGGOODMAN INTERNATIONAL LTDTRABILIN- 50 CAPSULESTRAMADOL50MGMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2003
911NDA/MAL/HDP/2359REMEDICA LTDGOODMAN INTERNATIONAL LTDASPIREM 75ASPIRIN75MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X2.0X28.0 TABLET BLISTER7/1/2007
912NDA/MAL/HDP/2360ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDFUNGISTIN PESSARIESNYSTATIN100000 IUELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | INDIA |VAGINAL TABLETS1.0X14.0 PESSARY PACK,5.0X3.0 PESSARY STRIP,1.0X100.0 PESSARY CONTAINER7/1/2002
913NDA/MAL/HDP/2361REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAREM 500CLARITHROMYCIN500MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2007
914NDA/MAL/HDP/2362GALENTIC PHARMA LTDVITACARE LIMITEDCANDISTATIN OINTMENTNYSTATIN100,000I.UGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
|
INDIA |TOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2009
915NDA/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, CHINA | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE7/1/2005
916NDA/MAL/HDP/2364AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDVOXEL-500LEVOFLOXACIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2015
917NDA/MAL/HDP/2367REMEDICA LTDGOODMAN INTERNATIONAL LTDFELEXIN 125CEPHALEXIN MONOHYDRATE125MG/5MLREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
918NDA/MAL/HDP/2368REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDERMIDEX CREAMMICONAZOLE NITRATE2%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
919NDA/MAL/HDP/2371PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIZONE CREAMFUSIDIC ACID + BETAMETHASONE VALERATE20MG/G+1MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
920NDA/MAL/HDP/2375GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULIN 1GAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X1.0X7.0 TABLET BLISTER7/1/2010
921NDA/MAL/HDP/2379PT SANBE FARMAMEDVIN PHARMA LIMITEDPUMPITOROMEPRAZOLE40MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT7/1/2014
922NDA/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.
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
923NDA/MAL/HDP/2384PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCLARIX 500CLARITHROMYCIN500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2007
924NDA/MAL/HDP/2385COSMOS LIMITEDASTRA PHARMA (U) LIMITEDCOZEPAM 5MGDIAZEPAM5MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2000
925NDA/MAL/HDP/2387DAWA LIMITEDSUPER MEDIC LTDVERMOUTMEBENDAZOLE100MG/5MLDAWA LIMITED -BABA DOGO RWARAKA |KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2010
926NDA/MAL/HDP/2388DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE400MG + 57MGBILIM ILAC SAN. VE. TIC. A.S.-CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 | TURKEY |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2011
927NDA/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-INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE,1.0X120.0 ML BOTTLE7/1/2008
928NDA/MAL/HDP/2391BIOMATRIX HEALTHCARE PVT LTDMEDIWORLD PHARMA AFRICA LTDHEADAID TABLETSASPIRIN + CAFFEINE + PARACETAMOL300MG + 30MG + 250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP7/1/1997
929NDA/MAL/HDP/2394MERCK SHARP & DOHME BV.SURGIPHARM (U) LIMITEDSTOCRINEFAVIRENZ600MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES€™ REPUBLIC OF CHINA | CHINA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2004
930NDA/MAL/HDP/2395A.MENARINI INDUSTRIE FARMACEUTICHE S.R.ISTAR PHARMACEUTICALS LTDFASTUM GELKETOPROFEN2.5%W/WA. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA SETTE SANTI 3, 50131 FIRENZE-ITALY | ITALY |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE7/1/2005
931NDA/MAL/HDP/2399SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDVOLINIMULTI INGREDIENTMULTI INGREDIENTSUN PHARMACEUTICAL IND. LTD-PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 | INDIA |TOPICAL EXTERNAL OTHER GELS/SOLS1.0X1.0X30.0 G TUBE7/1/2005
932NDA/MAL/HDP/2400PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIDIC 2%FUSIDIC ACID20MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
933NDA/MAL/HDP/2401MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDENATNATURAL VITAMIN E400IUMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 |THAILAND |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2005
934NDA/MAL/HDP/2404UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDLOSAR 50LOSARTAN POTASSIUM50MGUNICHEM LABORATORIES LTD---VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
935NDA/MAL/HDP/2409TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.DEPLATTCLOPIDOGREL75MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2004
936NDA/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, INDIA | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE7/1/2010
937NDA/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-361006 | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
938NDA/MAL/HDP/2415CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSOLINA TABLETSDIAZEPAM5MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/1997
939NDA/MAL/HDP/2423MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDATORIN ATORVASTATIN10MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
940NDA/MAL/HDP/2426MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPROBEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2000
941NDA/MAL/HDP/2427SHOSAAN ASIC PACIFICRENE PHARMACY LTDCLONEMCLOTRIMAZOLE1%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1997
942NDA/MAL/HDP/2428DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDCLOTRI-DENK 1% CREAMCLOTRIMAZOLE1%W/WC.P.M. CONTRACTPHARMA GMBH & COMPANY KG-FRUHLINGSTR. 7, 83620 FELDKIRCHEN - WESTERHAM | GERMANY |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1998
943NDA/MAL/HDP/2429DENK PHARMA GMBH & CO. KGBENLE 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,GERMANY | GERMANY |VAGINAL TABLETS1.0X6.0 PESSARY CARTON7/1/1998
944NDA/MAL/HDP/2431CADILA HEALTH CARE LIMITEDABACUS 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 382210 | INDIA |LUNG ADMINISTRATION METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON7/1/2007
945NDA/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 382210 | INDIA |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2007
946NDA/MAL/HDP/2438INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENACACECLOFENAC100MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2006
947NDA/MAL/HDP/2451ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN 75 SRDICLOFENAC SODIUM75 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH | SWITZERLAND |ORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2004
948NDA/MAL/HDP/2452REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDDELASED CHEST COUGH SYRUP (NON DROWSY)GUAIFENESIN + MENTHOL100MG/5ML + 1.1MG/5MLREGAL PHARMACEUTICALS-PLOT 7879/18 BABA DOGO ROAD NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2007
949NDA/MAL/HDP/2460COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS 2MGBENZHEXOL HCL2MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2000
950NDA/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, RUARAKA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN7/1/1997
951NDA/MAL/HDP/2467CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDNOKLOTCLOPIDOGREL75MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2003
952NDA/MAL/HDP/2472SHOSAAN ASIC PACIFICRENE PHARMACY LTDTRAN-GELDICLOFENAC DIETHYLAMMONIUM1%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE,1.0X20.0 G TUBE7/1/2011
953NDA/MAL/HDP/2473MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUGRELCLOPIDOGREL75MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2010
954NDA/MAL/HDP/2475WIN-MEDICURE LTDSURGIPHARM (U) LIMITEDURGENDOL INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA |PARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE7/1/2001
955NDA/MAL/HDP/2476GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDDERIVA AQUEOUS GELADAPALENE0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2003
956NDA/MAL/HDP/2478WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL PLUSPARACETAMOL+DICLOFENAC500MG+50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
957NDA/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.
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2012
958NDA/MAL/HDP/2497CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIMUNENEVIRAPINE50MG/5MLCIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,
SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA |
INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2004
959NDA/MAL/HDP/2500MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCHLORAMPHENICOL SODIUM SUCCINATE INJECTION BPCHLORAMPHENICOL SODIUM SUCCINATE1GMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2007
960NDA/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, PAKISTAN | PAKISTAN |OPHTHALMIC DROPS1.0X7.5 ML VIAL7/1/1997
961NDA/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
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X50.0X1.0X4.0 TABLET STRIP7/1/2008
962NDA/MAL/HDP/2506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDNADOXINNADIFLOXACIN1%W/WWOCKHARDT LTD -VILLAGE KUNJHAL P.O BAROTIWALA DIST SOLAN HIMACHAL PRADESH |INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X20.0 G TUBE7/1/2011
963NDA/MAL/HDP/2507CIPLA LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEXERMET 1000METFORMIN HCL1000MGCIPLA LIMITED ,.,.-VILLAGE UPPER MALPUR, P.O. BHUD, THE. NALAGARH DISTRICT SOLAN HIMACHAL PRADESH PIN 173205 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2007
964NDA/MAL/HDP/2508GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHYOSCINEHYOSCINE20MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANG |CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2011
965NDA/MAL/HDP/2509BETA HEALTHCARE UGANDA LIMITEDBETA 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,KENYA | KENYA |TOPICAL EXTERNAL LOTIONS1.0X50.0 ML BOTTLE7/1/1997
966NDA/MAL/HDP/2510PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDGIROORDNIDAZOLE500MGPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X2.0X10.0 TABLET BLISTER7/1/2013
967NDA/MAL/HDP/2512ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDDICLOFENAC SODIUM INJECTABLE SOLUTIONDICLOFENAC SODIUM25MG/ML WUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE,1.0X10.0X3.0 ML AMPOULE7/1/2009
968NDA/MAL/HDP/2513REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN DRY SYRUPPHENOXYMETHYLPENICILLIN125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
969NDA/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.
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
970NDA/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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
971NDA/MAL/HDP/2523SHOSAAN ASIC PACIFICRENE PHARMACY LTDSULPHUR OINTMENTSULPHUR10%W/WNEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/1997
972NDA/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
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
973NDA/MAL/HDP/2525DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 100 RETARDDICLOFENAC SODIUM100MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY |ORAL SOLID RETARD TABLETS10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/1998
974NDA/MAL/HDP/2526REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN COMBI PACKCLOTRIMAZOLE500MG & 1 %W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |VAGINAL COMBINATION PACK TABLETS1.0X1.0 PESSARY BLISTER + 1*20G TUBE7/1/2009
975NDA/MAL/HDP/2528LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABESTENCLOTRIMAZOLE1%W/WLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI |KENYA |TOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE7/1/1997
976NDA/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. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
977NDA/MAL/HDP/2553GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZ-20ESOMEPRAZOLE20MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP7/1/2003
978NDA/MAL/HDP/2554GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZESOMEPRAZOLE40MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP7/1/2005
979NDA/MAL/HDP/2555COSMOS LTDASTRA PHARMA (U) LIMITEDPHENOBARBITONE TABLETS BP 30MGPHENOBARBITONE30MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER7/1/1998
980NDA/MAL/HDP/2557REMEDICA LTDGOODMAN INTERNATIONAL LTDEPSITRON 25 TABLETSCAPTOPRIL25MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1999
981NDA/MAL/HDP/2562ACINO PHARMA AGGOODMAN INTERNATIONAL LTDTRABILIN-100TRAMADOL100MG/2MLMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY |PARENTERAL ORDINARY AMPOULES1.0X1.0X5.0X2.0 ML AMPOULE7/1/2005
982NDA/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 382210 | INDIA |PARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE,1.0X5.0X2.0 ML AMPOULE7/1/2001
983NDA/MAL/HDP/2567CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCIPROBID-500CIPROFLOXACIN500MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | S.KANT HEALTHCARE LIMITED--PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIA | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/1997
984NDA/MAL/HDP/2568GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL500MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON7/1/1997
985NDA/MAL/HDP/2570REMEDICA LTDGOODMAN INTERNATIONAL LTDAMOXAPEN 250 CAPSULESAMOXYCILLIN250MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,100.0X10.0 CAPSULE BLISTER7/1/1997
986NDA/MAL/HDP/2571GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
987NDA/MAL/HDP/2578REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMAGNOMINT TABLETSALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE125MG + 250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1997
988NDA/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, 64, 65 JAWAHAR CO-OP INDUSTRIAL ESTATE KAMOTHE, PANVEL NAVI MUMBAI | KESAR PHARMA PVT LTD-PLOT SURVEY NO. 50/2. VILLAGE BILESHWARPURA CHHATRAL- -382729 TA. KALOL, DIST. GANDHINAGAR GUJARAT | KENYA |ORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP7/1/1998
989NDA/MAL/HDP/2593DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDATENOLOL DENK 50ATENOLOL50MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
990NDA/MAL/HDP/2594GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2009
991NDA/MAL/HDP/2597E DENK OHGBENLE CONSULT LIMITEDPARA DENK 250PARACETAMOL250MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANY | BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY | GERMANY |RECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP7/1/2005
992NDA/MAL/HDP/2600IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDCLARIE-ODCLARITHROMYCIN(EXTENTED RELEASE)500MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X1.0X7.0 TABLET BLISTER7/1/2008
993NDA/MAL/HDP/2602: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM BIDAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MG/ 5 ML INDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2010
994NDA/MAL/HDP/2603CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDVIRADAYTENOFOVIR + 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 GOA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2011
995NDA/MAL/HDP/2604USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT SYRUPMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2000
996NDA/MAL/HDP/2610GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDATROPINEATROPINE1MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN |CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
997NDA/MAL/HDP/2628MICRO LABS LTDLABOREX UGANDA LIMITEDAZILIDE-500AZITHROMYCIN500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2004
998NDA/MAL/HDP/2641MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 250MGCEFUROXIME AXETIL250MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP7/1/2014
999NDA/MAL/HDP/2642MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMEDOXANUMCEFTRIAXONE1GMEDOCHEMIE (FACTORY C)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL | CYPRUS |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML AMPOULE WFI7/1/2009
1000NDA/MAL/HDP/2645SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANZIDIME 1000CEFTAZIDIME1000MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
|
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL7/1/2010
1001NDA/MAL/HDP/2647DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDIBUPROFEN DENK 400MGIBUPROFEN400MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1002NDA/MAL/HDP/2648E DENK OHGBENLE CONSULT LIMITEDPARA DENK 125PARACETAMOL125MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANY | BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY | GERMANY |RECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP7/1/2005
1003NDA/MAL/HDP/2650DENK PHARMABENLE CONSULT LIMITEDVIT-B-DENKTHIAMINE HCL + PYRIDOXINE HCL100MG + 200MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 MÜNCHEN, GÖLLSTR. 1, 84529 TITTMONING, GERMANY | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1004NDA/MAL/HDP/2651REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINAVIT SYRUPMULTIVITAMINMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1005NDA/MAL/HDP/2654MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.BEBE VITVITAMIN A+ VITAMIN D3+VITAMIN E+ VITAMIN C +VITAMIN B1 + VITAMIN B21500IU+ 400IU+ 5MG+ 40MG+0.5MG+0.6MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT |ORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE7/1/2006
1006NDA/MAL/HDP/2656ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDAMINOPHYLLINEAMINOPHYLLINE100MGSCOTT-EDIL PHARMACIA LTD (UNIT I)-56, EPIP, PHASE-1, JHARMAJRI, BADDI, DISTT. SOLAN, (H.P), INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2008
1007NDA/MAL/HDP/2671CIPLA LTD..CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOLIN RESPULESIPRATROPIUM BROMIDE & SALBUTAMOL500MG + 2.5 MG /2.5MLCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |LUNG ADMINISTRATION LIQUID FOR INHALATION4.0X5.0X2.5 ML VIAL7/1/2005
1008NDA/MAL/HDP/2675LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLIBITUS PLUS SYRUPTERBUTALINE/ BROMHEXINE/ GUAIPHENESIN1.25MG/ 4MG/ 50 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2011
1009NDA/MAL/HDP/2678CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFORCAN-150FLUCONAZOLE150MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X5.0 CAPSULE BLISTER7/1/2004
1010NDA/MAL/HDP/2679CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDALERID 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. |
INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X30.0 ML BOTTLE7/1/2006
1011NDA/MAL/HDP/2681RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA |
UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER7/1/2007
1012NDA/MAL/HDP/2683RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN CASCORBIC ACID100MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA |
UGANDA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER7/1/2005
1013NDA/MAL/HDP/2690ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-250AMPICILLIN250MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2011
1014NDA/MAL/HDP/2691ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-500AMPICILLIN500MGINJECT CARE PARENTERALS PVT LTD-PLOT NO. 130 SILVASSA ROAD, GIDC VAPI 396195 | REYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL,1.0X100.0 VIAL CARTON7/1/2011
1015NDA/MAL/HDP/2696BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDAMPHOTRETAMPHOTERICIN B50MGBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501 |INDIA |PARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON7/1/2012
1016NDA/MAL/HDP/2697REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDLUCIN OINTMENTHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
1017NDA/MAL/HDP/2699CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 12.5CARVEDILOL12.5 MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2005
1018NDA/MAL/HDP/2702CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 2GLIMEPIRIDE2MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
1019NDA/MAL/HDP/2703AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT 312.50CO-AMOXICLAV (AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNATE)250+62.50MG/ 5MLAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2007
1020NDA/MAL/HDP/2707KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMCLOXACLOXACILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA |UGANDA |ORAL SOLID ORDINARY CAPSULES100.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,10.0 CAPSULE CONTAINER7/1/1997
1021NDA/MAL/HDP/2708MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHYPER TABLETSPROPRANOLOL HYDROCHLORIDE40MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER7/1/2000
1022NDA/MAL/HDP/2710GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN BDAMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET BLISTER7/1/1997
1023NDA/MAL/HDP/2712NEON LABARATORIES LTD.NORVIK ENTERPRISES LIMITEDANAWINBUPIVACAINE0.025%W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2014
1024NDA/MAL/HDP/2715MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINELAMIVUDINE150MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X60.0 TABLET CONTAINER7/1/2008
1025NDA/MAL/HDP/2717CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUMYCIN EYE OINTMENTCHLORAMPHENICOL1%W/WCENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA | INDIA |OPHTHALMIC OINTMENTS1.0X3.5 G TUBE7/1/2000
1026NDA/MAL/HDP/2719SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDLORASEDLORATADINE10MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP7/1/2007
1027NDA/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,EGYPT | EGYPT |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE7/1/2007
1028NDA/MAL/HDP/2721MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRIMAFEN TABLETIBUPROFEN + PARACETAMOL400MG + 325MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1029NDA/MAL/HDP/2722MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDNO SORESCHOLINE SALICYLATE/LIDOCAINE8.7%W/W+2%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL TOPICAL GELS AND SOLS1.0X10.0 G TUBE7/1/2007
1030NDA/MAL/HDP/2734DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMLODAR-10AMLODIPINE BESILATE10MGDAR AL DAWA-NA'UR PLANT AMMAN |JORDAN |ORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER7/1/2009
1031NDA/MAL/HDP/2738WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ INFUSIONL-ORNITHINE- L-ASPARTATE5G/10MLWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA |PARENTERAL ORDINARY I V VIALS1.0X5.0X10.0 ML VIAL7/1/2001
1032NDA/MAL/HDP/2739REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL TABLETHYOSCINE BUTYLBROMIDE10MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/2001
1033NDA/MAL/HDP/2743BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDDUO-COTECXINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGKBN- ZHEJIANG PHARMACEUTICAL CO. LTD-NO. 340 YUNHAI ROAD JIAXING ECONOMIC DEVELOPMENT ZONE, JIAXING CITY, ZHEJIANG PROVINCE | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER,1.0X30.0X9.0 TABLET BLISTER7/1/2005
1034NDA/MAL/HDP/2745RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENFORMINMETFORMIN HYDROCHLORIDE500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
1035NDA/MAL/HDP/2746DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDACYCLOVIR DENK 200ACYCLOVIR200MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X25.0 TABLET BLISTER7/1/2000
1036NDA/MAL/HDP/2753MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRASILMETOCLOPRAMIDE HYDROCHLORIDE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2009
1037NDA/MAL/HDP/2754FDC LTDAIVEEN (U) LIMITEDZATHRIN 500AZITHROMYCIN DIHYDRATE500MGFDC LIMITED -PLOT NO. L121 B PHASE 111A VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER,1.0X50.0X1.0X1.0X3.0 TABLET BLISTER7/1/2016
1038NDA/MAL/HDP/2756PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDCYTOTECMISOPROSTOL200MCGPIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND NE 613YA |UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
1039NDA/MAL/HDP/2760REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDDELASED DRY COUGH SYRUPDIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN+SODIUM CITRATE+MENTHOL14MG+6.5MG+57MG+2MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1040NDA/MAL/HDP/2761REMEDICA LTDGOODMAN INTERNATIONAL LTDTRIFLUOPERAZINETRIFLUOPERAZINE HYDROCHLORIDE5MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
1041NDA/MAL/HDP/2763ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCANDISTATCLOTRIMAZOLE100MGELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA |VAGINAL SUPPOSITORIES1.0X2.0X3.0 PESSARY STRIP7/1/1997
1042NDA/MAL/HDP/2773REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL ELIXIRHYOSCINE-N-BUTYLBROMIDE5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA, NAIROBI, KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2004
1043NDA/MAL/HDP/2774ACINO PHARMA AGGOODMAN INTERNATIONAL LTDBACTIFLOX NEO 500CIPROFLOXACIN500MGACINO PHARMA AG.-DORNACHERSTRASSE 114, CH-4147 AESCH, SWITZERLAND | SWITZERLAND |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1044NDA/MAL/HDP/2777NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCO-DIOVAN 160/12.5MG TABLETSVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND |SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER7/1/2016
1045NDA/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-PAKISTAN |
PAKISTAN |TOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE
1046NDA/MAL/HDP/2781INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 6.25CARVEDILOL6.25MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1047NDA/MAL/HDP/2783NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 25MGDICLOFENAC SODIUM25MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE |RECTAL SYSTEMIC SUPPOSITORIES1.0X1.0X10.0 SUPPOSITORY STRIP7/1/2006
1048NDA/MAL/HDP/2787MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125 DTAMOXICILLIN125MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU |INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER11/19/2017
1049NDA/MAL/HDP/2796ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1,000,000I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON7/1/2001
1050NDA/MAL/HDP/2800NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPID HM PENFILLHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE | NOVO NORDISK PRODUCTION SAS-45 AVENUE D€™ORLEANS, 28000 CHARTRES, FRANCE | NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTDA-AV. "C", 1413, DISTRITO INDUSTRIAL - 390404 004 MONTES CLAROS, MINAS GERAIS - BRAZIL | DENMARK |PARENTERAL ORDINARY PRE-FILLED PENS1.0X1.5 ML PREFILLED PEN,1.0X3.0 ML PREFILLED PEN7/1/1997
1051NDA/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 403 526 |INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
1052NDA/MAL/HDP/2805REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 20R TABLETSNIFEDIPINE20MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
1053NDA/MAL/HDP/2807GUILIN PHARMACEUTICALS CO.LTDTRIDEM PHARMA UGANDA LIMITEDASAQ GPSCARTESUNATE + AMODIAQUINE100 MG + 270 MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA |CHINA |ORAL SOLID ORDINARY TABLETS1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER7/1/2011
1054NDA/MAL/HDP/2811REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSULPHUR OINTMENTSULPHUR PRECIPITATED10%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2001
1055NDA/MAL/HDP/2812DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDCO-ARTESIANEBETA ARTEMETHER + LUMEFANTRINE180 MG/60ML + 1080 MG/60MLS KANT HEALTHCARE LIMITED-1802 – 1805, G.I.D.C., PHASE III, VAPI -396195 GUJARAT, INDIA. | NETHERLANDS |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE7/1/2005
1056NDA/MAL/HDP/2813REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDINTACYCLINE SKIN OINTMENTTETRACYCLINE HYDROCHLORIDE3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
1057NDA/MAL/HDP/2816CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-100 TABLETSATENOLOL100MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER7/1/1997
1058NDA/MAL/HDP/2821LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIOLIN-MGLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS5MG+500MGLINCOLN PHARMACEUTICAL LIMITED..-LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2011
1059NDA/MAL/HDP/2826GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON SYRUPCHLORPHENIRAMINE MALEATE4MG/10ML GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBI | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X2.0 L BOTTLE7/1/1997
1060NDA/MAL/HDP/2835LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSOLUDINE-MPOVIDONE IODINE / METRONIDAZOLE5%W/W / 1%W/WLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE,1.0X125.0 G TUBE7/1/2011
1061NDA/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 ESTATE | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2010
1062NDA/MAL/HDP/2848MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDDIPROGENTA OINTMENTBETAMETHASONE /GENTAMICIN SULPHATE0.5MG/G+1.0MG/GSCHERING-PLOUGH LABONV-INDUSTRIE PARK 30, B-220 HEIST-OP-DEN-BERG, BELGIUM | CANADA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2001
1063NDA/MAL/HDP/2850MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM20MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT | EGYPT |PARENTERAL ORDINARY AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE7/1/2007
1064NDA/MAL/HDP/2868CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 50LOSARTAN POTASSIUM50MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X7.0 TABLET BLISTER7/1/2003
1065NDA/MAL/HDP/2869GLAXO SMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPRIORIX VACCINEMEASLES + MUMPS + RUBELLA103.0CCID50 + 103.7CCID50 + 103.0CCID50GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSART | BELGIUM |PARENTERAL ORDINARY DRY VIALS1.0X0.5 ML VIAL (1 DOSE)7/1/2010
1066NDA/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 GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X7.0X6.0 TABLET BLISTER7/1/2001
1067NDA/MAL/HDP/2878PHARCO 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
|
EGYPT |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
1068NDA/MAL/HDP/2879CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOFLIN-200OFLOXACIN200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X10.0 TABLET BLISTER7/1/2004
1069NDA/MAL/HDP/2880REMEDICA LTDGOODMAN INTERNATIONAL LTDCARBIMAZOLE 5CARBIMAZOLE5MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
1070NDA/MAL/HDP/2885MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDFORECOX-TRACRIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL150MG + 75MG+ 400MG + 275MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | OXALIS LABS LIMITED-VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER7/1/2005
1071NDA/MAL/HDP/2891MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 20ATORVASTATIN20MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2006
1072NDA/MAL/HDP/2893DAWA LIMITEDSUPER MEDIC LTDSTOPACID SUSPENSIONMAGNESIUM TRISILICATE + ALUMINIUM HYDROXIDE250MG/5ML + 120MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2009
1073NDA/MAL/HDP/2894EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDMUCOGEL SUSPENSIONDRIED ALUMINIUM HYDROXIDE + MAGNESSIUM HYDROXIDE + OXETHAZAINE8G/100ML + 2G/100ML + 0.2 G/100MLEGYPIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO EIPICO-10TH OF RAMADAN CITY-FIRST INDUSTRIAL AREA -EGYPT |EGYPT |ORAL LIQUID ORDINARY SUSPENSIONS1.0X125.0 ML BOTTLE7/1/2005
1074NDA/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, KAMPALA | UGANDA |TOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X25.0 G TUBE7/1/2005
1075NDA/MAL/HDP/2898MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 10ATORVASTATIN10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2006
1076NDA/MAL/HDP/2900MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-200CEFIXIME200MGMICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2005
1077NDA/MAL/HDP/2902MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMEGALIS-20TADALAFIL20MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X1.0X4.0 TABLET STRIP7/1/2005
1078NDA/MAL/HDP/2903STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDABACAVIR SULPHATE TABLETSABACAVIR SULFATE300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2009
1079NDA/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 ARE | EGYPT |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X125.0 ML BOTTLE7/1/2007
1080NDA/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 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2013
1081NDA/MAL/HDP/2908SHOSAAN ASIC PACIFICRENE PHARMACY LTDPAINGO MEDICATED CREAMMETHYLSALICYLATE+CAPSICUM OLEORESIN+TURPENTINE OIL15%W/W + 1%W/W + 1.47%W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |TOPICAL EXTERNAL CREAMS1.0X2.0X15.0 G TUBE7/1/2010
1082NDA/MAL/HDP/2910CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDTENVIR EMTENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE300MG+200MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/1/2009
1083NDA/MAL/HDP/2911ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL LORATADINELORATADINE10MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
1084NDA/MAL/HDP/2914REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDCHLOROCIDE SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/1997
1085NDA/MAL/HDP/2917REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCETAMOL TABLETSPARACETAMOL500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP,1.0X100.0X10.0 TABLET BLISTER7/1/1997
1086NDA/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 382210 | INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1087NDA/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 403 526 |INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X20.0 G TUBE,1.0X10.0 G TUBE7/1/2001
1088NDA/MAL/HDP/2940CENTAUR PHARMACEUTICALS PVT. LTDGITTOES PHARMACEUTICALS LIMITEDBENZOX 5 GELBENZOYL PEROXIDE5%W/WCENTAUR PHARMACEUTICALS LTD- PLOT NO. 39 TIVIN IN
|
INDIA |TOPICAL EXTERNAL OTHER GELS/SOLS1.0X20.0 G TUBE7/1/2005
1089NDA/MAL/HDP/2941CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 20ATORVASTATIN20MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X7.0 TABLET BLISTER7/1/2005
1090NDA/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 403 526 |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE,1.0X10.0 G TUBE7/1/2005
1091NDA/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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1092NDA/MAL/HDP/2946GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO ORAL SUSPENSIONCO-TRIMOXAZOLE240MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1998
1093NDA/MAL/HDP/2947GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO TABLETSCO-TRIMOXAZOLE480MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X250.0 BLISTER CARTON7/1/1998
1094NDA/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 GERMANY | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER,1.0X8.0X15.0 TABLET BLISTER7/1/2007
1095NDA/MAL/HDP/2951BLISS 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 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X2.0X6.0 TABLET BLISTER7/1/2007
1096NDA/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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2007
1097NDA/MAL/HDP/2957MEDIPHARM SALES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEDITROLCALCITRIOL0.25MCGMEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND | THAILAND |ORAL SOLID ORDINARY CAPSULES1.0X6.0X5.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER7/1/2009
1098NDA/MAL/HDP/2959REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDCETAMOL SYRUPPARACETAMOL120MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1099NDA/MAL/HDP/2960DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCLAVODARAMOXICILLIN/CLAVULANIC ACID400MG/57MGDAR AL DAWA-NA'UR PLANT AMMAN |JORDAN |ORAL SOLID ORDINARY GRANULES1.0X70.0 ML BOTTLE7/1/2010
1100NDA/MAL/HDP/2963WOCKHARDT LTDSTAR PHARMACEUTICALS LTDAZIWOK 500AZITHROMYCIN500MGWOCKHARDT LIMITED-PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS TABLET BLISTER, TABLET BLISTER7/1/2014
1101NDA/MAL/HDP/2970USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 500METFORMIN500MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
1102NDA/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.) | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2004
1103NDA/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, PAKISTAN | PAKISTAN |TOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/1997
1104NDA/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 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER,1.0X3.0X6.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER7/1/2007
1105NDA/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 INDIA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2004
1106NDA/MAL/HDP/2983CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFUCOL 200FLUCONAZOLE200MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X5.0X1.0X4.0 CAPSULE BLISTER7/1/2004
1107NDA/MAL/HDP/2985SANOFI 410 THALESSURGIPHARM (U) LIMITEDEPILIM CHRONOSODIUM VALPROATE PH. EUR500MGSANOFI WINTHROP INDUSTRIE-1,RUE DE LA VIERGE ,AMBARES ET LAGRAVE 33565,CARBON BLANC CEDEX FRANCE | FRANCE |ORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2004
1108NDA/MAL/HDP/2990MICRO LABS LTDLABOREX UGANDA LIMITEDPULMOCEF-500CEFUROXIME AXETIL USP500MGMICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X4.0 TABLET BLISTER7/1/2004
1109NDA/MAL/HDP/2995GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGALLOPLOPERAMIDE HYDROCHLORIDE USP2MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINERNULL
1110NDA/MAL/HDP/2997MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDACENAC TABLETSACECLOFENAC100 MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2017
1111NDA/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
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2009
1112NDA/MAL/HDP/3003GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIRACICLOVIR200MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER7/1/2007
1113NDA/MAL/HDP/3005ACINO PHARMA AG -GOODMAN INTERNATIONAL LTDOLFEN-100 SR PROLONGED-RELEASE CAPSULESDICLOFENAC SODIUM100MGACINO PHARMA AG-BIRSWEG 2, 4253, LIESBERG - SWITZERLAND | SWITZERLAND |ORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER7/1/1997
1114NDA/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 -HP | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL7/1/2009
1115NDA/MAL/HDP/3012WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
|
INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1998
1116NDA/MAL/HDP/3013GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZOLEALBENDAZOLE400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
1117NDA/MAL/HDP/3015CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPENEGRA-50 TABLETSSILDENAFIL50MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER,1.0X20.0X4.0 TABLET BLISTER7/1/2001
1118NDA/MAL/HDP/3019MJ BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN 30/70INSULIN SOLUBLE + INSULIN ISOPHANE30 I.U + 70 I.UMJ BIOPHARM PRT LTD-L-7 MIDC INDUSTRIAL AREA, TALOJA, NARI MUMBAI MAHARASHTRA | INDIA |PARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL7/1/2008
1119NDA/MAL/HDP/3020M.J BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN NINSULIN ISOPHANE100 I.U/MLM.J .BIOPHARM-L7, M.I.D.C INDUSTRIAL AREA TALOJA, NAVI MUMBAI MAHARAHTRA | INDIA |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/2008
1120NDA/MAL/HDP/3021GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDGLIBENCLAMIDE TABLETSGLIBENCLAMIDE5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2012
1121NDA/MAL/HDP/3023GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAXLEVAMISOLE HYDROCHLORIDE40MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X10.0X1.0X3.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER7/1/2007
1122NDA/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, INDIA | QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA. |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2008
1123NDA/MAL/HDP/3029GITTOES PHARMACEUTICALS 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 INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2007
1124NDA/MAL/HDP/3030MJ BIOPHARM PVT LTDVITACARE LIMITEDBIOSULIN RINSULIN SOLUBLE100 IU/MLM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/2008
1125NDA/MAL/HDP/3031GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMETHASONEDEXAMETHASONE0.5MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2007
1126NDA/MAL/HDP/3032ACINO PHARMA AGGOODMAN INTERNATIONAL LTDXYLO-ACINO 0.05%XYLOMETAZOLINE0.05%W/VMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY |NASAL TOPICAL SPRAYS WITHOUT GAS1.0X10.0 ML BOTTLE7/1/2007
1127NDA/MAL/HDP/3035GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFORTE TONICFERRIC AMMONIUM CITRATE + FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE + VITAMIN B1250MG + 0.55MG + 2.4MG + 1.2MG + 11MG + 2.5MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2007
1128NDA/MAL/HDP/3037GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT SYRUPVITAMIN A + VITAMIN D3 + VITAMIN B1 + VITAMIN B2 + NIACINAMIDE + VITAMIN B12 + VITAMIN C1000I.U + 200I.U + 1.5MG + 1.5MG+ 10MG + 2.5MCG + 40MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2007
1129NDA/MAL/HDP/3040GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODOXDOXYCYCLINE100MGAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1130NDA/MAL/HDP/3044CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDPIRICAM-20 CAPSULESPIROXICAM20MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,2.0X10.0 CAPSULE BLISTER7/1/1997
1131NDA/MAL/HDP/3046GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2009
1132NDA/MAL/HDP/3048GITTOES PHARMACEUTICALS 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,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2007
1133NDA/MAL/HDP/3051BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETROZOLEDILOXANIDE FUROATE+METRONIDAZOLE BENZOATE+SIMETHICONE125MG+160MG+25MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2005
1134NDA/MAL/HDP/3057GITTOES PHARMACEUTICALS 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,INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1135NDA/MAL/HDP/3058SANOFI-AVENTISSURGIPHARM (U) LIMITEDXATRAL LP 10MGALFUZOSIN10MGSANOFI WINTHROP INDUSTRIE,-30-36, AVENUE GUSTAVEEIFFEL BP 27166 - 37071 TOURS CEDEX 2 | FRANCE |ORAL SOLID ORDINARY COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2008
1136NDA/MAL/HDP/3060GITTOES PHARMACEUTICALS 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,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/7/2007
1137NDA/MAL/HDP/3063GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC-50DICLOFENAC SODIUM50MGAGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2007
1138NDA/MAL/HDP/3064GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTIN-TIN TABLETSTINIDAZOLE500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0 TABLET BLISTER7/1/2007
1139NDA/MAL/HDP/3067GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMAGO SYRUPPROMETHAZINE5MG/5MLAGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE7/1/2007
1140NDA/MAL/HDP/3069GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOVE CAPSULESPIROXICAM20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER7/1/2007
1141NDA/MAL/HDP/3072GITTOES PHARMACEUTICALS 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,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
1142NDA/MAL/HDP/3073COSMOS LTDASTRA PHARMA (U) LIMITEDCARDINOL TABLETATENOLOL50MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS2.0X14.0 TABLET STRIP7/1/1997
1143NDA/MAL/HDP/3076ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 40TELMISARTAN40MGARISTO PHAMACUTLAB PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2007
1144NDA/MAL/HDP/3077REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDUNISTEN HC CREAMCLOTRIMAZOLE + HYDROCORTISONE1%W/W + 1%W/WREGAL PHERMACUTICALS -PLOT 7879/18 OFF BABA RWARAKA NAIROBI KENYA |KENYA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2008
1145NDA/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 AFRICA | SOUTH AFRICA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2010
1146NDA/MAL/HDP/3083ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS 80TELMISARTAN80MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2007
1147NDA/MAL/HDP/3085GITTOES PHARMACEUTICALS 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,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER7/1/2007
1148NDA/MAL/HDP/3090PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOXCEFPODOXIME PROXETIL100MG/5MLPHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA |
JORDAN |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE7/1/2004
1149NDA/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-INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X2.0X5.0X2.0 ML AMPOULE7/1/2013
1150NDA/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 SPAIN | SWITZERLAND |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2015
1151NDA/MAL/HDP/3095LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDAMPHEN SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2007
1152NDA/MAL/HDP/3098AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOSEDINLORATADINE5MG/5MLAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2004
1153NDA/MAL/HDP/3099PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDZONA 0.1% CREAMHYDROCORTISONE 17-BUTYRATE0.1%W/WPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN |TOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE7/1/2007
1154NDA/MAL/HDP/3101DAWA LIMITEDSUPER MEDIC LTDDACOLD SYRUPPARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE120MG/5ML+10MG/5ML+2MG/5MLDAWA LTD-BABA DOGO ROAD RUARAKA |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2010
1155NDA/MAL/HDP/3104LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDNYSTALEB ORAL SUSPENSIONNYSTATIN100000IU/MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2007
1156NDA/MAL/HDP/3105CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDDEPIN-E RETARDNIFEDIPINE20MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET STRIP7/1/1997
1157NDA/MAL/HDP/3116LABORATORY & ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN125MG/5MLLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI |KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X100.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1158NDA/MAL/HDP/3117KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X10.0X100.0 MG VIAL,1.0X50.0X100.0 MG VIAL7/1/2010
1159NDA/MAL/HDP/3118CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLUMARTEMARTEMETHER /LUMEFANTRINE20MG /120MGQUALITY CHEMICAL INDUSTRIES LIMITED. -PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1.0X24.0 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 BLISTER7/1/2011
1160NDA/MAL/HDP/3122USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT CHEWABLE TABLETSMULTI-INGREDIENTMULTI-INGREDIENTREMIDEX PHARMA PVT LTD- B-249+ 250 II STAGE PEENYA INDUSTRIAL ESTATE BANGLORE 560058. |INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2002
1161NDA/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
INDIA |
INDIA |RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES1.0X1.0X5.0 SUPPOSITORY BLISTER7/1/2007
1162NDA/MAL/HDP/3125DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMLODAR 5AMLODIPINE BESILATE5MGDAR AL DAWA-NA'UR PLANT AMMAN |JORDAN |ORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER7/1/2009
1163NDA/MAL/HDP/3134PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDTOFF PLUSPARACETAMOL+CHLORPHENIRAMINE MALEATE+ DEXTROMETHORPHAN + PHENYLEPHRINE500 MG + 2 MG + 15 MG + 10 MGPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2004
1164NDA/MAL/HDP/3136MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/1/2007
1165NDA/MAL/HDP/3139DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDOMEDAROMEPRAZOLE20MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN |ORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER7/1/2009
1166NDA/MAL/HDP/3141CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDAMLOPRESS-5AMLODIPINE BESYLATE5MGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2007
1167NDA/MAL/HDP/3144KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDULSECOMEPRAZOLE20MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE STRIP7/1/2007
1168NDA/MAL/HDP/3147ARISTO PHARMACEUTICALS PVT LTDNORVIK 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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2009
1169NDA/MAL/HDP/3155MEDREICH PLCSURGIPHARM (U) LIMITEDBIOFERONFERRIC AMMONIUM CITRATE + CYANOCOBALAMIN + FOLIC ACID200MG/5ML + 10MG/5ML + 750MCG/5MLTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2007
1170NDA/MAL/HDP/3156PFIZER LABORATORIES (PTY)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN DAYTIME FLUPSEUDOEPHEDRINE HCL + IBUPROFEN30MG + 200MGJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP7/1/2008
1171NDA/MAL/HDP/3158MJ BIOPHARM PVT LTDVITACARE LIMITEDGLIBEX-5GLIBENCLAMIDE5MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2012
1172NDA/MAL/HDP/3163NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 50MGDICLOFENAC SODIUM50MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE |RECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X1.0X10.0 SUPPOSITORY STRIP7/1/2006
1173NDA/MAL/HDP/3175M.J.BIOPHARM PVT LTDVITACARE LIMITEDSPACOVINDROTAVERINE40MG M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208
NAVI MUMBAI, INDIA |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2012
1174NDA/MAL/HDP/3176AFRICURE PHARMACEUTICALS (INDIA) PRIVATELIMITEDROYAL PHARMA 2011 LIMITEDDOXYRONE-100DOXYCYCLINE HYDROCHLORIDE100AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2005
1175NDA/MAL/HDP/3177ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM CREAMBETAMETHASONE VALERATE0.1%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/1997
1176NDA/MAL/HDP/3178COSMOS LTDASTRA PHARMA (U) LIMITEDBENDURIC TABLETSBENDROFLUMETHIAZIDE5MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2005
1177NDA/MAL/HDP/3179GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDSULFUR OINTMENTSULPHUR10%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X1.0X25.0 G TUBE7/1/2013
1178NDA/MAL/HDP/3180MJ BIOPHARM PVT LTDVITACARE LIMITEDLOFIN 500METFORMIN HYDROCHLORIDE500MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2008
1179NDA/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
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
1180NDA/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 INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X30.0 ML BOTTLE7/1/2000
1181NDA/MAL/HDP/3198GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPEN-125PHENOXYMETHYL PENICILLIN POTASSIUM125MG/MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X100.0 ML BOTTLE7/1/2011
1182NDA/MAL/HDP/3199MERCK SHARP & DOHME BV.SURGIPHARM (U) LIMITEDISENTRESSRALTEGRAVIR400MGZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD -ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD XUNQIAE LINHAI ZHIJIANG |CHINA |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER7/1/2011
1183NDA/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, KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X200.0 TABLET CONTAINER,1.0X25.0X3.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER7/1/1997
1184NDA/MAL/HDP/3203SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDTETANUS ANTITOXINTETANUS ANTITOXIN1500 I.USERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X50.0X1.0 ML AMPOULE (1 DOSE AMPOULE)7/1/2013
1185NDA/MAL/HDP/3204GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDRELCER GELALUMINIUM HYDROXIDE/MAGNESIUM HYDROXIDE/DIMETHICONE/LIQUORICE6G+80MG+100MG+400MG/5MLGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X180.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2000
1186NDA/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 ESTATE | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2010
1187NDA/MAL/HDP/3208ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRFOL 1%PROPOFOL1%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA |PARENTERAL ORDINARY VIALS1.0X10.0X1.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL7/1/2010
1188NDA/MAL/HDP/3212CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCLOPRESS 75MGCLOPIDOGREL BISULPHATE75MGCIPLA LIMITED ,.,.-VILLAGE UPPER MALPUR, P.O. BHUD, THE. NALAGARH DISTRICT SOLAN HIMACHAL PRADESH PIN 173205 | CIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2005
1189NDA/MAL/HDP/3214MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDINDICONTININDAPAMIDE1.5MGMODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
1190NDA/MAL/HDP/3215CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDSEROCORT 125SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 125MCGCIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA | INDIA |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2009
1191NDA/MAL/HDP/3219GITTOES PHARMACEUTICALS 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 INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/1998
1192NDA/MAL/HDP/3221REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.OPTADEX-N EYE DROPSDEXAMETHASONE/NEOMYCIN1MG/3MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN |OPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/1999
1193NDA/MAL/HDP/3224KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM FLUFED ELIXIRMULTI-INGREDIENTMULTI-INGREDIENTTIL HEALTHCARE PVT LIMITED-PLOT 100, WEST R-5, SOUTH, SRICITY SEZ, CHERIVE9 (VI), DISTRICT: CHITOOR 517588 ANDHRA PRADESH- | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE7/1/1997
1194NDA/MAL/HDP/3225LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIFLAMEDICLOFENAC DIETHYLAMINE + LINSEED OIL + METHYL SALICYLATE MENTHOLN/ALINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2010
1195NDA/MAL/HDP/3233SHOSAAN ASIC PACIFICRENE PHARMACY LTDWHITFIELD'S OINTMENT BPBENZOIC ACID + SALICYLIC ACID0.06G+0.03GNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/1997
1196NDA/MAL/HDP/3237LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKONAZOL CREAMKETOCONAZOLE2% W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2008
1197NDA/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 INDIA |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE,1.0X15.0 G TUBE7/1/2008
1198NDA/MAL/HDP/3245EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDNYSTATIN ORAL DROPSNYSTATIN100,000 I.U/MLEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA |EGYPT |ORAL TOPICAL DROPS1.0X30.0 ML BOTTLE7/1/2013
1199NDA/MAL/HDP/3246GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2000
1200NDA/MAL/HDP/3248ATCO LABORATORIES LTDHARLEYS UGANDA LIMITEDRUMAFEN GEL 10%IBUPROFEN10%W/WATCO LABS (PVT) LTD-B18 S.I.T.E KARACHI, PAKISTAN | PAKISTAN |ORAL TOPICAL UNIT DOSE GELS/SOLS1.0X30.0 G TUBE7/1/2005
1201NDA/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, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2004
1202NDA/MAL/HDP/3252GALENTIC PHARMA LTDVITACARE LIMITEDPYLOOCAINBETAMETHASONE + PHENYLEPHRINE + LIDOCAINEO.5 MG/G + 1 MG/G + 25 MG/GGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X1.0X30.0 G TUBE7/1/2005
1203NDA/MAL/HDP/3255GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDSATISFIL-50SILDENAFIL CITRATE50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2011
1204NDA/MAL/HDP/3259SHOSAAN ASIC PACIFICRENE PHARMACY LTDTIGBODERMBETAMETHASONE + CHLOROCRESOL + GENTAMICIN + CLIOQUINOL + TOLNAFTATE0.05% W/W + 0.1% W/W + 0.1% W/W + 1% W/W + 1% W/WNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
1205NDA/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 ECONOMIC ZONE |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2008
1206NDA/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,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2009
1207NDA/MAL/HDP/3266BETA HEALTHCARE UGANDA LIMITEDBETA 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,KENYA | KENYA |TOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE7/1/1997
1208NDA/MAL/HDP/3270ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDFORTIFIED PROCAINE PENICILLINFORTIFIED PROCAINE PENICILLIN4000000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON7/1/2001
1209NDA/MAL/HDP/3273KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDBETASOL CREAMBETAMETHASONE VALERATE0.1%W/WKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/1997
1210NDA/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
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
1211NDA/MAL/HDP/3279ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDHAEMOFORTE SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | BAROQUE PHARMACEUTICALS PVT LTD --S.NO.192/2 & S.NO.192/2 &3 SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/1997
1212NDA/MAL/HDP/3282MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDKOFF-GOPHENYLEPHRINE HCL + CHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN5MG/5ML + 2MG/5ML + 10MG/5MLTORQUE PHARMACEUTICALS (P) LTD-P.O.DAPPAR VILLISS |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2009
1213NDA/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, KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
1214NDA/MAL/HDP/3285GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXIL FORTE 250MG/5MLAMOXYCILLIN250MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE | FRANCE |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
1215NDA/MAL/HDP/3286CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLOMAC-20OMEPRAZOLE20 MGCIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,
SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA |
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2009
1216NDA/MAL/HDP/3288REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDELASED CHESTY COUGHS SYRUPDIPHENHYDRAMINE HCL BP+AMMONIUM CHLORIDE BP+SODIUM CITRATE BP+MENTHOL BP14MG+135MG+57MG+1.1MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1997
1217NDA/MAL/HDP/3289GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID DUSTING POWDERCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |TOPICAL EXTERNAL DUSTING POWDERS1.0X30.0 G BOTTLE,1.0X100.0 G BOTTLE7/1/1999
1218NDA/MAL/HDP/3291GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDFINTOPBUTENAFINE HCL1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2003
1219NDA/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,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1997
1220NDA/MAL/HDP/3294WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL CAPSULESTRAMADOL HYDROCHLORIDE50 MGWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2004
1221NDA/MAL/HDP/3295GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVATECLOBETASOL0.05%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2008
1222NDA/MAL/HDP/3296MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR100MG / 25MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER,1.0X60.0 TABLET CONTAINER7/1/2011
1223NDA/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
|
INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
1224NDA/MAL/HDP/3300MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.MUCOSOL PEDIATRIC SYRUPCARBOCISTEINE125 MG/5 MLMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT |EGYPT |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2003
1225NDA/MAL/HDP/3302CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDAMOXICILLIN ORAL SUSPENSIONAMOXICILLIN125MG/5MLOKASA PVT LTD-346 KUNDAIM INDUSTRIAL ESTATE GOA, 403115 | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2009
1226NDA/MAL/HDP/3304REMEDICA LTDGOODMAN INTERNATIONAL LTDFELEXINCEFALEXIN MONOHYDRATE250MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1227NDA/MAL/HDP/3309UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDCLORIFORT VAGINAL TABLETSCLOTRIMAZOLE100MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA |VAGINAL TABLETS1.0X6.0 PESSARY STRIP7/1/2002
1228NDA/MAL/HDP/3312TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TIDOMET FORTECO-CARELDOPA25MG/250MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2004
1229NDA/MAL/HDP/3314SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSILVEREXSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE10MG/G+10MG/GSUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X250.0 G TUBE,1.0X25.0 G TUBE,1.0X10.0 G TUBE7/1/2004
1230NDA/MAL/HDP/3315GITTOES PHARMACEUTICALS LIMITEDGITTOES 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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINERNULL
1231NDA/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-361006 | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
1232NDA/MAL/HDP/3319MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDFERROTONE CAPSULESFERROUS FUMERATE+FOLIC ACID+VITAMIN B12162MG +0.75MG +7.5MCGMEGA LIFESCIENCES LTD.-384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKAN |THAILAND |ORAL SOLID ORDINARY CAPSULES1.0X5.0X10.0 CAPSULE BLISTER7/1/2005
1233NDA/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
|
INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2008
1234NDA/MAL/HDP/3328GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN1 MUCSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP -NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 MU VIAL,1.0X10.0X1.0 MU VIAL7/1/2001
1235NDA/MAL/HDP/3331NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDBETOPTICBETAXOLOLO.5%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM |OPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/1997
1236NDA/MAL/HDP/3333CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNOVACLAV-625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMEDISPRAY LABORATORIES PVT LTD,UNIT II-368-348 KUNDAIM INDUSTRIAL ESTATE,KUNDAIM GOA - 403115,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER7/1/2009
1237NDA/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 173 205 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP7/1/2005
1238NDA/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
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X6.0 TABLET BLISTER7/1/2008
1239NDA/MAL/HDP/3343REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDMEDIVEN-CREAMBETAMETHASONE VALERATE0.1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
1240NDA/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, INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1241NDA/MAL/HDP/3347REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN TABLETSPHENOXYMETHYLPENICILLIN250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
1242NDA/MAL/HDP/3348VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDPIMCEFCEFEPIME USP1GVENUS REMEDIES LTD.-UNIT 11 HOLL TOP INDUSTRIAL ESTATE JHARMAJRI |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL7/1/2007
1243NDA/MAL/HDP/3354REGAL PHARMA U LIMITEDREGAL PHARMA (U) LTDMEDIVEN OINTMENTBETAMETHASONE VALERATE0.1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
1244NDA/MAL/HDP/3356CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYCEL-100 CAPSULESCELECOXIB100MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER7/1/2001
1245NDA/MAL/HDP/3357CENTAUR PHAMACUITICALSGITTOES PHARMACEUTICALS LIMITEDESOREST 20ESOMEPRAZOLE20MGCENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEAR |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2008
1246NDA/MAL/HDP/3359SWISS PARENTERALS LTDSHREEJI CARE LIMITEDARTIARTEMETHER80MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE7/1/2011
1247NDA/MAL/HDP/3364CENTAUR PHAMACUITICALSGITTOES PHARMACEUTICALS LIMITEDESOREST 40ESOMEPRAZOLE40MGCENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEAR |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2008
1248NDA/MAL/HDP/3367GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL SUSPENSIONPARACETAMOL125 MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2000
1249NDA/MAL/HDP/3368PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDVIAGRA 50MGSILDENAFIL50MGPFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE |FRANCE |ORAL SOLID ORDINARY TABLETS1.0X12.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER7/1/1998
1250NDA/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
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X3.0 TABLET BLISTER7/1/2008
1251NDA/MAL/HDP/3372S K AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDMUCOLEXAMBROXOL HYDROCHLORIDE + SALBUTAMOL SULPHATE + GUAIFENESIN + MENTHOL30 MG/5ML + 1 MG/5ML + 50 MG/5ML + 0.5 MG/5MLS KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2005
1252NDA/MAL/HDP/3373UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMYCLAV 625AMOXILLICIN/CLAVULANATE500MG/125MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP7/1/2005
1253NDA/MAL/HDP/3374COSMOS LIMITEDASTRA PHARMA (U) LIMITEDZITHROX 250MGAZITHROMYCIN250MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTERNULL
1254NDA/MAL/HDP/3377GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMILINEAMITRIPTYLINE25 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/2011
1255NDA/MAL/HDP/3378GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLOZINE TABLETSCHLORPROMAZINE100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
1256NDA/MAL/HDP/3379EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIFASIHUMAN CHORIONIC GONADOTROPIN5000I.UEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA |EGYPT |PARENTERAL ORDINARY AMPOULES1.0X2.0 AMPOULE CARTON7/1/2011
1257NDA/MAL/HDP/3382GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOFEN SUSPENSIONIBUPROFEN100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2010
1258NDA/MAL/HDP/3383GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDZEPIN-200CARBAMAZEPINE200 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
1259NDA/MAL/HDP/3384GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDPROXIMEXA 250MGCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2007
1260NDA/MAL/HDP/3387GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDPROXIMEXA 500MGCEFUROXIME AXETIL500MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2007
1261NDA/MAL/HDP/3389BAYER PHARMA AGSURGIPHARM (U) LIMITEDCLARINASE REPE TABSLORATADINE + PSEUDOEPHEDRINE5MG + 120MGSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM | BELGIUM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2009
1262NDA/MAL/HDP/3390ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDALUGELALUMINIUM HYDROXIDEL / MAGNESIUM TRISLICATE120MG/250MG ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X5.0 ML JERRYCAN7/1/1997
1263NDA/MAL/HDP/3391GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZIN TABLETCETIRIZINE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,100.0X10.0 TABLET BLISTER7/1/2017
1264NDA/MAL/HDP/3393GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN 375MGAMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS2.0X10.0 TABLET BLISTER7/1/1997
1265NDA/MAL/HDP/3399MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 10ROSUVASTATIN10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
1266NDA/MAL/HDP/3400ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN GELDICLOFENAC SODIUM1%W/WSOFARIMEX INDUSTRIA QUIMIRA E FARMACEUTICA SA-AV. DAS INDUSTRIAS - ALTO DO COLARIDE, 2735-213 AGUALVA CACEM | GERMANY |TOPICAL EXTERNAL GELS AND SOLS1.0X50.0 G TUBE,1.0X20.0 G TUBE7/1/1997
1267NDA/MAL/HDP/3405GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL BABY AND INFANT 120MG/5MLPARACETAMOL120MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCE |FRANCE |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2008
1268NDA/MAL/HDP/3406ATCO LABORATORIES LTDHARLEYS UGANDA LIMITEDMICRONEMANYSTATIN ORAL SUSPENSION,SODIUM CITRATE + SODIUM LAURYL SULPHATE + GLYCERIN26,450MG/10ML+75MG/10ML+ 90%V/VATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI, PAKISTAN | PAKISTAN |RECTAL SYSTEMIC ENEMA LIQUIDS1.0X10.0 ML BOTTLE7/1/2005
1269NDA/MAL/HDP/3409BAYER PHARMA AGSURGIPHARM (U) LIMITEDCLARITYNELORATADINE10MGSCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM | NULL |ORAL SOLID ORDINARY TABLETS3.0X10.0 TABLET BLISTER7/1/2000
1270NDA/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 SPAIN | SWITZERLAND |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2007
1271NDA/MAL/HDP/3415GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID V-1CLOTRIMAZOLE500MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |VAGINAL TABLETS1.0X1.0 PESSARY STRIP7/1/2004
1272NDA/MAL/HDP/3426REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRUBEM CREAMMETHYL NICOTINATE + CAPSICUM OLEORESIN+ METHYLSALICYLATE1%W/W+0.1%W/W+5%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE7/1/1997
1273NDA/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 - SWITZERLAND | SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2016
1274NDA/MAL/HDP/3437REMEDICA LTDGOODMAN INTERNATIONAL LTDREMYCIN 100 CAPSULESDOXYCYCLINE HYDROCHLORIDE100MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
1275NDA/MAL/HDP/3440ELI-LILLY EXPORT SALABOREX UGANDA LIMITEDHUMALOGINSULIN LISPRO100IULILLY FRANCE SA-FRANCE |FRANCE |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/2000
1276NDA/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

|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2010
1277NDA/MAL/HDP/3449VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDIMMUNOXCEFTRIAXONE SODIUM1000MGVENUS REMEDIES LIMITED ,.-HILL TOP,INDUSTRIAL ESTATE,JHARMAJRI, EPIP,PHASE 1,(EXTN.) ,BHATOLI KALAN,BADDI -H.P.INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL,1.0X10.0X1.0X10.0 ML VIAL7/1/2008
1278NDA/MAL/HDP/3450DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDTRAMADEX 50TRAMADOL50MGDELORBIS PHARMACEUTICALS LTD-17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES P.O. BOX 28629, 2081 LEFKOSIA | CYPRUS |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2009
1279NDA/MAL/HDP/3451GITTOES PHARMACEUTICALS 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 INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER7/1/1998
1280NDA/MAL/HDP/3453MJ BIOPHARM PVT LTDVITACARE LIMITEDAMINOPHYLLINEAMINOPHYLLINE25MG/MLM.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI |INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X10.0 ML AMPOULE7/1/2014
1281NDA/MAL/HDP/3456EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDPREGAVALEX 150MGPREGABALIN150MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2013
1282NDA/MAL/HDP/3458REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIXIL 250MGAMOXYCILLIN TRIHYDRATE250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
1283NDA/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 EGYPT |EGYPT |RECTAL SYSTEMIC ENEMA LIQUIDS1.0X120.0 ML BOTTLE7/1/1997
1284NDA/MAL/HDP/3460GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDMALANIL ADULT TABLETSATOVAQUONE + PROGUANIL HCL250MG + 100MGGLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS | SPAIN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X12.0 TABLET BLISTER7/1/2007
1285NDA/MAL/HDP/3461MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZIDOVUDINEZIDOVUDINE300MGMYLAN LABORATORIES LTD .-F/4 & F/12, MALEGAON MIDC, SINNAR, NASHIK-422 113, MAHARASHTRA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2008
1286NDA/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 AFRICA |ORAL LIQUID ORDINARY OTHER LIQUIDS1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2007
1287NDA/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 ESTATE | INDIA |ORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2008
1288NDA/MAL/HDP/3466DAWA LIMITEDSUPER MEDIC LTDDAWASECSECNIDAZOLE1GDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2015
1289NDA/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) |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL7/1/2008
1290NDA/MAL/HDP/3473ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTRIXONECEFTRIAXONE1GSHANDONG P.R & INJECT CARE PARENTERALS PVT LTD-PLOT 130, SILVASSA ROAD,G.I.D.C,VAPI-396195,GUJARAT,INDIA | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL7/1/2011
1291NDA/MAL/HDP/3474RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMCLOREN DRY SYRUPAMPICILLIN + CLOXACILLIN125MG+125MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA |
UGANDA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2008
1292NDA/MAL/HDP/3475VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDRONEMMEROPENEM500MGVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2010
1293NDA/MAL/HDP/3482GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCLOX-250CLOXACILLIN250MGMILAN LABORATORIES (INDIA) PVT LTD-PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2011
1294NDA/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 AFRICA | SOUTH AFRICA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2007
1295NDA/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, INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X100.0X1.0 ML AMPOULE7/1/2007
1296NDA/MAL/HDP/3490MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.LAXOLAC SYRUPLACTULOSE67G/100MLMEDICAL UNION PHARMACEUTICALS LTD-ABU SULTAN, ISMAILLIA, EGYPT | EGYPT |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2003
1297NDA/MAL/HDP/3492ACINO PHARMA AG -GOODMAN INTERNATIONAL LTDOLFEN-50 GASTRO-RESISTANT TABLETSDICLOFENAC SODIUM50MGACINO PHARMA AG-BIRSWEG 2, 4253, LIESBERG - SWITZERLAND | SWITZERLAND |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1997
1298NDA/MAL/HDP/3494FERRER INTERNATIONAL, S.A.LABOREX UGANDA LIMITEDGAMALATE B6 SOLUTIONMAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B62G + 2G + 1G +1GFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN |ORAL LIQUID ORDINARY LIQUIDS1.0X80.0 ML BOTTLE7/1/2015
1299NDA/MAL/HDP/3497MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIVOLIN FORTEMULTI-INGREDIENTMULTI-INGREDIENTMEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND | THAILAND |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2009
1300NDA/MAL/HDP/3500DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDGIZLAN 300IRBESARTAN300MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1301NDA/MAL/HDP/3502EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDHYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATE100MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA |EGYPT |PARENTERAL ORDINARY DRY VIALS1.0X100.0 MG VIAL + 1*2ML AMPOULE OF WFI7/1/2010
1302NDA/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'AQUILA |ITALY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X7.0 TABLET BLISTER7/1/2015
1303NDA/MAL/HDP/3507MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 250AMOXICILLIN250MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2015
1304NDA/MAL/HDP/3512NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDLAMISIL 250MGTERBINAFINE250MGNORVATIS PHARMA PRODUKTIONS GMBH -79644 WEHR/BADEN-GERMANY |GERMANY |ORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET CARTON7/1/1997
1305NDA/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, AURANGBAD | AJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO)7/1/2007
1306NDA/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 AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET BLISTER7/1/1998
1307NDA/MAL/HDP/3517ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDTOTO ZINCZINC SULPHATE20MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
|
INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
1308NDA/MAL/HDP/3519STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/1/2010
1309NDA/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, INDIA | INDIA |TOPICAL EXTERNAL POWDERS1.0X100.0 G BOTTLE,1.0X10.0 G BOTTLE7/1/2010
1310NDA/MAL/HDP/3522GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCLOXACILLIN SODIUM FOR INJECTIONCLOXACILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SCIJIAZHUANG) CO. LTD WORKSHOP -NO. 88 YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE, CHINA WORKSHOP 406 AND 407 | CHINA |PARENTERAL ORDINARY VIALS1.0X10.0X500.0 MG VIALNULL
1311NDA/MAL/HDP/3525GITTOES PHARMACEUTICALS 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,INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/1998
1312NDA/MAL/HDP/3527AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDLEVOTOP-500LEVOFLOXACIN500MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2009
1313NDA/MAL/HDP/3535LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDADIFLAM-50DICLOFENAC SODIUM GASTRO-RESISTANT TABLETS BP50MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1314NDA/MAL/HDP/3542BETA HEALTH CARE 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,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP,1.0X110.0X2.0 TABLET STRIP7/1/2005
1315NDA/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 PRADESH | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2008
1316NDA/MAL/HDP/3545GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID MOUTH PAINTCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |ORAL TOPICAL LIQUIDS1.0X15.0 ML BOTTLE7/1/2000
1317NDA/MAL/HDP/3546RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM D.SSULPHAMETHOXAZOLE + TRIMETHOPRIM800MG + 160MGRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2013
1318NDA/MAL/HDP/3547UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORBIS-10BISOPROLOL10 MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2008
1319NDA/MAL/HDP/3548CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDBECORT 200BECLOMETASONE200MCG/DOSECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |LUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2009
1320NDA/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, NAIROBI | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2007
1321NDA/MAL/HDP/3551AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA-500MGAZITHROMYCIN500MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA | AJANTA PHARMA LIMITED-PLOT NO.Z/103/A,DAHEJ SEZ PART 11,DISTRICT: BHARUCH,GUJARAT-392130 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER,1.0X10.0X1.0X3.0 TABLET BLISTER7/1/2009
1322NDA/MAL/HDP/3556REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDGRISACTIN-500 TABLETSGRISEOFULVIN TABLETS500MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1323NDA/MAL/HDP/3558CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDSEROFLO-250SALMETEROL+ FLUTICASONE PROPIONATE25MCG + 250MCGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2009
1324NDA/MAL/HDP/3561GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCILLIN ORAL SUSPENSIONAMPICILLIN TRIHYDRATE125MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
1325NDA/MAL/HDP/3563I CARE PHARMA LIMITEDAIVEEN (U) LIMITEDLEVOLIFELEVOFLOXACIN500MG/100MLEUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHAND | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2010
1326NDA/MAL/HDP/3566SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE60 MGGUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI |CHINA |PARENTERAL ORDINARY DRY VIALS1.0X60.0 MG VIAL + 1*5% NAHCO3 + 5 ML NACL INJECTION7/1/2008
1327NDA/MAL/HDP/3569CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCARBADAC-200CARBAMAZEPINE200MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
1328NDA/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 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
1329NDA/MAL/HDP/3575PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFIX 400 CAPSULESCEFIXIME400MGPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN |ORAL SOLID ORDINARY CAPSULES1.0X1.0X5.0 CAPSULE BLISTER7/1/2007
1330NDA/MAL/HDP/3578REMEDICA LTDGOODMAN INTERNATIONAL LTDCINNARON 25CINNARIZINE25MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2005
1331NDA/MAL/HDP/3580ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDFEXOFEN-120FEXOFENADINE HYDROCHLORIDE120MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X6.0 TABLET BLISTER7/1/2008
1332NDA/MAL/HDP/3581CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOZ 5METOLAZONE5MGCENTAUR PHARMA PVT.LTD-PLANT I-PLOT 3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2007
1333NDA/MAL/HDP/3588ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDFEXOFEN-180FEXOFENADINE180MGARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X6.0 TABLET BLISTER7/1/2008
1334NDA/MAL/HDP/3590REMEDICA LTDGOODMAN INTERNATIONAL LTDALFOXAN 500 FC TABLETSMEFENAMIC ACID500MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2004
1335NDA/MAL/HDP/3591DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDARTESIANE 80MG/MLARTEMETHER80MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY |PARENTERAL ORDINARY I M AMPOULES1.0X5.0X1.0 ML AMPOULE7/1/1998
1336NDA/MAL/HDP/3597DAFRA PHARMA LTDMULTIPHAR UGANDA LIMITEDARTESIANE 20 PAEDIATRICARTEMETHER20MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY |PARENTERAL ORDINARY I M AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2001
1337NDA/MAL/HDP/3598WIN-MEDICURE LTDSURGIPHARM (U) LIMITEDMYOSPAZPARACETAMOL + CHLORZOXAZONE500MG + 250MGWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1338NDA/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-INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X9.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X15.0 TABLET BLISTER7/1/2008
1339NDA/MAL/HDP/3606STRIDES ARCOLAB LTDDELMAW ENTERPRISES LIMITEDCELLTRIAXONCEFTRIAXONE1GSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
| SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR |
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2010
1340NDA/MAL/HDP/3607PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDLINOPRILLISINOPRIL DIHYDRATE20MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |ORAL SOLID ORDINARY TABLETS1.0X14.0X2.0 TABLET BLISTER7/1/2004
1341NDA/MAL/HDP/3610COSMOS LTDASTRA PHARMA (U) LIMITEDPROMETHAZINE TABLETS BP 25MGPROMETHAZINE HYDROCHLORIDE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER7/1/1998
1342NDA/MAL/HDP/3611SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDCOLDRIL SYRUPPARACETAMOL + CHLORPHENIRAMINE + PSEUDOEPHEDRINE120MG+1MG+10MGBETA HEALTHCARE INTERNATIONAL LIMITED-PLOT NUMBER LR 209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA ROAD INDUSTRIAL AREA, P.O.BOX 42569-00100 NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2010
1343NDA/MAL/HDP/3612INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLOSARTAS-H 12.5LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1344NDA/MAL/HDP/3613HETERO LABS LTDAIVEEN (U) LIMITEDZIDOVUDINE ORAL SOLUTIONZIDOVUDINE50MG/5MLHETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH , | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE7/1/2013
1345NDA/MAL/HDP/3614RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDERYTHROREN SUSPENSIONERYTHROMYCIN STEARATE125MG/5MLRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2008
1346NDA/MAL/HDP/3618ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDCLOXACILLIN SODIUMCLOXACILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON7/1/2011
1347NDA/MAL/HDP/3619DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDCAPTOPRIL DENK -25CAPTOPRIL25MGDENK PHARMA, GOLLSTR.,-1-D-845 529 TITTMONING GERMANY
|
GERMANY |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2000
1348NDA/MAL/HDP/3620REMEDICA LTDGOODMAN INTERNATIONAL LTDHALOXEN 10 TABLETSHALOPERIDOL BP10MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER7/1/2004
1349NDA/MAL/HDP/3622GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDPROXIMEXACEFUROXIME AXETIL125MG/5MLGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X50.0 ML BOTTLE7/1/2007
1350NDA/MAL/HDP/3626CADILA HEALTH CARE LIMITEDABACUS 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-361006 |
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
1351NDA/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, AHMADABAD | INDIA |PARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE7/1/2001
1352NDA/MAL/HDP/3630MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDUNICONTIN 600THEOPHYLLINE600MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2009
1353NDA/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 GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2008
1354NDA/MAL/HDP/3634GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPLUSPARACETAMOL+DEXTROMETHORPHAN HCL+ CHLORPHENIRAMINE+PHENYLEPHRINE HCL500MG+15MG+2MG+10MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2008
1355NDA/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 INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2011
1356NDA/MAL/HDP/3637SHOSAAN ASIC PACIFICRENE PHARMACY LTDTINODERMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X18.0 G TUBE7/1/1997
1357NDA/MAL/HDP/3639GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL ADVANCEPARACETAMOL500MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X11.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER7/1/2010
1358NDA/MAL/HDP/3641MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDTRD-CONTIN 100TRAMADOL HYDROCHLORIDE