Drug Register (September 2021)
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S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER11/7/2018
2NDA/MAL/HHP/5498AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFIGURINAJANTA PHARMA LTD 31-0-AJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREACHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X6.0X10.0 CAPSULE BLISTER7/1/2000
3NDA/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
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/5518MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER7/1/2007
7NDA/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
8NDA/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
9NDA/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
10NDA/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
11NDA/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
12NDA/MAL/HHP/5547SHURIK LTDSHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTD-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X35.0X2.0 LOZENGE STRIP7/1/2001
13NDA/MAL/HHP/5549HIMALAYA DRUG COMPANY.EUROPA HEALTHCARE (U) LTDBONISAN LIQUIDHIMALAYA DRUG COMPANY-27256287 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2000
14NDA/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
15NDA/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
16NDA/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
17NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIAINDIATOPICAL EXTERNAL OINTMENTS1.0X12.0 G TUBE7/1/2001
18NDA/MAL/HHP/5560AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSTAMINAAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2000
19NDA/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
20NDA/MAL/HHP/5565ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDENTEX TOOTHACEPOOJA DRUGS-POOJA DRUGSINDIATOPICAL EXTERNAL LIQUIDS1.0X5.0 ML BOTTLE7/1/2000
21NDA/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
22NDA/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
23NDA/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
24NDA/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
25NDA/MAL/HHP/5576SHURIK 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
26NDA/MAL/HHP/5580MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDEUGICA SYRUPDHG PHARMACEUTICALJOINT-STOCK COMPANY (DHG PHARMA)-NO. 288 BIS, NGUYEN VAN CN STREET, AN HOA WARD, NINHKIEN DISTRICT, CAN THO CITY
VIETNAMORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2016
27NDA/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
28NDA/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
29NDA/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
30NDA/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
31NDA/MAL/HHP/5613DR. KIM AYURVEDIC PHARMACYJ.P.IMPEX PHARMACY (U) LIMITEDSMOOTH COUGH DROPSDR KIM AYURVEDIC PHARMACY-INDIAINDIAORAL SOLID ORDINARY LOZENGES1.0X100.0X2.0 LOZENGE STRIP7/1/2005
32NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVYBRANTVITAL CARE-INDIAINDIAORAL SOLID ORDINARY CAPSULES5.0X10.0 CAPSULE BLISTER7/1/2000
33NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF COLD RUBUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116
GUJARAT INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER7/1/2009
34NDA/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
35NDA/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
36NDA/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
37NDA/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
38NDA/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
39NDA/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
40NDA/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
41NDA/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
42NDA/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
43NDA/MAL/HHP/6915GREAT INDIA INDUSTRIAL & PHARAMCEUTICALS LABORATORIESMALIX PHARMA (U) LIMITEDGIPLA GRIPE WATERGREAT INDIA -19 SUN MILL COMPOUNDINDIAORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE7/1/2014
44NDA/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
45NDA/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
46NDA/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
47NDA/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
48NDA/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
49NDA/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
50NDA/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
51NDA/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
52NDA/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
53NDA/MAL/HHP/7946SHEBAC PHARMANORVIK ENTERPRISES LIMITEDAPONTISAEROMAC (INDIA) INC-12, MELDI ESTATE, GOTA AHMEDABAD -382481, GUJARAT, INDIA INDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X150.0 ML BOTTLE7/1/2015
54NDA/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
55NDA/MAL/HHP/7949UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL COUGH (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES --PLOT NO. 215-219 AND 304 - 308 G.I.D.C. INDUSTRIAL AREA,PANOLI—394 116,INDIA. INDIAORAL SOLID ORDINARY LOZENGES1.0X2.0X12.0 LOZENGE CONTAINER7/1/2016
56NDA/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
57NDA/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
58NDA/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
59NDA/MAL/HHP/7956UNIQUE PHARMACEUTICAL LABORATORIES. (A DIVISION OF J.B. CHEMICALS AND PHARMACEUTICALS LTD)TATA UGANDA LIMITEDZECUF HERBAL (SUGAR FREE)UNIQUE PHARMACEUTICAL LABORATORIES. -SURVEY NO.101/2 AND 102/1,DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN-396 210 INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
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/7959BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDTONIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2015
62NDA/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
63NDA/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
64NDA/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
65NDA/MAL/HHP/7965BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDCO-EXBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2017
66NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDPLANET PHARMACEUTICALS UGANDA LTDKIDFLAMEBHARGAVA PHYTOLAB PVT LTD-B-92, SECTOR – 2 , NOIDA – 201301, U.P. ( INDIA) INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER7/1/2015
67NDA/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 BOTTLE1/15/2019
68NDA/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
69NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDPOSTORALBHARGAVA 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
70NDA/MAL/HHP/8215AMRUTANJAN HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDAMRUTANJAN DRAGON BACK PAIN ROLL-ONAMRUTANJAN HEALTH CARE LIMITED - -PLOT NO.14, INDUSTRIAL DEVELOPMENT AREA, UPPAL HYDERABAD - 500039, INDIA INDIATOPICAL EXTERNAL LOTIONS1.0X50.0 ML CONTAINER7/1/2004
71NDA/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
72NDA/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
73NDA/MAL/HHP/8457BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDGASTICA SYRUPBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2017
74NDA/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
75NDA/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
76NDA/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
77NDA/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
78NDA/MAL/HHP/8511BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDTHUNDER-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
79NDA/MAL/HHP/8512BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDINFAB SYRUPBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE – 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2017
80NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDMENIPHIBBHARGAVA 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
81NDA/MAL/HHP/8548ARTURA PHARMACEUTICALS PVT LTDSWASTIK PHARMACEUTICAL LTDPEPSOLARTURA PHARMACEUTICALS PVT LTD-PLOT NO. 1505 PORTIA ROAD SIRI CITY SEZ SATYAVEDU MANDAL CHITTOOR DISTRICT ANDHRA PRADESHI - 517 588 INDIAINDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X3.0X10.0 CAPSULE BLISTER10/24/2017
82NDA/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
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X10.0 ML TUBE11/24/2017
83NDA/MAL/HHP/8553RAZA INTERNATIONALWIDE SPECTRUM ENTERPRISES (U) LIMITEDHONEY CUREOZONE COSMETICS & NATURAL PRODUCTS MANUFACTURING COMPANY?-SHARA BADRAN, MARJ ALFARAS, INDUSTRIAL ZONE, MUSAWAA STREET.
OZONE INDUSTRIAL COMPLEX. P.O. BOX : 1764. AMMAN 11953, JORDAN
JORDANTOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X15.0 G TUBE7/13/2017
84NDA/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
85NDA/MAL/HHP/8557MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-250TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER11/10/2017
86NDA/MAL/HHP/8837PILLAR PHARMA LIMITEDPILLAR LOGISTICS LIMITEDHEPTOVITMILENNIUM HERBAL CARE LTD-12B, NIRMAL, 241/242, BACKBAY RECLAMATION, NARIMAN POINT, MUMBAI 400 021 INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER6/7/2018
87NDA/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
88NDA/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
89NDA/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
90NDA/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
91NDA/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
92NDA/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
93NDA/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
94NDA/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
95NDA/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
96NDA/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
97NDA/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
98NDA/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
99NDA/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
100NDA/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
101NDA/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
102NDA/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
103NDA/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
104NDA/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
105NDA/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
106NDA/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
107NDA/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
108NDA/MAL/HHP/9181REDDYS PHARMA LIMITEDREDDYS PHARMA LIMITEDZEBAGREAT INDIA INDUSTRIAL AND PHARMACEUTICAL LABORATORIES-19,SUN MILLS COMPD,MUMBAI 400 013 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X135.0 ML BOTTLE3/11/2020
109NDA/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
110NDA/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
111NDA/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
112NDA/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
113NDA/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
114NDA/MAL/HHP/9334NABROS PHARMA PVT LTD.SHREEJI PHARMACEUTICALS LIMITEDKOFANOLNABROS PHARMA PVT LTD-SURVEY NO. 110/A/2, AMIT FARM JAIN UPASRAYA, NEAR COCACOLA FACTORY, NH NO. 8, KAJIPURA, DIST. KHEDA-387411, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP9/17/2020
115NDA/MAL/HHP/9335SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (RASPBERRY FLAVOUR)SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
116NDA/MAL/HHP/9336SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (MINT FLAVOUR)SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
117NDA/MAL/HHP/9337SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (PINEAPPLE FLAVOUR)SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
118NDA/MAL/HHP/9338SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (ORANGE FLAVOUR)SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
119NDA/MAL/HHP/9339SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (STRAWBERRY FLAVOUR) SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP9/23/2020
120NDA/MAL/HHP/9341SINO AFRICA MEDICALS AND HEALTHY LTDSINO AFRICA MEDICINES & HEALTH LTDLIANHUA QINGWEN CAPSULESHIJIAZHUANG YILING PHARMACEUTICAL CO.,LTD-NO. 238 TIANSHAN STREET, HIGH-TECH AREA, SHIJIAZHUANG, HEBEI PROVINCE CHINAORAL SOLID ORDINARY OTHER CAPSULES1.0X24.0 CAPSULE BLISTER10/15/2020
121NDA/MAL/HHP/9342GAYATRI AYUPHARMA PRIVATE LIMITEDSONA PHARMACEUTICALS LIMITEDLOZETS- ORANGEPRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL TOPICAL LOZENGES1.0X2.0X12.0 LOZENGE BLISTER11/5/2020
122NDA/MAL/HHP/9343GAYATRI AYUPHARMA PRIVATE LIMITEDSONA PHARMACEUTICALS LIMITEDLOZETS-WARM GINGERPRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL TOPICAL LOZENGES1.0X2.0X12.0 LOZENGE BLISTER11/5/2020
123NDA/MAL/HHP/9344GAYATRI AYUPHARMA PRIVATE LIMITEDSONA PHARMACEUTICALS LIMITEDLOZETS- COOL MINTPRINCE SUPPLICO-PLOT NO. 90-A, G.I.D.C, CHITRA, BHAVNAGAR INDIAORAL TOPICAL LOZENGES1.0X2.0X12.0 LOZENGE BLISTER11/5/2020
124NDA/MAL/HHP/9483LIBRA DRUGS INDIAVEERAM HEALTHCARE (U) LIMITEDGLYTUSS NATURAL COUGH SUPPRESSANT WITH HONEYLIBRA DRUGS INDIA-145/146/92 B, MANGALWAR PETH,PARGE CHOWK, PUNE - 411011,MAHARASTRA, INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X150.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X30.0 ML BOTTLE12/11/2020
125NDA/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
126NDA/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
127NDA/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
128NDA/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
129NDA/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
130NDA/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
131NDA/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
132NDA/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
133NDA/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
134NDA/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
135NDA/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
136NDA/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
137NDA/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
138NDA/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
139NDA/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
140NDA/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
141NDA/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
142NDA/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
143NDA/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
144NDA/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
S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/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/0002ABACUS PARENTERAL DRUGS LIMITED.ABACUS PARENTERAL DRUGS LIMITEDX-SONE-NDEXAMETHASONE+NEOMYCIN0.1W/V+ 0.35W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL7/1/2011
2NDA/MAL/HDP/0003UNI MEDICO LABROYAL PHARMA 2011 LIMITEDUMOXIL CLAV 625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGUNI MEDICOLABS-21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2015
3NDA/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 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
4NDA/MAL/HDP/0013MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDIMPLANON NXTETONOGESTREL68MGN.V. ORGANON-KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLAND NETHERLANDSPARENTERAL RETARD IMPLANTS1.0X68.0 MG IMPLANT7/1/2015
5NDA/MAL/HDP/0016REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
6NDA/MAL/HDP/0017SWISS PARENTERALS LTDSHREEJI CARE LIMITEDS-HYDROHYDROCORTISONE100MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X7.5 ML VIAL7/1/2011
7NDA/MAL/HDP/0021SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDQUINSQUININE DIHYDROCHLORIDE300MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE7/1/2013
8NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2009
9NDA/MAL/HDP/0024KOPRAN LIMITEDTATA UGANDA LIMITEDAMPICLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
10NDA/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
INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE7/1/2015
11NDA/MAL/HDP/0031MANKIND PHARM LTDTATA UGANDA LIMITEDCEFTATIME-SB 1.5CEFTRIAXONE+SULBACTAM1000MG+500MGMANKIND PHARMA LTD--VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESHINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL7/1/2015
12NDA/MAL/HDP/0041RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCIMETIDINE200MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
13NDA/MAL/HDP/0043KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL JUNIORPARACETAMOL250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
14NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
15NDA/MAL/HDP/0051H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY DENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/2015
16NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT EGYPTTOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2014
17NDA/MAL/HDP/0053H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN DENMARKPARENTERAL RETARD AMPOULES1.0X1.0 ML AMPOULE7/1/2015
18NDA/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 506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
19NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN DENMARKPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/2015
20NDA/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 INDIATOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE7/1/2015
21NDA/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 INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE7/1/1997
22NDA/MAL/HDP/0059NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
PAKISTANTOPICAL EXTERNAL CREAMS1.0X40.0 G TUBE + 1 APPLICATOR7/1/2006
23NDA/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 SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI ITALY SWITZERLANDPARENTERAL ORDINARY PRE-FILLED PENS1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION7/1/2015
24NDA/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.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2015
25NDA/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 SWITZERLANDPARENTERAL ORDINARY CARTRIDGES1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION7/1/2015
26NDA/MAL/HDP/0075SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDSYNRIAMARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE150 MG + 750 MGSUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2014
27NDA/MAL/HDP/0077ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDX-SONEDEXAMETHASONE SODIUM PHOSPHATE0.1 % W/VABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2015
28NDA/MAL/HDP/0079MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE 72LEVONORGESTREL750MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2014
29NDA/MAL/HDP/0083MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA-FLEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE150MCG + 30MCG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER7/1/2014
30NDA/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 INDIAORAL 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
31NDA/MAL/HDP/0097MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
32NDA/MAL/HDP/0098MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
33NDA/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 INDIAORAL 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
34NDA/MAL/HDP/0102MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2014
35NDA/MAL/HDP/0103MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
36NDA/MAL/HDP/0104MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2014
37NDA/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 INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1998
38NDA/MAL/HDP/0107NVS KENYA LTDSURGIPHARM (U) LIMITEDASUNRADEFERASIROX400MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSESWITZERLANDORAL SOLID ORDINARY SOLUBLE TABLETS1.0X5.0X6.0 TABLET BLISTER7/1/2015
39NDA/MAL/HDP/0110MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
40NDA/MAL/HDP/0111MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
41NDA/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 SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2007
42NDA/MAL/HDP/0114MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY 4MONTELUKAST SODIUM4MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
43NDA/MAL/HDP/0116MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
44NDA/MAL/HDP/0117ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 1.5GCEFUROXIME SODIUM1.5GALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 SANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.5 G VIAL + 1 AMPOULE OF WFI7/1/2013
45NDA/MAL/HDP/0118ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 750MGCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 SANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL + 1 AMPOULE WFI7/1/2013
46NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
47NDA/MAL/HDP/0121SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDPEDZINCZINC SULPHATE20MGBETA HEALTH CARE INTERNATIONAL LIMITED/-PLOT NO. LR 209/ 6534 MOGADISHU ROAD, KENYA TANZANIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2015
48NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2015
49NDA/MAL/HDP/0125DAWA LIMITEDSUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/2013
50NDA/MAL/HDP/0126DAWA LIMITEDSUPER MEDIC LTDWHITFIELD'SBENZOIC ACID + SALICYLIC ACID6.0%W/W +3.0%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/2014
51NDA/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 CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
52NDA/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 CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
53NDA/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 ROADTANZANIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2013
54NDA/MAL/HDP/0139DAWA LIMITED-SUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2014
55NDA/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 KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/1998
56NDA/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 CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
57NDA/MAL/HDP/0153DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 300IRBESARTAN300MG DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
58NDA/MAL/HDP/0155TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ASTHATOR 10MONTELUKAST SODIUM10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
59NDA/MAL/HDP/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
60NDA/MAL/HDP/0158MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
61NDA/MAL/HDP/0160UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDTIZIGESICTIZANIDINE HYDROCHLORIDE2MGUNICHEM LABORATORIES LIMITED-C–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2016
62NDA/MAL/HDP/0162RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
63NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENARENPROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2015
64NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
65NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2015
66NDA/MAL/HDP/0167TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 10OLANZAPINE ORODISPERSIBLE TABLETS10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
67NDA/MAL/HDP/0168MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
68NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSEN GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
69NDA/MAL/HDP/0178REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAYTIME AND NIGHT TIME CAPSULEDAY TIME(PARACETAMOL +CAFFEINE ANHYDROUS+PSEUDOEPHEDRINE HCL) AND NIGHT TIME(PARACETAMOL +CHLORPHENIRAMINE MALEATE)DAY TIME (500MG + 30MG + 30MG) AND NIGHT TIME (500MG +2MG)REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X8.0 CAPSULE BLISTER7/1/2013
70NDA/MAL/HDP/0182MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAY 40FEBUXOSTAT40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
71NDA/MAL/HDP/0186WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBBC SPRAYBENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE1.5%W/V+0.15%W/V+0.0413%W/VAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL TOPICAL SPRAYS WITHOUT GAS1.0X25.0 ML BOTTLE7/1/2014
72NDA/MAL/HDP/0187AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON TABLETTRANEXAMIC ACID500 MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
73NDA/MAL/HDP/0188AMOUN PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDLEVOXINLEVOFLOXACIN500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
74NDA/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 NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2013
75NDA/MAL/HDP/0192AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDAMOCOMB CREAMNEOMYCIN + TRIAMCINOLONE ACETONIDE + GRAMICIDIN0.25GM + 0.1G + 100000IU + 0.025G/100GAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
76NDA/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 NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER,1.0X2.0X10.0 TABLET STRIP7/1/2013
77NDA/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 UGANDAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2013
78NDA/MAL/HDP/0198CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIRAPINE TABLETS 200 MGNEVIRAPINE200MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
79NDA/MAL/HDP/0203GLAXOSMITHLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUX FRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2015
80NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOMUNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2015
81NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2013
82NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/10/2013
83NDA/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 INDIAORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE7/1/2013
84NDA/MAL/HDP/0210MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN140MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2011
85NDA/MAL/HDP/0212MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN1G/100MLMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT EGYPTORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE7/1/2012
86NDA/MAL/HDP/0213AUROBINDO PHARMA LTD (UNIT VI)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROPODOX 200CEFPODOXIME200MGAUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI- R7-AUROBINDO PHARMA LIMITED, FORMULATIONS UNIT-VI SY.NO.329/39 & 329/47 CHITKUL(V) PATANCHERU MANDAL, SANGA REDDY DISTTELANGANA502307 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2013
87NDA/MAL/HDP/0217PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDPALETHERARTEMETHER80MG/MLLINCOLN PARENTERAL LTD .-11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT INDIAPARENTERAL ORDINARY I M AMPOULES2.0X3.0X1.0 ML AMPOULE7/1/2014
88NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
89NDA/MAL/HDP/0220ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDZENOCET-10CETIRIZINE10MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
90NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
91NDA/MAL/HDP/0224ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAVIR-400ACYCLOVIR400LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
92NDA/MAL/HDP/0226AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDULTRASOLV SYRUPOXOMEMAZINE HCL & CARBOCYSTEINE & GUAIFENESIN2MG+125MG+100MG/5MLAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2014
93NDA/MAL/HDP/0228KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-960TRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
94NDA/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 INDIAORAL 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
95NDA/MAL/HDP/0232TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.BRANTALOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
96NDA/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 CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
97NDA/MAL/HDP/0234MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCEFIMED 200CEFIXIME TRIHYDRATE200MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X8.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
98NDA/MAL/HDP/0235MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 500CEFUROXIME AXETIL500MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP7/1/2014
99NDA/MAL/HDP/0245CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 4GLIMEPIRIDE4MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
100NDA/MAL/HDP/0248IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE40 MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
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101NDA/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 INDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER7/1/2013
102NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
103NDA/MAL/HDP/0253ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTENLOW-5AMLODIPINE BESYLATE5MGLINCO N PHARMACEUTICALS LIMITED-TRIMUL ESTATE KHATRAJ KALOL GUJARAT INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
104NDA/MAL/HDP/0254MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 5BISOPROLOL HEMIFUMARATE5MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADTGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
105NDA/MAL/HDP/0256HETERO LABS LTDAIVEEN (U) LIMITEDCAPETERO 500CAPECITABINE500MGHETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET CONTAINER7/1/2015
106NDA/MAL/HDP/0257SANOFI AVENTS FRANCESURGIPHARM (U) LIMITEDCORDARONEAMIODARONE HYDROCHLORIDE200MGSANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE
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107NDA/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) CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON7/1/2001
108NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
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109NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2001
110NDA/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 INDIAPARENTERAL ORDINARY AMPOULES1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)7/1/2001
111NDA/MAL/HDP/0272HETERO LABS LTDAIVEEN (U) LIMITEDLEVIN 250LEVOFLOXACIN250MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
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112NDA/MAL/HDP/0275GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD-39 HAWKINS AVENUE, EPPING INDUSTRIAL, CAPE TOWN, 7460, SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER7/1/2011
113NDA/MAL/HDP/0276MICRO LABS LTDLABOREX UGANDA LIMITEDMELANOV 80GLICLAZIDE80MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
114NDA/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 KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/1998
115NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2013
116NDA/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 506INDIATOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE,1.0X30.0 G TUBE7/1/2013
117NDA/MAL/HDP/0288UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDDUXCOSPANHYOSCINE BUTYL BROMIDE10MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
118NDA/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 KENYAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
119NDA/MAL/HDP/0293HETERO LABS LTDAIVEEN (U) LIMITEDDARUNAVIRDARUNAVIR600 MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2014
120NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
121NDA/MAL/HDP/0301HETERO LABS LTDAIVEEN (U) LIMITEDMONAST 10MONTELUKAST SODIUM10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
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122NDA/MAL/HDP/0303HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2014
123NDA/MAL/HDP/0304HETERO LABS LTDAIVEEN (U) LIMITEDDARUNAVIRDARUNAVIR400MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER7/1/2014
124NDA/MAL/HDP/0305SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250 DRY SYRUPCEFALEXIN250MG/5MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2013
125NDA/MAL/HDP/0307HETERO DRUGS LTDAIVEEN (U) LIMITEDLAMIVUDINE ORAL SOLUTIONLAMIVUDINE10MG/MLHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X240.0 ML CONTAINER7/1/2013
126NDA/MAL/HDP/0308SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFAX-250CEFALEXIN250MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
127NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLANDUNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2013
128NDA/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 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2013
129NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA -BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844 UNITED KINGDOMPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2013
130NDA/MAL/HDP/0317YURIA PHARM LTD-UKRAINEPHARMA VILLE LIMITEDCIPROFLOXACIN-UFCIPROFLOXACIN2MG/MLYURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
131NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULINSALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
132NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
133NDA/MAL/HDP/0322MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2009
134NDA/MAL/HDP/0326ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDOSTEBONCALCIUM + COLECALCIFEROL250MG + 125 IUARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X200.0 ML BOTTLE7/1/2014
135NDA/MAL/HDP/0333KOPRAN LIMITEDTATA UGANDA LIMITEDCLAVAMYN-625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG +125MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
136NDA/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 INDIATOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE7/1/2013
137NDA/MAL/HDP/0336ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAS-DP TABLETSDICYCLOMINE HCL + PARACETAMOL20MG+500MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
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139NDA/MAL/HDP/0338KOPRAN LIMITEDTATA UGANDA LIMITEDKORAB 20RABEPRAZOLE SODIUM20MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
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141NDA/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 506INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
142NDA/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 140507INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X10.0 TABLET BLISTER7/1/2014
143NDA/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 140507INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2014
144NDA/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 506INDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2013
145NDA/MAL/HDP/0344ZHUHAI UNITED LABORATORIESAARON PHARMACEUTICALS LTDCEROBACTAMOXICILLIN/CLAVULANATE POTASSIUM500MG/100MGZHUHAI UNITED LABORATORIES -12,JIALIAN ROAD,TANZHOU, ZHONGSHAN, GUANGDONG-528467, P.R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X600.0 MG VIAL7/1/2014
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147NDA/MAL/HDP/0346ZHUHAI UNITED LABORATORIESAARON PHARMACEUTICALS LTDCEROBACTAMOXICILLIN/CLAVULANATE POTASSIUM1000MG/200MGZHUHAI UNITED LABORATORIES -12,JIALIAN ROAD,TANZHOU, ZHONGSHAN, GUANGDONG-528467, P.R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL7/1/2013
148NDA/MAL/HDP/0348ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDXBETABETAMETHASONE SODIUM PHOSPHATE0.1%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2015
149NDA/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 INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL7/1/2013
150NDA/MAL/HDP/0350RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
151NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER7/1/2014
152NDA/MAL/HDP/0354KOPRAN LIMITEDTATA UGANDA LIMITEDLEVOKOPLEVOFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2013
153NDA/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 INDIAINDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2015
154NDA/MAL/HDP/0356DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 50OLEVOFLOXACIN HEMIHYDRATE500MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2014
155NDA/MAL/HDP/0358SWISS PARENTERALS LTDSHREEJI CARE LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY I M VIALS1.0X1.0 G VIAL7/1/2014
156NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE SWEDENORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON7/1/2001
157NDA/MAL/HDP/0362SWISS PARENTERALS LTDSHREEJI CARE LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2015
158NDA/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 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER7/1/2014
159NDA/MAL/HDP/0365UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDSULFRAN- DSTRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER7/1/2015
160NDA/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 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER7/1/2014
161NDA/MAL/HDP/0368ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDQUININE DI HYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU GERMANYPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/1997
162NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2010
163NDA/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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164NDA/MAL/HDP/0376EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-DAMLODIPINE + HYDROCHLOROTHIAZIDE2.5 MG + 12.5 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
165NDA/MAL/HDP/0377MEDOCHEMIE LTDSHREEJI PHARMACEUTICALS LIMITEDDUINUMCLOMIFENE50MGMEDOCHEMIE LTD-CENTRAL FACTORY A-1-10 CONSTANTINOUPOLEUS STREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2014
166NDA/MAL/HDP/0380MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAVERNOLCARVEDILOL6.25NGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
167NDA/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 AFRICAPARENTERAL ORDINARY VIALS1.0X10.0X10.0 ML VIAL7/1/2014
168NDA/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 AFRICAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BAG7/1/2014
169NDA/MAL/HDP/0384FRESENIUS KABI MANUFACTURING S.A (PTY) LTDSURGIPHARM (U) LIMITEDPANCURONIUM BROMIDE FRESENIUSPANCURONIUM BROMIDE4MG/2MLFRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH SOUTH AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2014
170NDA/MAL/HDP/0386EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-80ENOXAPARIN SODIUM80MG/ 0.8MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 ML PRE- FILLED SYRINGE7/1/2014
171NDA/MAL/HDP/0388KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY 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
172NDA/MAL/HDP/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IVPARACETAMOL1000MG/100MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2014
173NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDDOXYLEBDOXYCYCLINE100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2014
174NDA/MAL/HDP/0397EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-LTAMLODIPINE + LOSARTAN POTASSIUM2.5 MG + 50 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X3.0X10.0 TABLET BLISTER7/1/2013
175NDA/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 INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
176NDA/MAL/HDP/0403NEON LABARATORIES LTDAIVEEN (U) 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 INDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2013
177NDA/MAL/HDP/0404GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDACTIFED WET COUGH & COLDTRIPLORIDINE HCL/PSEUDOEPHEDRINE/GUAIPHENESIN1.25MG/30MG/100MGGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO EGYPTORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN7/1/1997
178NDA/MAL/HDP/0405NEON LABARATORIES LTDAIVEEN (U) LIMITEDCHEMLETLETROZOLE2.5MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
179NDA/MAL/HDP/0406NEON LABARATORIES LTDAIVEEN (U) LIMITEDEVATOCINOXYTOCIN10 I.U./ MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2015
180NDA/MAL/HDP/0407NEON LABARATORIES LTDAIVEEN (U) LIMITEDNEOROFPROPOFOL1%W/VNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2013
181NDA/MAL/HDP/0408MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDALGIC - PACECLOFENAC + PARACETAMOL100 MG + 500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
182NDA/MAL/HDP/0409NEON LABARATORIES LTDAIVEEN (U) LIMITEDTYDE-S*CHLORAMPHENICOL SODIUM SUCCINATE1G/VIALNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2013
183NDA/MAL/HDP/0410MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 20ROSUVASTATIN CALCIUM20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
184NDA/MAL/HDP/0411BAYER PHARMA AGSURGIPHARM (U) LIMITEDJADELLE SINELEVONORGESTREL150MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X10.0X1.0X2.0X75.0 MG IMPLANT7/1/2003
185NDA/MAL/HDP/0412MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 5ROSUVASTATIN CALCIUM5MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
186NDA/MAL/HDP/0413NEON LABARATORIES LTDAIVEEN (U) LIMITEDXSPASHYOSCINE BUTYLBROMIDE20MG/MLNEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA INDIAPARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2013
187NDA/MAL/HDP/0414SANDOZ GMBH, KUNDLSURGIPHARM (U) LIMITEDRAMIPRIL 10 MG TABLETSRAMIPRIL10MGLEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATESPOLANDORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
188NDA/MAL/HDP/0415MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRELEXDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL14.03MG+138MG+57.03MG+0.90MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
189NDA/MAL/HDP/0416NOVARTIS ACCESSSURGIPHARM (U) LIMITEDRAMIPRILRAMIPRIL5MGLEK S.A-95 - 010 STRYKÓW, PODLIPIE 16, POLAND POLANDORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
190NDA/MAL/HDP/0418ASTRA ZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2013
191NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USAUNITED STATESORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
192NDA/MAL/HDP/0421MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDPREGASAFE 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
193NDA/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 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
194NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2013
195NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/1998
196NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
197NDA/MAL/HDP/0428MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2013
198NDA/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. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
199NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER7/1/2013
200NDA/MAL/HDP/0433PT SAMBE FARMAMEDVIN PHARMA LIMITEDPROANES MCT/LCTPROPOFOL1%W/VPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY I V AMPOULES1.0X5.0X20.0 ML AMPOULE7/1/2014
201NDA/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 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP7/1/2010
202NDA/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 AFRICAPARENTERAL ORDINARY VIALS1.0X10.0X20.0 ML VIAL7/1/2015
203NDA/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 AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2014
204NDA/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 AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2015
205NDA/MAL/HDP/0440AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGICLOB-GMCLOBETASOL/GENTAMICIN/MICONAZOLE0.5MG+3.4MG+20MG/1GAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
206NDA/MAL/HDP/0441AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAGISECSECNIDAZOLE1GMAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0 TABLET BLISTER7/1/2015
207NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/2014
208NDA/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 AFRICAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2015
209NDA/MAL/HDP/0447PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON®125METHYLPREDNISOLONE SODIUM SUCCINATE125MG/VIALPT.CAPRIFARMINDO LABORATORIES-JI.INDUSTRI NO.8,KOMPLEKS INDUSTRI CIMAREME DESA CIMAREME,KEC PADALARANG,KAB BANDUNG INDONESIAPARENTERAL ORDINARY DRY VIALS1.0X125.0 MG VIAL + 1*2ML AMPOULE OF WFI7/1/2014
210NDA/MAL/HDP/0449PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD GRANULESCYANOCOBALAMIN5MCGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY GRANULES1.0X10.0X5.0 G SACHET7/1/2013
211NDA/MAL/HDP/0451PT SANBE FARMAMEDVIN PHARMA LIMITEDSANEXON®500METHYLPREDNISOLONE SODIUM SUCCINATE500MG/VIALPT.CAPRIFARMINDO LABORATORIES-JI.INDUSTRI NO.8,KOMPLEKS INDUSTRI CIMAREME DESA CIMAREME,KEC PADALARANG,KAB BANDUNG INDONESIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL + 1*8ML AMPOULE OF WFI7/1/2014
212NDA/MAL/HDP/0453PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMINOGUARD LIQUIDAMINO ACIDS + MULTIVITAMINSMULTI INGREDIENTSSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE7/1/2013
213NDA/MAL/HDP/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE500 MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2014
214NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDMETROLEBMETRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
215NDA/MAL/HDP/0457UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDUNIBROL 250MGAMINOSIDINE250MGUNIVERSAL CORPORATION LTD-UNIVERSAL CORPORATION LTDKENYAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER,1.0X4.0X6.0 TABLET BLISTER7/1/2012
216NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL LIQUID ORDINARY LIQUIDS1.0X15.0 ML BOTTLE7/1/2009
217NDA/MAL/HDP/0461BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDBEXITROL-F HFA 25/125SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG+125MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS1.0X120.0 METERED DOSE CANNISTER7/1/2015
218NDA/MAL/HDP/0462BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDDECOMIT 50 HFABECLOMETHASONE50MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS1.0X200.0 METERED DOSE CANNISTER7/1/2015
219NDA/MAL/HDP/0463GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHENPHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2011
220NDA/MAL/HDP/0465BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDDECOMIT 100 HFABECLOMETHASONE DIPROPIONATE200MCGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHTOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS1.0X200.0 METERED DOSE CANNISTER7/1/2015
221NDA/MAL/HDP/0466BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDALPHIN DSALBENDAZOLE400MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY CHEWABLE TABLETS1.0X50.0 TABLET BLISTER,1.0X50.0X1.0 TABLET BLISTER7/1/2015
222NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS50.0X2.0 TABLET STRIP7/1/1997
223NDA/MAL/HDP/0468NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXIT 750CEFUROXIME750MGNECTAR LIFESCIENCES LIMITED-VILL. BHATOLIKALAN, ADJOININGJHARMJRI,
P.O BAROTIWALA DIST SOLAN H.P 173205
INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL + 10ML WFI AMPOULE7/1/2013
224NDA/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 DENMARKPARENTERAL ORDINARY DRY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN7/1/2014
225NDA/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 DENMARKPARENTERAL ORDINARY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN7/1/2014
226NDA/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 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 ML VIAL,1.0X0.5 ML VIAL7/1/2015
227NDA/MAL/HDP/0475LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X25.0X4.0 TABLET BLISTER7/1/2015
228NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
229NDA/MAL/HDP/0480CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMERATE 600/300/300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG+300MG+300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA CIPLA L.T.D -MIDC PATALGANGA MAHARASHTRA 410 220 CIPLA LTD UNIT VII PD II-S-103 TO S-105, S-107 TO S-112, L-138, L-147/1 TO L-147/3, L-147A, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA 403722, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2014
230NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTDMALIX PHARMA (U) LIMITEDAZILEB-500AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X3.0 TABLET BLISTER7/1/2014
231NDA/MAL/HDP/0483FOUNTIL LIFE SCIENCES PVT LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDULGICID TABLETSALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE+ MAGNESIUM TRISILICATE + SIMETICONE200MG + 250MG + 250MG + 250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
232NDA/MAL/HDP/0484KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDPILPLAN PLUSETHINYL ESTRADIOL + LEVONORGESTREL / FERROUS FUMARATE0.03MG+0.15MG/75MGBAYER SCHERING PHARMA AG.-13342, BERLIN GERMANYORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X28.0 TABLET BLISTER7/1/2014
233NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER7/1/2014
234NDA/MAL/HDP/0490SANOFISURGIPHARM (U) LIMITEDORELOXCEFPODOXIME200MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPIÈGNE
FRANCEORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
235NDA/MAL/HDP/0491ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EYE DROPSCHLORAMPHENICOL0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X5.0 ML VIAL,1.0X10.0 ML VIAL7/1/2013
236NDA/MAL/HDP/0492BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDZOLFINACECLOFENAC100MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER7/1/2013
237NDA/MAL/HDP/0494BEXIMCO PHARMACEUTICALS LIMITEDLIFE PHARMA AFRICA LIMITEDINFORMET 500METFORMIN HYDROCHLORIDE500MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
238NDA/MAL/HDP/0496ADCOCK INGRAM LIMITEDSURGIPHARM (U) LIMITEDMYPRODOLPARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE250MG + 200MG + 10MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
INDIAORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
239NDA/MAL/HDP/0497LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL DRY SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
240NDA/MAL/HDP/0498BEXIMCO PHARMACEUTICALS LTDLIFE PHARMA AFRICA LIMITEDEVO 500LEVOFLOXACIN500MGBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2013
241NDA/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 SLOVENIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/2014
242NDA/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 INDIAORAL LIQUID ORDINARY LIQUIDS1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
243NDA/MAL/HDP/0505MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE75MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER7/1/2013
244NDA/MAL/HDP/0506REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.OPTA-ATROPINE EYE DROPSATROPINE SULPHATE1%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2001
245NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET STRIP7/1/2004
246NDA/MAL/HDP/0518RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCYCLORENACICLOVIR200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2006
247NDA/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 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2014
248NDA/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
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INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
249NDA/MAL/HDP/0526LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDAMILEB- 25AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA– 444 104 (MS).
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250NDA/MAL/HDP/0531LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDENDERM-GMCLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE0.05%W/W + 0.10%W/W + 2.0%W/WLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE7/1/2014
251NDA/MAL/HDP/0536MANKIND PHARMA LIMITEDTATA UGANDA LIMITEDMOXIKIND-CV 625AMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER7/1/2014
252NDA/MAL/HDP/0538MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
253NDA/MAL/HDP/0540PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDHYDRICORTHYDROCORTISONE SODIUM SUCCINATE100MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY DRY VIALS1.0X50.0X100.0 MG VIAL7/1/2014
254NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
255NDA/MAL/HDP/0542DAWA LIMITEDSUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
256NDA/MAL/HDP/0543UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 2GLIMEPIRIDE2MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
257NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
258NDA/MAL/HDP/0547NAARI LTDGITTOES PHARMACEUTICALS LIMITEDMISO-KAREMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16 &55-57, SECTOR-5, IIE, PANTNAGAR, RUDRAPUR-263153, DIST. U.S. NAGAR, UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0 TABLET BLISTER (COMBIPACK),1.0X3.0X4.0 TABLET BLISTER7/1/2013
259NDA/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 SECURITYJORDANORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
260NDA/MAL/HDP/0549ABOTT LABORATORIES S.A (PTY) LTDHARLEYS UGANDA LIMITEDHIDRASECRACECADOTRIL100 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE FRANCEORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2014
261NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2014
262NDA/MAL/HDP/0552ABOTT LABORATORIES S.A (PTY) LIMITEDHARLEYS UGANDA LIMITEDHIDRASEC INFANTSRACECADOTRIL10 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE FRANCEORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X16.0 SACHET CARTON7/1/2014
263NDA/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
INDIAPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL (5 DOSE VIAL)7/1/2013
264NDA/MAL/HDP/0556ABOTT LABORATORIES S.A (PTY) LTDHARLEYS UGANDA LIMITEDHIDRASEC CHILDRENRACECADOTRIL30 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE FRANCEORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X30.0 SACHET CARTON7/1/2014
265NDA/MAL/HDP/0558ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABGENTA EYE DROPSGENTAMICIN SULPHATE0.3% W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOPHTHALMIC DROPS1.0X10.0 ML BOTTLE,1.0X5.0 ML VIAL7/1/2014
266NDA/MAL/HDP/0560UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 1GLIMEPIRIDE1MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITYJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
267NDA/MAL/HDP/0562KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM COTRICO-TRIMOXAZOLE240MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL LIQUID ORDINARY SUSPENSIONS100.0 ML BOTTLE,60.0 ML BOTTLE7/1/1997
268NDA/MAL/HDP/0563IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDEZO 40ESOMEPRAZOLE MAGNESIUM40MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI INDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
269NDA/MAL/HDP/0568RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
270NDA/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 MALAYSIAORAL LIQUID ORDINARY SYRUPS1.0X90.0 ML BOTTLE7/1/2014
271NDA/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
INDIAPARENTERAL ORDINARY I M VIALS1.0X1.0X2.0 ML VIAL (1 DOSE VIAL)7/1/2013
272NDA/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 MALAYSIAORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE7/1/2015
273NDA/MAL/HDP/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/2010
274NDA/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 MALAYSIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2014
275NDA/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. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER7/1/2013
276NDA/MAL/HDP/0576GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY GERMANYORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER7/1/2015
277NDA/MAL/HDP/0580KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPMULTINGREDIENTMULTINGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
278NDA/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) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2015
279NDA/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) 173205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
280NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDNISOLONE ACETATE1%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE7/1/2013
281NDA/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) 173205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
282NDA/MAL/HDP/0590BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDASNA ANTIVENOM CB.GABONICA/B.ARIENTANS/ B.NASICORNIS/ DENDROASPIS/ POLYEPIS/D.ANGUSTICEPS/ N.NIVEA /N.NLGRCOLLIS/N.HAJE25/25/20/25/25/25/25/25/20/25/20/25 I.UBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
INDIAPARENTERAL ORDINARY VIALS1.0X1.0X10.0 ML VIAL7/1/2012
283NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC LIQUIDS1.0X10.0 ML CONTAINER7/1/2013
284NDA/MAL/HDP/0593ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPANTOP-DPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES20MG+10MGARISTO PHARMACEUTICALS PVT LTD .-MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESHINDIAORAL SOLID ORDINARY ENTERIC-COATED CAPSULES1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP7/1/2014
285NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2015
286NDA/MAL/HDP/0596MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2011
287NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2003
288NDA/MAL/HDP/0599MICRO LABS LIMITEDLABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
289NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
290NDA/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 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/1999
291NDA/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 KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
292NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
293NDA/MAL/HDP/0608CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLOPINAVIR AND RITONAVIR TABLETS 200MG/50MGLOPINAVIR + RITONAVIR200MG + 50MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET BOTTLE7/1/2012
294NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
295NDA/MAL/HDP/0610ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPYLOR KITLANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2014
296NDA/MAL/HDP/0611GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDGALCIPRO 500CIPROFLOXACIN HYDROCHLORIDE500MGGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
297NDA/MAL/HDP/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID125MG/5ML + 31.25MG/5MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1998
298NDA/MAL/HDP/0617PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDSILVEXSILVER SULFADIAZINE + CHLORHEXIDINE1%W/W + 0.2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
299NDA/MAL/HDP/0619ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD10GLUCOSE10%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2013
300NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
301NDA/MAL/HDP/0623ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGELCIDMAGNESIUM SULPHATE50%W/VLINCOLN PHARMACEUTICALS LTD--11 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0X10.0 ML AMPOULE,1.0X10.0X5.0X5.0 ML AMPOULE IN BLISTER PACK,1.0X5.0 ML AMPOULE IN BLISTER PACK7/1/2015
302NDA/MAL/HDP/0625SANOFI PASTEURLABOREX UGANDA LIMITEDVERORABRABIES VACCINE1 DOSESANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE FRANCEPARENTERAL ORDINARY VIALS1.0X1.0 DOSE VIAL,1.0X5.0X1.0 DOSE VIAL + 1.0X5.0X0.5ML GLASS AMPOULES OF 0.9% SODIUM CHLORIDE7/1/1997
303NDA/MAL/HDP/0626KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCARDIPAC-10AMLODIPINE BESILATE10MGKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0X10.0 TABLET BLISTER7/1/2015
304NDA/MAL/HDP/0627KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAMOXIKIDAMOXICILLIN TRIHYDRATE125MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2015
305NDA/MAL/HDP/0630CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEO LORIDINDESLORATADINE5MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2011
306NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL7/1/2013
307NDA/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 INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2014
308NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2009
309NDA/MAL/HDP/0636MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDREVOKE-1.5LEVONORGESTREL1.5MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER7/1/2014
310NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
311NDA/MAL/HDP/0638PHARMACIE BETHELABACUS PARENTERAL DRUGS LIMITEDABLOL-5 EYE DROPSTIMOLOL MALEATE0.5% W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2013
312NDA/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 INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
313NDA/MAL/HDP/0652NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUSVILDAGLIPTIN50MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. NOVARTIS BARBERA -SPAINSWITZERLANDORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2014
314NDA/MAL/HDP/0654NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER7/1/2013
315NDA/MAL/HDP/0657NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER7/1/2013
316NDA/MAL/HDP/0658NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER7/1/2013
317NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
318NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2013
319NDA/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 MALAYSIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/2013
320NDA/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 MALAYSIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/2013
321NDA/MAL/HDP/0670GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY CAPSULES1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER7/1/2014
322NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/2013
323NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2013
324NDA/MAL/HDP/0675ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
325NDA/MAL/HDP/0677GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
326NDA/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 MALAYSIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/2014
327NDA/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 INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2013
328NDA/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 INDIAPARENTERAL ORDINARY DRY VIALS1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI7/1/2013
329NDA/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 INDIAORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
330NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
331NDA/MAL/HDP/0690MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHEALTHEASE CREAMBECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/2014
332NDA/MAL/HDP/0691MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
333NDA/MAL/HDP/0692DAWA LIMITEDSUPER MEDIC LTDDAWACLOX -250CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2015
334NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2014
335NDA/MAL/HDP/0694GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON7/1/2013
336NDA/MAL/HDP/0696BYANSI SERVICES LIMITEDAIVEEN (U) LIMITEDRITONAVIRRITONAVIR100MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2014
337NDA/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 INDIAPARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)7/1/2015
338NDA/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 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL,1.0X100.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL7/1/2014
339NDA/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 506INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE7/1/2013
340NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER7/1/2013
341NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2011
342NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
343NDA/MAL/HDP/0707HETERO LABS LTDAIVEEN (U) LIMITEDPENVIR 500FAMCICLOVIR500MGHETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
344NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
345NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE100MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCEFRANCEORAL LIQUID ORDINARY SUSPENSIONS1.0X20.0 ML BOTTLE7/1/1997
346NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2015
347NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN GERMANYORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2015
348NDA/MAL/HDP/0716LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-1GLIMEPIRIDE+METFORMIN HYDROCHLORIDE1MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2014
349NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER7/1/2014
350NDA/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 INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.4 ML PRE- FILLED SYRINGE7/1/2011
351NDA/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 INDIAORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE7/1/2013
352NDA/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 INDIAPARENTERAL ORDINARY I M AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE7/1/2014
353NDA/MAL/HDP/0722FDC LTDAIVEEN (U) LIMITEDIOTIM 0.5%TIMOLOL MALEATE0.5% W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/2014
354NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE50MGTROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHANDINDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2014
355NDA/MAL/HDP/0727MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTOMACH FIT SYRUPBISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL140MG+9MG+0.15MG+0.2/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X225.0 ML BOTTLE7/1/2013
356NDA/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. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
357NDA/MAL/HDP/0731IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 50/135ARTESUNATE + AMODIAQUINE50/135MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
358NDA/MAL/HDP/0732AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDVOLTAMED-100DICLOFENAC100 MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
359NDA/MAL/HDP/0733CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYNACACECLOFENAC100MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
360NDA/MAL/HDP/0734AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDOMMED -20OMEPRAZOLE20MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/2015
361NDA/MAL/HDP/0736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMABRON 50TRAMADOL HYDROCHLORIDE50MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
362NDA/MAL/HDP/0737SANOFI AVENTISSURGIPHARM (U) LIMITEDTAXOTERE 80MGDOCETAXEL TRIHYDRATE80MG/4MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
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363NDA/MAL/HDP/0739SANOFI AVENTISSURGIPHARM (U) LIMITEDTAXOTERE 20MGDOCETAXEL TRIHYDRATE20MG/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOESCHST,BRUNINGSTRASSEN BUIDING,H65065926, FRANKFURT AM MAIN GERMANYPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0 ML VIAL7/1/2014
364NDA/MAL/HDP/0740MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDCOTRIMCO-TRIMOXAZOLE960MGMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X17.0X6.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
365NDA/MAL/HDP/0741MEDOCHEMIE LTDSHREEJI PHARMACEUTICALS LIMITEDMEDOCIPRINCIPROFLOXACIN500MG MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
366NDA/MAL/HDP/0742MEDOCHEMIE LTDSHREEJI PHARMACEUTICALS LIMITEDBROTMETFORMIN HYDROCHLORIDE500MGMEDOCHEMIE LTD-CENTRAL FACTORY A-1-10 CONSTANTINOUPOLEUS STREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
367NDA/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
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KENYAORAL LIQUID ORDINARY UNIT DOSE POWDERS1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER7/1/2013
368NDA/MAL/HDP/0747MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE ORANGE CO-PACKGLUCOSE ANHYDROUS + SODIUM CHLORIDE + TRISSODIUM CITRATE DEHYDRATE + POTASSIUM CHLORIDE / ZINC SULPHATE13.5G + 2.6G + 2.9G + 1.5G/ SACHET + 27.43MG/5ML: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE
POSTAL ADDRESS : P.O.BOX 5917, KAMPALA.
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369NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER7/1/2013
370NDA/MAL/HDP/0749AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 1000MEROPENEM1000MGAURONEXT PHARMA PVT LTD.-A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADI INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2014
371NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSENGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER7/1/2013
372NDA/MAL/HDP/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
373NDA/MAL/HDP/0753AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 500MEROPENEM500MGAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2014
374NDA/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 GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
375NDA/MAL/HDP/0756CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 100TOLPERISONE100MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
376NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2011
377NDA/MAL/HDP/0765PHARM ACCESS AFRICA LTDUNITED HEALTHCARE DISTRIBUTORS LTDLEVOPLANTLEVONORGESTREL75MGSHANGHAI DAHUA PHARMACEUTICAL CO. LTD-CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAI CHINAPARENTERAL RETARD IMPLANTS1.0X10.0X2.0 ROD IMPLANT7/1/2010
378NDA/MAL/HDP/0768FDC LTDAIVEEN (U) LIMITEDPYRIMON EYE DROPDEXAMETHASONE/CHLORAMPHENICOL1%W/V + 0.1%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA. INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/1999
379NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
380NDA/MAL/HDP/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 75PREGABALIN75MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
381NDA/MAL/HDP/0776FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL TABLETSPARACETAMOL TABLETS500MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1999
382NDA/MAL/HDP/0780CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDATORVA TABLETSATORVASTATIN10MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X1.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2001
383NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER7/1/2013
384NDA/MAL/HDP/0783TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDCYPOLIVECYPROHEPTADINE HYDROCHLORIDE4 MGTRIVENI FORMULATIONS LIMITED--PLOT NO: 52,53,54, 62,63 & 64 ALEAP INDUSTRIAL ESTATE SURAMPALI VILLAGE, GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X50.0 TABLET BLISTER7/1/2013
385NDA/MAL/HDP/0784COSMOS LTDASTRA PHARMA (U) LIMITEDHEMOSANFERROUS FUMERATE300MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
386NDA/MAL/HDP/0788TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRIDANTINNITROFURANTOIN100 MGTRIVENI FORMULATIONS LIMITED .- PLOT NO 52,53-54,63-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAN MANDAL KRISHNA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
387NDA/MAL/HDP/0794REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTDHEALTHCARE LTD.AMYGYDEXTOBRAMYCIN/DEXAMETHASONE3MG+1MG/MLREMINGTON PHARMACEUTICALS (PVT) LTD-18KM, MULTAN ROAD, LAHORE 53800, PAKISTAN PAKISTANOPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/2014
388NDA/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) INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
389NDA/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. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
390NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
391NDA/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 SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2015
392NDA/MAL/HDP/0806SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSQUARE ZINCZINC SULPHATE20MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
393NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
394NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2GLIMEPIRIDE2MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
395NDA/MAL/HDP/0820MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFIXIME 400MGCEFIXIME400MGNKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2015
396NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3GLIMEPIRIDE3MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONINGGERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
397NDA/MAL/HDP/0822ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X0.5 G VIAL,1.0X100.0X0.5 G VIAL,1.0X10.0X0.5 G VIAL7/1/2014
398NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
399NDA/MAL/HDP/0824I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLINCLOXACILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2013
400NDA/MAL/HDP/0826I CARE PHARMA LIMITEDVITACARE LTDAMOXYCILLINAMOXYCILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2013
401NDA/MAL/HDP/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER7/1/2015
402NDA/MAL/HDP/0831I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN CAPSULESAMPICILLIN250MGMEDICO REMEDIES PVT LTD,.-8 & 9 DEWAN AND SONS, UDYOG NAGAR, PALGHAR, DIST. THANE-401404, MAHARSHITRA INDIAORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2013
403NDA/MAL/HDP/0832MERCKUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER7/1/2015
404NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARATINDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2013
405NDA/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 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
406NDA/MAL/HDP/0836LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONE-500CALCIUM CARBONATE + COLECALCIFEROL1250MG + 250 I.ULINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2012
407NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X2.0 TABLET BLISTER7/1/2013
408NDA/MAL/HDP/0843MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCOXERINCYCLOSERINE250MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/2013
409NDA/MAL/HDP/0845VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDOLEVO-500LEVOFLOXACIN500 MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X10.0 TABLET BLISTER,1.0X5.0X1.0X10.0 TABLET BLISTER7/1/2013
410NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMANINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
411NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2014
412NDA/MAL/HDP/0850LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLCT KITLANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2012
413NDA/MAL/HDP/0854GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-50BECLOMETASONE50MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2013
414NDA/MAL/HDP/0855HETERO LABS LTDAIVEEN (U) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
415NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAVAGINAL TABLETS1.0X6.0 PESSARY STRIP7/1/2000
416NDA/MAL/HDP/0858ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2001
417NDA/MAL/HDP/0860MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFLOXSAFE 400MOXIFLOXACIN HYDROCHLORIDE400MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2012
418NDA/MAL/HDP/0861SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDPROZINEPROMETHAZINE25MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES2.0X5.0X2.0 ML AMPOULE7/1/2013
419NDA/MAL/HDP/0862GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR- 200BECLOMETASONE200MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2013
420NDA/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 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
421NDA/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 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
422NDA/MAL/HDP/0867HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-20PANTOPRAZOLE SODIUM20MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
423NDA/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 INDIAPARENTERAL ORDINARY VIALS1.0X2.0X6.0X2.0 ML VIAL7/1/2013
424NDA/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 INDIAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE7/1/2013
425NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2010
426NDA/MAL/HDP/0871SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDDEXADEXAMETHASONE SODIUM4MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA INDIAPARENTERAL ORDINARY DRY VIALS2.0X6.0X2.0 ML VIAL7/1/2013
427NDA/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 CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
428NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
429NDA/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 MAHARASHTRAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X170.0 ML BOTTLE7/1/2007
430NDA/MAL/HDP/0879COSMOS LTD.ASTRA PHARMA (U) LIMITEDTRIBEES FORTE FILM COATED TABLETSTHIAMINE + PYRIDOXINE + CYANOCOBALAMIN200MG + 50MG +1000MCGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2012
431NDA/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 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER7/1/2012
432NDA/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 SEMOYFRANCEORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER7/1/2012
433NDA/MAL/HDP/0888UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDUNIVIR 400ACYCLOVIR400MGUNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
434NDA/MAL/HDP/0889ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDNSSODIUM CHLORIDE + GLUCOSE0.9%W/V + 5% W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE7/1/2012
435NDA/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.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER7/1/2014
436NDA/MAL/HDP/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTHSODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0 ML PRE- FILLED SYRINGE7/1/2015
437NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2015
438NDA/MAL/HDP/0898HETERO LABS LTDAIVEEN (U) LIMITEDLOSAGEN 50LOSARTAN POTASSIUM50MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
439NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML VIAL WFI7/1/2013
440NDA/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 INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
441NDA/MAL/HDP/0905NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPODCEFPODOXIME PROXETIL200MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
442NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2015
443NDA/MAL/HDP/0907NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXITCEFUROXIME AXETIL250MGNECTAR LIFE SCIENCES LTD--UNIT VI BHATOLIKALAN DIST SOLAN H.PINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP7/1/2013
444NDA/MAL/HDP/0909NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDFIXINECTCEFIXIME100MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP7/1/2013
445NDA/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 INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2015
446NDA/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 INDIAPARENTERAL ORDINARY VIALS1.0X3.0 ML VIAL,1.0X3.0 ML PREFILLED PEN7/1/2015
447NDA/MAL/HDP/0915NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET STRIP7/1/2014
448NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0X4.0 ML VIAL7/1/2012
449NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP7/1/2004
450NDA/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. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
451NDA/MAL/HDP/0929IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDDUOQUINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG +320MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER7/1/2012
452NDA/MAL/HDP/0934CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDODIMONT 4MONTELUKAST4MGCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210INDIAORAL SOLID ORDINARY CHEWABLE COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
453NDA/MAL/HDP/0938FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 20MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS20MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER7/1/2013
454NDA/MAL/HDP/0939LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARHALPHA -BETA ARTEETHER150MG /2MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X2.0 ML AMPOULE7/1/2012
455NDA/MAL/HDP/0940FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 40MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS40MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER7/1/2013
456NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X15.0 ML BOTTLE7/1/2013
457NDA/MAL/HDP/0942LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH FORTEALPHA -BETA ARTEETHER225MG/ 3MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X3.0X3.0 ML AMPOULE7/1/2012
458NDA/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 KENYAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE7/1/2013
459NDA/MAL/HDP/0951NEON LABARATORIES LTDAIVEEN (U) LIMITEDNORADSTERILE NORADRENALINE CONCENTRATE2MG/2MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY S C AMPOULES1.0X5.0X2.0 ML AMPOULE7/1/2013
460NDA/MAL/HDP/0952NEON LABARATORIES LTDAIVEEN (U) LIMITEDEFECATALCEFTRIAXONE1GNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2013
461NDA/MAL/HDP/0953NEON LABARATORIES LTDAIVEEN (U) LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL7/1/2013
462NDA/MAL/HDP/0954NEON LABARATORIES LTDAIVEEN (U) LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL RETARD OTHER VIALS1.0X20.0 ML VIAL7/1/2013
463NDA/MAL/HDP/0957MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDLYRED SYRUPVITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC2500 IU + 10 IU + 50MG + 35MCG + 3MGTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2012
464NDA/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 INDIAINDIAORAL 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
465NDA/MAL/HDP/0963AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMODARTESUNATE+AMODIAQUINE50MG+135MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X3.0 TABLET BLISTER7/1/2013
466NDA/MAL/HDP/0964AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 25 / 67.5ARTESUNATE + AMODIAQUINE25 MG + 67.5 MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABADINDIAORAL SOLID ORDINARY LAYERED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
467NDA/MAL/HDP/0966SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDREFINAC DTDICLOFENAC SODIUM50MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
468NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2005
469NDA/MAL/HDP/0974SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME100MG/5MLSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH BANGLADESHORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE7/1/2015
470NDA/MAL/HDP/0978SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDAMBROX 75 SR CAPSULEAMBROXOL75MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2012
471NDA/MAL/HDP/0984CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.JOVAN T20TADALAFIL20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
472NDA/MAL/HDP/0986EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
473NDA/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 EGYPTTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
474NDA/MAL/HDP/0995LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDFLUCOMOLPARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE250MG + 5MG + 10MG + 2MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
475NDA/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 EGYPTORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
476NDA/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 EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
477NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE7/1/2012
478NDA/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 EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
479NDA/MAL/HDP/1002SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDCIPROCIN T 750CIPROFLOXACIN750MGSQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2013
480NDA/MAL/HDP/1003EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDZEFICAMLORNOXICAM8MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
481NDA/MAL/HDP/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
482NDA/MAL/HDP/1007COSMOS LTDASTRA PHARMA (U) LIMITEDZINCOS DISPERSIBLE TABLETS 20MGZINC SULPHATE20MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
483NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2012
484NDA/MAL/HDP/1011COSMOS LTDASTRA PHARMA (U) LIMITEDDABORAL SYRUPAMINOSIDINE125MG/5MLCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2012
485NDA/MAL/HDP/1012NEON LABARATORIES LTDAIVEEN (U) LIMITEDLOX 2%LIDOCAINE2% W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY OTHER VIALS1.0X50.0 ML VIAL,1.0X20.0 ML VIAL7/1/2013
486NDA/MAL/HDP/1013NEON LABARATORIES LTDAIVEEN (U) LIMITEDTHIOSOLTHIOPENTAL SODIUM500MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X20.0 ML VIAL7/1/2013
487NDA/MAL/HDP/1015DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN250MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
488NDA/MAL/HDP/1018KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM CHLORCHLORAMPHENICOL250MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL 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
489NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID RETARD LAYERED TABLETS1.0X10.0X1.0X12.0 TABLET BLISTER7/1/2012
490NDA/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 EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
491NDA/MAL/HDP/1023MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDZINNIA PLEVONORGESTREL + ETHINYLESTRADIOL 150MCG + 30MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER,3.0X28.0 TABLET BLISTER7/1/2013
492NDA/MAL/HDP/1031EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOXIFLOXMOXIFLOXACIN400MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X1.0X5.0 TABLET BLISTER7/1/2013
493NDA/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 EGYPTORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
494NDA/MAL/HDP/1033FAES FARMA S.APHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDYNAMOGENGLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE3MG +1GFAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA SPAINORAL LIQUID ORDINARY LIQUIDS1.0X20.0X10.0 ML SACHET7/1/2015
495NDA/MAL/HDP/1034VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOXAMOXICILLIN250MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS CYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
496NDA/MAL/HDP/1035GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDG-CIPROXCIPROFLOXACIN500MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
497NDA/MAL/HDP/1038SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3CEFIXIME TRIHYDRATE200MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER7/1/2014
498NDA/MAL/HDP/1040SQUARE CEPHALOSPORINS LTDGAMA PHARMACEUTICALS (U) LIMITEDCEF-3 DSCEFIXIME TRIHYDRATE400MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2014
499NDA/MAL/HDP/1041SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDREPOITINRECOMBINANT HUMAN ERYTHROPOIETIN4000 I.U/1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X1.0X1.0 ML VIAL7/1/2013
500NDA/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. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP7/1/2013
501NDA/MAL/HDP/1044UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDANGINET 80MGVALSARTAN80MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
502NDA/MAL/HDP/1045SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIMAX 500AZITHROMYCIN500MGSQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTER7/1/2013
503NDA/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 HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER7/1/2013
504NDA/MAL/HDP/1048UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 120MGFEXOFENADINE120MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER7/1/2013
505NDA/MAL/HDP/1049GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2012
506NDA/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)
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER7/1/2013
507NDA/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 INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
508NDA/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) INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
509NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2011
510NDA/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. INDIATOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE7/1/2013
511NDA/MAL/HDP/1057NECTAR LIFESCIENCES LTDSUPER MEDIC LTDFIXINECT-200MGCEFIXIME200MGNECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL.
NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
512NDA/MAL/HDP/1061SHOSAAN ASIC PACIFICRENE PHARMACY LTDBISACODYL TABLETSBISACODYL5MGNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
513NDA/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
INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON7/1/2013
514NDA/MAL/HDP/1064VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDOXOLOXALIPLATIN2MG/MLVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL7/1/2012
515NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIARECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER7/1/2007
516NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN+PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2010
517NDA/MAL/HDP/1068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDAROFF 100ACECLOFENAC100MGUNICHEM LABORATORIES LIMITED-C–31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
518NDA/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 INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X1.0 ML AMPOULE7/1/2014
519NDA/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 HOUSINGJORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
520NDA/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 JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
521NDA/MAL/HDP/1073GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDIBICAR-250BECLOMETASONE250MCG PER ACTUATIONGLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2013
522NDA/MAL/HDP/1074NECTAR LIFESCIENCES LTDSUPER MEDIC LTDCEFUAXITCEFUROXIME500MGNECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL.
NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
523NDA/MAL/HDP/1075NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPIMECEFEPIME1000MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION7/1/2013
524NDA/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 HOUSINGJORDANORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
525NDA/MAL/HDP/1077NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECTRAMCEFTRIAXONE1GNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WFI AMPOULE7/1/2013
526NDA/MAL/HDP/1078MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2013
527NDA/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 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2000
528NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2009
529NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
530NDA/MAL/HDP/1083GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCHOCOFER SYRUPIRON + FOLIC ACID50MG + 0.5MG /5MLGALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2013
531NDA/MAL/HDP/1084DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE4MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
532NDA/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
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
533NDA/MAL/HDP/1087GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2013
534NDA/MAL/HDP/1088GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDRESTUMCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL7/1/2015
535NDA/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 099INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
536NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2012
537NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2012
538NDA/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 INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X5.0 G TUBE7/1/2013
539NDA/MAL/HDP/1102MATRIX UGANDA LTDROYAL PHARMA 2011 LIMITEDOVUREXCLOMIPHENE50MG Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2011
540NDA/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 INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
541NDA/MAL/HDP/1105DAWA LIMITEDSUPER MEDIC LTDDERMAZINE PLUSSILVER SULPHADIAZINE AND CHLORHEXIDINE GLUCONATE1%W/W / 10.0%W/WDAWA LIMITED -BABA DOGO RWARAKAKENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
542NDA/MAL/HDP/1106EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT EGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER7/1/2013
543NDA/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 INDIAPARENTERAL ORDINARY I M VIALS1.0X25.0X5.0 ML VIAL (10 DOSES),1.0X10.0X0.5 ML VIAL (1 DOSE)7/1/2005
544NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2014
545NDA/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 KENYATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE7/1/2013
546NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE7/1/1997
547NDA/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
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER7/1/2012
548NDA/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
INDIAOPHTHALMIC OINTMENTS1.0X20.0X3.5 G TUBE7/1/2013
549NDA/MAL/HDP/1118EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 52.5TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR), (TNK-T-PA)52.5GENNOVA BIOPHARMACEUTICALS LIMITED-BLOCK 1, PLOT NO. P-1 AND P-2, ITBT PARK, PHASE II, MIDC, HINJAWADI, PUNE - 411057 INDIAPARENTERAL ORDINARY I V VIALS1.0X52.5 MG VIAL + (1*10ML AMPOULE WFI)7/1/2013
550NDA/MAL/HDP/1122ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDABCHLOR EAR DROPSCHLORAMPHENICOL5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAOTIC DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL7/1/2013
551NDA/MAL/HDP/1123GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPARPARACETAMOL500 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2012
552NDA/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 INDIATOPICAL EXTERNAL LIQUIDS1.0X1.0X500.0 ML BOTTLE7/1/2013
553NDA/MAL/HDP/1127FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDCLARION TABLETS 500MGCLARITHROMYCIN500MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
554NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARATINDIAORAL SOLID ORDINARY COMBINATION PACK TABLETS1.0X4.0 TABLET BLISTER7/1/2013
555NDA/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
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2012
556NDA/MAL/HDP/1131FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDXAVOR 50LOSARTAN50MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2014
557NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2012
558NDA/MAL/HDP/1133MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDMEDICOL SUSPENSIONCHLORAMPHENICOL125MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2007
559NDA/MAL/HDP/1134FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDXAVOR DIULOSARTAN AND HYDROCHLORTHIAZIDE50/12.5MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
PAKISTANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
560NDA/MAL/HDP/1136GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL EMULSIONS1.0X1.0X100.0 ML BOTTLE7/1/2013
561NDA/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 INDIATOPICAL EXTERNAL LOTIONS1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2013
562NDA/MAL/HDP/1139GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
563NDA/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. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
564NDA/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 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2012
565NDA/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 INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
566NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
567NDA/MAL/HDP/1145HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HILACLACTULOSE68%W/VHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2005
568NDA/MAL/HDP/1148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 10MONTELUKAST10MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2012
569NDA/MAL/HDP/1149UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDNEUROBAGABAPENTIN300MGUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU KENYAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2015
570NDA/MAL/HDP/1150AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDFEBRAMOLPARACETAMOL INFUSION10MG/MLAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2013
571NDA/MAL/HDP/1154SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITED-INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.

INDIAPARENTERAL ORDINARY DRY VIALS1.0X30.0 ML VIAL7/1/2012
572NDA/MAL/HDP/1156CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFUNGICIPCLOTRIMAZOLE1%W/WCIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2011
573NDA/MAL/HDP/1157Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDTRETINONTRETINOIN0.05%W/WY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA MALAYSIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
574NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2012
575NDA/MAL/HDP/1159Y.S.P INDUSTRIES (M) SDN BHDROYAL PHARMA 2011 LIMITEDVORENDICLOFENAC SODIUM50MGY.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA MALAYSIARECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X10.0X10.0 SUPPOSITORY STRIP7/1/2013
576NDA/MAL/HDP/1160DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + CLAVULANIC ACID875MG+125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG TURKEYORAL SOLID ORDINARY TABLETS1.0X2.0X5.0 TABLET BLISTER7/1/2011
577NDA/MAL/HDP/1162TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDWINKLOTCLOPIDOGREL75MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2012
578NDA/MAL/HDP/1163SHOSAAN ASIC PACIFICRENE PHARMACY LTDFRUSEMIDEFUROSEMIDE40MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE – 401 210, MAHARASHTRA – INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
579NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
580NDA/MAL/HDP/1166PANACEA BIOTEC LTDVITACARE LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
581NDA/MAL/HDP/1167CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDMETOCLOPRAMIDE INJECTIONMETOCLOPRAMIDE5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2010
582NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYA KENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2009
583NDA/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 PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X3.0X10.0 TABLET BLISTER7/1/2013
584NDA/MAL/HDP/1170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO MEGANEURONMETHYLCOBALAMIN500MCGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAPARENTERAL ORDINARY I M AMPOULES1.0X1.0 ML AMPOULE7/1/2013
585NDA/MAL/HDP/1172CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE 20MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL,1.0X30.0 ML VIAL7/1/2010
586NDA/MAL/HDP/1176AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDFUNGISAFETERBINAFINE HYDROCHLORIDE1%W/WAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
587NDA/MAL/HDP/1178HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
588NDA/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 SWITZERLANDPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON7/1/2015
589NDA/MAL/HDP/1181TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 4MONTELUKAST SODIUM4 MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
590NDA/MAL/HDP/1182TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 5MONTELUKAST SODIUM5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
591NDA/MAL/HDP/1183HETERO DRUGS LTDAIVEEN (U) LIMITEDFLUVIROSELTAMIVIR PHOSPHATE75 MGHETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABAD HETERO LABS LIMITED .-UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2010
592NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
593NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
594NDA/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 NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
595NDA/MAL/HDP/1187GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDKEFTAZ-1000CEFTAZIDIME1 GALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION7/1/2013
596NDA/MAL/HDP/1189ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDDICLOMAX-75DICLOFENAC SODIUM75MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE7/1/2013
597NDA/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 INDIAPARENTERAL ORDINARY VIALS1.0X1.0X30.0 ML VIAL7/1/2009
598NDA/MAL/HDP/1195UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDALTRINECETIRIZINE5MG/5MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2013
599NDA/MAL/HDP/1196UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDACNESOLTRETINOIN0.05%W/WUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU KENYATOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE7/1/2012
600NDA/MAL/HDP/1202MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDQUINIMIX SYRUPQUININE HYDROCHLORIDE100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2003
601NDA/MAL/HDP/1205MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDEFAVIRENZEFAVIRENZ600MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2008
602NDA/MAL/HDP/1206THE METHOLATUM CO. LTDHARLEYS UGANDA LIMITEDDEEP RELIEFIBUPROFEN + MENTHOL5%W/W + 3% W/WTHE MENTHOLATUM CO. LTD. -1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDEUNITED KINGDOMTOPICAL EXTERNAL OTHER GELS/SOLS1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER7/1/2013
603NDA/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 PRADESHINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2011
604NDA/MAL/HDP/1209MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
605NDA/MAL/HDP/1211ASTRA ZENECAMACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2011
606NDA/MAL/HDP/1212GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDGLINTHERARTEMETHER80MG/MLGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI CHINAPARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE7/1/2011
607NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN500MG+65,000I.U+100,000I.UBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAVAGINAL SUPPOSITORIES1.0X10.0 TABLET BLISTER7/1/2013
608NDA/MAL/HDP/1218BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGSUNATE-50ARTESUNATE50MGM/S BLISS GVS PHARMA LIMITED -PLOT 10, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE PALGHAR, DIST. THANE - 401404 INDIARECTAL SYSTEMIC SUPPOSITORIES1.0X6.0 SUPPOSITORY STRIP7/1/2009
609NDA/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 GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
610NDA/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 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BLISTER7/1/2008
611NDA/MAL/HDP/1223REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X1.0X25.0 G TUBE7/1/1997
612NDA/MAL/HDP/1225AMOUN PHARMACEUTICAL COMPANYBOOTS PHARMACEUTICALS LIMITEDMOSEDIN PLUS SRPSEUDOEPHEDRINE HYDROCHLORIDE + LORATADINE120MG + 5MGAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTORAL SOLID ORDINARY CAPSULES1.0X1.0X10.0 CAPSULE BLISTER7/1/2013
613NDA/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. INDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2005
614NDA/MAL/HDP/1227AMOUN PHARMACEUTICALS COMPANYBOOTS PHARMACEUTICALS LIMITEDFUNGISAFETERBINAFINE HCL250MGAMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY,
KALYOUBIA CAIRO EGYPT
EGYPTORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0 TABLET STRIP7/1/2013
615NDA/MAL/HDP/1230MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDLOXAMPAMPICILLIN + CLOXACILLIN250 MG + 250 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
616NDA/MAL/HDP/1231NORVIK ENTERPRISES LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125AMOXYCILLIN125MG/5MLMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
617NDA/MAL/HDP/1232MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOCILLIN 125AMPICILLIN125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE
618NDA/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.
INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2007
619NDA/MAL/HDP/1242GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
620NDA/MAL/HDP/1243DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 250LEVOFLOXACIN HEMIHYDRATE250MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
621NDA/MAL/HDP/1247GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER7/1/2012
622NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2013
623NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER7/1/1998
624NDA/MAL/HDP/1255CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADINDIAORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1997
625NDA/MAL/HDP/1259IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ- 6.25CARVEDILOL6.25MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2013
626NDA/MAL/HDP/1261IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDCARDOZ-12.5CARVEDILOL12.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2013
627NDA/MAL/HDP/1264CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUCYCLINE EYE OINTMENTTETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIAOPHTHALMIC OINTMENTS1.0X5.0 G TUBE,1.0X3.5 G TUBE7/1/2000
628NDA/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 INDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2008
629NDA/MAL/HDP/1271INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDONASERONONDANSETRON4MG/5MLINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHORAL LIQUID ORDINARY LIQUIDS1.0X1.0X50.0 ML BOTTLE7/1/2012
630NDA/MAL/HDP/1272GULF PHARMACEUTICAL INDUSTRIES(JULPHAR)OMASI MED LIMITEDMEBO HERBAL OINTMENTB-SITOSTEROL0.25%W/WGULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA, P.O.BOX:
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RAS AL KHAIMAH,
U.A.E.
UNITED ARAB EMIRATESTOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/1999
631NDA/MAL/HDP/1274SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN250MGNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. PAKISTANORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2007
632NDA/MAL/HDP/1275REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 10 F.C TABLETSNIFEDIPINE10MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1997
633NDA/MAL/HDP/1276INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDPANTONIX 40 INJECTIONPANTOPRAZOLE SODIUM SEQUIHYDRATE40MGINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
BANGLADESHPARENTERAL ORDINARY AMPOULES1.0X1.0X40.0 MG VIAL 1*10ML AMPOULE OF 0.9% NACL7/1/2013
634NDA/MAL/HDP/1278SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXICHINAORAL SOLID ORDINARY TABLETS1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X25.0X1.0X9.0 TABLET BLISTER7/1/2013
635NDA/MAL/HDP/1282ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDLOSABERGLOSARTAN POTASSIUM50MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
636NDA/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. INDIAPARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL7/1/2012
637NDA/MAL/HDP/1287SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX- DS 100CEFIXIME100MG/5MLSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2014
638NDA/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
EGYPTORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/1998
639NDA/MAL/HDP/1290SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX 400 CAPCEFIXIME400MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
640NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300IOPROMIDE300MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL,1.0X100.0 ML VIAL7/1/2012
641NDA/MAL/HDP/1293ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEGRA - 100SILDENAFIL CITRATE100MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0 TABLET BLISTER7/1/2016
642NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0X100.0 ML VIAL,1.0X50.0 ML VIAL7/1/2012
643NDA/MAL/HDP/1295SHAIGAN PHARMACEUTICALS (PVT) LTDHARLEYS UGANDA LIMITEDZEPARALBENDAZOLE200MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/1997
644NDA/MAL/HDP/1299SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANAXONE PLUS-1000CEFTRIAXONE+SULBACTAM1000MG+500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL,1.0X50.0X1.0 VIAL CARTON7/1/2012
645NDA/MAL/HDP/1302CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDHIPEN CAPSULESAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
646NDA/MAL/HDP/1303MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFIBRALFINOFIBRATE200MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
647NDA/MAL/HDP/1304MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN1MG + 500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
648NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
649NDA/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 INDIAINDIARECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER7/1/2007
650NDA/MAL/HDP/1315ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-20ESOMEPRAZOLE20MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
651NDA/MAL/HDP/1319REMEDICA LTDGOODMAN INTERNATIONAL LTDZESTAVAL 200 F.C TABLETSALBENDAZOLE200MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS50.0X2.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER7/1/1997
652NDA/MAL/HDP/1324MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY LIQUIDS1.0X1.0X18.0 ML BOTTLE7/1/2005
653NDA/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 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE)7/1/1997
654NDA/MAL/HDP/1330IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDRAPICLAV-625AMOXYCILLIN+CLAVULANIC ACID500MG+125MGIPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X2.0 TABLET STRIP,1.0X7.0X3.0 TABLET STRIP7/1/2003
655NDA/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 PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/1997
656NDA/MAL/HDP/1334MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE30MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER,1.0X30.0 CAPSULE CONTAINER7/1/2016
657NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2012
658NDA/MAL/HDP/1336MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDOSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE45MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER, CAPSULE CONTAINER7/1/2015
659NDA/MAL/HDP/1338LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDGRISEBEN 500GRISEOFULVIN500 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
660NDA/MAL/HDP/1341AUROLABSWASTIK PHARMACEUTICAL LTDG-FLOXGATIFLOXACIN SESQUIHYDRATE0.3%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA INDIAOPHTHALMIC LIQUIDS1.0X5.0 ML VIAL7/1/2016
661NDA/MAL/HDP/1345ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDSWICH-200CEFPODOXIME200MGALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
662NDA/MAL/HDP/1347MICRO LABS LIMITEDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
663NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2009
664NDA/MAL/HDP/1351MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDATORINATORVASTATIN CALCIUM20MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
665NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
666NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2015
667NDA/MAL/HDP/1359KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENAC-100 SRDICLOFENAC SODIUM100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2016
668NDA/MAL/HDP/1360CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDABAMUNE-L BABYABACAVIR SULPHATE + LAMIVUDINE60MG + 30MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET CONTAINER7/1/2016
669NDA/MAL/HDP/1361SWISS PARENTERALS LTDSHREEJI CARE LIMITEDFALCI CAREARTESUNATE120MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL 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
670NDA/MAL/HDP/1362MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN + CLAVULANATE875 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X6.0 TABLET STRIP7/1/2013
671NDA/MAL/HDP/1366F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDHERCEPTIN 440MGTRASTUZUMAB440MGF. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGSTSWITZERLANDPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X440.0 MG VIAL ,2OML VIAL OF SOLVENT7/1/2016
672NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2013
673NDA/MAL/HDP/1368ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD5GLUCOSE5%W/VABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2010
674NDA/MAL/HDP/1369MEDIPHARM (EA) LTDMEDIPHARM INDUSTRIES (E.A) LTDORALYTE CO-PACK ORANGE FLAVOURDT ZINC-20 + ORAL REHYDRATION SALTS (ORS)20GMEDICAMEN BIOTECH LTD,.-SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA INDIAORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X2.0X20.8 G SACHET + 1.0 *10.0 TABLET BLISTER7/1/2016
675NDA/MAL/HDP/1370ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSTERILIZED WATER FOR INJECTIONWATER FOR INJECTIONNEUTRALABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. UGANDAPARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE7/1/2010
676NDA/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 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2014
677NDA/MAL/HDP/1374HILTON PHARMA (PVT) LTDHEALTHCARE LTD.VALODIN -125CEPHADRINE125MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2003
678NDA/MAL/HDP/1377OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDWATER FOR INJECTIONWATER FOR INJECTIONN/AOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0 ML AMPOULE7/1/2014
679NDA/MAL/HDP/1380KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDHYCORT CREAMHYDROCORTISONE1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/1997
680NDA/MAL/HDP/1381CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDLAMIVUDINE,/ ZIDOVUDINE TABLETSLAMIVUDINE,+ ZIDOVUDINE150MG+300MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2007
681NDA/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 INDIAORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
682NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY CAPSULES1.0X1.0X5.0X10.0 CAPSULE STRIP7/1/2004
683NDA/MAL/HDP/1389UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDNELSTATNYSTATIN100000 I.U/MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2010
684NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO PUERTO RICOORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
685NDA/MAL/HDP/1391UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDUNIVIR 5%ACYCLOVIR5%W/WUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYATOPICAL EXTERNAL CREAMS1.0X1.0X10.0 G TUBE7/1/2010
686NDA/MAL/HDP/1392ASTRA ZENECAMACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON7/1/1997
687NDA/MAL/HDP/1393SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANFURCEFUROXIME500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
688NDA/MAL/HDP/1394SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANPIME -1000CEFEPIME1000MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X15.0 ML VIAL7/1/2010
689NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJE SWEDENPARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL7/1/2010
690NDA/MAL/HDP/1397ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2001
691NDA/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 INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2010
692NDA/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.
INDIAORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER7/1/2015
693NDA/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.
INDIAORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER7/1/2015
694NDA/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 MAHARASHTRAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
695NDA/MAL/HDP/1407PHARMATHEN S.AGOODMAN INTERNATIONAL LTDBELIFAXOMEPRAZOLE20MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE GREECEORAL SOLID ORDINARY CAPSULES1.0X14.0 CAPSULE BOTTLE7/1/1997
696NDA/MAL/HDP/1408TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ROSUCORROSUVASTATIN20MGTORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P) INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
697NDA/MAL/HDP/1409SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN200MG/5MLNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. PAKISTANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X15.0 ML BOTTLE7/1/2007
698NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
699NDA/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 KENYAORAL TOPICAL LIQUIDS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2014
700NDA/MAL/HDP/1415ASTRA ZENECAMACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE
SWEDENORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2011
701NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2001
702NDA/MAL/HDP/1418SHOSAAN ASIC PACIFICRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD-PLOT NO. 133 KRISHNA IND. ESTATE, VASAI E,DIST PALGHAR- 401210, MAHARASHTRA STATE INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
703NDA/MAL/HDP/1419GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOPRIL 10LISINOPRIL10MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2005
704NDA/MAL/HDP/1422SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDSTAMINCETIRIZINE DIHYDROCHLORIDE10MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2005
705NDA/MAL/HDP/1423SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INCSURGIPHARM (U) LIMITEDCURAMAMOXYCILLIN + POTASSIUM CLAVULANATE500MG+125MGSANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA AUSTRIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X2.0 TABLET BLISTER7/1/2016
706NDA/MAL/HDP/1425LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDL-TRIMCOTRIMOXAZOLE240MG/5MLLEBEN LABORATORIES PVT. LTD-L-4, PHASE –III, M.I.D.C, INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2007
707NDA/MAL/HDP/1426LEBEN LABORATORIES PVT.LTDMALIX PHARMA (U) LIMITEDMETROLEBMETRONIDAZOLE200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
708NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
709NDA/MAL/HDP/1431INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDTORTAS 10TORSEMIDE10MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
710NDA/MAL/HDP/1432CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDCHLORAMPHENICOL EAR DROPSCHLORAMPHENICOL5%W/VCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA INDIAOTIC DROPS1.0X10.0 ML VIAL7/1/2007
711NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY VIALS1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL7/1/1997
712NDA/MAL/HDP/1436MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 10BISOPROLOL HEMIFUMARATE10MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADTGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
713NDA/MAL/HDP/1441AXA PARENTERALS LTDVITACARE LIMITEDSODIUM CHLORIDESODIUM CHLORIDE0.9%W/VAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2014
714NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL7/1/2003
715NDA/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 UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2015
716NDA/MAL/HDP/1447EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITONA PLUSVITAMINS + MINERALSMULTI-INGREDIENTEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER7/1/2014
717NDA/MAL/HDP/1449SHAIGAN PHARMACEUTICALS (PVT) LTDHARLEYS UGANDA LIMITEDZEPAR SUSPENSIONALBENDAZOLE200MG/5MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2000
718NDA/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 SWITZERLANDTOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X50.0 G TUBE7/1/1997
719NDA/MAL/HDP/1451NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN INJECTIONDICLOFENAC25MG/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.SWITZERLANDPARENTERAL ORDINARY AMPOULES1.0X3.0 ML AMPOULE7/1/1997
720NDA/MAL/HDP/1452ASTRA ZENECAMACNAUGHTON LIMITEDZESTORETICLISINOPRIL/HYDROCHLOROTHIAZIDE20MG/12.5MGASTRAZENECA MACCLESFIELD-CHESHIREUNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/1997
721NDA/MAL/HDP/1453ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZESOZ-40ESOMEPRAZOLE40MGMADRAS PHARMACEUTICALS -137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI – 600 096, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
722NDA/MAL/HDP/1454RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPAINEXPARACETAMOL + ASPIRIN + CAFFEINE500MG + 400MG + 50 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP7/1/2003
723NDA/MAL/HDP/1457NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2006
724NDA/MAL/HDP/1460VENUS REMEDIES LTDAARON PHARMACEUTICALS LTDPARIN EENOXAPARIN80MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X10.0X2.0X0.8 ML PRE- FILLED SYRINGE7/1/2009
725NDA/MAL/HDP/1463ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDARISTOZYME LIQUIDDIASTASE+PEPSIN50MG+10MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE7/1/2015
726NDA/MAL/HDP/1464ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNIDAORNIDAZOLE500MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
727NDA/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 INDIAORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/1998
728NDA/MAL/HDP/1469VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 125AMOXICILLIN125MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS CYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
729NDA/MAL/HDP/1471PT SAMBE FARMAMEDVIN PHARMA LIMITEDTEMIRALACICLOVIR30MG/GPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE7/1/2011
730NDA/MAL/HDP/1474GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC GELDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE7/1/2016
731NDA/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. INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2016
732NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2001
733NDA/MAL/HDP/1482SANOFI PASTEURLABOREX UGANDA LIMITEDSTAMARIL PASTEURYELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED)NLT 1000 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) FRANCEPARENTERAL ORDINARY 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
734NDA/MAL/HDP/1484SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCLYCIN.VCLINDAMYCIN2%W/WSHAIGAN PHARMACEUTICALS (PVT) LIMITED-14 KM ADYALA RD, RAWALPINDI, PAKISTAN PAKISTANTOPICAL EXTERNAL OTHER CREAMS1.0X40.0 G TUBE + APPLICATOR7/1/2004
735NDA/MAL/HDP/1485UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDDICLOFEN 25DICLOFENAC25MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANRECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER7/1/2011
736NDA/MAL/HDP/1486ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-1AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL7/1/2011
737NDA/MAL/HDP/1488DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAU GERMANYRECTAL SYSTEMIC ADULT SUPPOSITORIES10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP7/1/2000
738NDA/MAL/HDP/1492DENK PHARMA GMBH & CO. KGBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY. GERMANYPARENTERAL ORDINARY AMPOULES1.0X10.0X3.0 ML AMPOULE7/1/1998
739NDA/MAL/HDP/1493AUROBINDO PHARMA LTD UNIT VIIGITTOES PHARMACEUTICALS LIMITEDKOACT 1000AMOXICILLIN/CLAVULANATE POTASSIUM875MG/125MGAUROBINDO PHARMA LTD (UNIT XII) -SURVEY NO. 314, BACHUPALLY VILLAGE, QUTHUBULLAPUR, MANDAL, RANGA REDDY DISTRICT, PIN CODE - 500090, ANDHRA PRADESH INDIAORAL SOLID RETARD TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2007
740NDA/MAL/HDP/1495WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPELOX-400PEFLOXACIN400MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP7/1/1997
741NDA/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 KENYATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE7/1/1997
742NDA/MAL/HDP/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE7/1/2005
743NDA/MAL/HDP/1500MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA NETHERLANDSORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2008
744NDA/MAL/HDP/1501REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDCURAQUIN SYRUPQUININE HYDROCHLORIDE100MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2009
745NDA/MAL/HDP/1503MEDICAL UNION PHARMACUITICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT CREAMHYDROCORTISONE+CINCHOCAINE0.5%W/W + 0.5%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTTOPICAL EXTERNAL OTHER CREAMS1.0X20.0 G TUBE7/1/2003
746NDA/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
FRANCELUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON7/1/2007
747NDA/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 INDIAPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE7/1/2011
748NDA/MAL/HDP/1508DAWA LIMITED-SUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2009
749NDA/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, KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
750NDA/MAL/HDP/1510JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLISTERINE ANTISEPTICTHYMOL + ALCOHOL 95%12.78MG/20ML + 5.60ML/MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2001
751NDA/MAL/HDP/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MGJOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X6.0 TABLET BLISTER7/1/1997
752NDA/MAL/HDP/1516WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL PTRAMADOL/ PARACETAMOL37.5MG/ 325MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
753NDA/MAL/HDP/1517SHOSAAN ASIC PACIFICRENE PHARMACY LTDVEST MENTAMU BALMCOMPOUND METHYLSALICYLATEMULTI INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1998
754NDA/MAL/HDP/1523RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIRENAMPICILLIN125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
755NDA/MAL/HDP/1524RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE125 MG / 5 MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2008
756NDA/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 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2007
757NDA/MAL/HDP/1527MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAVAMOXICILLIN + CLAVULANATE POTASSIUM200MG + 28.5MG/ 5MLMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X100.0 ML BOTTLE7/1/2012
758NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER7/1/2007
759NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1997
760NDA/MAL/HDP/1532BF BIOSCIENCES LTDHARLEYS UGANDA LIMITEDNOVAPRESSINTERLIPRESSIN1MG/VIALBF BIOSCIENCES LTD. -RAIWIND,PAKISTAN PAKISTANPARENTERAL ORDINARY VIALS1.0X1.0 MG VIAL7/1/2014
761NDA/MAL/HDP/1533OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITED5DGLUCOSE50G/LOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2007
762NDA/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. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X4.0 MU VIAL,1.0X100.0X4.0 MU VIAL,1.0X10.0X4.0 MU VIAL7/1/2011
763NDA/MAL/HDP/1537ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLEALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B’, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
KENYAORAL SOLID ORDINARY TABLETS1.0X20.0X2.0 TABLET BLISTER7/1/2005
764NDA/MAL/HDP/1543MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDPROMAZINE ELIXIRPROMETHAZINE HYDROCHLORIDE5MG/MLMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA UGANDAORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE7/1/1997
765NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
766NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0X2.0X10.0 CAPSULE BLISTER7/1/1999
767NDA/MAL/HDP/1547MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLUSIA-FNORGESTREL/ ETHINYL ESTRADIOL + FERROUS FUMARATE0.3MG/ 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER7/1/2007
768NDA/MAL/HDP/1549REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.PREDNICOL EYE DROPSPREDNISOLONE/CHLORAMPHENICOL5MG/2MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/1999
769NDA/MAL/HDP/1550GALENTIC PHARMA LTDVITACARE LIMITEDRUBIGELMULTI-INGREDIENTMULTI-INGREDIENTGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIAORAL TOPICAL GELS AND SOLS1.0X30.0 G TUBE7/1/2007
770NDA/MAL/HDP/1551EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCALOSHELL-500CALCIUM CARBONATE + VITAMIN D31250MG + 250IUEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2004
771NDA/MAL/HDP/1553EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDVIFEXSALBUTAMOL + BROMHEXINE + GUAIFENESIN1MG/5ML+2MG/5ML+50MG/5MLEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2004
772NDA/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 MALAYSIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2010
773NDA/MAL/HDP/1555GALENTIC PHARMA LTDVITACARE LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL LIQUIDS1.0X500.0 ML BOTTLE7/1/2008
774NDA/MAL/HDP/1556VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDDOMI UPONDASENTRON2MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2014
775NDA/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 RIXENSARTBELGIUMPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE)7/1/2010
776NDA/MAL/HDP/1559LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDOLOMOLPARACETAMOL500MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X1.0X10.0 TABLET BLISTER7/1/2003
777NDA/MAL/HDP/1561LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDNEOVAGNYSTATIN10000IULINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAVAGINAL TABLETS1.0X14.0 PESSARY STRIP7/1/2004
778NDA/MAL/HDP/1563GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN125MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE FRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
779NDA/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 NULLORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2009
780NDA/MAL/HDP/1568: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAMAMOXICILLIN AND CLAVULANATE POTASSIUM156.25MGINDCHEMIE HEALTH SPECIALITIES PVT. LTD-VILLAGE-THANA, BADDI, DIST. SOLAN, HIMACHAL PRADESH-173 205. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2008
781NDA/MAL/HDP/1569ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDKALETRALOPINAVIR+RITONAVIR80MG + 20MGAESICA PHARMACEUTICALS SRL-QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM UNITED KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X5.0X1.0X60.0 ML BOTTLE7/1/2007
782NDA/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
INDIAPARENTERAL ORDINARY DRY VIALS1.0X2.0 ML VIAL (1 DOSE VIAL)7/1/2013
783NDA/MAL/HDP/1572SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDROSUVAS 20ROSUVASTATIN20MG SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN
EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2011
784NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER7/1/2003
785NDA/MAL/HDP/1575ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL20MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. ASTRAZENECA MACCLESFIELD-CHESHIRE UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/1997
786NDA/MAL/HDP/1576ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL10MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. ASTRAZENECA MACCLESFIELD-UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER7/1/1997
787NDA/MAL/HDP/1577SEARLE PAKISTAN LTDHEALTHCARE LTD.SPIROMIDESPIRONOLACTONE + FRUSEMIDE50MG+20MGTHE SEARLE COMPANY-32-KM MULTAN ROAD, LAHORE INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP7/1/2005
788NDA/MAL/HDP/1579PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID100MG/MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE7/1/2011
789NDA/MAL/HDP/1581MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDPANTOTABPANTOPRAZOLE40MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2006
790NDA/MAL/HDP/1582LINCON PHARMCUETICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDCEEPRO-500CIPROFLOXACIN500MGLINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
791NDA/MAL/HDP/1583INDOCO REMEDIES LIMITEDSTAR PHARMACEUTICALS LTDABZEEALBENDAZOLE200MG/5MLINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2001
792NDA/MAL/HDP/1584UNI MEDICO LABROYAL PHARMA 2011 LIMITEDUCLOXCLOXACILLIN SODIUM500MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197INDIAPARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2015
793NDA/MAL/HDP/1585WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDUDIHEP FORTEURSODEOXYCHOLIC ACID300MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2010
794NDA/MAL/HDP/1588TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOZAAR-HLOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE50MG + 12.5MGTORRENT PHARMACEUTICALS LIMITED -AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARAT INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X4.0X7.0 TABLET BLISTER7/1/2005
795NDA/MAL/HDP/1589CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDCENTACID SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE40MG+200MG+250MG/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE7/1/1997
796NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE7/1/1997
797NDA/MAL/HDP/1598GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
798NDA/MAL/HDP/1605RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER7/1/2001
799NDA/MAL/HDP/1614ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRA-50SILDENAFIL50MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X4.0 TABLET BLISTER7/1/2011
800NDA/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 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2005
801NDA/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 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2011
802NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAVAGINAL GELS AND SOLS1.0X30.0 G TUBE7/1/2004
803NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
804NDA/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 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2007
805NDA/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 EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN – 248011 (U.K), INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON + 1 AMPOULE OF WFI7/1/2005
806NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL7/1/1997
807NDA/MAL/HDP/1636NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDVIGAMOXMOXIFLOXACIN5MG/MLS.A.ALCON COUVREUR N.V-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/2013
808NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/2005
809NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRA WITH OPTIZORBPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON7/1/2003
810NDA/MAL/HDP/1640GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDALBEN TABLETSALBENDAZOLE400MGMEDREICH LIMITED - UNIT 3-SURVEY NO. 4/3, AVALAHALLI, ANJANAPURA, OFF KANAKAPURA ROAD, BANGALORE-560062 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X500.0 TABLET BLISTER7/1/1999
811NDA/MAL/HDP/1641UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDUNIENZYME C MPSNICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL25MG+50MG+30MG+20MG+75MGUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
812NDA/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. INDIAPARENTERAL ORDINARY VIALS1.0X1.0 G VIAL7/1/2004
813NDA/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 KENYAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER7/1/2002
814NDA/MAL/HDP/1650NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL CR 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY ITALYORAL SOLID RETARD TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2006
815NDA/MAL/HDP/1652TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 300SODIUM VALPROATE300MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2009
816NDA/MAL/HDP/1655UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDUNIGENTYLSECNIDAZOLE500MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2010
817NDA/MAL/HDP/1656AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDAZIGYL-500AZITHROMYCIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER7/1/2015
818NDA/MAL/HDP/1660GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP7/1/2005
819NDA/MAL/HDP/1661ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIA 100/25LOPINAVIR/ RITONAVIR100MG/25MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2007
820NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIAINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE7/1/2003
821NDA/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) INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1998
822NDA/MAL/HDP/1666SANOFI AVENTISSURGIPHARM (U) LIMITEDAMARYL 1GLIMEPIRIDE1MGSANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICASOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
823NDA/MAL/HDP/1669SANOFI AVENTISSURGIPHARM (U) LIMITEDAMARYL 2GLIMEPIRIDE2MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
824NDA/MAL/HDP/1670SANOFI AVENTISSURGIPHARM (U) LIMITEDAMARYL 4GLIMIPIRIDE4MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
825NDA/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 FRANCEORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER7/1/2005
826NDA/MAL/HDP/1675MERCK SHARP & DOHME BVSURGIPHARM (U) LIMITEDGARDASILQUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18)(20MCG+40MCG+40MCG+20MCG)/0.5MLMERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA UNITED STATESPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X10.0X0.5 ML VIAL (1 DOSE)7/1/2007
827NDA/MAL/HDP/1676KOPRAN LIMITEDTATA UGANDA LIMITEDCLOXIN-250CLOXACILLIN250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
828NDA/MAL/HDP/1680SHOSAAN ASIC PACIFICRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
829NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2005
830NDA/MAL/HDP/1685LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKONAZOLKETOCONAZOLE200MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2005
831NDA/MAL/HDP/1686LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIAORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
832NDA/MAL/HDP/1689SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDOMESKOMEPRAZOLE20MGS.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/2010
833NDA/MAL/HDP/1690PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE1MG/MLPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2004
834NDA/MAL/HDP/1691WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN500MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPTEGYPTORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER7/1/2011
835NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN JORDANORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE7/1/2007
836NDA/MAL/HDP/1693PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDOPTIMAL (0.05%) CREAMTRETINOIN USP0.5MG/1GPHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDANTOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE7/1/2005
837NDA/MAL/HDP/1697PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
838NDA/MAL/HDP/1698CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDAZEE-500AZITHROMYCIN500MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIAINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER7/1/2009
839NDA/MAL/HDP/1701KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFORMINMETFORMIN HYDROCHLORIDE500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
840NDA/MAL/HDP/1702PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDDELORCLOBETASOL PROPIONATE0.05%W/WPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANTOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2005
841NDA/MAL/HDP/1704DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM ILAC SAN. VE. TIC. A.S.-CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 TURKEYORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2011
842NDA/MAL/HDP/1707XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDFEBRICOL TABLETSPARACETAMOL / PSEUDOEPHEDRINE / CHLORPHENIRAMINE500MG / 30MG /2MGXEPA-SOUL PATTINSON (MALAYSIA) SDN BLD -1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA
MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER7/1/1997
843NDA/MAL/HDP/1708LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDDENTAMOLACETAMINOPHEN500MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1997
844NDA/MAL/HDP/1709REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDLUCIN CREAMHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/1997
845NDA/MAL/HDP/1711KOPRAN LIMITEDTATA UGANDA LIMITEDAMYN-250AMOXYCILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
846NDA/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 INDIAORAL 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
847NDA/MAL/HDP/1714REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.REMICOL EAR DROPSCHLORAMPHENICOL1%W/VREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANOTIC DROPS1.0X10.0 ML BOTTLE7/1/1999
848NDA/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 TANZANIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2011
849NDA/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 INDIAPARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
850NDA/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 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
851NDA/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 INDIAORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE7/1/2000
852NDA/MAL/HDP/1724GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK UNITED KINGDOMNASAL TOPICAL SPRAYS WITHOUT GAS1.0X120.0 METERED DOSE CANNISTER7/1/2009
853NDA/MAL/HDP/1725REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL CREAM 1%CLOTRIMAZOLE1%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
854NDA/MAL/HDP/1726GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDHAVRIX 720INACTIVATED HEPATITIS A VIRUS ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED720 ELISA UNITS ADSORBED ON 0.25MG ALUMINIUM HYDROXIDEGLAXOSMITHKLINE BIOLOGICALS-RUE DE L' LNSTITUT 89-1330 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X0.5 ML VIAL (1 DOSE)7/1/1997
855NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP7/1/2007
856NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2008
857NDA/MAL/HDP/1731REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMEDIVEN-S OINTMENTBETAMETHASONE VALERATE + SALICYLIC ACID0.05%W/W + 3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
858NDA/MAL/HDP/1732MICRO LABS LTDLABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1999
859NDA/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 INDIAORAL 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
860NDA/MAL/HDP/1736MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDKLERIMEDCLARITHROMYCIN500MGMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2009
861NDA/MAL/HDP/1739MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMELOXMELOXICAM15MG MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA CYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2009
862NDA/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 JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
863NDA/MAL/HDP/1743MEDOCHEMIE LTDSHREEJI PHARMACEUTICALS LIMITEDDAPRILLISINOPRIL DIHYDRATE10MGMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2009
864NDA/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 JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
865NDA/MAL/HDP/1747IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPRESARTAN H 50LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE 50MG + 12.5MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2008
866NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER7/1/2011
867NDA/MAL/HDP/1749LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVITAMIN B COMPLEXVITAMIN B COMPLEXN/ALINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARAT INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2005
868NDA/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 JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
869NDA/MAL/HDP/1751AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIFUCINFUSIDIC ACID1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X5.0 ML AMPOULE7/1/2005
870NDA/MAL/HDP/1754AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIMOLTIMOLOL MALEATE0.5%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X5.0 ML VIAL7/1/2005
871NDA/MAL/HDP/1756AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICROM 2%SODIUM CROMOGLYCATE2%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
872NDA/MAL/HDP/1758AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICORTPREDNISOLONE ACETATE0.12%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
873NDA/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 JORDANOTIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
874NDA/MAL/HDP/1761EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDATAZOR-RATAZANAVIR + RITONAVIR300 MG + 100 MGEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/1/2014
875NDA/MAL/HDP/1762AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPITROPINATROPINE1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN JORDANOPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
876NDA/MAL/HDP/1763LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDASPIRIN TABLETS BPACETYL SALICYLIC ACID300MGLABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1997
877NDA/MAL/HDP/1764JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFRESH BURST LISTERINEALCOHOL + THYMOL95 % W/V + 12 MGJOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794
SOUTH AFRICAORAL LIQUID ORDINARY LIQUIDS1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER7/1/2006
878NDA/MAL/HDP/1765UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDRILIF PLUSACECLOFENAC + PARACETAMOL100MG + 500MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
879NDA/MAL/HDP/1766RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOLDEASE CAPSULESPARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE400MG+30MG+4MG+30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2005
880NDA/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 EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
881NDA/MAL/HDP/1768BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDULTIVA INJECTION 2MGREMIFENTANIL2MGGLAXOSMITHKLINE MANUFACTURING SPA ,.,-STRADA PROVINCIALE ASOLANA, 90-43056, S.POLO DI TORRILE (PARMA) ITALYPARENTERAL ORDINARY DRY VIALS1.0X5.0 VIAL CARTON7/1/1999
882NDA/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 RIXENSARTBELGIUMPARENTERAL ORDINARY VIALS1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE)7/1/1997
883NDA/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. INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET BLISTER7/1/2000
884NDA/MAL/HDP/1773MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2005
885NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2003
886NDA/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
EGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/1998
887NDA/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
PAKISTANTOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE7/1/2006
888NDA/MAL/HDP/1780RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKAUGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE7/1/2000
889NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE UNITED STATESORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2000
890NDA/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 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
891NDA/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 KENYATOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE7/1/1997
892NDA/MAL/HDP/1784MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAZICURE-500AZITHROMYCIN500MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2005
893NDA/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 KENYAORAL SOLID ORDINARY TABLETS1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER7/1/1997
894NDA/MAL/HDP/1786GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2001
895NDA/MAL/HDP/1790REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM TABLETCO-TRIMOXAZOLE480MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1997
896NDA/MAL/HDP/1792DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDLIPODARATORVASTATIN20MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
897NDA/MAL/HDP/1793MACNAUNGHTON LIMITEDMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL80MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENLUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X60.0 DOSE CANNISTER7/1/2001
898NDA/MAL/HDP/1795KOPRAN LIMITEDTATA UGANDA LIMITEDAMPIK-250AMPICILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
899NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER7/1/2006
900NDA/MAL/HDP/1797KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDAMPICILLIN+CLOXACILLINAMPICILLIN + CLOXACILLIN250 MG + 250 MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 INDIAPARENTERAL ORDINARY DRY VIALS1.0X10.0X500.0 MG VIAL7/1/2010
901NDA/MAL/HDP/1798INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDCARDITAS RETARDNIFEDIPINE20MG
INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA
INDIAORAL SOLID RETARD FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/1997
902NDA/MAL/HDP/1799INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSECZOL DSSECNIDAZOLE1GMINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2001
903NDA/MAL/HDP/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2009
904NDA/MAL/HDP/1801LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAVAGINAL TABLETS1.0X1.0X6.0 PESSARY STRIP7/1/1997
905NDA/MAL/HDP/1803ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MGESOMEPRAZOLE40MGASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLMSWEDENORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON7/1/2001
906NDA/MAL/HDP/1804TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LISTRILLISINOPRIL5MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2001
907NDA/MAL/HDP/1805MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 1000MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2014
908NDA/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 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X8.0 ML BOTTLE7/1/1997
909NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
910NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2010
911NDA/MAL/HDP/1811CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIR TABLETSZIDOVUDINE+ LAMIVUDINE300MG + 150MGCIPLA 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
912NDA/MAL/HDP/1812RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN TABLETSQUININE SULPHATE300MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2001
913NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKAKENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
914NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL OTHER OINTMENTS1.0X15.0 G TUBE7/1/2003
915NDA/MAL/HDP/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/1998
916NDA/MAL/HDP/1821BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL 500 TABLETSMEFENAMIC ACID500MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/1997
917NDA/MAL/HDP/1822RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDEPHEDRINEEPHEDRINE HYDROCHLORIDE30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2005
918NDA/MAL/HDP/1825RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCOLDEASE SYRUPPARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+2MG+15MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2005
919NDA/MAL/HDP/1827REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL SUSPENSIONALBENDAZOLE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2006
920NDA/MAL/HDP/1833ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMOXAMOXICILLIN500MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2011
921NDA/MAL/HDP/1838INDOCO REMEDIES LIMITEDSTAR PHARMACEUTICALS LTDABZEEALBENDAZOLE400MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER7/1/2004
922NDA/MAL/HDP/1840REMEDICA LTDGOODMAN INTERNATIONAL LTDOVA-MITCLOMIPHENE50MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2011
923NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
924NDA/MAL/HDP/1842KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDSUGAQUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDAUGANDAORAL SOLID ORDINARY OTHER COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2002
925NDA/MAL/HDP/1843USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
926NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
927NDA/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. INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X170.0 ML BOTTLE7/1/2013
928NDA/MAL/HDP/1847MICRO LABSMALIX PHARMA (U) LIMITEDMOXILEB-250 CAPSULEAMOXICILLIN250MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2007
929NDA/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 KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
930NDA/MAL/HDP/1849ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIFINCIPROFLOXACIN0.2%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
UGANDAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2011
931NDA/MAL/HDP/1850RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDALZOL TABLETSALBENDAZOLE400MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2010
932NDA/MAL/HDP/1851PHILLIPS PHARMACEUTICALS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCAPSIFENAC GELCAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE0.438 G + 0.335 G + 0.135 G + 0.918 GSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA INDIATOPICAL EXTERNAL EMULSION GELS1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE7/1/2011
933NDA/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 BELGIUMORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X150.0 ML BOTTLE7/1/2007
934NDA/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 CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE7/1/2004
935NDA/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 KENYAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
936NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM400MG /80MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
937NDA/MAL/HDP/1863AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDORACURE GELLIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE2 GM+0.1 GMAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. EGYPTORAL TOPICAL GELS AND SOLS1.0X15.0 G TUBE7/1/2004
938NDA/MAL/HDP/1864NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDPATANOLOLOPATADINE HYDROCHLORIDE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/2009
939NDA/MAL/HDP/1873MSD (PTY) LIMITED SASURGIPHARM (U) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 850MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2014
940NDA/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 UGANDAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2007
941NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
942NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2004
943NDA/MAL/HDP/1881SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMOXAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2004
944NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2004
945NDA/MAL/HDP/1887KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOLPARACETAMOL500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL 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
946NDA/MAL/HDP/1889KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PREDSOLPREDNISOLONE5MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL 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
947NDA/MAL/HDP/1891MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLEVOMAC 500LEVOFLOXACIN500MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER7/1/2005
948NDA/MAL/HDP/1892MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDLEVOMAC 250LEVOFLOXACIN250MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER7/1/2012
949NDA/MAL/HDP/1894KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-480CO-TRIMOXAZOLE480MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
950NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2007
951NDA/MAL/HDP/1898WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDZAPACID - 30LANSOPRAZOLE30MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER7/1/2001
952NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP7/1/2007
953NDA/MAL/HDP/1901AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDIBUMOLIBUPROFEN + PARACETAMOL100MG + 162.5 MG /5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATEINDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
954NDA/MAL/HDP/1902KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMODIUMLOPERAMIDE HYDROCHLORIDE2MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
955NDA/MAL/HDP/1903DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 100ARTEMETHER100MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU GERMANYPARENTERAL ORDINARY I M AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2007
956NDA/MAL/HDP/1906ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ TABLETS 600MGEFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
957NDA/MAL/HDP/1911COSMOS LTDASTRA PHARMA (U) LIMITEDCODEINE PHOSPHATE TABLETS BP 30CODEINE PHOSPHATE30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
958NDA/MAL/HDP/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2008
959NDA/MAL/HDP/1914RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCHLORPHENIRAMINECHLORPHENIRAMINE4MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2003
960NDA/MAL/HDP/1918UNIVERSAL CORPORATION LTDPHARMA VILLE LIMITEDUNIVIRACYCLOVIR200MGUNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET STRIP7/1/2010
961NDA/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 INDIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/1999
962NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
963NDA/MAL/HDP/1921SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDANTIMINLORATIDINE10MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2005
964NDA/MAL/HDP/1922IPCA LABORATORIESMEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA IPCA LABORATORIES LTD, PLOT NO. T-139-PLOT NO. T-139, MIDC, INDUSTRIAL ESTATE, TARAPUR, BOISOR, DIST- PALGHAR, THANE 401506, MAHARASHTRA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X3.0 TABLET BLISTER7/1/2007
965NDA/MAL/HDP/1923GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDBETAMETHASONEBETAMETHASONE0.1%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
966NDA/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) CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL7/1/2013
967NDA/MAL/HDP/1925BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDG - ALFENAC- PACECLOFENAC + PARACETAMOL100MG + 500MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2014
968NDA/MAL/HDP/1927REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDINTAPLEX TABLETVITAMIN B COMPOUNDN/AREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
969NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
970NDA/MAL/HDP/1929CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
971NDA/MAL/HDP/1931ASTRAZENECAMACNAUGHTON LIMITEDZOLADEX LAGOSERELIN ACETATE10.8MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, UNITED KINGDOMPARENTERAL RETARD PRE-FILLED SYRINGES1.0X10.8 MG IMPLANT7/1/2010
972NDA/MAL/HDP/1934RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR SUSPENSIONCHLORAMPHENICOL125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2001
973NDA/MAL/HDP/1936GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON EXPECTORANTCHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDEMULTINGREDIENTGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
974NDA/MAL/HDP/1937AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ600MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2005
975NDA/MAL/HDP/1938YURIA-PHARM LTDPHARMA VILLE LIMITEDINFULGANPARACETAMOL10MG/MLYURIA-PHARM LLC MANUFACTURING SITE NO. 1-108, KOBZARSKA STREET, CHERKASY, 18030 UKRAINEPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE7/1/2013
976NDA/MAL/HDP/1940REMEDICA LTDGOODMAN INTERNATIONAL LTDCLOXACILLIN CAPSULESCLOXACILLIN SODIUM250MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER7/1/2001
977NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL7/1/2005
978NDA/MAL/HDP/1942RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDAMCLORENAMPICILLIN + CLOXACILLIN250 MG + 250 MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER7/1/2009
979NDA/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 INDIAORAL SOLID RETARD TABLETS1.0X25.0 TABLET CONTAINER7/1/2009
980NDA/MAL/HDP/1946WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDSOLUDOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR
PRADESH - INDIA
INDIAORAL SOLID ORDINARY SOLUBLE TABLETS10.0X10.0 TABLET STRIP7/1/1998
981NDA/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
982NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDVITACARE LIMITEDTRENAXA 500TRANEXAMIC ACID500MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X6.0 TABLET BLISTER7/1/2011
983NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDCLOPI 75CLOPIDOGREL75MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP7/1/2006
984NDA/MAL/HDP/1954: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDRAPEED-20RABEPRAZOLE20MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP7/1/2011
985NDA/MAL/HDP/1956MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2006
986NDA/MAL/HDP/1958MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2005
987NDA/MAL/HDP/1959MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDBETRIM 480CO-TRIMOXAZOLE480MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
988NDA/MAL/HDP/1960KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENACDICLOFENAC SODIUM50MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2003
989NDA/MAL/HDP/1962BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDNIMBEXCISATRACURIUM BESYLATE2MG/MLGLAXOSMITHKLINE S.P.A -STRADA PROVINCIALE ASOLANA 9ITALYPARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL,1.0X2.5 ML VIAL7/1/1997
990NDA/MAL/HDP/1963MILAN LABERATORIES PVT LTDGITTOES PHARMACEUTICALS LIMITEDDICLOFENAC GELDICLOFENAC1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIATOPICAL EXTERNAL GELS AND SOLS1.0X35.0 G TUBE7/1/2006
991NDA/MAL/HDP/1964MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDCLONEXCLOTRIMAZOLE1%W/WMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2007
992NDA/MAL/HDP/1966MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPARACINPARACETAMOL500MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
993NDA/MAL/HDP/1969NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SR 75MGDICLOFENAC SODIUM75MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA ITALYORAL SOLID RETARD TABLETS1.0X30.0 TABLET CONTAINER7/1/1997
994NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMACCETIRIZINE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
995NDA/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 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
996NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2013
997NDA/MAL/HDP/1975LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBET-CODERM NBETAMETHASONE + NEOMYCIN0.1 W/W + 0.5 W/WLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
998NDA/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

INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
999NDA/MAL/HDP/1984ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDCIALISTADALAFIL20MGLILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRID SPAINORAL SOLID ORDINARY TABLETS2.0X2.0 TABLET BLISTER7/1/2004
1000NDA/MAL/HDP/1988KUNMING PHARMACEUTICALS CORPSINO AFRICA MEDICINES & HEALTH LTDARTEMEDINE INJECTIONARTEMETHER80MG/MLKUNMING PHARMACEUTICAL CORP.-QIGONGLI, WEST SURBURB, KUNMING 650106 - YUNNAM PROVINCE, P.R. CHINA CHINAPARENTERAL ORDINARY I M AMPOULES1.0X8.0X1.0 ML AMPOULE7/1/1999
1001NDA/MAL/HDP/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X2.0 TABLET BLISTER7/1/2005
1002NDA/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 INDIAORAL 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
1003NDA/MAL/HDP/1999TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CARBATOL 200CARBAMAZEPINE200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER7/1/2000
1004NDA/MAL/HDP/2000TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CALCIGARD RETARDNIFEDIPINE(SR)20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID RETARD TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER7/1/2000
1005NDA/MAL/HDP/2004MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDR.B.TONEFERROUS GLUCONATE + VITAMIN C + VITAMIN B12 + VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + CALCIUM PANTOTHENATE + VITAMIN B3 + FOLIC ACID + DIBASIC CA PO4 + ZINC SULPHATE200MG + 38MG + 4MCG + 3MG + 2.5MG + 1MG + 2.5MG + 1MG + 2.5MG + 23MG + 0.5MG + 100MG + 33MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X15.0 CAPSULE BLISTER7/1/2008
1006NDA/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 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2005
1007NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2001
1008NDA/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 INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2004
1009NDA/MAL/HDP/2009COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN200MG/5MLCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
1010NDA/MAL/HDP/2011HETERO LABS LTDAIVEEN (U) LIMITEDGIAGRA 50SILDENAFIL CITRATE50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER,1.0X10.0X1.0X4.0 TABLET BLISTER7/1/2013
1011NDA/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 INDIATOPICAL EXTERNAL LOTIONS1.0X15.0 ML BOTTLE7/1/2004
1012NDA/MAL/HDP/2014SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCANI-MAKSCLOTRIMAZOLE1%W/W S KANT HEALTHCARE LTD-1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE7/1/2009
1013NDA/MAL/HDP/2016GLENMARK PHARMACUTICALS LTDSTAR PHARMACEUTICALS LTDCANDID CREAMCLOTRIMAZOLE1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
1014NDA/MAL/HDP/2018CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDORAXIN SYRUPCYPROHEPTADINE+TRICHOLINE CITRATE2MG+275MGCENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1015NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
1016NDA/MAL/HDP/2020KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDQUINEQUININE SULPHATE300MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL 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
1017NDA/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
EGYPTORAL SOLID ORDINARY CAPSULES1.0X12.0X2.0 CAPSULE BLISTER7/1/2000
1018NDA/MAL/HDP/2022MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTORACTINCYPROHEPTADINE2MG/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1997
1019NDA/MAL/HDP/2024TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.NEXPRO - 40ESOMEPRAZOLE MAGNESIUM TABLET40MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
1020NDA/MAL/HDP/2025REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDFERRO-B COMPLEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1021NDA/MAL/HDP/2026BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 10MGAMLODIPINE BESYLATE10MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN
PAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2009
1022NDA/MAL/HDP/2027UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 160/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
1023NDA/MAL/HDP/2028SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.SELANZ - SRLANSOPRAZOLE30MGSEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTAN PAKISTANORAL SOLID ORDINARY CAPSULES1.0X1.0X7.0 CAPSULE BLISTER7/1/2005
1024NDA/MAL/HDP/2029ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDCHLORAMPHENICOL PALMITATECHLORAMPHENICOL PALMITATE125MG/5MLMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
1025NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
1026NDA/MAL/HDP/2033MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-50LOSARTAN POTASSIUM50MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2009
1027NDA/MAL/HDP/2035KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDNEOSIDARSULPHADOXINE + PYRIMETHAMINE500MG + 25MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER7/1/2004
1028NDA/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 FRANCEPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE7/1/1998
1029NDA/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 INDIAINDIAORAL 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
1030NDA/MAL/HDP/2041IDAKIMSY MEDS LTDOXYTOCINOXYTOCIN10IUGLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE,1.0X1.0X10.0X1.0X10.0 ML AMPOULE,1.0X10.0X1.0X10.0X1.0 ML AMPOULE7/1/2005
1031NDA/MAL/HDP/2042SHOSAAN ASIC PACIFICRENE PHARMACY LTDBURNCURESILVER SULFADIAZINE1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X200.0 G TUBE,1.0X15.0 G TUBE7/1/1997
1032NDA/MAL/HDP/2043COSMOS LTDASTRA PHARMA (U) LIMITEDDIASTOP TABLETSATTAPULGITE/ ALUMINIUM HYDROXIDEN/ACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP7/1/1998
1033NDA/MAL/HDP/2045ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICANBUPIVACAINE0.5% W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2006
1034NDA/MAL/HDP/2046COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINALORATADINE10MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
1035NDA/MAL/HDP/2049WOCKHARDT LTDSTAR PHARMACEUTICALS LTDKEFSTAR-500CEFUROXIME AXETIL500MGSANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET STRIP,1.0X1.0X10.0 TABLET BLISTER7/1/2005
1036NDA/MAL/HDP/2051GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON TABLETSCHLORPHENIRAMINE MALEATE4MGGLAXO WELLCOME (KENYA) LTD-KENYAKENYAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
1037NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2005
1038NDA/MAL/HDP/2055SHANGHAI FOSUN PHARMACEUTICAL DEVELOPMENT CO. LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE120MGGUILIN PHARMACEUTICAL CO. LTD.-NO. 43 QILIDIAN ROAD, GUILIN 541004 CHINAPARENTERAL 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
1039NDA/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 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1040NDA/MAL/HDP/2058MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDQUININE SULPHATEQUININE SULPHATE300MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2006
1041NDA/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 ROADTANZANIAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2006
1042NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL.0.15MG / 0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X1.0X28.0 TABLET BLISTER7/1/1997
1043NDA/MAL/HDP/2066REMEDICA LTDGOODMAN INTERNATIONAL LTDMETHOTREXATEMETHOTREXATE2.5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1044NDA/MAL/HDP/2067UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDZYNCETCETIRIZINE DIHYDROCHLORIDE10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X4.0X5.0X10.0 TABLET BLISTER7/1/1999
1045NDA/MAL/HDP/2068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDDOMADOLTRAMADOL HYDROCHLORIDE50MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1999
1046NDA/MAL/HDP/2069SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSK DERMBETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN0.05%W/W + 1%W/W + 0.1%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2010
1047NDA/MAL/HDP/2070BAYER PHARMA AGSURGIPHARM (U) LIMITEDMIRENALEVONORGESTREL52MGBAYER OY-PANSIONATE 47 20210 TURKU FINLANDFINLANDPARENTERAL RETARD IMPLANTS1.0X1.0 IMPLANT CARTON7/1/2009
1048NDA/MAL/HDP/2071CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR DRY SYRUPCEFALEXIN125MG/5MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2000
1049NDA/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 INDIAPARENTERAL 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
1050NDA/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 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
1051NDA/MAL/HDP/2075GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPREDPREDNISOLONE5MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2006
1052NDA/MAL/HDP/2076GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMIDEFUROSEMIDE40MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2006
1053NDA/MAL/HDP/2077ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2007
1054NDA/MAL/HDP/2078LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDALCLOX SYRUPCLOXACILLIN SODIUM125MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIAINDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
1055NDA/MAL/HDP/2079GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDNETRAVIRACICLOVIR5%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA INDIATOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE7/1/2005
1056NDA/MAL/HDP/2080GALENTIC PHARMA LTDVITACARE LIMITEDBETAMETHASONE VALERATEBETAMETHASONE VALERATE0.1%W/VGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2009
1057NDA/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 INDIAPARENTERAL ORDINARY VIALS1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL)7/1/2015
1058NDA/MAL/HDP/2087ABBVIE LOGISTICS BVMEDICAL ACCESS (UGANDA) LIMITEDNORVIRRITONAVIR100MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. GERMANYORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
1059NDA/MAL/HDP/2090RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCIPRORENCIPROFLOXACIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1060NDA/MAL/HDP/2091KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCAMSTONCLOTRIMAZOLE1%W/WKPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDAUGANDATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2001
1061NDA/MAL/HDP/2093CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TRIGAN-D TABLETPARACETAMOL + DICYCLOMINE500MG + 20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP7/1/1999
1062NDA/MAL/HDP/2094MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT-750LEVOFLOXACIN HEMIHYDRATE750MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
1063NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2010
1064NDA/MAL/HDP/2097LEBEN LABORATORIES PVT LTDMALIX PHARMA (U) LIMITEDALCLOXCLOXACILLIN250MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2011
1065NDA/MAL/HDP/2098GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO QUININEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2006
1066NDA/MAL/HDP/2099XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDHYDROCORTISONE 1% CREAMHYDROCORTISONE1%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA
MALAYSIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1998
1067NDA/MAL/HDP/2100MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDORALCON - FLEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE0.15MG + 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER7/1/2007
1068NDA/MAL/HDP/2101COSMOS LTDASTRA PHARMA (U) LIMITEDCARDISPRINACETYL SALICYLIC ACID75MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
1069NDA/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
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2006
1070NDA/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
INDIAORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2006
1071NDA/MAL/HDP/2106MEDREICH PLCSURGIPHARM (U) LIMITEDAMEDIN-5AMLODIPINE5 MG MEDREICH LIMITED-UNIT 3-SURVEY NO.4/3, AVALAHALLI, ANJANAPURA, OFF KANAKAPURA ROAD, BANGALORE-560062 INDIAORAL SOLID ORDINARY TABLETS1.0X14.0X2.0 TABLET BLISTER7/1/2006
1072NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2011
1073NDA/MAL/HDP/2116MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDAMLOVAS-10AMLODIPINE BESILATE10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET STRIP7/1/2005
1074NDA/MAL/HDP/2118AVENTIS PHARMA (PTY) LTD SOUTH AFRICASURGIPHARM (U) LIMITEDRIFAFOURE E-275RIFAMPICIN+ISONIAZID+PYRAZINAMIDE+ETHAMBUTOL150MG+75MG+400MG+275MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA SOUTH AFRICAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X20.0 TABLET BLISTER7/1/2005
1075NDA/MAL/HDP/2120ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDMEGAPIMECEFEPIME1GALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA. SANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL7/1/2011
1076NDA/MAL/HDP/2122ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYMOLPARACETAMOL120MG/5MLELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1077NDA/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 INDIANASAL SYSTEMIC METERED-DOSE LIQUIDS1.0X200.0 METERED DOSE CANNISTER7/1/2009
1078NDA/MAL/HDP/2128HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN INJECTION 500MGTRANEXAMIC ACID500MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANPARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE7/1/2005
1079NDA/MAL/HDP/2129DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCLAVODARAMOXICILLIN/CLAVULANIC ACID500MG/125MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2011
1080NDA/MAL/HDP/2130IPCA LABORATORIESMEDVIN PHARMA LIMITEDZERODOL-CRACECLOFENAC200MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1081NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2010
1082NDA/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 DENMARKPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/1997
1083NDA/MAL/HDP/2134CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR-250CEFALEXIN250MGCADILA PHARMACEUTICALS LTD-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0X20.0 CAPSULE BLISTER7/1/1997
1084NDA/MAL/HDP/2136MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT SUPOSITORYHYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN5MG + 5MG +10MG +10MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPTEGYPTTOPICAL EXTERNAL SUPPOSITORIES1.0X6.0 SUPPOSITORY STRIP7/1/2003
1085NDA/MAL/HDP/2137REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTANHEALTHCARE LTD.SEPRODERM OINTMENTSALICYLIC ACID + SULPHUR COMPOUND3.6 + 2.4 MGREMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM PAKISTANTOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/1998
1086NDA/MAL/HDP/2141CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDINFLAZONEMULTIINGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2005
1087NDA/MAL/HDP/2144EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICOTILTENOXICAM20MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTPARENTERAL ORDINARY VIALS1.0X3.0 VIAL CARTON + 1*3*2ML WFI AMPOULE7/1/2014
1088NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/1997
1089NDA/MAL/HDP/2151USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 850METFORMIN850MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
1090NDA/MAL/HDP/2154ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYNASEGLIPIZIDE5MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
1091NDA/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 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2011
1092NDA/MAL/HDP/2158ACULIFE HEALTHCARE PVT LTDASTRA PHARMA (U) LIMITEDNIRPIDINTRAVENOUS FAT EMULSION20%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
1093NDA/MAL/HDP/2159SANOFI PASTEURLABOREX UGANDA LIMITEDVAXIGRIPINFLUENZA VIRUS STRAINS H1N1 + H3N2 + B15MCG + 15MCG + 15MCGSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) FRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)7/1/2011
1094NDA/MAL/HDP/2160EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDACEM-500CLARITHROMYCIN500MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1095NDA/MAL/HDP/2161REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX CREAMACICLOVIR5%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSTOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/1997
1096NDA/MAL/HDP/2165RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2014
1097NDA/MAL/HDP/2167BAYER AGSURGIPHARM (U) LIMITEDMYCOSPOR SOLUTIONBIFONAZOLE10MGBAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANY GERMANYTOPICAL EXTERNAL LIQUIDS1.0X15.0 ML BOTTLE,1.0X50.0 ML BOTTLE7/1/1997
1098NDA/MAL/HDP/2170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDALSARTAN-AMLOSARTAN + AMLODIPINE50MG + 5MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2011
1099NDA/MAL/HDP/2173GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDGLEVO-500LEVOFLOXACIN500MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X5.0 TABLET BLISTER7/1/2003
1100NDA/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 INDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP7/1/2005
1101NDA/MAL/HDP/2176INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDRISPITAS-2RISPERIDONE2MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2011
1102NDA/MAL/HDP/2181KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PHENPHENOXYMETHYLPENICILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,250.0 TABLET CONTAINER7/1/1997
1103NDA/MAL/HDP/2183CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID I.V.OMEPRAZOLE40MG/VIALCADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA INDIAPARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON7/1/2007
1104NDA/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 BELGIUMORAL 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
1105NDA/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
MALAYSIAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2008
1106NDA/MAL/HDP/2188CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDPREDNISOLONEPREDNISOLONE5MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
1107NDA/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 MALAYSIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/2008
1108NDA/MAL/HDP/2191LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN250MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
1109NDA/MAL/HDP/2193CIPLA LTD..CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLOX-500CIPROFLOXACIN500MGCIPLA LIMITED.-PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2007
1110NDA/MAL/HDP/2195XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDEUDERM CREAMUREA10%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA
MALAYSIATOPICAL EXTERNAL CREAMS1.0X45.0 G TUBE7/1/1997
1111NDA/MAL/HDP/2197LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
KENYATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/1997
1112NDA/MAL/HDP/2199MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 50MCGLEVOTHYROXINE SODIUM50MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER7/1/2013
1113NDA/MAL/HDP/2201SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCLYCINCLINDAMYCIN PHOSPHATE10MG/MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANTOPICAL EXTERNAL LOTIONS1.0X30.0 ML BOTTLE7/1/2004
1114NDA/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
INDIATOPICAL EXTERNAL EMULSIONS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE7/1/2005
1115NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1116NDA/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 CHINAPARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE7/1/1997
1117NDA/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 CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2005
1118NDA/MAL/HDP/2217GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMINOPHYLINEAMINOPHYLLINE20MGNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA CHINAPARENTERAL ORDINARY AMPOULES1.0X50.0X10.0 ML AMPOULE7/1/2005
1119NDA/MAL/HDP/2218LEBEN LABORATORIES LTDMALIX PHARMA (U) LIMITEDZINECTIL-100CHLORPROMAZINE100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2008
1120NDA/MAL/HDP/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER,1.0X2.0X15.0 TABLET BLISTER7/1/1997
1121NDA/MAL/HDP/2220CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 5AMLODIPINE BESYLATE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER7/1/2003
1122NDA/MAL/HDP/2223ROYAL PHARMAROYAL PHARMA 2011 LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2400000 I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) CHINAPARENTERAL ORDINARY DRY VIALS1.0X2.4 MU VIAL7/1/2002
1123NDA/MAL/HDP/2224VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 500AMOXICILLIN500MGVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS CYPRUSORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1124NDA/MAL/HDP/2226WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ GRANULESL-ORNITHINE-L-ASPARTATE3G/5GWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X10.0X5.0 G SACHET7/1/2004
1125NDA/MAL/HDP/2231MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDPIRITEX WITH CODEINEMULTI-INGREDIENTMULTI-INGREDIENTMEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1126NDA/MAL/HDP/2232UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICASTMONTELUKAST10MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSINGJORDANORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1127NDA/MAL/HDP/2233ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.25MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN SWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION1.0X4.0X5.0X2.0 ML VIAL7/1/2011
1128NDA/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 INDIAPARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL7/1/2006
1129NDA/MAL/HDP/2236NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY ITALYORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/1997
1130NDA/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 INDIAPARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X3.0 ML VIAL7/1/2006
1131NDA/MAL/HDP/2239NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL ORAL SUSPENSIONCARBAMAZEPINE20MG/MLDELPHARMA HUNINGUE S.A.S-26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCE FRANCEORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2006
1132NDA/MAL/HDP/2242REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX 200 TABLETSACYCLOVIR200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/1997
1133NDA/MAL/HDP/2243AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITEDROYAL PHARMA 2011 LIMITEDSIMDOL TABLETSPARACETAMOL500MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
1134NDA/MAL/HDP/2245RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER7/1/2008
1135NDA/MAL/HDP/2248GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDTETRACYCLINE OPHTHALMICTETRACYCLINE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA INDIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE,1.0X5.0 G TUBE7/1/2004
1136NDA/MAL/HDP/2249WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-RINSULIN100MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA INDIAPARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL7/1/2006
1137NDA/MAL/HDP/2250GALENTIC PHARMA LTDVITACARE LIMITEDCANDIGENCLOTRIMAZOLE1%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2004
1138NDA/MAL/HDP/2252JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE500MGJOHNSON & JOHNSON (PTY) LTD-241 MAIN ROAD, RETREAT, 7945, CAPE TOWN SOUTH AFRICAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER7/1/2000
1139NDA/MAL/HDP/2254MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDBURN CUR CREAMACRIFLAVINE/THYMOLN/ATORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1998
1140NDA/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 KINGDOMORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X70.0 ML BOTTLE7/1/2010
1141NDA/MAL/HDP/2258MYLAN LABORATORIES LIMITED (OTL)KIMSY MEDS LTDTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZ300MG/300MG/600MGMYLAN 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 INDIAORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE,1.0X1.0X30.0 TABLET BOTTLE7/1/2009
1142NDA/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 INDIAPARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE7/1/2001
1143NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2010
1144NDA/MAL/HDP/2266SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDQUININE SULPHATE TABLETS BPQUININE SULPHATE300MGSKANT HEALTH CARE LTD -1802-1805 GIDC PHASE III VAPI GUJARATINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
1145NDA/MAL/HDP/2267MYLAN LABORATORIES LIMITED (OTL)KIMSY MEDS LTDTENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG+300MGMYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRAINDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2007
1146NDA/MAL/HDP/2269DAWA LIMITEDSUPER MEDIC LTDDAWAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
1147NDA/MAL/HDP/2270UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDZITHROCIN 500AZITHROMYCIN500MGJ.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, G.I.D.C. INDUSTRIAL AREA, ANKLESHWAR, GUJARAT 393002 INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2006
1148NDA/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.
INDIAORAL 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
1149NDA/MAL/HDP/2272AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLARANTA -500CLARITHROMYCIN500MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X2.0X10.0 TABLET BLISTER7/1/2005
1150NDA/MAL/HDP/2278AVENTIS INTERCONTINENTALSURGIPHARM (U) LIMITEDORELOXCEFPODOXIME PROXETIL100MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPIÈGNE
FRANCEORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
1151NDA/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 PAKISTANOPHTHALMIC DROPS1.0X7.5 ML VIAL7/1/1999
1152NDA/MAL/HDP/2281SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDLUMFORTLORATADINE10MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1153NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
1154NDA/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 INDIAPARENTERAL 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
1155NDA/MAL/HDP/2287GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON7/1/1997
1156NDA/MAL/HDP/2290MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2008
1157NDA/MAL/HDP/2291HETERO DRUGS LTDAIVEEN (U) LIMITEDVALOVIRVALACYCLOVIR500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
1158NDA/MAL/HDP/2292MEDREICH PLCSURGIPHARM (U) LIMITEDFLEMING 1200AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE1000MG + 200MGNATCO PHARMA LTD-VIJAYAPUR, NORTH NAGARIJUNA SAGA,INDIA INDIAPARENTERAL ORDINARY DRY VIALS1.0X5.0X20.0 ML VIAL7/1/2007
1159NDA/MAL/HDP/2293GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIOCONTIOCONAZOLE1%W/WGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, EGYPTTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2005
1160NDA/MAL/HDP/2295DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 10ROSUVASTATIN CALCIUM10MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
1161NDA/MAL/HDP/2297DAWA LIMITEDSUPER MEDIC LTDSABULIN SYRUPSALBUTAMOL SULPHATE2MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2008
1162NDA/MAL/HDP/2298MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESHINDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
1163NDA/MAL/HDP/2299DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 20ROSUVASTATIN CALCIUM20MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDANORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
1164NDA/MAL/HDP/2303MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1165NDA/MAL/HDP/2304MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 10/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE10 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1166NDA/MAL/HDP/2305MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 2.5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE2.5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANYGERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1167NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY GERMANYORAL SOLID ORDINARY TABLETS1.0X3.0X35.0 TABLET BLISTER7/1/2010
1168NDA/MAL/HDP/2312REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER7/1/2006
1169NDA/MAL/HDP/2313REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 375AMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER7/1/2006
1170NDA/MAL/HDP/2314MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDRABEMAC-20RABEPRAZOLE SODIUM20MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2005
1171NDA/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 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2006
1172NDA/MAL/HDP/2318MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE-4GLIMEPIRIDE4MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2006
1173NDA/MAL/HDP/2319COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOLPARACETAMOL120MG/5MLCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1998
1174NDA/MAL/HDP/2320GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDERO-125 DRY SYRUPERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2006
1175NDA/MAL/HDP/2322EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTREFLUCANFLUCONAZOLE150MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREAEGYPTORAL SOLID ORDINARY CAPSULES1.0X2.0X1.0 CAPSULE STRIP7/1/2007
1176NDA/MAL/HDP/2324SWISS PARENTERALS LTDSHREEJI CARE LIMITEDSWISSCLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIAINDIAPARENTERAL ORDINARY DRY VIALS1.0X7.5 ML VIAL7/1/2011
1177NDA/MAL/HDP/2326EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDSYLATE-500ETAMSYLATE50MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X6.0 TABLET STRIP7/1/2004
1178NDA/MAL/HDP/2330NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCOARTEMARTEMETHER + LUMEFANTRINE20MG + 120MGBEIJING NOVARTIS PHARMA LTD-31ST YONG'AN ROAD, CHANGPING DISTRICT, BEIJING P.R NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY SWITZERLANDORAL 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 BLISTER7/1/2005
1179NDA/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 INDIAPARENTERAL 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
1180NDA/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 INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT7/1/1997
1181NDA/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 INDIAORAL 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
1182NDA/MAL/HDP/2338GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGGLAXO WELLCOME PRODUCTION-ZI DE LA PEYENNIERE, 53100, MAYENNE FRANCEORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE7/1/2003
1183NDA/MAL/HDP/2342AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2007
1184NDA/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 INDIAPARENTERAL ORDINARY I M VIALS1.0X10.0X10.0 ML VIAL (10 DOSE VIAL),1.0X50.0X1.0 ML VIAL (1 DOSE VIAL)7/1/2005
1185NDA/MAL/HDP/2350ASTRA ZENECA ABMACNAUGHTON LIMITEDPULMICORT TURBUHALERBUDESONIDE200MCGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM SWEDENLUNG ADMINISTRATION METERED-DOSE INHALER1.0X100.0 DOSE CANNISTER7/1/2001
1186NDA/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 KENYAORAL SOLID ORDINARY CAPSULES1.0X1.0X12.0 CAPSULE BLISTER7/1/2007
1187NDA/MAL/HDP/2353ASTRA ZENECAMACNAUGHTON LIMITEDNEXIUMESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE)10MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) SWEDENORAL SOLID ORDINARY GRANULES1.0X28.0 SACHET CARTON7/1/2013
1188NDA/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 CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2005
1189NDA/MAL/HDP/2357ACINO PHARMA AGGOODMAN INTERNATIONAL LTDTRABILIN- 50 CAPSULESTRAMADOL50MGMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN GERMANYORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2003
1190NDA/MAL/HDP/2359REMEDICA LTDGOODMAN INTERNATIONAL LTDASPIREM 75ASPIRIN75MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X2.0X28.0 TABLET BLISTER7/1/2007
1191NDA/MAL/HDP/2361REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAREM 500CLARITHROMYCIN500MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2007
1192NDA/MAL/HDP/2362GALENTIC PHARMA LTDVITACARE LIMITEDCANDISTATIN OINTMENTNYSTATIN100,000I.UGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2009
1193NDA/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 CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE7/1/2005
1194NDA/MAL/HDP/2364AIVEEN (U) LIMITEDAIVEEN (U) LIMITEDVOXEL-500LEVOFLOXACIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2015
1195NDA/MAL/HDP/2366UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDIFICIPRO INJECTIONCIPROFLOXACIN200MG/100MLUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116 INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2005
1196NDA/MAL/HDP/2367REMEDICA LTDGOODMAN INTERNATIONAL LTDFELEXIN 125CEPHALEXIN MONOHYDRATE125MG/5MLREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
1197NDA/MAL/HDP/2368REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDERMIDEX CREAMMICONAZOLE NITRATE2%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1198NDA/MAL/HDP/2369ARISTO PHARMACEUTICALSNORVIK ENTERPRISES LIMITEDTRANLOK 500MG INJECTIONTRANEXAMIC ACID500MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH INDIAPARENTERAL ORDINARY AMPOULES1.0X5.0X5.0 ML AMPOULE7/1/2010
1199NDA/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 JORDANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1200NDA/MAL/HDP/2375GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULIN 1GAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X1.0X7.0 TABLET BLISTER7/1/2010
1201NDA/MAL/HDP/2376INDOCO REMEDIES LTDSTAR PHARMACEUTICALS LTDMETCHEK-500METFORMIN500MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1202NDA/MAL/HDP/2379PT SANBE FARMAMEDVIN PHARMA LIMITEDPUMPITOROMEPRAZOLE40MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNGINDONESIAPARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT7/1/2014
1203NDA/MAL/HDP/2384PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCLARIX 500CLARITHROMYCIN500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2007
1204NDA/MAL/HDP/2385COSMOS LIMITEDASTRA PHARMA (U) LIMITEDCOZEPAM 5MGDIAZEPAM5MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2000
1205NDA/MAL/HDP/2386HILTON PHARMA (PVT) LTDHEALTHCARE LTD.NEOGABGABAPENTIN100MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2005
1206NDA/MAL/HDP/2387DAWA LIMITEDSUPER MEDIC LTDVERMOUTMEBENDAZOLE100MG/5MLDAWA LIMITED -BABA DOGO RWARAKAKENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2010
1207NDA/MAL/HDP/2388DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE400MG + 57MGBILIM ILAC SAN. VE. TIC. A.S.-CERKEZKOY ORGANIZE SANAYI BOLGESI, KARAAGAC, MH. 5. SK. NO. 6, KAPAKLI - TEKIRDAG 59510 TURKEYORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2011
1208NDA/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 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE,1.0X120.0 ML BOTTLE7/1/2008
1209NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP7/1/1997
1210NDA/MAL/HDP/2394MERCK SHARP & DOHME BV.SURGIPHARM (U) LIMITEDSTOCRINEFAVIRENZ600MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA CHINAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2004
1211NDA/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 ITALYTOPICAL 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
1212NDA/MAL/HDP/2399SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDVOLINIMULTI INGREDIENTMULTI INGREDIENTSUN PHARMACEUTICAL IND. LTD-PLOT NO. B-2, MADKAI INDUSTRIAL ESTATE, PONDA- GOA, INDIA-403404 INDIATOPICAL EXTERNAL OTHER GELS/SOLS1.0X1.0X30.0 G TUBE7/1/2005
1213NDA/MAL/HDP/2400PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIDIC 2%FUSIDIC ACID20MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN JORDANTOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1214NDA/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 10280THAILANDORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2005
1215NDA/MAL/HDP/2404UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDLOSAR 50LOSARTAN POTASSIUM50MGUNICHEM LABORATORIES LTD---VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1216NDA/MAL/HDP/2408RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRON TONICMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2001
1217NDA/MAL/HDP/2409TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.DEPLATTCLOPIDOGREL75MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2004
1218NDA/MAL/HDP/2410RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDDOXYRENDOXYCYCLINE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1219NDA/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 INDIATOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE7/1/2010
1220NDA/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 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
1221NDA/MAL/HDP/2415CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSOLINA TABLETSDIAZEPAM5MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/1997
1222NDA/MAL/HDP/2421INDOCO REMEDIES LIMITEDSTAR PHARMACEUTICALS LTDTAMIGEN EYE/EAR DROPSGENTAMICIN SULPHATE0.3%W/VINDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722 INDIAOPHTHALMIC DROPS1.0X5.0 ML BOTTLE,1.0X10.0 ML BOTTLE7/1/2006
1223NDA/MAL/HDP/2423MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDATORIN ATORVASTATIN10MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1224NDA/MAL/HDP/2426MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPROBEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL LIQUID ORDINARY SYRUPS1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2000
1225NDA/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 INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1997
1226NDA/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 GERMANYTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1998
1227NDA/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 GERMANYVAGINAL TABLETS1.0X6.0 PESSARY CARTON7/1/1998
1228NDA/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 INDIALUNG ADMINISTRATION METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON7/1/2007
1229NDA/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 INDIALUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2007
1230NDA/MAL/HDP/2438INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENACACECLOFENAC100MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2006
1231NDA/MAL/HDP/2440KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL KIDSPARACETAMOL250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALAUGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
1232NDA/MAL/HDP/2451ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN 75 SRDICLOFENAC SODIUM75 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2004
1233NDA/MAL/HDP/2452REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDELASED CHEST COUGH SYRUP (NON DROWSY)GUAIFENESIN + MENTHOL100MG/5ML + 1.1MG/5MLREGAL PHARMACEUTICALS-PLOT 7879/18 BABA DOGO ROAD NAIROBIKENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2007
1234NDA/MAL/HDP/2455ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 600/750 LACTABARTESUNATE + MEFLOQUINE200 MG + 250 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2004
1235NDA/MAL/HDP/2459MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDP2LEVONORGESTREL0.75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X2.0 TABLET BLISTER7/1/2007
1236NDA/MAL/HDP/2460COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS 2MGBENZHEXOL HCL2MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI KENYAORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2000
1237NDA/MAL/HDP/2461UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDUMERAN SR - 100DICLOFENAC100MGUMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1238NDA/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 KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN7/1/1997
1239NDA/MAL/HDP/2467CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDNOKLOTCLOPIDOGREL75MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2003
1240NDA/MAL/HDP/2471GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.1% NASAL DROPSXYLOMETAZOLINE0.1%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND SWITZERLANDNASAL SYSTEMIC DROPS1.0X10.0 ML BOTTLE7/1/2003
1241NDA/MAL/HDP/2472SHOSAAN ASIC PACIFICRENE PHARMACY LTDTRAN-GELDICLOFENAC DIETHYLAMMONIUM1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE,1.0X20.0 G TUBE7/1/2011
1242NDA/MAL/HDP/2473MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUGRELCLOPIDOGREL75MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADUINDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2010
1243NDA/MAL/HDP/2474SANOFI PASTEURLABOREX UGANDA LIMITEDTYPHIM VIPOLYSACCHARIDES OF SALMONELLA TYPHI(TY2 STRAIN)25MCGSANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) FRANCEPARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)7/1/1997
1244NDA/MAL/HDP/2475WIN-MEDICURE LTDSURGIPHARM (U) LIMITEDURGENDOL INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. INDIAPARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE7/1/2001
1245NDA/MAL/HDP/2476GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDDERIVA AQUEOUS GELADAPALENE0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIATOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2003
1246NDA/MAL/HDP/2478WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL PLUSPARACETAMOL+DICLOFENAC500MG+50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1247NDA/MAL/HDP/2479SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANCEPH-250 CAPCEPHALEXIN250MGSANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2012
1248NDA/MAL/HDP/2481GALENTIC PHARMA (PVT)LTDVITACARE LIMITEDNETRACORTHYDROCORTISONE1%W/WGALENTIC PHARMA PVT LIMITED-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI MUMBAI INDIATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X20.0 G TUBE7/1/2005
1249NDA/MAL/HDP/2489UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDUMETAC-150RANITIDINE150MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2006
1250NDA/MAL/HDP/2496MACLEODS PDHARMACEUTICALS LTVITACARE LIMITEDZETIVAS 20ATORVASTATIN/EZETIMIBE20MG/10MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2008
1251NDA/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
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2004
1252NDA/MAL/HDP/2498MACLEODS PDHARMACEUTICALS LTVITACARE LIMITEDZETIVAS 10ATORVASTATIN/EZETIMIBE10MG/10MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2008
1253NDA/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. INDIAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2007
1254NDA/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 PAKISTANOPHTHALMIC DROPS1.0X7.5 ML VIAL7/1/1997
1255NDA/MAL/HDP/2504LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRESTOCINPARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL500MG+ 2MG+ 2MG + 30MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
INDIAORAL SOLID ORDINARY TABLETS1.0X50.0X1.0X4.0 TABLET STRIP7/1/2008
1256NDA/MAL/HDP/2506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDNADOXINNADIFLOXACIN1%W/WWOCKHARDT LTD -VILLAGE KUNJHAL P.O BAROTIWALA DIST SOLAN HIMACHAL PRADESHINDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X20.0 G TUBE7/1/2011
1257NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2007
1258NDA/MAL/HDP/2508GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHYOSCINEHYOSCINE20MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANGCHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2011
1259NDA/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 KENYATOPICAL EXTERNAL LOTIONS1.0X50.0 ML BOTTLE7/1/1997
1260NDA/MAL/HDP/2510PANACEA BIOTEC PHARMA LTDVITACARE LIMITEDGIROORDNIDAZOLE500MGPANACEA BIOTEC PHARMA LIMITED-MALPURI BADDI, DISTRICT SOLAN, HIMACHAL PRADESH-173205 - INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X2.0X10.0 TABLET BLISTER7/1/2013
1261NDA/MAL/HDP/2511BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDULTIVA INJECTION 5MGREMIFENTANIL5MGGLAXOSMITHKLINE MANUFACTURING SPA ,.,-STRADA PROVINCIALE ASOLANA, 90-43056, S.POLO DI TORRILE (PARMA) ITALYPARENTERAL ORDINARY DRY VIALS1.0X5.0 VIAL CARTON7/1/1999
1262NDA/MAL/HDP/2512ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDDICLOFENAC SODIUM INJECTABLE SOLUTIONDICLOFENAC SODIUM25MG/MLWUHAN FUXING BIOPHARMACEUTICAL CO., LTD-NO.9, FUXING ROAD, HANCUAN ECONOMIC & DEVELOPMENT DISTRICT, HUBEI PROVINCE CHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X3.0 ML AMPOULE,1.0X10.0X3.0 ML AMPOULE7/1/2009
1263NDA/MAL/HDP/2513REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN DRY SYRUPPHENOXYMETHYLPENICILLIN125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
1264NDA/MAL/HDP/2515AFRICURE PHARMACEUTICALS (INDIA) LTDROYAL PHARMA 2011 LIMITEDSIMFEN 200 TABLETSIBUPROFEN200MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER
1265NDA/MAL/HDP/2519MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDVITA CAPMULTI-INGREDIENTMULTI-INGREDIENTMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280THAILANDORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2009
1266NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1267NDA/MAL/HDP/2523SHOSAAN ASIC PACIFICRENE PHARMACY LTDSULPHUR OINTMENTSULPHUR10%W/WNEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/1997
1268NDA/MAL/HDP/2524MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPRIMODIL-5AMLODIPINE BESYLATE5MGMEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI
CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210
INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1269NDA/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 GERMANYORAL SOLID RETARD TABLETS10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/1998
1270NDA/MAL/HDP/2526REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN COMBI PACKCLOTRIMAZOLE500MG & 1 %W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAVAGINAL COMBINATION PACK TABLETS1.0X1.0 PESSARY BLISTER + 1*20G TUBE7/1/2009
1271NDA/MAL/HDP/2528LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABESTENCLOTRIMAZOLE1%W/WLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBIKENYATOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE7/1/1997
1272NDA/MAL/HDP/2529B & O PHARM ZACSTAR PHARMACEUTICALS LTDG-CEFTRIACEFTRIAXONE1GGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI CHINA NATIONAL MEDICINES, GUORUI PHARMACEUTICAL CO., LTD-CAOYANG EAST ROAD, HUAINAN ECONOMICAL AND TECHNOLOGICAL DEVELOPMENT ZONE, HUAINAN CITY ANHUI PROVINCE CHINAPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML AMPOULE WFI,1.0X1.0X50.0 G VIAL,1.0X1.0 VIAL CARTON7/1/2012
1273NDA/MAL/HDP/2545NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBREXTOBRAMYCIN0.3%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM BELGIUMOPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/1997
1274NDA/MAL/HDP/2552AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCAROFITVITAMIN C/ VITAMIN A/ ZINC SULPHATE150MG/10MG/75MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
1275NDA/MAL/HDP/2553GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZ-20ESOMEPRAZOLE20MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP7/1/2003
1276NDA/MAL/HDP/2554GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDESOZESOMEPRAZOLE40MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP7/1/2005
1277NDA/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 KENYAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER7/1/1998
1278NDA/MAL/HDP/2556GILEAD SCIENCES INCMEDICAL ACCESS (UGANDA) LIMITEDTRUVADAEMTRICITABINE/TENOFOVIR200MG/300MGPATHEON INC-ADDRESS: 2100 SYNTEX COURT, MISSISSAUGA, ONTARIO L5N 7K9
COUNTRY: CANADA
TAKEDA GMBH-16515 ORANIENBURG GERMANY ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICA
UNITED STATESORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2005
1279NDA/MAL/HDP/2557REMEDICA LTDGOODMAN INTERNATIONAL LTDEPSITRON 25 TABLETSCAPTOPRIL25MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1999
1280NDA/MAL/HDP/2558RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMYCOREN SUSPENSIONNYSTATIN100000 I.U/ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2007
1281NDA/MAL/HDP/2559RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDERYTHRORENERYTHROMYCIN STEARATE250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2007
1282NDA/MAL/HDP/2561PHARMATHEN LTDGOODMAN INTERNATIONAL LTDLANOMYCINAMIKACIN SULPHATE500MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE GREECEPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE7/1/1997
1283NDA/MAL/HDP/2562ACINO PHARMA AGGOODMAN INTERNATIONAL LTDTRABILIN-100TRAMADOL100MG/2MLMERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN GERMANYPARENTERAL ORDINARY AMPOULES1.0X1.0X5.0X2.0 ML AMPOULE7/1/2005
1284NDA/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 INDIAPARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE,1.0X5.0X2.0 ML AMPOULE7/1/2001
1285NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/1997
1286NDA/MAL/HDP/2568GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL500MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED UNITED KINGDOMORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON7/1/1997
1287NDA/MAL/HDP/2569SANOFI AVENTISSURGIPHARM (U) LIMITEDNO-SPADROTAVERINE HYDROCHLORIDE40MG/2MLCHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO. LTD CSANYIKVOLGY SITE-CSANYIKVOLGY, P.O.BOX 565.3510, MISKOLC, HUGARY HUNGARYPARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE,1.0X25.0X2.0 ML AMPOULE7/1/1998
1288NDA/MAL/HDP/2570REMEDICA LTDGOODMAN INTERNATIONAL LTDAMOXAPEN 250 CAPSULESAMOXYCILLIN250MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,100.0X10.0 CAPSULE BLISTER7/1/1997
1289NDA/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 INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
1290NDA/MAL/HDP/2575HILTON PHARMA (PVT) LTDHEALTHCARE LTD.MYTEKAMONTELUKAST SODIUM10MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIPAKISTANORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2005
1291NDA/MAL/HDP/2576RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEQUINE TABLETSCHLOROQUINE PHOSPHATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY TABLETS1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2000
1292NDA/MAL/HDP/2577TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.TOPCEF 200CEFIXIME200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1293NDA/MAL/HDP/2578REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMAGNOMINT TABLETSALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE125MG + 250MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL 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
1294NDA/MAL/HDP/2579ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 300/375 LACTABARTESUNATE + MEFLOQUINE300 MG + 375 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH SWITZERLANDORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2005
1295NDA/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 KENYAORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP7/1/1998
1296NDA/MAL/HDP/2591HEALTHCARE LTD.HEALTHCARE LTD.VITAGLOBIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTAL FAZAL PHARMA INDUSTRIES (PVT) LTD-PLOT 20,21,22, DEFENSE INDUSTRIAL ZONE LAHORE PAKISTAN PAKISTANORAL LIQUID ORDINARY SYRUPS1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2001
1297NDA/MAL/HDP/2593DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDATENOLOL DENK 50ATENOLOL50MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1298NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2009
1299NDA/MAL/HDP/2595MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDZEPILENCEFAZOLIN1000MGMEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS CYPRUSPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON7/1/2009
1300NDA/MAL/HDP/2597E DENK OHGBENLE CONSULT LIMITEDPARA DENK 250PARACETAMOL250MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANY BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY GERMANYRECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP7/1/2005
1301NDA/MAL/HDP/2600IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDCLARIE-ODCLARITHROMYCIN(EXTENTED RELEASE)500MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X1.0X7.0 TABLET BLISTER7/1/2008
1302NDA/MAL/HDP/2601MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDAXETINE 750MGCEFUROXIME750MGMEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS CYPRUSPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON7/1/2009
1303NDA/MAL/HDP/2602: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDCLAVAM BIDAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MG/ 5 MLINDCHEMIE HEALTH SPECIALTIES PVT. LTD-(UNIT 3 BETA LACTAM BLOCK) VILLAGE: THANA, TEHSIL: BADDI, DISTRICT: SOLAN HIMACHAL PRADESH -173205 INDIA INDIAORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2010
1304NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2011
1305NDA/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 INDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2000
1306NDA/MAL/HDP/2606SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDPROTAS 40ESOMEPRAZOLE40MGSQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR – 1750, BANGLADESH BANGLADESHORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
1307NDA/MAL/HDP/2607SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDFLOTRALALFUZOSIN HCL10MGSUN PHARMACEUTICAL INDUSTRIES LTD-VILLAGE GANGUWALA, PAONTA SAHIB,173 025,DISTRICT SIRMOUR HIMACHAL PRADESH INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
1308NDA/MAL/HDP/2610GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDATROPINEATROPINE1MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MINCHINAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
1309NDA/MAL/HDP/2612RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRONMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER7/1/2005
1310NDA/MAL/HDP/2617BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUDROX TABLETS DISPERSABLECEFADROXIL250MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP7/1/2001
1311NDA/MAL/HDP/2628MICRO LABS LTDLABOREX UGANDA LIMITEDAZILIDE-500AZITHROMYCIN500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2004
1312NDA/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 CYPRUSORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP7/1/2014
1313NDA/MAL/HDP/2642MEDOCHEMIE LTDBOOTS PHARMACEUTICALS LIMITEDMEDOXANUMCEFTRIAXONE1GMEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOLCYPRUSPARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML AMPOULE WFI7/1/2009
1314NDA/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.
INDIAPARENTERAL ORDINARY DRY VIALS1.0X20.0 ML VIAL7/1/2010
1315NDA/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 GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1316NDA/MAL/HDP/2648E DENK OHGBENLE CONSULT LIMITEDPARA DENK 125PARACETAMOL125MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANY BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY GERMANYRECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP7/1/2005
1317NDA/MAL/HDP/2650DENK PHARMABENLE CONSULT LIMITEDVIT-B-DENKTHIAMINE HCL + PYRIDOXINE HCL100MG + 200MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 MÜNCHEN, GÖLLSTR. 1, 84529 TITTMONING, GERMANY GERMANYORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1318NDA/MAL/HDP/2651REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINAVIT SYRUPMULTIVITAMINMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1319NDA/MAL/HDP/2652AVENTIS PHARMA (PTY) LTD SOUTH AFRICASURGIPHARM (U) LIMITEDFLAGENTYL TABLETSSECNIDAZOLE500MGFAMAR LYON-29 AVENUE CHARLES DE GAULLE SAINTFRANCEORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/1997
1320NDA/MAL/HDP/2653BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDSONADERM-GMCLOBETASOL + MICONAZOLE + GENTAMICIN0.05%W/W + 2% W/W+ 0.1%W/WBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 INDIATOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2007
1321NDA/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 EGYPTORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE7/1/2006
1322NDA/MAL/HDP/2657SHAIGAN PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDXEPILCARBAMAZEPINE200MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN PAKISTANORAL SOLID ORDINARY TABLETS1.0X10.0X5.0 TABLET BLISTER7/1/1997
1323NDA/MAL/HDP/2670ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDSENSINILLIDOCAINE2%W/VCLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARATINDIAPARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL,1.0X20.0 ML VIAL,1.0X30.0 ML VIAL,1.0X5.0X20.0 ML VIAL,1.0X10.0X20.0 ML VIAL7/1/2005
1324NDA/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 INDIALUNG ADMINISTRATION LIQUID FOR INHALATION4.0X5.0X2.5 ML VIAL7/1/2005
1325NDA/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 MAHARASHTRAINDIAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2011
1326NDA/MAL/HDP/2678CIPLA LTD.CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFORCAN-150FLUCONAZOLE150MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA INDIAORAL SOLID ORDINARY CAPSULES1.0X5.0 CAPSULE BLISTER7/1/2004
1327NDA/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.
INDIAORAL LIQUID ORDINARY SYRUPS1.0X30.0 ML BOTTLE7/1/2006
1328NDA/MAL/HDP/2680RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIREN CAPSULESAMPICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER7/1/2007
1329NDA/MAL/HDP/2681RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER7/1/2007
1330NDA/MAL/HDP/2683RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN CASCORBIC ACID100MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER7/1/2005
1331NDA/MAL/HDP/2685RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEDOL(SUSPENSION)PARACETAMOL120MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA
UGANDAORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE7/1/2007
1332NDA/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 CHINAORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2011
1333NDA/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 CHINAPARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL,1.0X100.0 VIAL CARTON7/1/2011
1334NDA/MAL/HDP/2696BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDAMPHOTRETAMPHOTERICIN B50MGBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501INDIAPARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON7/1/2012
1335NDA/MAL/HDP/2697REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDLUCIN OINTMENTHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
1336NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2005
1337NDA/MAL/HDP/2701UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDUMIFULVINGRISEOFULVIN500MGUMEDICA LABORATORIES PVT. LTD-PLOT 221-GIDC, 2ND PHASE, VAPI 396195 GUJARAT INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1338NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
1339NDA/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 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2007
1340NDA/MAL/HDP/2705ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.5MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN SWEDENLUNG ADMINISTRATION LIQUID FOR INHALATION1.0X4.0X5.0X2.0 ML VIAL7/1/2011
1341NDA/MAL/HDP/2707KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMCLOXACLOXACILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDAUGANDAORAL SOLID ORDINARY CAPSULES100.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,10.0 CAPSULE CONTAINER7/1/1997
1342NDA/MAL/HDP/2708MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHYPER TABLETSPROPRANOLOL HYDROCHLORIDE40MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER7/1/2000
1343NDA/MAL/HDP/2710GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN BDAMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH UNITED KINGDOMORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET BLISTER7/1/1997
1344NDA/MAL/HDP/2712NEON LABARATORIES LTDAIVEEN (U) LIMITEDANAWINBUPIVACAINE0.025%W/VNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD INDIAPARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2014
1345NDA/MAL/HDP/2714NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDANAFRANILCLOMIPRAMINE25MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA ITALYORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/1997
1346NDA/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 INDIAOPHTHALMIC OINTMENTS1.0X3.5 G TUBE7/1/2000
1347NDA/MAL/HDP/2719SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDLORASEDLORATADINE10MGSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT EGYPTORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP7/1/2007
1348NDA/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 EGYPTORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE7/1/2007
1349NDA/MAL/HDP/2721MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRIMAFEN TABLETIBUPROFEN + PARACETAMOL400MG + 325MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1350NDA/MAL/HDP/2722MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDNO SORESCHOLINE SALICYLATE/LIDOCAINE8.7%W/W+2%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506INDIAORAL TOPICAL GELS AND SOLS1.0X10.0 G TUBE7/1/2007
1351NDA/MAL/HDP/2723TABROS PHARMAHEALTHCARE LTD.DURAGESIC TABLETPARACETAMOL + ORPHENADRINE450MG+35MGTABROS PHARMA-L-20/B SECTOR 22 FB INDUSTRIAL AREA KARACHI PAKISTANPAKISTANORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER
1352NDA/MAL/HDP/2725ASTRA PHARMA (U) LTDASTRA PHARMA (U) LIMITEDSTREPTOMYCIN SULPHATE FOR INJECTIONSTREPTOMYCIN SULPHATE1GMCSPC ZHONGUO (SHIJIAZHUANG) PHARMACEUTICAL CO.LTD-NO. 188 GONGNONGCHINAPARENTERAL ORDINARY DRY VIALS1.0X5.0X1.0X10.0 VIAL CARTON7/1/2011
1353NDA/MAL/HDP/2734DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMLODAR-10AMLODIPINE BESILATE10MGDAR AL DAWA-NA'UR PLANT AMMANJORDANORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER7/1/2009
1354NDA/MAL/HDP/2738WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ INFUSIONL-ORNITHINE- L-ASPARTATE5G/10MLWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH INDIAPARENTERAL ORDINARY I V VIALS1.0X5.0X10.0 ML VIAL7/1/2001
1355NDA/MAL/HDP/2739REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL TABLETHYOSCINE BUTYLBROMIDE10MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/2001
1356NDA/MAL/HDP/2745RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENFORMINMETFORMIN HYDROCHLORIDE500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
1357NDA/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 GERMANYORAL SOLID ORDINARY TABLETS1.0X25.0 TABLET BLISTER7/1/2000
1358NDA/MAL/HDP/2753MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRASILMETOCLOPRAMIDE HYDROCHLORIDE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2009
1359NDA/MAL/HDP/2754FDC LTDAIVEEN (U) LIMITEDZATHRIN 500AZITHROMYCIN DIHYDRATE500MGFDC LIMITED -PLOT NO. L121 B PHASE 111A VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER,1.0X50.0X1.0X1.0X3.0 TABLET BLISTER7/1/2016
1360NDA/MAL/HDP/2760REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDELASED DRY COUGH SYRUPDIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN+SODIUM CITRATE+MENTHOL14MG+6.5MG+57MG+2MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1361NDA/MAL/HDP/2761REMEDICA LTDGOODMAN INTERNATIONAL LTDTRIFLUOPERAZINETRIFLUOPERAZINE HYDROCHLORIDE5MGREMEDICA LTD-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE, 3056 LIMASSOL CYPRUSORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
1362NDA/MAL/HDP/2765CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HAEM FFOLICACID+ VITAMIN B12+IRON AMMONIUM CITRATE1MG+5MCG+200MG/15MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA INDIAORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2004
1363NDA/MAL/HDP/2773REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL ELIXIRHYOSCINE-N-BUTYLBROMIDE5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2004
1364NDA/MAL/HDP/2774ACINO PHARMA AGGOODMAN INTERNATIONAL LTDBACTIFLOX NEO 500CIPROFLOXACIN500MGACINO PHARMA AG.-DORNACHERSTRASSE 114, CH-4147 AESCH, SWITZERLAND SWITZERLANDORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1365NDA/MAL/HDP/2776UNIQUE PHARMACEUTICALS LABORATORIESTATA UGANDA LIMITEDTENSIMIN-100ATENOLOL100MGUNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCHINDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,14.0X10.0 TABLET BLISTER7/1/1997
1366NDA/MAL/HDP/2777NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCO-DIOVAN 160/12.5MG TABLETSVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLANDSWITZERLANDORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER7/1/2016
1367NDA/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
PAKISTANTOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE
1368NDA/MAL/HDP/2781INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 6.25CARVEDILOL6.25MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1369NDA/MAL/HDP/2782INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDKWINILQUININE DIHYDROCHLORIDE300MG/MLINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT INDIAPARENTERAL ORDINARY AMPOULES20.0X5.0X2.0 ML AMPOULE7/1/1998
1370NDA/MAL/HDP/2783NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 25MGDICLOFENAC SODIUM25MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE FRANCERECTAL SYSTEMIC SUPPOSITORIES1.0X1.0X10.0 SUPPOSITORY STRIP7/1/2006
1371NDA/MAL/HDP/2784MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)AMOXICILLIN ORAL SUSPENSIONAMOXICILLIN125MG/5MLMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2009
1372NDA/MAL/HDP/2787MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDMEDOMOX 125 DTAMOXICILLIN125MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADUINDIAORAL SOLID ORDINARY SOLUBLE TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER11/19/2017
1373NDA/MAL/HDP/2788RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMULTIVITAMIN TABLETSMULTIINGREDIENTN/ARENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA UGANDAORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2010
1374NDA/MAL/HDP/2790UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 20ATORVASTATIN20MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2003
1375NDA/MAL/HDP/2792UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 10ATORVASTATIN10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2003
1376NDA/MAL/HDP/2793GILEAD SCIENCES INCMEDICAL ACCESS (UGANDA) LIMITEDVIREADTENOFOVIR DISOPROXIL FUMARATE300MGPATHEON YM INC. TORONTO- TORONTO, CANADA ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICA TAKEDA GMBH,PLANT ORANIENBURG-LEHNITZSTRASSE 70-98,16515,ORANIENBURG-GERMANY CANADAORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BOTTLE7/1/2004
1377NDA/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) CHINAPARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON7/1/2001
1378NDA/MAL/HDP/2797RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDLUMARENARTEMETHER + LUMEFANTRINE20 MG + 120 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA UGANDAORAL SOLID ORDINARY TABLETS1.0X3.0X8.0 TABLET BLISTER7/1/2010
1379NDA/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 DENMARKPARENTERAL ORDINARY PRE-FILLED PENS1.0X1.5 ML PREFILLED PEN,1.0X3.0 ML PREFILLED PEN7/1/1997
1380NDA/MAL/HDP/2802CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDTASOLCLOBETASOL0.05%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
1381NDA/MAL/HDP/2805REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 20R TABLETSNIFEDIPINE20MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS CYPRUSORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
1382NDA/MAL/HDP/2807GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDASAQ GPSCARTESUNATE + AMODIAQUINE100 MG + 270 MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINACHINAORAL SOLID ORDINARY 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
1383NDA/MAL/HDP/2808UNIVERSAL CORPORATION LTD.PHARMA VILLE LIMITEDQUININEQUININE300MGUNIVERSAL CORPORATION LTD-CLUB ROAD, KIKUYU TOWN PAST POST OFFICE, P.O. BOX 1748-00902 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2005
1384NDA/MAL/HDP/2811REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSULPHUR OINTMENTSULPHUR PRECIPITATED10%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2001
1385NDA/MAL/HDP/2812DAFRA PHARMA LTDLABOREX 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. NETHERLANDSORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE7/1/2005
1386NDA/MAL/HDP/2813REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDINTACYCLINE SKIN OINTMENTTETRACYCLINE HYDROCHLORIDE3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
1387NDA/MAL/HDP/2814THE ARAB DRUG COMPANYGOODMAN INTERNATIONAL LTDVENTAL PLUSSALBUTAMOL + BECLOMETHASONE DIPROPIONATE0.1MG + 0.05MG/ PUFFTHE ARAB DRUG COMPANY-5-EL MASSANEI ST AL AMEREYA CAIROEGYPTLUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 DOSE CANNISTER7/1/2014
1388NDA/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 INDIAORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER7/1/1997
1389NDA/MAL/HDP/2821LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIOLIN-MGLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS5MG+500MGLINCOLN PHARMACEUTICAL LIMITED..-LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2011
1390NDA/MAL/HDP/2826GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON SYRUPCHLORPHENIRAMINE MALEATE4MG/10ML GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBI KENYAORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X2.0 L BOTTLE7/1/1997
1391NDA/MAL/HDP/2830MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDQUINIMIX MIXTUREQUININE HYDROCHLORIDE100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD (BWEYOGERERE) UGANDAORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2003
1392NDA/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
INDIATOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE,1.0X125.0 G TUBE7/1/2011
1393NDA/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 INDIAORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2010
1394NDA/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 CANADATOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2001
1395NDA/MAL/HDP/2850MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM20MGMEDICAL UNION PHARMACEUTICAL CO.-PLANT: ABU-SULTAN, ISMAILIA, EGYPT EGYPTPARENTERAL ORDINARY AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE7/1/2007
1396NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X7.0 TABLET BLISTER7/1/2003
1397NDA/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 BELGIUMPARENTERAL ORDINARY DRY VIALS1.0X0.5 ML VIAL (1 DOSE)7/1/2010
1398NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X7.0X6.0 TABLET BLISTER7/1/2001
1399NDA/MAL/HDP/2875GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.05% NASAL DROPSXYLOMETAZOLINE0.05%W/VGSK CONSUMER HEALTH SA-GSK CONSUMER HEALTH SA, ROUTE DE L’ETRAZ, NYON, 1260, SWITZERLAND SWITZERLANDNASAL TOPICAL DROPS1.0X10.0 ML BOTTLE7/1/2003
1400NDA/MAL/HDP/2877AMANTA HEALTHCARE LTDPHARMA VILLE LIMITEDCANDICANFLUCONAZOLE0.2%W/VAMANTA HEALTHCARE LIMITED (FORMERLY KNOWN AS MARCK BIOSCIENCES LTD)-PLOT NO. 876, N.H. NO. 8, VILLAGE - HARIYALA, DIST - KHEDA 387411, GUJARAT INDIAPARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2005
1401NDA/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
EGYPTTOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
1402NDA/MAL/HDP/2879CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOFLIN-200OFLOXACIN200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL 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
1403NDA/MAL/HDP/2880REMEDICA LTDGOODMAN INTERNATIONAL LTDCARBIMAZOLE 5CARBIMAZOLE5MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL CYPRUSORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
1404NDA/MAL/HDP/2882TATA UGANDA LIMITEDTATA UGANDA LIMITEDHYOSCINE BROMIDEHYOSCINE BROMIDE2OMG/MLGLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043INDIAPARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
1405NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER7/1/2005
1406NDA/MAL/HDP/2887MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)QUININE SULPHATEQUININE SULPHATE300MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER7/1/2009
1407NDA/MAL/HDP/2890KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDBETASOL NBETAMETHASONE+NEOMYCIN1MG/G+5MG/GKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA UGANDATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
1408NDA/MAL/HDP/2891MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 20ATORVASTATIN20MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2006
1409NDA/MAL/HDP/2892UNIQUE PHARMACEUTICAL LABORATORIESTATA UGANDA LIMITEDNICARDIA-20 TABLETSNIFEDIPINE20MGUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA.
INDIAORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
1410NDA/MAL/HDP/2893DAWA LIMITEDSUPER MEDIC LTDSTOPACID SUSPENSIONMAGNESIUM TRISILICATE + ALUMINIUM HYDROXIDE250MG/5ML + 120MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2009
1411NDA/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 -EGYPTEGYPTORAL LIQUID ORDINARY SUSPENSIONS1.0X125.0 ML BOTTLE7/1/2005
1412NDA/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 UGANDATOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X25.0 G TUBE7/1/2005
1413NDA/MAL/HDP/2898MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDTORVAST 10ATORVASTATIN10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2006
1414NDA/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 INDIAORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2005
1415NDA/MAL/HDP/2902MACLEODS PHARMACEUTICALS LTDVITACARE LIMITEDMEGALIS-20TADALAFIL20MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X1.0X4.0 TABLET STRIP7/1/2005
1416NDA/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 EGYPTORAL LIQUID ORDINARY SYRUPS1.0X1.0X125.0 ML BOTTLE7/1/2007
1417NDA/MAL/HDP/2907BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONART DSARTEMETHER + LUMEFANTRINE80 MG + 480 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIAINDIAORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2013
1418NDA/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-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAIINDIATOPICAL EXTERNAL CREAMS1.0X2.0X15.0 G TUBE7/1/2010
1419NDA/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 INDIAORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/1/2009
1420NDA/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 MALAYSIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
1421NDA/MAL/HDP/2914REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCHLOROCIDE SUSPENSIONCHLORAMPHENICOL PALMITATE125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/1997
1422NDA/MAL/HDP/2915VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDTREXOLMETHOTREXATE50MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)INDIAPARENTERAL ORDINARY VIALS1.0X1.0X2.0 ML VIAL7/1/2009
1423NDA/MAL/HDP/2917REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCETAMOL TABLETSPARACETAMOL500MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA KENYAORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP7/1/1997
1424NDA/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 INDIAORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1425NDA/MAL/HDP/2920CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDTRANSLIPO -C CREAMCLOTRIMAZOLE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X20.0 G TUBE,1.0X10.0 G TUBE7/1/2001
1426NDA/MAL/HDP/2940CENTAUR PHARMACEUTICALS PVT. LTDGITTOES PHARMACEUTICALS LIMITEDBENZOX 5 GELBENZOYL PEROXIDE5%W/WCENTAUR PHARMACEUTICALS LTD- PLOT NO. 39 TIVIN IN
INDIATOPICAL EXTERNAL OTHER GELS/SOLS1.0X20.0 G TUBE7/1/2005
1427NDA/MAL/HDP/2941CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 20ATORVASTATIN20MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA INDIAORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X7.0 TABLET BLISTER7/1/2005
1428NDA/MAL/HDP/2942CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDARGISSEPT CREAMCHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE0.2%W/W / 1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526INDIATOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE,1.0X10.0 G TUBE7/1/2005
1429NDA/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 INDIAORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1430NDA/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 INDIAORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1998
1431NDA/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