Drug Register (April 2020)
This list is updated regularly when available data on such products are evaluated and relevant sites are inspected by National Drug Authority. Please enter the criteria below to display products from the Drug Register database.

S/NNDA REGISTRATION NUMBERLICENSE HOLDERLOCAL TECHNICAL REPRESENTATIVENAME OF DRUGMANUFACTURERCOUNTRY OF MANUFACTUREDOSAGE FORMPACK SIZEREGISTRATION DATE
1NDA/MAL/HHP/9115NZEN ENTERPRISEHEALTHCARE LTD.DO-MO CAPSULES ABARIS HEALTHCARE PVT. LTD-SURVEY NO. 1407/11, VILLAGE RAJPUR, TAL KADI DIST. MEHSANA, GUJARAT-382740 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X4.0X10.0 CAPSULE BLISTER7/16/2019
2NDA/MAL/HHP/8379CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDM2 TONE TABLET CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE9/20/2017
3NDA/MAL/HHP/8505CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDLIVOMYN SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE2/2/2018
4NDA/MAL/HHP/8506CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDALKA 5 SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE2/2/2018
5NDA/MAL/HHP/8508CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDKOFOL SF SYRUP CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE2/2/2018
6NDA/MAL/HHP/8509CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDEVANOVA CAPSULE CHARAK PHARMA PVT LTD-INDUSTRIALESTATE, SHAUTI MILL LANE, MUMBAI-400011 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER11/29/2017
7NDA/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 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X20.0 TABLET BLISTER7/1/2011
8NDA/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 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X250.0 MG BOTTLE7/1/2016
9NDA/MAL/HHP/5528VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDAQUAREST288,SIDCO ESTATE-AMBATTUR, CHENNAI 600 098, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY POWDERS1.0X10.0X765.0 MG SACHET7/1/2009
10NDA/MAL/HHP/7946SHEBAC PHARMANORVIK ENTERPRISES LIMITEDAPONTISAEROMAC (INDIA) INC-12, MELDI ESTATE, GOTA AHMEDABAD -382481, GUJARAT, INDIA | INDIA |TOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X150.0 ML BOTTLE7/1/2015
11NDA/MAL/HHP/5574AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNEW PINKOO GRIPE WATERAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE |INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2009
12NDA/MAL/HHP/8220AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDNOCOLICAJANTA PHARMA LTD - -31-0 M.I.D.C. INDUSTRIAL AREA CHIKALTHANA- AURANGABAD 431210 DIST AURANGABAD |INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE7/1/2017
13NDA/MAL/HHP/5498AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFIGURINAJANTA PHARMA LTD 31-0-AJANTA PHARMA LTD 31-0 MIDC INDUSTRIAL AREACHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X6.0X10.0 CAPSULE BLISTER7/1/2000
14NDA/MAL/HHP/5560AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDSTAMINAAJANTA PHARMA LTD-31-0, M.I.D.C. CHIKALTHANA, CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2000
15NDA/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 |
INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X10.0 ML TUBE11/24/2017
16NDA/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 | INDIA |TOPICAL EXTERNAL OTHER OINTMENTS1.0X10.0 ML CONTAINER,1.0X5.0 ML CONTAINER7/1/2004
17NDA/MAL/HHP/9182NZEN ENTERPRISEHEALTHCARE LTD.HERBICUFASIAN LIFECARE PVT.LTD-MANJUSAR,SAVLI,VADODARA,GUJARAT, INDIA PLOT NO. 3 & 3/A,SHAH INDUSTRIAL PARK-2,NEAR LAMPDAPURA CROSSING,AT&PO | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE3/11/2020
18NDA/MAL/HHP/9093BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDCOFTA EXTRA SYRUPBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD |KENYA |ORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE3/22/2019
19NDA/MAL/HHP/9094BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDBETASIL HERBAL COUGH SYSRUPBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD |KENYA |ORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE3/22/2019
20NDA/MAL/HHP/7966BHARGAVA PHYTOLAB PVT LTDPLANET PHARMACEUTICALS UGANDA LTDKIDFLAMEBHARGAVA PHYTOLAB PVT LTD-B-92, SECTOR ? 2 , NOIDA ? 201301, U.P. ( INDIA) | INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER7/1/2015
21NDA/MAL/HHP/7959BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDTONIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2015
22NDA/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 | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2017
23NDA/MAL/HHP/8094BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDPOSTORALBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER7/1/2017
24NDA/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 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2017
25NDA/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 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2017
26NDA/MAL/HHP/8513BHARGAVA PHYTOLAB PVT. LTDPLANET PHARMACEUTICALS UGANDA LTDMENIPHIBBHARGAVA PHYTOLAB PVT. LTD -E-1216, PHASE ? 1, EXTN. GHATAL, BHIWADI INDUSTRIAL AREA, BHIWADI (RAJ.) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X20.0 TABLET BLISTER7/1/2016
27NDA/MAL/HHP/9106BHARGAVA PHYTOLAB PVT. LTDFARHAN LIMITED - SOLOT AVENUEPILORALBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER6/13/2019
28NDA/MAL/HHP/9107BHARGAVA PHYTOLAB PVT. LTDFARHAN LIMITED - SOLOT AVENUEHEPATINA TABLETSBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X15.0 TABLET BLISTER6/13/2019
29NDA/MAL/HHP/9108BHARGAVA PHYTOLAB PVT. LTDFARHAN LIMITED - SOLOT AVENUEARTHARAL TABLETBHARGAVA PHYTOLAB PVT.LTD-E-1216 PHASE-1, EXTN. GHATAL,BHIWADI INDUSTRIAL AREA, BHIWADI(RAJ.) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER6/13/2019
30NDA/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 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2017
31NDA/MAL/HHP/8510BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDFRICKS COUGH SYRUPBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE3/6/2018
32NDA/MAL/HHP/5500CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDAPTIZOOM SYRUPCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2000
33NDA/MAL/HHP/5546CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDPAEDRITONE SYRUPCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
34NDA/MAL/HHP/5550CHARAK PHARMA PVT LTDABACUS PHARMA (AFRICA) LIMITEDGUM TONE GELCHARAK PHARMA PVT LTD,-EVERGREEN INDUSTRIAL ESTATE, SHAUTI MILL LANE, MUMBAI-400011 INDIA | INDIA |ORAL TOPICAL GELS AND SOLS1.0X50.0 G TUBE7/1/2015
35NDA/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 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER1/29/2020
36NDA/MAL/HHP/5597CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDTOOCHE DROPSCIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA |ORAL TOPICAL DROPS1.0X10.0 ML BOTTLE7/1/2014
37NDA/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. | JORDAN |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2012
38NDA/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
|
VIETNAM |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2016
39NDA/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
|
THAILAND |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2016
40NDA/MAL/HHP/5613DR. KIM AYURVEDIC PHARMACYJ.P.IMPEX PHARMACY (U) LIMITEDSMOOTH COUGH DROPSDR KIM AYURVEDIC PHARMACY-INDIA |INDIA |ORAL SOLID ORDINARY LOZENGES1.0X100.0X2.0 LOZENGE STRIP7/1/2005
41NDA/MAL/HHP/9086DR. KIM AYURVEDIC PHARMACYJ.P.IMPEX PHARMACY (U) LIMITEDSMOOTH C-COOL COUGH TABLETSDR KIM AYURVEDIC PHARMACY-SHED NO. 139, ADARSH ESTATE, NEAR CHAKUDIA TEMPLE, RAKHIAL AHMEDABAD GUJARAT - INDIA | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X100.0 LOZENGE CARTON
42NDA/MAL/HHP/5536ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDMENTHO PLUS PAIN BALMEMAMI LTD-EMAMI LIMITED COLLEGE NAGAR ABHOYPUR, GUWAHATI 781031, ASSAM INDIA / EMAMI LIMITED PLOT NO 200 SANJAN -AMAGOAN ROAD DONGARI TALASARI | INDIA |NASAL 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
43NDA/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 | EGYPT |TOPICAL EXTERNAL LOTIONS1.0X1.0X40.0 G TUBE7/1/2017
44NDA/MAL/HHP/7934STAR PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR RUBEFACIENTGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2015
45NDA/MAL/HHP/7937GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSENSUR OILGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI | INDIA |TOPICAL EXTERNAL LIQUIDS1.0X10.0 ML VIAL7/1/2015
46NDA/MAL/HHP/7940GLENMARK PHARMACEUTICALS LTDSTAR PHARMACEUTICALS LTDSENSUR LOTIONGLENMARK PHARMACEUTICAL LIMITED-61-62 COMPOUND, DEWAS NAKA, LASUDIA MORI | INDIA |TOPICAL EXTERNAL OTHER CREAMS1.0X50.0 ML BOTTLE7/1/2015
47NDA/MAL/HHP/6915GREAT INDIA INDUSTRIAL & PHARAMCEUTICALS LABORATORIESANDYCO PHARMACY (UGANDA) LTDGIPLA GRIPE WATERGREAT INDIA -19 SUN MILL COMPOUND |INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X135.0 ML BOTTLE7/1/2014
48NDA/MAL/HHP/9181REDDY'S PHARMA LTD -REDDYS PHARMA LIMITEDZEBAGREAT INDIA INDUSTRIAL AND PHARMACEUTICAL LABORATORIES-19,SUN MILLS COMPD,MUMBAI 400 013 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X120.0 ML BOTTLE,1.0X135.0 ML BOTTLE3/11/2020
49NDA/MAL/HHP/9096HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDCOFCIDHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTAN |PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/24/2019
50NDA/MAL/HHP/9097HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDFLUCIDHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTAN |PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/24/2019
51NDA/MAL/HHP/9098HIMONT LABORATORIES PVT LTDBOOTS PHARMACEUTICALS LIMITEDCARIPEPTIC SYRUPHIMONT LABORATORIES (PVT) LTD-17KM FEROZEPUR ROAD LAHORE PAKISTAN |PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
52NDA/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 | PAKISTAN |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON5/31/2019
53NDA/MAL/HHP/9100HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SACHETHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON5/31/2019
54NDA/MAL/HHP/9101HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
55NDA/MAL/HHP/9102HINUCONBOOTS PHARMACEUTICALS LIMITEDEPTI SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
56NDA/MAL/HHP/9103HINUCONBOOTS PHARMACEUTICALS LIMITEDHILGAS SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE5/31/2019
57NDA/MAL/HHP/9104HINUCONBOOTS PHARMACEUTICALS LIMITEDCOLOREST DROPSHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY DROPS1.0X30.0 ML BOTTLE5/31/2019
58NDA/MAL/HHP/9105HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA CAPSULESHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER5/31/2019
59NDA/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 | PAKISTAN |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON3/11/2020
60NDA/MAL/HHP/9122HINUCONBOOTS PHARMACEUTICALS LIMITEDCOFERB DROPSHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY DROPS1.0X20.0 ML BOTTLE3/11/2020
61NDA/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 | PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/11/2020
62NDA/MAL/HHP/9124HINUCONBOOTS PHARMACEUTICALS LIMITEDINSTUM QUICK MELT SACHET (ORANGE FLAVOUR)HINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X12.0X5.0 SACHET CARTON3/11/2020
63NDA/MAL/HHP/9125HINUCONBOOTS PHARMACEUTICALS LIMITEDRIMONA SACHETHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X10.0 SACHET CARTON3/11/2020
64NDA/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 | PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/11/2020
65NDA/MAL/HHP/9127HINUCONBOOTS PHARMACEUTICALS LIMITEDFIBO JARHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X175.0 G JAR3/11/2020
66NDA/MAL/HHP/9128HINUCONBOOTS PHARMACEUTICALS LIMITEDELFERB SYRUPHINUCON -PLOT NO.12/1 SECTOR 15,KORANGI INDUSTRIAL AREA, KARACHI 9TH FLOOR PROGRESSIVE PLAZA,BEAUMONT ROAD,KARACHI,PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE3/11/2020
67NDA/MAL/HHP/7926HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDHOVID GINGKOHOVID BERHAD-121, JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
68NDA/MAL/HHP/5553ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDMENTHOXYL DOUBLE ACTION HERBAL COUGH LOZENGESLEAMARK HEALTHCAREPVT LTD-SARKHEJ-BAVLA HIGHWAY MATODA AHMEDABAD |INDIA |ORAL SOLID ORDINARY LOZENGES1.0X10.0X2.0 LOZENGE STRIP,1.0X50.0X2.0 LOZENGE STRIP7/1/2009
69NDA/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 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE1/28/2019
70NDA/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 | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X1.0X100.0 LOZENGE CARTON7/1/2009
71NDA/MAL/HHP/5547SHURIK LTDSHURIK LTDMENTHOSIL COUGH DROPMEHTA HERBALS PVT LTD-INDIA |INDIA |ORAL SOLID ORDINARY LOZENGES1.0X35.0X2.0 LOZENGE STRIP7/1/2001
72NDA/MAL/HHP/5518MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPENODEX OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIA |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER7/1/2007
73NDA/MAL/HHP/5559SHURIK LTDSHURIK LTDSTAR SKIN OINTMENTMEHTA UNANI PHARMACY & CO LTD-INDIA |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X12.0 G TUBE7/1/2001
74NDA/MAL/HHP/3115SHURIK LTDSHURIK LTDRHINO BALMMEHTA UNANI PHARMACY & CO LTD-INDIA |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER,1.0X10.0 G CONTAINER11/7/2018
75NDA/MAL/HHP/5532MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDATMANANTHAN COLD RUBMETA UNANI PHARMACY & CO PVT-G 5524, GIDC, LODHIKA METODA, DIST RAJKOT, GUJARATI | INDIA |NASAL TOPICAL LIQUID INHALATIONS1.0X12.0X1.0 G ROD7/1/2009
76NDA/MAL/HHP/5576SHURIK LTDSHURIK LTDNO SCAR CREAMMETHA UNANI PHARMACY-METHA UNANI PHARMACY G-524 LODHIKA, G.I.D.C METODA | INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2007
77NDA/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 |
JORDAN |TOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X15.0 G TUBE7/13/2017
78NDA/MAL/HHP/5570PANACEA BIOTEC LTDVITACARE LIMITEDSITCOMPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH ? 173 205 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2013
79NDA/MAL/HHP/9170SMC ECOPHARMYURIA PHARM EAST AFRICA LIMITEDPROTEFLAZIDPHARMEX GROUP LLC100 -SHEVCHENKA STR., BORYSPIL, KYIV REGION, 08300, UKRAINE | UKRAINE |RECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER12/11/2019
80NDA/MAL/HHP/9171SMC ECOPHARMYURIA PHARM EAST AFRICA LIMITEDPROTEFLAZID DROPSPHARMEX GROUP LLC100 -SHEVCHENKA STR., BORYSPIL, KYIV REGION, 08300, UKRAINE | UKRAINE |VAGINAL LIQUIDS1.0X30.0 ML BOTTLE12/11/2019
81NDA/MAL/HHP/5505VENUS REMIDIES LTDHARLEYS UGANDA LIMITEDAMPUCARE HERBAL OILPLANET HERBS LIFESCIENCES LIMITED -B-4 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN-248197, UTTARKHAND, INDIA | INDIA |TOPICAL EXTERNAL LIQUIDS1.0X50.0 ML BOTTLE7/1/2008
82NDA/MAL/HHP/5503ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAMODEX OINTMENTPOOJA DRUGS-POOJA DRUGS |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X25.0 G JAR7/1/2000
83NDA/MAL/HHP/5565ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDDENTEX TOOTHACEPOOJA DRUGS-POOJA DRUGS |INDIA |TOPICAL EXTERNAL LIQUIDS1.0X5.0 ML BOTTLE7/1/2000
84NDA/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 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2004
85NDA/MAL/HHP/5534SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)WIDE SPECTRUM ENTERPRISES (U) LIMITEDEUCARBONSOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, 6 OCTOVER CITY, P.O. BOX 43 | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2000
86NDA/MAL/HHP/7938SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDSILYBIN 140SQUARE HERBAL AND NUTRACEUTICALS LTD -48 MOHAKHALI COMERCIAL AREA, DHAKA-1212 | BANGLADESH |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
87NDA/MAL/HHP/7939SQUARE HERBAL AND NUTRACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDGINTEXSQUARE HERBAL AND NUTRACEUTICALS LTD-48, MOHAKHALI COMMERCIAL AREA, DHAKA-1212 | BANGLADESH |ORAL SOLID ORDINARY CAPSULES1.0X5.0X6.0 CAPSULE STRIP7/1/2014
88NDA/MAL/HHP/8507SYDLER REMEDIES PVT LTD M-190ROYAL PHARMA 2011 LIMITEDCUFSOL LOZENGES ORANGESYDLER REMEDIES PVT LTD-M-190 MIDC WALUJ AURANGABAD 431136 |INDIA |ORAL SOLID ORDINARY LOZENGES1.0X2.0X50.0 LOZENGE BLISTER2/2/2018
89NDA/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 | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X120.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2014
90NDA/MAL/HHP/9092SYDLER REMEDIES PVT LTDABACUS PHARMA (AFRICA) LIMITEDEAZOL HERBAL COUGH LOZENGES (HERBAL FLAVOUR)SYDLER REMEDIES-PRIM-190, MIDC, WALUJ, AURANGABAD-431136, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP3/22/2019
91NDA/MAL/HHP/7929WOCKHARD LTDSTAR PHARMACEUTICALS LTDMANIX HERBAL CAPSULESTIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2015
92NDA/MAL/HHP/8556MANKIND PHARMA LTD.TATA UGANDA LIMITEDUNIORTHO-500TIRUPATI LIFESCIENCES-NAHAN ROAD, PAONTA SAHIB, DISTT. SIRMOUR HIMACHAL PRADESH-173025, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER11/10/2017
93NDA/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. | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2000
94NDA/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. | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X2.0X12.0 LOZENGE CONTAINER7/1/2016
95NDA/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 | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2005
96NDA/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 | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2005
97NDA/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 | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
98NDA/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 | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
99NDA/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 | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
100NDA/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 | INDIA |ORAL SOLID ORDINARY LOZENGES1.0X5.0X4.0 LOZENGE STRIP7/1/2014
101NDA/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 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
102NDA/MAL/HHP/5620UNIQUE PHARMACEUTICAL LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDZECUF COLD RUBUNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 4 PASE IV, GIDC PANOLI -394 116
GUJARAT INDIA |
INDIA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G CONTAINER7/1/2009
103NDA/MAL/HHP/5618SHURIK LTDSHURIK LTDVYBRANTVITAL CARE-INDIA |INDIA |ORAL SOLID ORDINARY CAPSULES5.0X10.0 CAPSULE BLISTER7/1/2000
104NDA/MAL/HHP/9090I_CARE PHARMA LIMITEDAIVEEN (U) LIMITEDFATNILEWEST COAST PHARMACEUTICAL WORKS LTD-1143,MELDI ESTATE,NR PRASANG PARTY PLOT,GOTA, AHMEDEBAD | INDIA |ORAL SOLID ORDINARY OTHER CAPSULES1.0X4.0X15.0 CAPSULE BLISTER1/28/2019
105NDA/MAL/HHP/9095WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.X-TREMEWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER4/23/2019
106NDA/MAL/HHP/7974WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.APPERIZE SYRUP 120MLWILSHIRE LABORATORIES (PVT) LTD-124/1 INDUSTRIAL AREA, KOT LAKHPAT LAHORE PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE
107NDA/MAL/HHP/6850WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.BENZIM NATURAL SYRUP 120MLWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE12/3/2016
108NDA/MAL/HHP/6852WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.DE-FLU SYRUP 120MLWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE12/3/2016
109NDA/MAL/HHP/6853WILSHIRE LABORATORIES (PVT) LTDHEALTHCARE LTD.LIV-LONG TABLETWILSHIRE LABORATORIES LIMITED-124/1-INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE, PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2016
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/0001INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDMICARDIS 40TELMISARTAN40MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/1997
2NDA/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
|
UGANDA |OPHTHALMIC DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL7/1/2011
3NDA/MAL/HDP/0003UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOXIL CLAV 625AMOXICILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGUNI MEDICOLABS-21-22 PHARMACITY SELAQUI DEHRADUN 248197 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2015
4NDA/MAL/HDP/0006HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIAMIDEGLIBENCLAMIDE + METFORMIN HYDROCHLORIDE5MG + 500MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X12.0 TABLET BLISTER7/1/2014
5NDA/MAL/HDP/0007GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIP SYRUPCYPROHEPTADINE HYDROCHLORIDE2MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
6NDA/MAL/HDP/0010STALLION LABORATORIES PVT LTDSHREEJI PHARMACEUTICALS LIMITED02-LONOFLOXACIN + ORNIDAZOLE200MG + 500MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
7NDA/MAL/HDP/0011INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDMICARDIS 80TELMISARTAN80MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2015
8NDA/MAL/HDP/0012HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDPENGESIC SRTRAMADOL HYDROCHLORIDE SR100MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA |ORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
9NDA/MAL/HDP/0014PLOUGHUNITED HEALTHCARE DISTRIBUTORS LTDMONTELAIR 10MG TABLETMONTELUKAST10MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
10NDA/MAL/HDP/0016REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCODIMEX-CT TABLETSCETIRIZINE DIHYDROCHLORIDE10MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2014
11NDA/MAL/HDP/0017SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDHYCORTHYDROCORTISONE100MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X10.0X7.5 ML VIAL7/1/2011
12NDA/MAL/HDP/0018INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDCO-MICARDISTELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/1997
13NDA/MAL/HDP/0021SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDQUINSQUININE DIHYDROCHLORIDE300MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE7/1/2013
14NDA/MAL/HDP/0022GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2009
15NDA/MAL/HDP/0024KOPRAN LIMITEDTATA UGANDA LIMITEDAMPICLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
16NDA/MAL/HDP/0025ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-5AMLODIPINE5MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220,TALUKA BAVLA DIST AHMEDABAD, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
17NDA/MAL/HDP/0026ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAMLOAS-10AMLODIPINE10MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
18NDA/MAL/HDP/0028ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-50ATENOLOL50MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
19NDA/MAL/HDP/0029ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDHYPERLOK-100ATENOLOL100MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
20NDA/MAL/HDP/0030UNOSOURCE PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDTRADMINTRAMADOL HYDROCHLORIDE50MG/MLAKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
|
INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE7/1/2015
21NDA/MAL/HDP/0031MANKIND PHARM LTDTATA UGANDA LIMITEDCEFTATIME-SB 1.5CEFTRIAXONE+SULBACTAM1000MG+500MGMANKIND PHARMA LTD--VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESH |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL7/1/2015
22NDA/MAL/HDP/0032INGELHEIM PHARMACEUTICAL LTDSURGIPHARM (U) LIMITEDCO-MICARDISTELMISARTAN + HYDROCHLOROTHIZIDE80MG + 12.5MGBOEHRINGER INGELHEIM PHARMA GMBH & CO. KG.,-BIRKENDORFER STRASSE 65, 88397, BIBERACH AN DER RISS | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2013
23NDA/MAL/HDP/0033ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYVATE CREAMBETAMETHASONE VALERATE0.1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
24NDA/MAL/HDP/0041RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECIMCIMETIDINE200MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
25NDA/MAL/HDP/0043KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOL JUNIORPARACETAMOL250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
26NDA/MAL/HDP/0045GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOL CAPLETSPARACETAMOL500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
27NDA/MAL/HDP/0047MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAMIHOPE ETEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG + 300MG + 300MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK ?N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE,1.0X90.0 TABLET CONTAINER,1.0X180.0 TABLET CONTAINER7/1/2015
28NDA/MAL/HDP/0051H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL ACUPHASE ZUCLOPENTHIXOL ACETATE50MG/MLH. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY | DENMARK |PARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/2015
29NDA/MAL/HDP/0052MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM0.5%W/VMEDICAL UNION PHARMACEUTICALS CO -36 DR MOHAMED HASSAN EL GAMAL ST. 6TH DISTRICT NASR CITY, CAIRO | EGYPT |TOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2014
30NDA/MAL/HDP/0053H. LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFLUANXOL DEPOTFLUPENTIXOL DECANOATE20MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK |PARENTERAL RETARD AMPOULES1.0X1.0 ML AMPOULE7/1/2015
31NDA/MAL/HDP/0054GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDFUNGOALCLOTRIMAZOLE1%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
32NDA/MAL/HDP/0055H.LUNDBECK A/SPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDCLOPIXOL DEPOT ZUCLOPENTHIXOL DECANOATE200MG/MLH. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK |PARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/2015
33NDA/MAL/HDP/0056TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDDYNAPAR QPSDICLOFENAC4%W/VTROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA | TROIKAA PHARMACEUTICALS LTD-BLOCK NO. 2019, 2020, 2023, VILLAGE VIROCHANNAGAR, TAL-SANAND CITY: AHMEDABAD, DIST. AHMEDABAD-382170, GUJARAT STATE | INDIA |TOPICAL EXTERNAL SPRAYS WITHOUT GAS1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE7/1/2015
34NDA/MAL/HDP/0058NIRMA LIMITED.LIFE PHARMA AFRICA LIMITEDWATER FOR INJECTION B.P.WATER FOR INJECTIONN/AACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE7/1/1997
35NDA/MAL/HDP/0059NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDVAGIBACT CREAMCLINDAMYCIN PHOSPHATE2%W/WNABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
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PAKISTAN |TOPICAL EXTERNAL CREAMS1.0X40.0 G TUBE + 1 APPLICATOR7/1/2006
36NDA/MAL/HDP/0060MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 300 IU/0,5 ML (22 ?G/0,5 ML)FOLLITROPIN ALFA22 ?G/0,5 MLMERCK SERONO SPA (BARI)-VIA DELLE MAGNOLIE, 15 (LOC FRAZ ZONA INDUSTRIALE) 70026, MODUGNO, BARI | ITALY | SWITZERLAND |PARENTERAL ORDINARY PRE-FILLED PENS1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION7/1/2015
37NDA/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.
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2015
38NDA/MAL/HDP/0064MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDGONAL-F PEN 450 IU/ IE 0,75 ML (33 ?G)FOLLITROPIN ALFA33?G/ 0.7MLMERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLAND | SWITZERLAND |PARENTERAL ORDINARY CARTRIDGES1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION7/1/2015
39NDA/MAL/HDP/0065HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDALENDRONATE 70MGALENDRONATE SODIUM70MGHOVID BHD-LOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMOR |MALAYSIA |ORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/2015
40NDA/MAL/HDP/0067SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDARTEES?-? ARTEETHER75MG/MLSAKAR HEALTHCARE PVT LTD --406, SILVER OAKS COMMERCIAL COMPLEX, | INDIA |PARENTERAL ORDINARY AMPOULES1.0X3.2 ML AMPOULE7/1/2013
41NDA/MAL/HDP/0069PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN10MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER7/1/1999
42NDA/MAL/HDP/0070PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDLIPITORATORVASTATIN20MGPFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER7/1/1999
43NDA/MAL/HDP/0072VHB MEDI SCIENCES LTDLLOYDS PHARMACY LIMITEDAMTERICINAMPHOTERICIN50MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X50.0 MG VIAL7/1/2013
44NDA/MAL/HDP/0073NAARI LTDECHO PHARMACY (U) LIMITEDFASILE-ONELEVONORGESTREL TABLETS BP1.5MGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER7/1/2013
45NDA/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 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2014
46NDA/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
|
UGANDA |OPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2015
47NDA/MAL/HDP/0079MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDREVOKE 72LEVONORGESTREL750MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2014
48NDA/MAL/HDP/0083MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDZINNIA-FLEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE150MCG + 30MCG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER7/1/2014
49NDA/MAL/HDP/0088GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDD-LYTE CO-PACKANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC,ANHYDROUS GLUCOSE+SODIUM CHLORIDE+TRISODIUM CITRATE+POTASSIUM CHLORIDE/ZINC2.7MG+0.52MG+0.58MG+0.30MG+20MG PER 200ML,6.75MG+1.30MG+1.45MG+0.75MG+20MG PER 500ML SACHET,13.5MG+2.60MG+2.90MG+1.50MG+20MG PER 1000ML SACHETAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY COMBINATION PACK POWDERS/GRANULES4.0X500.0 ML SACHET + 1*10 BLISTERS,10.0X200.0 ML SACHET + 1*10 BLISTERS,2.0X1000.0 ML SACHET + 1*10 BLISTERS7/1/2015
50NDA/MAL/HDP/0093ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLORASLORATADINE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
51NDA/MAL/HDP/0096ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDLIPORATORVASTATIN20MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER7/1/2015
52NDA/MAL/HDP/0097MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 750LEVOFLOXACIN 750MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
53NDA/MAL/HDP/0098MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDATOREM 10ATORVASTATIN10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
54NDA/MAL/HDP/0099ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDCARBASCARBAMAZEPINE200MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2014
55NDA/MAL/HDP/0101GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTETRA CAPSULESTETRACYCLINE HYDROCHLORIDE250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/1998
56NDA/MAL/HDP/0102MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 100SILDENAFIL CITRATE100MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2014
57NDA/MAL/HDP/0103MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDATOREM 20ATORVASTATIN20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
58NDA/MAL/HDP/0104MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSILMELT 50SILDENAFIL CITRATE50MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2014
59NDA/MAL/HDP/0105GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSPRIN TABLETSACETYL SALICYLIC ACID300MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1998
60NDA/MAL/HDP/0110MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
61NDA/MAL/HDP/0111MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDSAFETELMI 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
62NDA/MAL/HDP/0112NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE 5MG/160MGAMLODIPINE + VALSARTAN5 MG + 160 MGNOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE | NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SWITZERLAND |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2007
63NDA/MAL/HDP/0114MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY 4MONTELUKAST SODIUM4MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
64NDA/MAL/HDP/0116MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDBREATHEZY CW 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
65NDA/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. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0X1.5 G VIAL + 1 AMPOULE OF WFI7/1/2013
66NDA/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. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL + 1 AMPOULE WFI7/1/2013
67NDA/MAL/HDP/0119DAWA LIMITEDSUPER MEDIC LTDDACOLDCAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSEUDOEPHEDRINE30MG+4MG+400MG+30MGDAWA LIMITED -BABA DOGO RWARAKA |KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
68NDA/MAL/HDP/0121SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDPEDZINCZINC SULPHATE20MGSHELYS PHAMACEUTICALS LTD .-NEW BAGAMOYO RD, MWENGE, PLOT 696, DAR ES SALAAM | BETA HEALTH CARE INTERNATIONAL LIMITED/-PLOT NO. LR 209/ 6534 MOGADISHU ROAD, KENYA | TANZANIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2015
69NDA/MAL/HDP/0124DAWA LIMITEDSUPER MEDIC LTDAMPECINAMPICILLIN TRIHYDRATE125MG/5MLDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2015
70NDA/MAL/HDP/0125DAWA LIMITEDSUPER MEDIC LTDSULPHUR OINTMENTSULPHUR10%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/2013
71NDA/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 NAIROBI |KENYA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/2014
72NDA/MAL/HDP/0127DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE300MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
73NDA/MAL/HDP/0128DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDCORYCARDONIRBESARTAN + HYDROCHLOROTHIAZIDE150MG + 12.5MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
74NDA/MAL/HDP/0131ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P125CLARITHROMYCIN125MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715 |
SOUTH AFRICA |ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1998
75NDA/MAL/HDP/0132ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 500MGCLARITHROMYCIN500MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715 |
SOUTH AFRICA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X14.0 TABLET BLISTER7/1/1998
76NDA/MAL/HDP/0133ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID P250CLARITHROMYCIN250MG/5MLABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715 |
SOUTH AFRICA |ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1998
77NDA/MAL/HDP/0135SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDHEMOVIT SYRUPIRON + FOLIC ACID + PYRIDOXINE + CYANOCOBALAMIN + ZINC200MG + 1.5MG + 0.5MG + 50 MCG + 2.33MGBETA HEALTHCARE INTERNATIONAL LTD -PLOT NO LR 209/6534 MOGADISHU ROAD | SHELYS PHAMACEUTICALS LTD .-NEW BAGAMOYO RD, MWENGE, PLOT 696, DAR ES SALAAM | TANZANIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2013
78NDA/MAL/HDP/0139ANGLIAN NUTRITION PRODUCTS COMPANYSUPER MEDIC LTDMOXAFORTEFLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE250MG + 250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2014
79NDA/MAL/HDP/0141COSMOS LTDASTRA PHARMA (U) LIMITEDNYCOSTAT SUSPENSIONNYSTATIN100,000 I.U/MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/1998
80NDA/MAL/HDP/0142PFIZER LAB LTDLABOREX UGANDA LIMITEDPREVENAR 13PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT.ADSORBED)2.2MCG OF POLYSACCHARIDE FOR SEROTYPES 1,3,4,5,6A,7F.9V,14,18C,19A,19F,23F,AND 4.4MCG FOR SEROTYPE 6BWYETH PHARMACEUTICALS INC-401 N MIDDLETOWN RD PEARL RIVER NY 10965 |UNITED STATES |PARENTERAL ORDINARY VIALS1.0X0.5 ML VIAL (1 DOSE)7/1/2011
81NDA/MAL/HDP/0144MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDNEXQUIN 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2013
82NDA/MAL/HDP/0145MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDTELKAST 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
83NDA/MAL/HDP/0148MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSYNCLAV 1000AMOXICILLIN + CLAVULANATE POTASSIUM875 MG + 125 MGMEDREICH LIMITED UNIT 1-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR, BANGOLORE-560049 | MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2013
84NDA/MAL/HDP/0149MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSYNCLAV 625AMOXICILLIN + POTASSIUM CLAVULANATE500 MG + 125 MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
| MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU |
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2013
85NDA/MAL/HDP/0150MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDSYNCLAV 228AMOXYCILLIN + CLAVULANATE POTASSIUM200 MG + 28.5 MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
|
INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2013
86NDA/MAL/HDP/0151MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCARDITEL 80TELMISARTAN80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
87NDA/MAL/HDP/0152DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 150IRBESARTAN150MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA | DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
88NDA/MAL/HDP/0153DELORBIS PHARMACEUTICALS LTDABACUS PHARMA (AFRICA) LIMITEDRYCARDON 300IRBESARTAN300MG ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA | DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
89NDA/MAL/HDP/0155TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ASTHATOR 10MONTELUKAST SODIUM10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
90NDA/MAL/HDP/0157RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRECODINCODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE10MG + 4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
91NDA/MAL/HDP/0158MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDKIPEL 10MONTELUKAST SODIUM10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
92NDA/MAL/HDP/0160UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDTIZIGESICTIZANIDINE HYDROCHLORIDE2MGUNICHEM LABORATORIES LIMITED-C?31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2016
93NDA/MAL/HDP/0162RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOSYP-D LINCTUSDEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE10MG +4MG /5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2015
94NDA/MAL/HDP/0163RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDPHENARENPROMETHAZINE HYDROCHLORIDE5MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2015
95NDA/MAL/HDP/0164RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENPRESSPROPRANOLOL40MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
96NDA/MAL/HDP/0165TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 5OLANZAPINE ORODISPERSIBLE TABLETS5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
97NDA/MAL/HDP/0166RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2015
98NDA/MAL/HDP/0167TORRENT PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TOLANZ 10OLANZAPINE ORODISPERSIBLE TABLETS10MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
99NDA/MAL/HDP/0168MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAYFEBUXOSTAT80MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
100NDA/MAL/HDP/0169ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 10ROSUVASTATIN10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER7/1/2015
101NDA/MAL/HDP/0175BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDXARELTO 10MGRIVAROXABAN10MGBAYER HEALTHCARE AG,-D-51368, LEVERKUSEN | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
102NDA/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 | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X8.0 CAPSULE BLISTER7/1/2013
103NDA/MAL/HDP/0182MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFEBUDAY 40FEBUXOSTAT40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
104NDA/MAL/HDP/0186WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDBBC SPRAYBENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE1.5%W/V+0.15%W/V+0.0413%W/VAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT |ORAL TOPICAL SPRAYS WITHOUT GAS1.0X25.0 ML BOTTLE7/1/2014
105NDA/MAL/HDP/0187AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDKAPRON TABLETTRANEXAMIC ACID500 MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
106NDA/MAL/HDP/0188AMOUN PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDLEVOXINLEVOFLOXACIN500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
107NDA/MAL/HDP/0189CIPLA LTDQUALITY CHEMICALS LTD - HUMANNEVIMUNE TABLETSNEVIRAPINE200MGCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET CONTAINER7/1/2001
108NDA/MAL/HDP/0191MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 228.5AMOXICILLIN + CLAVULANATE200 MG + 28.5 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU |INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2013
109NDA/MAL/HDP/0193MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDCLEDOMOX 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2013
110NDA/MAL/HDP/0196CIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDDUOVIRLAMIVUDINE/ZIDOVUDINE150MG/300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | UGANDA |ORAL SOLID ORDINARY OTHER COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2013
111NDA/MAL/HDP/0197CIPLA LTDQUALITY CHEMICALS LTD - HUMANEFAVIR-600EFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2004
112NDA/MAL/HDP/0198CIPLA LIMITEDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDNEVIRAPINE TABLETS 200 MGNEVIRAPINE200MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
113NDA/MAL/HDP/0203GLAXOSMITHLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALER 250SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE25MCG + 250MCGGLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUX | FRANCE |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2015
114NDA/MAL/HDP/0204GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDTIVICAYDOLUTEGRAVIR SODIUM50MGGLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOM |UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2015
115NDA/MAL/HDP/0206MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDCARDITEL 40TELMISARTAN40MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
116NDA/MAL/HDP/0207MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATELAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE300MG +300MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 | MACLEODS PHARMACEUTICALS LIMITED (BLOCK ?N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/10/2013
117NDA/MAL/HDP/0209HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLHETERO LABS PRIVATE LIMITED UNIT III-SURVEY NO. 51, PLOT 22-110, INDUSTRIAL DEVELOPMENT AREA (I.D.A) JEEDIMETLA, HYDERABAD-500 055, TELANGANA STATE | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE7/1/2013
118NDA/MAL/HDP/0210MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN140MGMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT |EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2011
119NDA/MAL/HDP/0212MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.HEPATICUMSILYMARIN1G/100MLMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT |EGYPT |ORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE7/1/2012
120NDA/MAL/HDP/0213AUROBINDO PHARMA LTD (UNIT VI)PHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROPODOX 200CEFPODOXIME200MGAUROBINDO PHARMA LTD (UNIT VI) ,.,.,-SURVEY NOS. 329/39 & 329/47, CHITKUL VILLAGE, PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2013
121NDA/MAL/HDP/0217ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDPALETHERARTEMETHER80MG/MLLINCOLN PARENTERAL LTD .-11, TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. BOX KHATRAJ 382721 TA: KALOL DIST. GANDHINAGAR GUJARAT | INDIA |PARENTERAL ORDINARY I M AMPOULES2.0X3.0X1.0 ML AMPOULE7/1/2014
122NDA/MAL/HDP/0221DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN250 MG + 250 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
123NDA/MAL/HDP/0222ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDAVIR-200ACYCLOVIR500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
124NDA/MAL/HDP/0225ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKON PLUSDICLOFENAC/SALICYLATE/MENTHOL/LINSEED1%W/W+10%W/W+5%W/W+3%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G CONTAINER7/1/2013
125NDA/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. | EGYPT |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2014
126NDA/MAL/HDP/0227AMOUM PHARMACEUTICALS LTDBOOTS PHARMACEUTICALS LIMITEDCYRINOL SYRUPPHOLCODINE+EPHEDRINE HCL +CARBINOXAMINE MALEATE4MG+7MG+2MG /5MLAMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT |EGYPT |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2014
127NDA/MAL/HDP/0228KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-960TRIMETHOPRIM/SULFAMETHOXAZOLE160MG/800MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
128NDA/MAL/HDP/0230STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCOMBIARTARTHEMETHER + LUMEFANTRINE20MG +120MGSTRIDES SHASUN LIMITED-NO. 36/7, SURAGAJAKKANAHALLI, INDLAVADI CROSS, ANEKAL TALUK, BENGALURU, KARNATAKA, 562106 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER7/1/2013
129NDA/MAL/HDP/0232TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.BRANTALOSARTAN POTASSIUM + AMLODIPINE BESILATE50MG + 5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
130NDA/MAL/HDP/0236INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDCLOBCLOTRIMAZOLE1%W/WINDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNA |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE,1.0X15.0 G TUBE7/1/2004
131NDA/MAL/HDP/0237MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDKOMEFAN 280ARTEMETHER + LUMEFANTRINE40 MG + 240 MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X12.0 TABLET BLISTER7/1/2041
132NDA/MAL/HDP/0239MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDKOMEFAN 140ARTEMETHER + LUMEFANTRINE20 MG+ 120 MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0X3.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER7/1/2014
133NDA/MAL/HDP/0245CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 4GLIMEPIRIDE4MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
134NDA/MAL/HDP/0248IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDPANTONEX DR-40PANTOPRAZOLE40 MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
|
INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
135NDA/MAL/HDP/0250ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDDIKONDICLOFENAC1%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER7/1/2013
136NDA/MAL/HDP/0252LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVAST-40ATORVASTATIN40MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
137NDA/MAL/HDP/0253ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTENLOW-5AMLODIPINE BESYLATE5MGLINCO N PHARMACEUTICALS LIMITED-TRIMUL ESTATE KHATRAJ KALOL GUJARAT INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
138NDA/MAL/HDP/0254MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 5BISOPROLOL HEMIFUMARATE5MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT | WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
139NDA/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. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET CONTAINER7/1/2015
140NDA/MAL/HDP/0257SANOFI AVENTS FRANCELABOREX UGANDA LIMITEDCORDARONEAMIODARONE HYDROCHLORIDE200MGSANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE
|
FRANCE |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X15.0 TABLET BLISTER7/1/1998
141NDA/MAL/HDP/0266ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZATHINE PENICILLIN INJECTIONBENZATHINE PENICILLIN2.400.000 IUCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON7/1/2001
142NDA/MAL/HDP/0269LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-8ONDANSETRON8MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
143NDA/MAL/HDP/0270HETERO LABS LTDAIVEEN (U) LIMITEDLEVIN 500MGLEVOFLOXACIN HEMIHYDRATE500MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2001
144NDA/MAL/HDP/0271BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBETTTETANUS VACCNE ADSORBED40 I.UBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA |PARENTERAL ORDINARY AMPOULES1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES)7/1/2001
145NDA/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.
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2019
146NDA/MAL/HDP/0275GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE400MGGLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD-39 HAWKINS AVENUE, EPPING INDUSTRIAL, CAPE TOWN, 7460, SOUTH AFRICA | SOUTH AFRICA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER7/1/2011
147NDA/MAL/HDP/0276MICRO LABS LTDLABOREX UGANDA LIMITEDMELANOV 80GLICLAZIDE80MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
148NDA/MAL/HDP/0278COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 100MGCHLORPROMAZINE HYDROCHLORIDE100MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/1998
149NDA/MAL/HDP/0283DAWA LIMITEDSUPER MEDIC LTDAMPICLO-DAWAAMPICILLIN + CLOXACILLIN125 MG + 125 MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2013
150NDA/MAL/HDP/0284GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID1000 MG + 200 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |PARENTERAL ORDINARY DRY VIALS10.0X1.2 G VIAL7/1/2009
151NDA/MAL/HDP/0286GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDGLUMACARTEMETHER+LUMEFANTRINE20MG+120MGGUILIN PHARMACEUTICAL CO. LTD-NO. 17 SHANGHAI ROAD, GUILIN 541002, GUANXI CHINA | CHINA |ORAL SOLID ORDINARY TABLETS1.0X24.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X18.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER7/1/2014
152NDA/MAL/HDP/0287GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDPOWER HEATMETHYL SALICYLATE15%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X25.0 G TUBE,1.0X30.0 G TUBE7/1/2013
153NDA/MAL/HDP/0288UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDDUXCOSPANHYOSCINE BUTYL BROMIDE10MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
154NDA/MAL/HDP/0290LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDNATOAMEBENDAZOLE100MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
155NDA/MAL/HDP/0296COSMOS LTDASTRA PHARMA (U) LIMITEDPRAZITEL TABLETSPRAZIQUANTEL600MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
156NDA/MAL/HDP/0298SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDSEFIXI-50 DRY SYRUPCEFIXIME50MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X60.0 ML BOTTLE7/1/2013
157NDA/MAL/HDP/0301HETERO LABS LTDAIVEEN (U) LIMITEDMONAST 10MONTELUKAST SODIUM10MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
158NDA/MAL/HDP/0303HETERO LABS LTDAIVEEN (U) LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2014
159NDA/MAL/HDP/0304HETERO LABS LTDAIVEEN (U) LIMITEDDARUNAVIRDARUNAVIR400MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER7/1/2014
160NDA/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 | INDIA |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2013
161NDA/MAL/HDP/0307HETERO DRUGS LTDAIVEEN (U) LIMITEDLAMIVUDINE ORAL SOLUTIONLAMIVUDINE10MG/MLHETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA | INDIA |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X240.0 ML CONTAINER7/1/2013
162NDA/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 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
163NDA/MAL/HDP/0311MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDFENTANYLFENTANYL CITRATE50MCG/MLMARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND |UNITED KINGDOM |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2013
164NDA/MAL/HDP/0312SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDCLOXISPA ORAL SOLUTION 125CLOXACILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2013
165NDA/MAL/HDP/0314MARTINDALE PHARMACEUTICALS LTDLABOREX UGANDA LIMITEDSUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTIONSUXAMETHONIUM CHLORIDE50MG/MLMARTINDALE PHARMA -BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844 | UNITED KINGDOM |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2013
166NDA/MAL/HDP/0318DAWA LIMITEDSUPER MEDIC LTDSABULINSALBUTAMOL4MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
167NDA/MAL/HDP/0320DAWA LIMITEDSUPER MEDIC LTDDAZOLECLOTRIMAZOLE1%W/WDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
168NDA/MAL/HDP/0322MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-5NEBIVOLOL HCL5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2009
169NDA/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 | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X200.0 ML BOTTLE7/1/2014
170NDA/MAL/HDP/0332ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDROSUVAX 20ROSUVASTATIN CALCIUM20MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER7/1/2015
171NDA/MAL/HDP/0333KOPRAN LIMITEDTATA UGANDA LIMITEDCLAVAMYN-625AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE500MG +125MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
172NDA/MAL/HDP/0335GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDNEOMYCIN SULPHATE CREAM USPNEOMYCIN SULPHATE CREAM USP0.5%WWKREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE7/1/2013
173NDA/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 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
174NDA/MAL/HDP/0337IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *500AZITHROMYCIN500MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER7/1/2014
175NDA/MAL/HDP/0338KOPRAN LIMITEDTATA UGANDA LIMITEDKORAB 20RABEPRAZOLE SODIUM20MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
176NDA/MAL/HDP/0339IND-SWIFTPLANET PHARMACEUTICALS UGANDA LTDSWAZI *250AZITHROMYCIN250MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER7/1/2014
177NDA/MAL/HDP/0340GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDSONADAYCLOBETASOL-17-BUTYRATE + GENTAMYCIN SULPHATE + MICONAZOLE NITRATE0.05%W/W+0.1%W/W+2%W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
178NDA/MAL/HDP/0341IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 40TELMISARTAN + HYDROCHLOROTHIAZIDE40MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X10.0 TABLET BLISTER7/1/2014
179NDA/MAL/HDP/0342IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDTELSWIFT- H 80TELMISARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2014
180NDA/MAL/HDP/0343GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDWHITFIELD'S OINTMENT B.PBENZOIC ACID + SALICYLIC ACID6% W/W + 3% W/WKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2013
181NDA/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. | UGANDA |OPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2015
182NDA/MAL/HDP/0350RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCETRIRENCETIRIZINE HYDROCHLORIDE10MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
183NDA/MAL/HDP/0351MANKIND PHARM LTDTATA UGANDA LIMITEDDEPREGDINALEVONORGESTREL1.5MGACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER7/1/2014
184NDA/MAL/HDP/0353HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDEROX-10AMLODIPINE BESILATE10MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X3.0X1.0X10.0 TABLET BLISTER7/1/2015
185NDA/MAL/HDP/0354KOPRAN LIMITEDTATA UGANDA LIMITEDLEVOKOPLEVOFLOXACIN500MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2013
186NDA/MAL/HDP/0355SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBICO VITATHIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE10MG + 0.1MG + 1MG + 10MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2015
187NDA/MAL/HDP/0356DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 50OLEVOFLOXACIN HEMIHYDRATE500MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2014
188NDA/MAL/HDP/0358SWISS PARENTERALS PVT LTDSHREEJI PHARMACEUTICALS LIMITEDSTREPTOCINSTREPTOMYCIN SULPHATE1GMSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY I M VIALS1.0X1.0 G VIAL7/1/2014
189NDA/MAL/HDP/0360ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 20MGESOMEPRAZOLE20MGASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE | SWEDEN |ORAL SOLID ORDINARY TABLETS1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON7/1/2001
190NDA/MAL/HDP/0362SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDBUPIBUPIVACAINE5 MG/MLSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2015
191NDA/MAL/HDP/0363BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCINAZITHROMYCIN250MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X6.0 TABLET BLISTER7/1/2014
192NDA/MAL/HDP/0366BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDAGYCIN 500AZITHROMYCIN500MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0 TABLET BLISTER7/1/2014
193NDA/MAL/HDP/0368ROTEX MEDICA GBH ARZNEIMITTELIGITTOES PHARMACEUTICALS LIMITEDQUININE DI HYDROCHLORIDE INJECTIONQUININE DIHYDROCHLORIDE300MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/1997
194NDA/MAL/HDP/0369ABBOT LABORATORIES S.A. (PTY) LTDHARLEYS UGANDA LIMITEDKLACID 250MGCLARITHROMYCIN250MGABBOTT LABORATORIES S.A (PTY) LTD-ABBOTT PLACE,219 GOLF CLUB
TERRACE,CONSTANTIA KLOOF 1709 P.O BOX 7208 WELTEVREDENPARK 1715 |
SOUTH AFRICA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
195NDA/MAL/HDP/0370MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNEBILONG-HNEBIVOLOL + HYDROCHLOROTHIAZIDE5MG + 12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2010
196NDA/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

|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER,5.0X2.0X10.0 TABLET BLISTER7/1/2009
197NDA/MAL/HDP/0376EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-DAMLODIPINE + HYDROCHLOROTHIAZIDE2.5 MG + 12.5 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
198NDA/MAL/HDP/0385ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASFORMINMETFORMIN HYDROCHLORIDE500MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
199NDA/MAL/HDP/0386EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDLOMOH-80ENOXAPARIN SODIUM80MG/ 0.8MLEMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 |INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 ML PRE- FILLED SYRINGE7/1/2014
200NDA/MAL/HDP/0388KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAZUCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE STRIP,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/1997
201NDA/MAL/HDP/0389PT SANBE FARMAMEDVIN PHARMA LIMITEDSANMOL INFUSION IVPARACETAMOL1000MG/100MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2014
202NDA/MAL/HDP/0394LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDDOXYLEBDOXYCYCLINE100MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2014
203NDA/MAL/HDP/0397EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-LTAMLODIPINE + LOSARTAN POTASSIUM2.5 MG + 50 MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X3.0X10.0 TABLET BLISTER7/1/2013
204NDA/MAL/HDP/0400CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDIBSOL 1.2MESALAMINE DELAYED RELEASE1.2GMCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
205NDA/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 | INDIA |PARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2013
206NDA/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 | EGYPT |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN7/1/1997
207NDA/MAL/HDP/0405NEON LABARATORIES LTDAIVEEN (U) LIMITEDCHEMLETLETROZOLE2.5MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
208NDA/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 | INDIA |PARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2015
209NDA/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 | INDIA |PARENTERAL ORDINARY I V AMPOULES1.0X20.0 ML AMPOULE7/1/2013
210NDA/MAL/HDP/0408MSN LABORATORIES LTDMETRO PHARMACEUTICALS LIMITEDALGIC - PACECLOFENAC + PARACETAMOL100 MG + 500 MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
211NDA/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 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2013
212NDA/MAL/HDP/0410MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 20ROSUVASTATIN CALCIUM20MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
213NDA/MAL/HDP/0412MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDLDNIL 5ROSUVASTATIN CALCIUM5MGMSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
214NDA/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 | INDIA |PARENTERAL ORDINARY I V AMPOULES1.0X2.0X5.0X1.0 ML AMPOULE7/1/2013
215NDA/MAL/HDP/0415MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDRELEXDIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL14.03MG+138MG+57.03MG+0.90MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
216NDA/MAL/HDP/0418ASTRA ZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 5MG/1000SAXAGLIPTIN + METFORMIN5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA |UNITED STATES |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2013
217NDA/MAL/HDP/0419ASTRAZENECAMACNAUGHTON LIMITEDKOMBIGLYZE XR 2.5MG/1000MGSAXAGLIPTIN + METFORMIN2.5MG + 1000MGASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA |UNITED STATES |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
218NDA/MAL/HDP/0421MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDPREGASAFE 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
219NDA/MAL/HDP/0422GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPARAFLAMIBUPROFEN + PARACETAMOL100MG + 162.5MG /5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
220NDA/MAL/HDP/0423GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRAMTRAMADOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2013
221NDA/MAL/HDP/0424COSMOS LTDASTRA PHARMA (U) LIMITEDCHLORPROMAZINE TABLETS B.P 25MGCHLORPROMAZINE25MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/1998
222NDA/MAL/HDP/0427MICRO LABS LTDLABOREX UGANDA LIMITEDAMLOZAAR -HLOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE50MG + 5MG + 12.5MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
223NDA/MAL/HDP/0428MICRO LABS LTDLABOREX UGANDA LIMITEDMICROMOX-400MOXIFLOXACIN400MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2013
224NDA/MAL/HDP/0429ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDFLEXON MRIBUPROFEN + PARACETAMOL + CHLORZOXAZONE400MG + 325MG + 250MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
225NDA/MAL/HDP/0430ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO ACECLO PLUSACECLOFENAC+PARACETAMOL100MG+500MGARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X15.0X10.0 TABLET BLISTER7/1/2013
226NDA/MAL/HDP/0433PT SAMBE FARMAMEDVIN PHARMA LIMITEDPROANES MCT/LCTPROPOFOL1%W/VPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY I V AMPOULES1.0X5.0X20.0 ML AMPOULE7/1/2014
227NDA/MAL/HDP/0434LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDPROHIBINOMEPRAZOLE20MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP7/1/2010
228NDA/MAL/HDP/0436PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 130POLY (0-2-HYDROXYETHYL) STARCH30GPT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA | INDONESIA |PARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE7/1/2014
229NDA/MAL/HDP/0438PT SANBE FARMAMEDVIN PHARMA LIMITEDSANBE HEST 200POLY (0-2-HYDROXYETHYL) STARCHMW 200,000PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA | INDONESIA |PARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE7/1/2014
230NDA/MAL/HDP/0445AGIO PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDAZIAGIO 500AZITHROMYCIN500MGAGIO PHARMACEUTICALS LTD-PLOT NO. T-81, 82 MIDC, BHOSARI, PUNE-26 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2014
231NDA/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 | INDONESIA |PARENTERAL ORDINARY DRY VIALS1.0X125.0 MG VIAL + 1*2ML AMPOULE OF WFI7/1/2014
232NDA/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 | INDIA |ORAL SOLID ORDINARY GRANULES1.0X10.0X5.0 G SACHET7/1/2013
233NDA/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 | INDONESIA |PARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL + 1*8ML AMPOULE OF WFI7/1/2014
234NDA/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 | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE7/1/2013
235NDA/MAL/HDP/0454PT SANBE FARMAMEDVIN PHARMA LIMITEDLEVOCIN INFUSIONLEVOFLOXACIN HEMIHYDRATE500 MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2014
236NDA/MAL/HDP/0456LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDMETROLEBMETRONIDAZOLE125MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
237NDA/MAL/HDP/0457UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDUNIBROL 250MGAMINOSIDINE250MGUNIVERSAL CORPORATION LTD-UNIVERSAL CORPORATION LTD |KENYA |ORAL SOLID ORDINARY TABLETS1.0X2.0X6.0 TABLET BLISTER,1.0X4.0X6.0 TABLET BLISTER7/1/2012
238NDA/MAL/HDP/0460ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE7.5MG/MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X15.0 ML BOTTLE7/1/2009
239NDA/MAL/HDP/0463GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHENPHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2011
240NDA/MAL/HDP/0467DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTDCURAMOL PLUSPARACETAMOL/CAFFEINE500MG/60MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL SOLID ORDINARY TABLETS50.0X2.0 TABLET STRIP7/1/1997
241NDA/MAL/HDP/0470NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVOMIX 30 FLEXPENINSULIN ASPART100I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD |DENMARK |PARENTERAL ORDINARY DRY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN7/1/2014
242NDA/MAL/HDP/0471NOVO NORDISK PHARMA GULF FZ-LCPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNOVORAPID FLEXPENINSULIN ASPART100 I.U/MLNOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD |DENMARK |PARENTERAL ORDINARY PRE-FILLED PENS1.0X5.0X3.0 ML PREFILLED PEN7/1/2014
243NDA/MAL/HDP/0472SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDBCG VACCINE (FREEZE DRIED)BCG VACCINE(FREEZE DRIED)1.33*100000 C.F.U/0.1MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 ML VIAL,1.0X0.5 ML VIAL7/1/2015
244NDA/MAL/HDP/0475LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDTINI-500TINIDAZOLE500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X25.0X4.0 TABLET BLISTER7/1/2015
245NDA/MAL/HDP/0477LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMISTAT-4ONDANSETRON4MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
246NDA/MAL/HDP/0480CIPLA LTDQUALITY CHEMICALS LTD - HUMANEFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMERATE 600/300/300 MGEFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE600MG+300MG+300MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | CIPLA L.T.D -MIDC PATALGANGA MAHARASHTRA 410 220 | CIPLA LTD UNIT VII PD II-S-103 TO S-105, S-107 TO S-112, L-138, L-147/1 TO L-147/3, L-147A, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA 403722, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2014
247NDA/MAL/HDP/0482LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDAZILEB-500AZITHROMYCIN500MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X3.0 TABLET BLISTER7/1/2014
248NDA/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 | INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
249NDA/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 | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X28.0 TABLET BLISTER7/1/2014
250NDA/MAL/HDP/0489LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDCEBAY-200 DTCEFIXIME200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER7/1/2014
251NDA/MAL/HDP/0490SANOFILABOREX UGANDA LIMITEDORELOXCEFPODOXIME200MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPI?GNE
|
FRANCE |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
252NDA/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
|
UGANDA |OPHTHALMIC DROPS1.0X5.0 ML VIAL,1.0X10.0 ML VIAL7/1/2013
253NDA/MAL/HDP/0493MSN LABORATORIES PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDPRASUSAFE 10PRASUGREL10MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
254NDA/MAL/HDP/0496ADCOCK INGRAM LIMITEDUGANDA HEALTH MARKETING GROUP LIMITEDMYPRODOLPARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE250MG + 200MG + 10MGADCOCK INGRAM LIMITED -49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
255NDA/MAL/HDP/0497LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDKEMOXYL DRY SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
|
KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
256NDA/MAL/HDP/0502STEDMAN PHARMACEUTICALS LTDVEERAM HEALTHCARE (U) LIMITEDDREZ GARGLEIODINATED POVIDONE2%W/VSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
257NDA/MAL/HDP/0517SANOFI AVENTIS KENYA LTDLABOREX UGANDA LIMITEDSHANVAC -BR- DNA HEPATITIS -B SURFACE ANTIGEN PURIFIED20MCG/MLSHANTHA BIOTECHNICS LTD -SURVEY NO. 274, ATHVELLI VILLAGE, MEDCHAL MANDAL ? 501401, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X35.0X1.0 ML VIAL (1 ADULT DOSE),1.0X35.0X0.5 ML VIAL (1 PEDIATRIC DOSE)7/1/2015
258NDA/MAL/HDP/0518RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCYCLORENACICLOVIR200MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2006
259NDA/MAL/HDP/0521ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDPAN 40PANTOPRAZOLE SODIUM40MGALKEM LABORATORIES LTD .- VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESH |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2014
260NDA/MAL/HDP/0522MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDVAZORTAN 50LOSARTAN POTASSIUM50MGMEDLEY PHARMACEUTICALS LTD -PLOT NO. 18 AND 19, SURVEY NO. 378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM
, DAMAN-396 210, INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
261NDA/MAL/HDP/0526LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDAMILEB- 25AMITRIPTYLINE25MG LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA? 444 104 (MS).
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
262NDA/MAL/HDP/0528ABACUS PARENTERAL DRUGS LIMITEDABACUS PHARMA (AFRICA) LIMITEDCLARY 500CLARITHROMYCIN500MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
263NDA/MAL/HDP/0531LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDENDERM-GMCLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE0.05%W/W + 0.10%W/W + 2.0%W/WLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA |TOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE,1.0X15.0 G TUBE7/1/2014
264NDA/MAL/HDP/0532ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSARTAN-50LOSARTAN POTASSIUM50MGLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
265NDA/MAL/HDP/0533MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDTELKAST 5MONTELUKAST SODIUM5MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
266NDA/MAL/HDP/0538MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 180FEXOFENADINE HYDROCHLORIDE180 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
267NDA/MAL/HDP/0539MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIAKIMSY MEDS LTDTELKAST 4MONTELUKAST SODIUM4MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
268NDA/MAL/HDP/0540ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDHYDRICORTHYDROCORTISONE SODIUM SUCCINATE100MGLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X100.0 MG VIAL7/1/2014
269NDA/MAL/HDP/0541MICRO LABS LTDLABOREX UGANDA LIMITEDXONADINE 120FEXOFENADINE HYDROCHLORIDE120MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
270NDA/MAL/HDP/0542DAWA LIMITEDSUPER MEDIC LTDPHENBITALPHENOBARBITAL30MGDAWA LTD-BABA DOGO ROAD RUARAKA |KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
271NDA/MAL/HDP/0543UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 2GLIMEPIRIDE2MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
272NDA/MAL/HDP/0544MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN PLUSACECLOFENAC + PARACETAMOL100 MG + 500 MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
273NDA/MAL/HDP/0548UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICASTMONTELUKAST5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITY |JORDAN |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
274NDA/MAL/HDP/0549ABOTT LABORATORIES S.A (PTY) LTDHARLEYS UGANDA LIMITEDHIDRASECRACECADOTRIL100 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE | FRANCE |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/2014
275NDA/MAL/HDP/0550DAWA LIMITEDSUPER MEDIC LTDDA-ZEPAMDIAZEPAM5MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2014
276NDA/MAL/HDP/0551SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDREDAMOXAMOXICILLIN + CLAVULANIC ACID125 MG/ 5 ML + 31.25 MG/ 5 MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
277NDA/MAL/HDP/0552ABOTT LABORATORIES S.A (PTY) LIMITEDHARLEYS UGANDA LIMITEDHIDRASEC INFANTSRACECADOTRIL10 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE | FRANCE |ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X16.0 SACHET CARTON7/1/2014
278NDA/MAL/HDP/0553BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDEQUIRABRABIES ANTISERUM1000IU/ 5MLBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
|
INDIA |PARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL (5 DOSE VIAL)7/1/2013
279NDA/MAL/HDP/0555HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCARZEPINCARBAMAZEPINE200MGHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
280NDA/MAL/HDP/0556ABOTT LABORATORIES S.A (PTY) LTDHARLEYS UGANDA LIMITEDHIDRASEC CHILDRENRACECADOTRIL30 MGLABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE | FRANCE |ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X30.0 SACHET CARTON7/1/2014
281NDA/MAL/HDP/0557SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDREDAMOX 312.5AMOXICILLIN + POTASSIUM CLAVULANATE250 MG/5 ML + 62.5 MG/5 MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2013
282NDA/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. | UGANDA |OPHTHALMIC DROPS1.0X10.0 ML BOTTLE7/1/2014
283NDA/MAL/HDP/0559HOVID BHDMEDICAL ACCESS (UGANDA) LIMITEDDIABETMIN RETARDMETFORMIN HYDROCHLORIDE850MGHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA |ORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
284NDA/MAL/HDP/0560UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDGLIMERYL 1GLIMEPIRIDE1MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITY |JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
285NDA/MAL/HDP/0563IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDEZO 40ESOMEPRAZOLE MAGNESIUM40MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA |ORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
286NDA/MAL/HDP/0566SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTIL SUSPENSIONCEFUROXIME AXETIL125MG/5MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X1.0X50.0 ML BOTTLE7/1/2013
287NDA/MAL/HDP/0567KOTRA PHARMA SDN BDNABACUS PHARMA (AFRICA) LIMITEDVAXCEL CEFTRIAZONE 500MGCEFTRIAXONE500MGKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA |PARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2013
288NDA/MAL/HDP/0568RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDFLUOXIRENFLUOXETINE20MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
289NDA/MAL/HDP/0569KOTRA PHARMA SDN BDNABACUS PHARMA (AFRICA) LIMITEDAXCELLRIDIN LINCTUSPHOLCODINE10MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL LIQUID ORDINARY SYRUPS1.0X90.0 ML BOTTLE7/1/2014
290NDA/MAL/HDP/0570BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDTETGLOB 250 I.UHUMAN TETANUS IMMUNOGLOBULIN250IUBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
|
INDIA |PARENTERAL ORDINARY I M VIALS1.0X1.0X2.0 ML VIAL (1 DOSE VIAL)7/1/2013
291NDA/MAL/HDP/0571KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL KAOPECLIGHT KAOLIN + PECTIN (CITRUS)1G + 20MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X120.0 ML BOTTLE7/1/2015
292NDA/MAL/HDP/0572NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDAZARGABRINZOLAMIDE + TIMOLOL10MG/ML + 5MG/MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM |OPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/2010
293NDA/MAL/HDP/0573KOTRA PHARMA (M) SDN,BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL PARACETAMOL-250PARACETAMOL250MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2014
294NDA/MAL/HDP/0574IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE TABLETS 100/270ARTESUNATE AND AMODIAQUINE100MG+270MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER7/1/2013
295NDA/MAL/HDP/0576GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDDUODARTDUTASTERIDE + TAMSULOSIN0.5MG + 0.4MGCATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY | GERMANY |ORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE CONTAINER7/1/2015
296NDA/MAL/HDP/0577TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDXYKAA EXTENDEDPARACETAMOL650MGTROIKAA PHARMACUETICALS LIMITED-C-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIA | INDIA |ORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
297NDA/MAL/HDP/0580KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFLUCAPMULTINGREDIENTMULTINGREDIENTKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
298NDA/MAL/HDP/0582ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDACECLO SERAACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE100MG + 500MG + 15MGARISTO PHARMACEUTICALS PVT LTD-VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2015
299NDA/MAL/HDP/0584ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 1GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE1MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
300NDA/MAL/HDP/0586CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETTONDANSETRON2MG/MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE7/1/2013
301NDA/MAL/HDP/0587CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CADIGRELCLOPIDOGREL75MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
302NDA/MAL/HDP/0588AUROLABSWASTIK PHARMACEUTICAL LTDAUROFORTPREDNISOLONE ACETATE1%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIA | INDIA |OPHTHALMIC SUSPENSIONS1.0X5.0 ML BOTTLE7/1/2013
303NDA/MAL/HDP/0589ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDTRIGLIMIPREX 2GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE2MG+15MG+500MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
304NDA/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
|
INDIA |PARENTERAL ORDINARY VIALS1.0X1.0X10.0 ML VIAL7/1/2012
305NDA/MAL/HDP/0592AUROLABSWASTIK PHARMACEUTICAL LTDAUROCHROMECROMOLYN SODIUM2%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIA | INDIA |OPHTHALMIC LIQUIDS1.0X10.0 ML CONTAINER7/1/2013
306NDA/MAL/HDP/0593ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDPANTOP-DPANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES20MG+10MGARISTO PHARMACEUTICALS PVT LTD .-MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESH |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP7/1/2014
307NDA/MAL/HDP/0594AUROLABSWASTIK PHARMACEUTICAL LTDAUROVISC-2ML PFSHYPROMELLOSE OPHTHALMIC SOLUTION USP2%W/VAUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA | INDIA |OPHTHALMIC PRE-FILLED SYRINGES1.0X2.0 ML PRE- FILLED SYRINGE7/1/2013
308NDA/MAL/HDP/0595ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNOFORNIDAZOLE + OFLOXACIN500MG + 200MGARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2015
309NDA/MAL/HDP/0596MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-HTELMISARTAN/HYDROCHLOROTHIAZIDE40MG/12.5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2011
310NDA/MAL/HDP/0598INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLIPICURE-20ATORVASTATIN20MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2003
311NDA/MAL/HDP/0599MICRO LABS LIMITEDLABOREX UGANDA LIMITEDGRAMOCEF-O-400CEFIXIME400MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
312NDA/MAL/HDP/0600DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 6.25CARVEDILOL6.25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
313NDA/MAL/HDP/0603MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDGROMIN SYRUPMULTI-INGREDIENTMULTI-INGREDIENTMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/1999
314NDA/MAL/HDP/0604DAWA PHARMACEUTICALS LIMITEDSUPER MEDIC LTD-MBARARATRIMOXOLCO-TRIMOXAZOLE480MGDAWA LIMITED -16633-00620, RUARAKA, BABA DOGO ROAD, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/1997
315NDA/MAL/HDP/0605DENK PHARM GMBH&CO.KGBENLE CONSULT LIMITEDCARVEDI-DENK 25CARVEDILOL25MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
316NDA/MAL/HDP/0608CIPLA LTDQUALITY CHEMICALS LTD - HUMANLOPINAVIR AND RITONAVIR TABLETS 200MG/50MGLOPINAVIR + RITONAVIR200MG + 50MGCIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X120.0 TABLET BOTTLE7/1/2012
317NDA/MAL/HDP/0609DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDCLOPI-DENK 75CLOPIDOGREL BESYLATE75MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
318NDA/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 | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2014
319NDA/MAL/HDP/0611GALPHAR LABORATORIES LTDAIVEEN (U) LIMITEDGALCIPRO 500CIPROFLOXACIN HYDROCHLORIDE500MGGALPHA LABORATORIES LIMITED-VILLAGE ? THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
320NDA/MAL/HDP/0614GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID126 MG/ 5 ML + 31.25 MG/ 5 MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1998
321NDA/MAL/HDP/0615HETERO LABS LTDAIVEEN (U) LIMITEDVALSAR 80VALSARTAN80MGHETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
322NDA/MAL/HDP/0617ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDSILVEXSILVER SULFADIAZINE + CHLORHEXIDINE1%W/W + 0.2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
323NDA/MAL/HDP/0618HETERO LABS LTDAIVEEN (U) LIMITEDVALSAR 160VALSARTAN160MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
324NDA/MAL/HDP/0619ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDD10GLUCOSE10%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
|
UGANDA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2013
325NDA/MAL/HDP/0621HETERO LABS LTDAIVEEN (U) LIMITEDALZERDONEPEZIL HYDROCHLORIDE10MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
326NDA/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 | INDIA |PARENTERAL 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
327NDA/MAL/HDP/0625SANOFI PASTEURLABOREX UGANDA LIMITEDVERORABRABIES VACCINE1 DOSESANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE | FRANCE |PARENTERAL 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
328NDA/MAL/HDP/0626KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCARDIPAC-10AMLODIPINE BESILATE10MGKPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0X10.0 TABLET BLISTER7/1/2015
329NDA/MAL/HDP/0627KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDAMOXIKIDAMOXICILLIN TRIHYDRATE125MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2015
330NDA/MAL/HDP/0630CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDNEO LORIDINDESLORATADINE5MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2011
331NDA/MAL/HDP/0633ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIPROCINCIPROFLOXACIN0.3%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
|
UGANDA |OPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2013
332NDA/MAL/HDP/0634MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDTRISOLIVANDROGRAPHOLIDES/TRICHOLINE CITRATE50MCG+50MG/MLMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2014
333NDA/MAL/HDP/0635GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-AMINAMINOPHYLLINE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2009
334NDA/MAL/HDP/0636MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDREVOKE-1.5LEVONORGESTREL1.5MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER7/1/2014
335NDA/MAL/HDP/0637NABIQASIM INDUSTRIES (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDZUDICORTFUSIDIC ACID + BETAMETHASONE VALERATE20MG + 1MG/GNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
336NDA/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
|
UGANDA |OPHTHALMIC DROPS1.0X10.0 ML VIAL7/1/2013
337NDA/MAL/HDP/0639NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDRHEUMATIC CREAMMULTI-INGREDIENTMULTI-INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
338NDA/MAL/HDP/0641ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDGYNAZOLECLOTRIMAZOLE2%W/WLINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |TOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/2014
339NDA/MAL/HDP/0643NAARI AGECHO PHARMACY (U) LIMITEDMISOPROMISOPROSTOL200MCGNAARI PHARMA PRIVATE LIMITED-PLOT NO. 14-16, 55-57, SECTOR-5, IIE, PANT NAGAR RUDRAPUR-263153 DIST-U.S. NAGAR UTTARAKHAND | ARGENTINA |ORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER,25.0X1.0X4.0 TABLET BLISTER7/1/2013
340NDA/MAL/HDP/0652NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUSVILDAGLIPTIN50MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | NOVARTIS BARBERA -SPAIN |SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2014
341NDA/MAL/HDP/0654NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG/500MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER7/1/2013
342NDA/MAL/HDP/0657NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN / METFORMIN50MG / 850MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER7/1/2013
343NDA/MAL/HDP/0658NVS KENYA LTDSURGIPHARM (U) LIMITEDGALVUS METVILDAGLIPTIN/ METFORMIN50MG/1000MGNORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER7/1/2013
344NDA/MAL/HDP/0665HETERO LABS LTDAIVEEN (U) LIMITEDIRBIS 150IRBESARTAN150MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
345NDA/MAL/HDP/0666HETERO LABS LTDAIVEEN (U) LIMITEDIRBIS-H 300IRBESARTAN300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2013
346NDA/MAL/HDP/0667KOTRA PHARMA (M) SDN,BHDABACUS PHARMA (AFRICA) LIMITEDAXEL MICONAZOLEMICONAZOLE NITRATE2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/2013
347NDA/MAL/HDP/0668CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TELI 40TELMISARTAN40MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
348NDA/MAL/HDP/0669KOTRA PHARMA (M) SDN,BHDABACUS PHARMA (AFRICA) LIMITEDAXEL FUNGICORT CREAMMICONAZOLE NITRATE + HYDROCORTISONE2% W/W + 1% W/WKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/2013
349NDA/MAL/HDP/0670GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFLUNAZ-200FLUCONAZOLE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER7/1/2014
350NDA/MAL/HDP/0671KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL LIGNOCAINELIDOCAINE2%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE7/1/2014
351NDA/MAL/HDP/0672GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONOR TABLETSNORFLOXACIN400MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/2013
352NDA/MAL/HDP/0673MIRACLE CENTRE KAWEMPEKARURI PHARMACEUTICALS LTD.ONSETT 8ONDANSETRON8MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
353NDA/MAL/HDP/0674GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODAPS-100DAPSONE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2013
354NDA/MAL/HDP/0675KOTRA PHARMA (M) SDN,BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL METRONIDAZOLE 400METRONIDAZOLE400MGKOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
|
MALAYSIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
355NDA/MAL/HDP/0676CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.ONSETT 4ONDANSETRON4MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
356NDA/MAL/HDP/0677GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDOPAMETMETHYLDOPA250MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
357NDA/MAL/HDP/0678KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL HYDROCORTISONE CREAMHYDROCORTISONE1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/2014
358NDA/MAL/HDP/0679GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMEFENA-250 CAPSULESMEFENAMIC ACID250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2013
359NDA/MAL/HDP/0681GENNOVA BIOPHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDELAXIM 40TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR)40MG/VIALEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057 |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI7/1/2013
360NDA/MAL/HDP/0684TROGE MEDICAL GMBHECHO PHARMACY (U) LIMITEDTRO-CEFTRIAX 1GCEFTRIAXONE1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 1X5ML WFI AMPOULE7/1/2014
361NDA/MAL/HDP/0685FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN |PARENTERAL RETARD I M AMPOULES1.0X5.0X4.0 ML AMPOULE7/1/2015
362NDA/MAL/HDP/0687FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDSOMAZINACITICOLINE1000MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN |ORAL LIQUID ORDINARY LIQUIDS1.0X6.0X10.0 ML SACHET7/1/2015
363NDA/MAL/HDP/0688GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHBBHYOSCINE BUTYLBROMIDE10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
364NDA/MAL/HDP/0689GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONALNALIDIXIC ACID500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
365NDA/MAL/HDP/0690MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHEALTHEASE CREAMBECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/2014
366NDA/MAL/HDP/0691MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDOLMAT-20OLMESARTAN MEDOXOMIL20 MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
367NDA/MAL/HDP/0692DAWA LIMITEDSUPER MEDIC LTDDAWACLOX -250CLOXACILLIN SODIUM250MGDAWA LIMITED -BABA DOGO RWARAKA |KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2015
368NDA/MAL/HDP/0693DAWA LIMITEDSUPER MEDIC LTDMOXACIL -250AMOXYCILLIN TRIHYDRATE250MGDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2014
369NDA/MAL/HDP/0694GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDDT ZINC-20 TABLETSZINC SULPHATE20MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON7/1/2013
370NDA/MAL/HDP/0698ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID+SALICYLIC CID6%W/W + 3%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/2003
371NDA/MAL/HDP/0700CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDVAXIRAB NINACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN)>2.5 I.UCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA |PARENTERAL ORDINARY VIALS1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL)7/1/2015
372NDA/MAL/HDP/0702ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDSEPTOCINSTREPTOMYCIN SULPHATE1GMREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL7/1/2014
373NDA/MAL/HDP/0703GOOD DAY PHARMACY LIMITEDPLANET PHARMACEUTICALS UGANDA LTDDICLODAY GELDICLOFENAC DIETHYLAMINE+ LINSEED OIL+ METHYL SALICYLATE +MENTHOL11.6MG + 30MG + 100MG + 50MGKREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 |INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE7/1/2013
374NDA/MAL/HDP/0704HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDM-FLOXMOXIFLOXACIN HYDROCHLORIDE400MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | HETERO LABS LTD-UNIT II & III BADDI THE NALAGARH DIST SOLAN H.P | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X5.0 TABLET BLISTER7/1/2013
375NDA/MAL/HDP/0705LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDACICLOVIRACICLOVIR5%W/WLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2011
376NDA/MAL/HDP/0706INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 5ROSUVASTATIN5MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
377NDA/MAL/HDP/0707HETERO LABS LTDAIVEEN (U) LIMITEDPENVIR 500FAMCICLOVIR500MGHETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
378NDA/MAL/HDP/0710INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDROVAS 20ROSUVASTATIN20MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
379NDA/MAL/HDP/0712GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDZENTELALBENDAZOLE100MG/5MLFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCE |FRANCE |ORAL LIQUID ORDINARY SUSPENSIONS1.0X20.0 ML BOTTLE7/1/1997
380NDA/MAL/HDP/0713DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 20PANTOPRAZOLE SODIUM SESQUIHYDRATE20MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | GERMANY |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2015
381NDA/MAL/HDP/0715DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDPANTO-DENK 40PANTOPRAZOLE SODIUM SESQUIHYDRATE40MGADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | GERMANY |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2015
382NDA/MAL/HDP/0716LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-1GLIMEPIRIDE+METFORMIN HYDROCHLORIDE1MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2014
383NDA/MAL/HDP/0718LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDGLYMET-2GLIMEPIRIDE+METFORMIN HYDROCHLORIDE2MG + 500MGLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER7/1/2014
384NDA/MAL/HDP/0719WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 4000RECOMBINANT HUMAN ERYTHROPOIETIN4000 I.UWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.4 ML PRE- FILLED SYRINGE7/1/2011
385NDA/MAL/HDP/0720STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDJUSDEE 400 DROPSCOLECALCIFEROL400 I.U/MLSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA |ORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE7/1/2013
386NDA/MAL/HDP/0721MISSION PHARMAMETRO PHARMACEUTICALS LIMITEDARH-AARTEMETHER80MG/MLLINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA |PARENTERAL ORDINARY I M AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE7/1/2014
387NDA/MAL/HDP/0722FDC LTDAIVEEN (U) LIMITEDIOTIM 0.5%TIMOLOL MALEATE0.5% W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA |OPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/2014
388NDA/MAL/HDP/0726TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT DOL RAPIDTRAMADOL HYDROCHLORIDE50MGTROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND |INDIA |ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2014
389NDA/MAL/HDP/0727MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDSTOMACH FIT SYRUPBISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL140MG+9MG+0.15MG+0.2/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X225.0 ML BOTTLE7/1/2013
390NDA/MAL/HDP/0728IPCA LABORATOIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 25/67.5ARTESUNATE+AMODIAQUINE25MG+67.5MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
391NDA/MAL/HDP/0731IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDARTESUNATE AND AMODIAQUINE 50/135ARTESUNATE + AMODIAQUINE50/135MGIPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
392NDA/MAL/HDP/0732ANHIUMAISHA MEDICAL SUPPLIES LIMITEDVOLTAMED-100DICLOFENAC100 MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
393NDA/MAL/HDP/0733CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDZYNACACECLOFENAC100MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
394NDA/MAL/HDP/0737SANOFI AVENTISLABOREX UGANDA LIMITEDTAXOTERE 80MGDOCETAXEL TRIHYDRATE80MG/4MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
|
GERMANY |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X4.0 ML VIAL7/1/2014
395NDA/MAL/HDP/0739SANOFI AVENTISLABOREX UGANDA LIMITEDTAXOTERE 20MGDOCETAXEL TRIHYDRATE20MG/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOESCHST,BRUNINGSTRASSEN BUIDING,H65065926, FRANKFURT AM MAIN | GERMANY |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X1.0 ML VIAL7/1/2014
396NDA/MAL/HDP/0745CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TELI 80TELMISARTAN80MGB. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
397NDA/MAL/HDP/0746COSMOS LTDASTRA PHARMA (U) LIMITEDDTS-Z KITTABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSETABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75GCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
|
KENYA |ORAL LIQUID ORDINARY UNIT DOSE POWDERS1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER7/1/2013
398NDA/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.
|
UGANDA |ORAL LIQUID ORDINARY OTHER SOLID SPECIAL FORMS1.0X20.8 G SACHET + 60 ML BOTTLE7/1/2013
399NDA/MAL/HDP/0748BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 15MGRIVAROXABAN15MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER7/1/2013
400NDA/MAL/HDP/0749AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 1000MEROPENEM1000MGAURONEXT PHARMA PVT LTD.-A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADI | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2014
401NDA/MAL/HDP/0750BAYER PHARMASURGIPHARM (U) LIMITEDXARELTO 20MGRIVAROXABAN20MGBAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER7/1/2013
402NDA/MAL/HDP/0751MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWINACECLOFENAC100MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
403NDA/MAL/HDP/0753AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDMEROGRAM 500MEROPENEM500MGAURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2014
404NDA/MAL/HDP/0754DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDTORAS DENK 10TORASEMIDE10MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2015
405NDA/MAL/HDP/0755TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDT- DOLTRAMADOL HYDROCHLORIDE50MG/MLTROIKAA PHARMACEUTICALS LIMITED..-THOL, DIST MEHSANA PIN 382728, GUJARAT | INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE7/1/2014
406NDA/MAL/HDP/0756CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 100TOLPERISONE100MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
407NDA/MAL/HDP/0757CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTOLFREE 150TOLPERISONE150MGCADILA HEALTHCARE LIMITED -KUNDAIM INDUSTRIAL ESTATE,PLOT NO.203-213, KUNDAIM GOA, 403115, | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
408NDA/MAL/HDP/0759MICRO LABS LTDPHARMA VILLE LIMITEDCOTRIMOXAZOLECOTRIMOXAZOLE960MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2011
409NDA/MAL/HDP/0764UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDCORVADIL 5AMLODIPINE5MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2011
410NDA/MAL/HDP/0765PHARM ACCESS AFRICA LTDUNITED HEALTHCARE DISTRIBUTORS LTDLEVOPLANTLEVONORGESTREL75MGSHANGHAI DAHUA PHARMACEUTICAL CO. LTD-CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAI | CHINA |PARENTERAL RETARD IMPLANTS1.0X10.0X2.0 ROD IMPLANT7/1/2010
411NDA/MAL/HDP/0768FDC LTDAIVEEN (U) LIMITEDPYRIMON EYE DROPDEXAMETHASONE/CHLORAMPHENICOL1%W/V + 0.1%W/VFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA |OPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/1999
412NDA/MAL/HDP/0772MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 150PREGABALIN150MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
413NDA/MAL/HDP/0775MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDLIGABA - 75PREGABALIN75MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2014
414NDA/MAL/HDP/0776FREDUN PHARMACEUTICALS LTDPLANET PHARMACEUTICALS UGANDA LTDFREMOL TABLETSPARACETAMOL TABLETS500MGFREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1999
415NDA/MAL/HDP/0780CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDATORVA TABLETSATORVASTATIN10MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X1.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2001
416NDA/MAL/HDP/0781TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRICOLDPARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE/CAFFEINE ANHYDROUS/CHLORPHENIRAMINE500MG/10MG/30MG/2MGTRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER7/1/2013
417NDA/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 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X50.0 TABLET BLISTER7/1/2013
418NDA/MAL/HDP/0784COSMOS LTDASTRA PHARMA (U) LIMITEDHEMOSANFERROUS FUMERATE300MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
|
KENYA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
419NDA/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 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
420NDA/MAL/HDP/0795GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPEN-250PHENOXYMETHYL PENICILLIN POTASSIUM250MGMILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI) | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
421NDA/MAL/HDP/0796HETERO LABS LTDAIVEEN (U) LIMITEDAMLO-H 5AMLODIPINE BESILATE5MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
422NDA/MAL/HDP/0797NVS KENYA LTDSURGIPHARM (U) LIMITEDAFINITOR 5MGEVEROLIMUS5MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER7/1/2015
423NDA/MAL/HDP/0798HETERO LABS LTDAIVEEN (U) LIMITEDAMLOSIN 10AMLODIPINE BESILATE10MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
424NDA/MAL/HDP/0799NVS KENYA LTDSURGIPHARM (U) LIMITEDAFINITOR 10MGEVEROLIMUS10MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER7/1/2015
425NDA/MAL/HDP/0802NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDEXFORGE HCT 5MG/ 160MG/12.5MGAMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE5MG+ 160MG+ 12.5MGNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SWITZERLAND |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2015
426NDA/MAL/HDP/0808PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDISOFLURANEISOFLURANE250MLPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH | INDIA |OTHER SYSTEMIC LIQUID INHALATIONS1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2005
427NDA/MAL/HDP/0809BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDPARAPAEDPARACETAMOL120MG/5MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND | IRELAND |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
428NDA/MAL/HDP/0811MICRO LABS LIMITEDLABOREX UGANDA LIMITEDDOLOWIN -SRACECLOFENAC200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
429NDA/MAL/HDP/0812BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDFENPAEDIBUPROFEN100MG/5MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND | IRELAND |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
430NDA/MAL/HDP/0816DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 2GLIMEPIRIDE2MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING |GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
431NDA/MAL/HDP/0820MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFIXIME 400MGCEFIXIME400MGNKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA | SOUTH AFRICA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2015
432NDA/MAL/HDP/0821DENK PARMA GMBH & CO. KGBENLE CONSULT LIMITEDGLIMEPIRIDE DENK 3GLIMEPIRIDE3MGDENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING |GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
433NDA/MAL/HDP/0822ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLOXCIN-500CLOXACILLIN SODIUM500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X0.5 G VIAL7/1/2014
434NDA/MAL/HDP/0823CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDTRAP TABLETSTRAMADOL HCL + PARACETAMOL37.5MG+325MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
435NDA/MAL/HDP/0824I CARE PHARMA LIMITEDVITACARE LTDCLOXACILLINCLOXACILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2013
436NDA/MAL/HDP/0826I CARE PHARMA LIMITEDVITACARE LTDAMOXYCILLINAMOXYCILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2013
437NDA/MAL/HDP/0830MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 25 MCGLEVOTHYROXINE SODIUM25 MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER7/1/2015
438NDA/MAL/HDP/0831I CARE PHARMA LIMITEDVITACARE LTDAMPICILLIN CAPSULESAMPICILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA |ORAL SOLID ORDINARY OTHER CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2013
439NDA/MAL/HDP/0832MERCKUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 100MCGLEVOTHYROXINE100MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER7/1/2015
440NDA/MAL/HDP/0834LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDVOMI-6DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE10MG + 10MGLINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARAT |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2013
441NDA/MAL/HDP/0835GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBISBISACODYL5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
442NDA/MAL/HDP/0836LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDCALBONE-500CALCIUM CARBONATE + COLECALCIFEROL1250MG + 250 I.ULINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2012
443NDA/MAL/HDP/0842LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSACSECNIDAZOLE1000MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X2.0 TABLET BLISTER7/1/2013
444NDA/MAL/HDP/0846MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMOXIMACMOXIFLOXACIN400MGMACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2014
445NDA/MAL/HDP/0848MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDMACROZIDE 500PYRAZINAMIDE500MGMACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2014
446NDA/MAL/HDP/0850LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDLCT KITLANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE30MG + 250MG + 500MGLINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2012
447NDA/MAL/HDP/0853RANBAXY LABORATORIES LTD GOASTAR PHARMACEUTICALS LTDBRUSTAN GELIBUPROFEN + LEVOMENTHOL5% W/W+ 3%W/WRANBAXY LABORATORIES LTD GOA-NO.2 MADKAI INDUSTRIAL ESTATE GOA 403 404 |INDIA |TOPICAL EXTERNAL LOTIONS1.0X50.0 G CONTAINER7/1/2012
448NDA/MAL/HDP/0855HETERO LABS LTDAIVEEN (U) LIMITEDLAZINELEVOCETIRIZINE DIHYDROCHLORIDE5MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/2013
449NDA/MAL/HDP/0858ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE5MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2001
450NDA/MAL/HDP/0860MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDFLOXSAFE 400MOXIFLOXACIN HYDROCHLORIDE400MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0 TABLET BLISTER7/1/2012
451NDA/MAL/HDP/0861SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDPROZINEPROMETHAZINE25MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES2.0X5.0X2.0 ML AMPOULE7/1/2013
452NDA/MAL/HDP/0864HETERO LABS LTD UNIT IXAIVEEN (U) LIMITEDPANTIN-40PANTOPRAZOLE SODIUM40 MGHETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301 | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
453NDA/MAL/HDP/0866GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLIDLINEZOLID2MG/MLAMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2013
454NDA/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 | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
455NDA/MAL/HDP/0868SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDVARMIKA-500AMIKACIN500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X2.0X5.0X2.0 ML AMPOULE7/1/2013
456NDA/MAL/HDP/0869SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDLARTRMARTEMETHER80MG/MLSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA |PARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE7/1/2013
457NDA/MAL/HDP/0870TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROY-KPHYTOMENADIONE10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2010
458NDA/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 | INDIA |PARENTERAL ORDINARY DRY VIALS2.0X6.0X2.0 ML VIAL7/1/2013
459NDA/MAL/HDP/0873GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDOXYTOCIN INJECTIONOXYTOCIN10I.U/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
460NDA/MAL/HDP/0874LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLEBASMA-4SALBUTAMOL4MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
461NDA/MAL/HDP/0877LEBEN LABORATORIES LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT DS GEL MINT FLAVOURDRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X170.0 ML BOTTLE7/1/2007
462NDA/MAL/HDP/0879COSMOS LTD.ASTRA PHARMA (U) LIMITEDTRIBEES FORTE FILM COATED TABLETSTHIAMINE + PYRIDOXINE + CYANOCOBALAMIN200MG + 50MG +1000MCGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
|
KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2012
463NDA/MAL/HDP/0882MERCKUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/2.5MGMETFORMIN + GLIBENCLAMIDE500MG + 2.5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY |FRANCE |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER7/1/2012
464NDA/MAL/HDP/0883MERCKUNITED HEALTHCARE DISTRIBUTORS LTDGLUCOVANCE 500MG/5MGMETFORMIN + GLIBENCLAMIDE500MG + 5MGMERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY |FRANCE |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER7/1/2012
465NDA/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. | UGANDA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE7/1/2012
466NDA/MAL/HDP/0892ASTRA ZENECAMACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN2.5MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620
USA |
UNITED STATES |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
467NDA/MAL/HDP/0894HETERO LABS LTDAIVEEN (U) LIMITEDGIAGRA 100SILDENAFIL CITRATE100MGHETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),
JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER7/1/2014
468NDA/MAL/HDP/0895VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHYORTHSODIUM HYALURONATE10MG/1MLVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X2.0 ML PRE- FILLED SYRINGE7/1/2015
469NDA/MAL/HDP/0897VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDDEBRIDACEPAPAIN + UREA521700UNITS+100MG/GVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2015
470NDA/MAL/HDP/0899VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDVIRIAXONECEFTRIAXONE1GINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML VIAL WFI7/1/2013
471NDA/MAL/HDP/0902GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPINE SRNIFEDIPINE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
472NDA/MAL/HDP/0904ASTRA ZENECAMACNAUGHTON LIMITEDONGLYZASAXAGLIPTIN5MGBRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620
USA | ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, |
UNITED STATES |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
473NDA/MAL/HDP/0905NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECPODCEFPODOXIME PROXETIL200MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
474NDA/MAL/HDP/0906VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDIONSILSILVER NITRATE0.2%W/WVIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2015
475NDA/MAL/HDP/0907NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDCEFUAXITCEFUROXIME AXETIL250MGNECTAR LIFE SCIENCES LTD--UNIT VI BHATOLIKALAN DIST SOLAN H.P |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP7/1/2013
476NDA/MAL/HDP/0909NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDFIXINECTCEFIXIME100MGNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET STRIP7/1/2013
477NDA/MAL/HDP/0911VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDHEALACERECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B100MCG/GVIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X15.0 G TUBE7/1/2015
478NDA/MAL/HDP/0913NOVARTIS PHARMASURGIPHARM (U) LIMITEDFEMARALETROZOLE2.5MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
479NDA/MAL/HDP/0914VIRCHOW HEALTHCARE PVT LTDSURGIPHARM (U) LIMITEDOSTEOTIDETERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION250MCG/MLVIRCHOW BIOTECH PVT LTD -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT ANDHRA PRADESH | INDIA |PARENTERAL ORDINARY VIALS1.0X3.0 ML VIAL7/1/2015
480NDA/MAL/HDP/0920TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY HEAVYBUPIVACAINE HYDROCHLORIDE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X5.0X4.0 ML VIAL7/1/2012
481NDA/MAL/HDP/0926MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-375AMOXICILLIN +CLAVULANATE POTASSIUM250MG + 125MGMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP7/1/2004
482NDA/MAL/HDP/0928AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDINSTACLOP 75CLOPIDOGREL75MGAJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
483NDA/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.
|
INDIA |ORAL SOLID ORDINARY TABLETS10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER7/1/2012
484NDA/MAL/HDP/0931LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH JUNIORALPHA-BETA ARTEETHER75MG/MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X3.0X1.0 ML AMPOULE7/1/2012
485NDA/MAL/HDP/0934CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDODIMONT 4MONTELUKAST4MGCADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210 |INDIA |ORAL SOLID ORDINARY CHEWABLE COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
486NDA/MAL/HDP/0938FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 20MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS20MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER7/1/2013
487NDA/MAL/HDP/0939LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARHALPHA -BETA ARTEETHER150MG /2MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X3.0X2.0 ML AMPOULE7/1/2012
488NDA/MAL/HDP/0940FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDESOMEGA 40MGESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS40MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X7.0 CAPSULE BLISTER7/1/2013
489NDA/MAL/HDP/0941AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHAAZITHROMYCIN200MG/5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X15.0 ML BOTTLE7/1/2013
490NDA/MAL/HDP/0942LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDARH FORTEALPHA -BETA ARTEETHER225MG/ 3MLSAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X3.0X3.0 ML AMPOULE7/1/2012
491NDA/MAL/HDP/0946ASTRAZENECAMACNAUGHTON LIMITEDTENORETICATENOLOL + CHLORTHALIDONE100 MG + 25 MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER7/1/1997
492NDA/MAL/HDP/0948COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINA SYRUP 5MG/5MLLORATADINE5MG/5MLCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE7/1/2013
493NDA/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 | INDIA |PARENTERAL ORDINARY S C AMPOULES1.0X5.0X2.0 ML AMPOULE7/1/2013
494NDA/MAL/HDP/0952NEON LABARATORIES LTDAIVEEN (U) LIMITEDEFECATALCEFTRIAXONE1GNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2013
495NDA/MAL/HDP/0953NEON LABARATORIES LTDAIVEEN (U) LIMITEDCIZCANCISPLATIN10MG/10MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL7/1/2013
496NDA/MAL/HDP/0954NEON LABARATORIES LTDAIVEEN (U) LIMITEDANAWINBUPIVACAINE50MG/20MLNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL RETARD OTHER VIALS1.0X20.0 ML VIAL7/1/2013
497NDA/MAL/HDP/0957MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDLYRED SYRUPVITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC2500 IU + 10 IU + 50MG + 35MCG + 3MGTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2012
498NDA/MAL/HDP/0959AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDARTEFAN DISPERSIBLE 20/120ARTEMETHER + LUMEFANTRINE20MG + 120MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER7/1/2013
499NDA/MAL/HDP/0963AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMODARTESUNATE+AMODIAQUINE50MG+135MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD |INDIA |ORAL SOLID ORDINARY LAYERED TABLETS1.0X3.0 TABLET BLISTER7/1/2013
500NDA/MAL/HDP/0964AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPMOD 25 / 67.5ARTESUNATE + AMODIAQUINE25 MG + 67.5 MGAJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD |INDIA |ORAL SOLID ORDINARY LAYERED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2013
501NDA/MAL/HDP/0969EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-2.5AMLODIPINE BESILATE2.5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2005
502NDA/MAL/HDP/0972PHARCO PHARMACEUTICALS COMPANY LTDECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN DIHYDRATE200 MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
|
EGYPT |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE7/1/2013
503NDA/MAL/HDP/0975PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDCETRAK SYRUPCETIRIZINE DIHYDROCHLORIDE5MG/5MLPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
|
EGYPT |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2013
504NDA/MAL/HDP/0980PHARCO PHARMACEUTICALSECHO PHARMACY (U) LIMITEDAZOMYCINAZITHROMYCIN250MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
|
EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2013
505NDA/MAL/HDP/0981HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCLOFENAC SR TABLETSDICLOFENAC SODIUM100MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2008
506NDA/MAL/HDP/0982ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASMETO-10METOCLOPRAMIDE10MGASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA |ORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2014
507NDA/MAL/HDP/0984CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.JOVAN T20TADALAFIL20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
508NDA/MAL/HDP/0986EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
509NDA/MAL/HDP/0988CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CADITOR 20ATORVASTATIN20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
510NDA/MAL/HDP/0990EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDFUSIDERM CREAMFUSIDIC ACID2%W/WEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
511NDA/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 INDIA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
512NDA/MAL/HDP/0997EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDGENUPHILGLUCOSAMINE SULPHATE SODIUM CHLORIDE+METHYLSULPHONYLMETHANE+CHONDROITIN SULPHATE375MG+375MG+300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
513NDA/MAL/HDP/0999EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID600MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2014
514NDA/MAL/HDP/1000TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDTROYCURIUMATRACURIUM10MG/MLTROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE7/1/2012
515NDA/MAL/HDP/1001EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDTHIOEVATHIOTIC ACID300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
516NDA/MAL/HDP/1003EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDZEFICAMLORNOXICAM8MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
517NDA/MAL/HDP/1006MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTRIPRIDE-2GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN2MG+15MG+500MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
518NDA/MAL/HDP/1007COSMOS LTDASTRA PHARMA (U) LIMITEDZINCOS DISPERSIBLE TABLETS 20MGZINC SULPHATE20MGCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
|
KENYA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
519NDA/MAL/HDP/1009TROIKAA PHARMACEUTICALS LIMITEDABACUS PHARMA (AFRICA) LIMITEDBUPITROY 0.5%BUPIVACAINE5MG/ML TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2012
520NDA/MAL/HDP/1011COSMOS LTDASTRA PHARMA (U) LIMITEDDABORAL SYRUPAMINOSIDINE125MG/5MLCOSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
|
KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2012
521NDA/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 | INDIA |PARENTERAL ORDINARY OTHER VIALS1.0X50.0 ML VIAL,1.0X20.0 ML VIAL7/1/2013
522NDA/MAL/HDP/1013NEON LABARATORIES LTDAIVEEN (U) LIMITEDTHIOSOLTHIOPENTAL SODIUM500MGNEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0X20.0 ML VIAL7/1/2013
523NDA/MAL/HDP/1015DAWA LIMITEDSUPER MEDIC LTDORACEFCEFALEXIN250MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
524NDA/MAL/HDP/1017ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCLOXAMPICILLIN/CLOXACILLIN125MG/125MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
|
KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2015
525NDA/MAL/HDP/1020LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDPA-12PARACETAMOL SUSTAINED RELEASE1000MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID RETARD LAYERED TABLETS1.0X10.0X1.0X12.0 TABLET BLISTER7/1/2012
526NDA/MAL/HDP/1022EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDCONVENTINGABAPENTIN300MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2013
527NDA/MAL/HDP/1023MYLAN LABORATORIES LIMITEDNORVIK ENTERPRISES LIMITEDZINNIA PLEVONORGESTREL + ETHINYLESTRADIOL 150MCG + 30MCGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BLISTER,3.0X28.0 TABLET BLISTER7/1/2013
528NDA/MAL/HDP/1025SANOFI ?AVENTIS DEUTSCHLANDLABOREX UGANDA LIMITEDINSUMAN COMB 30INSULIN HUMAN100IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
|
GERMANY |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X3.0 ML PRE- FILLED SYRINGE7/1/2014
529NDA/MAL/HDP/1031EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDMOXIFLOXMOXIFLOXACIN400MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X1.0X5.0 TABLET BLISTER7/1/2013
530NDA/MAL/HDP/1032EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDARTHFREE 20LEFLUNOMIDE20MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
531NDA/MAL/HDP/1034VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOXAMOXICILLIN250MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
532NDA/MAL/HDP/1035GUILIN PHARMACEUTICAL CO.LTDSTAR PHARMACEUTICALS LTDG-CIPROXCIPROFLOXACIN500MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
533NDA/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 | INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X1.0X1.0 ML VIAL7/1/2013
534NDA/MAL/HDP/1042ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO TELVAS-H 80/12.5TELMISARTAN +HYDROCHLOROTHIAZIDE80MG +12.5 MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP7/1/2013
535NDA/MAL/HDP/1044UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDANGINET 80MGVALSARTAN80MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
536NDA/MAL/HDP/1047UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 180MGFEXOFENADINE180MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER7/1/2013
537NDA/MAL/HDP/1048UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEXOFEN 120MGFEXOFENADINE120MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X15.0 TABLET BLISTER7/1/2013
538NDA/MAL/HDP/1049GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE VALERATE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2012
539NDA/MAL/HDP/1050INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDAMTAS-10AMLODIPINE10MGINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER7/1/2013
540NDA/MAL/HDP/1051UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPIVAL 300MGSODIUM VALPROATE300MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X50.0 TABLET CONTAINER7/1/2013
541NDA/MAL/HDP/1052GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMICLOGENMICONAZOLE NITRATE+CLOBETASOLE PROPIONATE+GENTAMICIN SULPHATE2.0%W/W+0.05%W/W+0.1W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
542NDA/MAL/HDP/1053GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN-125 DTAMOXICILLIN125MGMILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI) | INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
543NDA/MAL/HDP/1054GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-250AZITHROMYCIN250MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2011
544NDA/MAL/HDP/1055DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 40ROSUVASTATIN CALCIUM40MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
545NDA/MAL/HDP/1056GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-N OINTMENTBETAMETHASONE + NEOMYCIN0.1%W/W + 0.5% W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE7/1/2013
546NDA/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 |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
547NDA/MAL/HDP/1061NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBISACODYL TABLETSBISACODYL5MGNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
548NDA/MAL/HDP/1062VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDVANCONEX-CPVANCOMYCIN500MGVENUS REMEDIES LIMITED-UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP
PHASE I BHATOLI BADDI (HP) 173205
INDIA |
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON7/1/2013
549NDA/MAL/HDP/1063EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDVIRECTASILDENAFIL CITRATE100MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X3.0 TABLET BLISTER7/1/2013
550NDA/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) |INDIA |PARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL7/1/2012
551NDA/MAL/HDP/1065BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM-5DIAZEPAM5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |RECTAL SYSTEMIC ADULT SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER7/1/2007
552NDA/MAL/HDP/1067MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDIBUPARAIBUPROFEN+PARACETAMOL200MG+ 250MG/10MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2010
553NDA/MAL/HDP/1068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDAROFF 100ACECLOFENAC100MGUNICHEM LABORATORIES LIMITED-C?31,32 & D-10, INDUSTRIAL AREA, MEERUT ROAD, GHAZIABAD, U.P. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
554NDA/MAL/HDP/1069CIRON DRUGS & PHARMACEUTICALS PVT LTDRENE PHARMACY LTDK-ONE INJECTIONPHYTOMENADIONE10MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X1.0 ML AMPOULE7/1/2014
555NDA/MAL/HDP/1071UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 160/25MGVALSARTAN + HYDROCHLOROTHIAZIDE160 MG + 25 MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
556NDA/MAL/HDP/1072UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 80/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE80MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .-57 UBAYBIN MUAATH STREET AL RAGEEM-SAHAB, AMMAN, JORDAN | JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
557NDA/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 |
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2013
558NDA/MAL/HDP/1076UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICAST 4MGMONTELUKAST SODIUM4MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
559NDA/MAL/HDP/1077NECTAR LIFESCIENCES LTDAIVEEN (U) LIMITEDNECTRAMCEFTRIAXONE1GNECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WFI AMPOULE7/1/2013
560NDA/MAL/HDP/1078MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT INFUSIONLEVOFLOXACIN HEMIHYDRATE500MGAHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2013
561NDA/MAL/HDP/1079GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOG-QUININE SYRUPQUININE HYDROCHLORIDE100MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2000
562NDA/MAL/HDP/1080ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDZOCEF 250 TABLETSCEFUROXIME AXETIL250MGALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | EAST AFRICAN (INDIA) OVERSEAS-PLOT NO.1, PHARMACITY SELAQUI DEHRADUN ? 248011 (U.K), INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2009
563NDA/MAL/HDP/1081BRICVED LTDBOOTS PHARMACEUTICALS LIMITEDACIDEXSODIUM BICARBONATE + SODIUM ALGINATE + CALCIUM CARBONATE267MG + 500MG + 160MG /10MLPINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND | IRELAND |ORAL LIQUID ORDINARY SUSPENSIONS1.0X200.0 ML BOTTLE7/1/2013
564NDA/MAL/HDP/1082DAWA LIMITEDSUPER MEDIC LTDDACOF PAEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL75MG + 28.5MG + 0.55MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
565NDA/MAL/HDP/1083GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDCHOCOFER SYRUPIRON + FOLIC ACID50MG + 0.5MG /5MLGALPHA LABORATORIES LIMITED-VILLAGE ? THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
|
INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2013
566NDA/MAL/HDP/1084DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE4MGDAWA LTD-BABA DOGO ROAD RUARAKA |KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
567NDA/MAL/HDP/1086NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDSYNOGEN TABLETSDIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE50MG +250MG + 750MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA ? INDIA |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
568NDA/MAL/HDP/1087GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCYCLINETETRACYCLINE3%W/WAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2013
569NDA/MAL/HDP/1088GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDRESTUMCEFUROXIME SODIUM750MGALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL7/1/2015
570NDA/MAL/HDP/1094MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-100CEFIXIME100MG/5MLMICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
571NDA/MAL/HDP/1095MICRO LABS LTDLABOREX UGANDA LIMITEDEROSTINE-20EBASTINE20MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2012
572NDA/MAL/HDP/1100GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIR SKIN CREAMACICLOVIR5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X5.0 G TUBE7/1/2013
573NDA/MAL/HDP/1103GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIN CREAMNEOMYCIN SULPHATE0.5% W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
574NDA/MAL/HDP/1104HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDLIPIDUCE 10ATORVASTATIN10MGHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X3.0 TABLET BLISTER7/1/2014
575NDA/MAL/HDP/1105DAWA LIMITEDSUPER MEDIC LTDDERMAZINE PLUSSILVER SULPHADIAZINE AND CHLORHEXIDINE GLUCONATE1%W/W / 10.0%W/WDAWA LIMITED -BABA DOGO RWARAKA |KENYA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2014
576NDA/MAL/HDP/1106EVA PHARMAWIDE SPECTRUM ENTERPRISES (U) LIMITEDDIACEREINDIACEREIN50MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER7/1/2013
577NDA/MAL/HDP/1107SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) (PAEDIATRIC))HEPATITIS B VACCINE(RDNA)10MCG /0.5MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY I M VIALS1.0X25.0X5.0 ML VIAL (10 DOSES),1.0X10.0X0.5 ML VIAL (1 DOSE)7/1/2005
578NDA/MAL/HDP/1109DAWA LIMITEDSUPER MEDIC LTDDAWA-CPMCHLORPHENIRAMINE MALEATE2MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2014
579NDA/MAL/HDP/1111DAWA LIMITEDSUPER MEDIC LTDFAST-ACT GELDICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS1.16%W/W + 10%W/W + 3%W/W + 5%W/WDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE7/1/2013
580NDA/MAL/HDP/1112AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDZIDOVUDINE CAPSULESZIDOVUDINE100MGAUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHU |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER7/1/2008
581NDA/MAL/HDP/1113MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-YELLOWMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE7/1/1997
582NDA/MAL/HDP/1114NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTRANGEL ULTRADICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN10MG/80MG/60MG/0.15MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA ? INDIA |
INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G CONTAINER7/1/2012
583NDA/MAL/HDP/1117NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTETRACYCLINE EYE OINTMENT USP 1%TETRACYCLINE1%W/WNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA ? INDIA |
INDIA |OPHTHALMIC OINTMENTS1.0X20.0X3.5 G TUBE7/1/2013
584NDA/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. | UGANDA |OTIC DROPS1.0X10.0 ML VIAL,1.0X5.0 ML VIAL7/1/2013
585NDA/MAL/HDP/1123GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPARPARACETAMOL500 MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2012
586NDA/MAL/HDP/1124GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO SCRUBCHLORHEXIDINE GLUCONATE4%W/VAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |TOPICAL EXTERNAL LIQUIDS1.0X1.0X500.0 ML BOTTLE7/1/2013
587NDA/MAL/HDP/1125AUROBINDO PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXONE 1000CEFTRIAXONE1000MGAUROBINDO 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 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2009
588NDA/MAL/HDP/1127FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDCLARION TABLETS 500MGCLARITHROMYCIN500MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
|
PAKISTAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
589NDA/MAL/HDP/1128LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBTC KITFLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE150MG + 1G + 1GLINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT |INDIA |ORAL SOLID ORDINARY COMBINATION PACK TABLETS1.0X4.0 TABLET BLISTER7/1/2013
590NDA/MAL/HDP/1130LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDKLARO-500CLARITHROMYCIN TABLETS500MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2012
591NDA/MAL/HDP/1131FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDXAVOR 50LOSARTAN50MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
|
PAKISTAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2014
592NDA/MAL/HDP/1132STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDM-CALZCALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL1000MG+100MG+4MG+200.I.USTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2012
593NDA/MAL/HDP/1133MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDMEDICOL SUSPENSIONCHLORAMPHENICOL125MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2007
594NDA/MAL/HDP/1134FEROZSONS LABORATORIES LTDHARLEYS UGANDA LIMITEDXAVOR DIULOSARTAN AND HYDROCHLORTHIAZIDE50/12.5MGFEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
|
PAKISTAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2013
595NDA/MAL/HDP/1136GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOSCAB APPLICATIONBENZYL BENZOATE25%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL EMULSIONS1.0X1.0X100.0 ML BOTTLE7/1/2013
596NDA/MAL/HDP/1138GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO-CALAMINECALAMINE15%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |TOPICAL EXTERNAL LOTIONS1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2013
597NDA/MAL/HDP/1139GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATEBETAMETHASONE0.1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
598NDA/MAL/HDP/1140GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVATE-NBETAMETHASONE+NEOMYCIN SULPHATE0.1%W/W+0.5%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
599NDA/MAL/HDP/1142GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCANDIZOLCLOTRIMAZOLE1%W/WAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2013
600NDA/MAL/HDP/1143LINCOLN P'CALS LTDMETRO PHARMACEUTICALS LIMITEDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
601NDA/MAL/HDP/1145HILTON PHARMA (PVT) LTDHEALTHCARE LTD.HILACLACTULOSE68%W/VHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI |PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X120.0 ML BOTTLE7/1/2005
602NDA/MAL/HDP/1148CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDODIMONT 10MONTELUKAST10MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2012
603NDA/MAL/HDP/1149UNIVERSAL CORPORATION LTDDELMAW ENTERPRISES LIMITEDNEUROBAGABAPENTIN300MGUNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2015
604NDA/MAL/HDP/1150MARCK BIO SCIENCES LTDPHARMA VILLE LIMITEDFEBRAMOLPARACETAMOL INFUSION10MG/MLMARCK BIOSCIENCES -PLOT NO 876, NH NO 8 HARIYALA KHEDA- 387411 GUJARAT, INDIA | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2013
605NDA/MAL/HDP/1154SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDBACQUREIMIPENEM + CILASTATIN500MG + 500MGSUN PHARMACEUTICAL INDUSTRIES LIMITED-INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.

|
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X30.0 ML VIAL7/1/2012
606NDA/MAL/HDP/1156CIPLA LTDQUALITY CHEMICALS LTD - HUMANFUNGICIPCLOTRIMAZOLE1%W/WCIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722 |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2011
607NDA/MAL/HDP/1158TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDTRAMADOLTRAMADOL50MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2012
608NDA/MAL/HDP/1160DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + CLAVULANIC ACID875MG+125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG | TURKEY |ORAL SOLID ORDINARY TABLETS1.0X2.0X5.0 TABLET BLISTER7/1/2011
609NDA/MAL/HDP/1163NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDFRUSEMIDEFUROSEMIDE40MGNEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA ? INDIA |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
610NDA/MAL/HDP/1164TRIVENI FORMULATIONS LIMITEDAIVEEN (U) LIMITEDPIROXICAMPIROXICAM20MGTRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
611NDA/MAL/HDP/1166PANACEA BIOTEC LTDVITACARE LIMITEDDOLZEROTRAMADOL HYDROCHLORIDE + PARACETAMOL37.5MG + 325MGPANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
612NDA/MAL/HDP/1167CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDMETOCLOPRAMIDE INJECTIONMETOCLOPRAMIDE5MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2010
613NDA/MAL/HDP/1168DAWA LIMITEDSUPER MEDIC LTDDAWA-CORT CREAMHYDROCORTISONE1%W/WDAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2009
614NDA/MAL/HDP/1169ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDNEBI 5NEBIVOLOL HYDROCHLORIDE5MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2013
615NDA/MAL/HDP/1170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDARISTO MEGANEURONMETHYLCOBALAMIN500MCGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA |PARENTERAL ORDINARY I M AMPOULES1.0X1.0 ML AMPOULE7/1/2013
616NDA/MAL/HDP/1172CIRON DRUGS AND PHARMACEUTICALS PVT LTDRENE PHARMACY LTDLIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE 20MG/MLCIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL,1.0X30.0 ML VIAL7/1/2010
617NDA/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
|
EGYPT |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2013
618NDA/MAL/HDP/1178HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIRTENOFOVIR DISOPROXIL FUMARATE300MGHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
619NDA/MAL/HDP/1179MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDOVITRELLECHORIOGONADOTROPIN ALFA250MCG/0.5MLMERCK SERONO SA-1170 AUBONNE(SWITZERLAND) | MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY | SWITZERLAND |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON7/1/2015
620NDA/MAL/HDP/1180SQUARE PHARMACEUTICALS LTDGAMA PHARMACEUTICALS (U) LIMITEDZIF TIMED RELEASED CAPSULESDRIED FERROUS SULPHATE+ZINC SULPHATE MONOHYDRATE+FOLIC ACID150MG+61.8MG+0.5MGSQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH |ORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
621NDA/MAL/HDP/1181TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 4MONTELUKAST SODIUM4 MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
622NDA/MAL/HDP/1182TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ASTHATOR 5MONTELUKAST SODIUM5MGTORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
623NDA/MAL/HDP/1184DAWA LIMITEDSUPER MEDIC LTDDACOF MUCOLYTICSALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL2.0MG + 4.0MG +100MG + 1.0MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
624NDA/MAL/HDP/1185DAWA LIMITEDSUPER MEDIC LTDDACOF DRYDIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL12.5MG + 6.5MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
625NDA/MAL/HDP/1186DAWA LIMITEDSUPER MEDIC LTDDACOF EXPECTORANTDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL14.0MG + 135.0MG + 57.0MG + 1.10MGDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2013
626NDA/MAL/HDP/1187GALPHA LABORATORIES LTDAIVEEN (U) LIMITEDKEFTAZ-1000CEFTAZIDIME1 GALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION7/1/2013
627NDA/MAL/HDP/1194VENUS REMEDIES LTDHARLEYS UGANDA LIMITEDPISAPIPERACILLIN + TAZOBACTAM4000MG/VIAL + 500MG/VIALVENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA |PARENTERAL ORDINARY VIALS1.0X1.0X30.0 ML VIAL7/1/2009
628NDA/MAL/HDP/1195UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDALTRINECETIRIZINE5MG/5MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2013
629NDA/MAL/HDP/1202MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDQUINIMIX SYRUPQUININE HYDROCHLORIDE100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2003
630NDA/MAL/HDP/1205MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDEFAVIRENZEFAVIRENZ600MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2008
631NDA/MAL/HDP/1206THE METHOLATUM CO. LTDHARLEYS UGANDA LIMITEDDEEP RELIEFIBUPROFEN + MENTHOL5%W/W + 3% W/WTHE MENTHOLATUM CO. LTD. -1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDE |UNITED KINGDOM |TOPICAL EXTERNAL OTHER GELS/SOLS1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER7/1/2013
632NDA/MAL/HDP/1208ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDVISCO LIQUIDALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE100 MG + 250 MG + 125 MG + 50 MGARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2011
633NDA/MAL/HDP/1209MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL-80TELMISARTAN80MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
634NDA/MAL/HDP/1211ASTRA ZENECAMACNAUGHTON LIMITEDBRILINTATICAGRELOR90MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2011
635NDA/MAL/HDP/1212GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDGLINTHERARTEMETHER80MG/MLGUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI | CHINA |PARENTERAL ORDINARY I M AMPOULES1.0X6.0X1.0 ML AMPOULE7/1/2011
636NDA/MAL/HDP/1214FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDNUCLEO C.M.P FORTECYTIDINE+URIDINE5MG+3MGFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN |ORAL SOLID ORDINARY CAPSULES1.0X2.0X15.0 CAPSULE BLISTER7/1/2013
637NDA/MAL/HDP/1215BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDGYNANFORT VAGINAL PESSARYMETRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN500MG+65,000I.U+100,000I.UBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |VAGINAL SUPPOSITORIES1.0X10.0 TABLET BLISTER7/1/2013
638NDA/MAL/HDP/1217SANOFI AVENTISLABOREX UGANDA LIMITEDINSUMAN BASALRECOMBINANT HUMAN INSULIN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
|
GERMANY |PARENTERAL ORDINARY VIALS1.0X5.0X3.0 ML CARTRIDGE,1.0X5.0 ML VIAL7/1/2014
639NDA/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 | INDIA |RECTAL SYSTEMIC SUPPOSITORIES1.0X6.0 SUPPOSITORY STRIP7/1/2009
640NDA/MAL/HDP/1219DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDTORAS-DENK 5TORASEMIDE5MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
641NDA/MAL/HDP/1220BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDLONARTARTEMETHER + LUMEFANTRINE180 MG + 1080 MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BLISTER7/1/2008
642NDA/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 | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X1.0X25.0 G TUBE7/1/1997
643NDA/MAL/HDP/1224KOTRAPHARMA (M) SDN.BHDABACUS PHARMA (AFRICA) LIMITEDVAXCEL CEFTRIAXONECEFTRIAXONE1GKOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2013
644NDA/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
|
EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X1.0X10.0 CAPSULE BLISTER7/1/2013
645NDA/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
|
EGYPT |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0 TABLET STRIP7/1/2013
646NDA/MAL/HDP/1228ASTRA LIFECARE (INDIA) PVT. LTDASTRA PHARMA (U) LIMITEDLUMETHERARTEMETHER + LUMEFANTRINE20 MG + 120 MGASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X6.0 TABLET BLISTER7/1/2010
647NDA/MAL/HDP/1229MARCK BIOSCIENCES LIMITEDPHARMA VILLE LIMITEDLIDOCAINELIDOCAINE2%W/VMARCK BIOSCIENCES LIMITED-PLOT NO 876, NH NO 8 HARIYALA KHEDA- 387411 GUJARAT, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X10.0ML VIAL7/1/2012
648NDA/MAL/HDP/1230MEDOPHARM PRIVATE LIMITEDPLANET PHARMACEUTICALS UGANDA LTDLOXAMPAMPICILLIN + CLOXACILLIN250 MG + 250 MGMEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
649NDA/MAL/HDP/1238BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDSEPTRIN INJECTIONCO-TRIMOXAZOLE480MG/5MLDRAXIS PHARMA INC.- QUEBEC, CANADA | CANADA |PARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE7/1/1997
650NDA/MAL/HDP/1242GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTOPHEN-100PHENYTOIN100MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2013
651NDA/MAL/HDP/1243DENK PHARMA GMBH & CO KGBENLE CONSULT LIMITEDLEVO DENK 250LEVOFLOXACIN HEMIHYDRATE250MGROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2014
652NDA/MAL/HDP/1247GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROCIPCYPROHEPTADINE4MGAGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X5.0X10.0 TABLET BLISTER7/1/2012
653NDA/MAL/HDP/1250STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDSTRIMOL EXTRAPARACETAMOL+CAFFEINE500MG+30MGSTRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAWADICROSS ANEKAL TALUK BANYALURE-562106 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET BLISTER7/1/2014
654NDA/MAL/HDP/1252MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDZOYSILDENAFIL50MGTORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2013
655NDA/MAL/HDP/1254COSMOS LTDASTRA PHARMA (U) LIMITEDCOSATRIM TABLETSCO-TRIMOXAZOLE480MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER7/1/1998
656NDA/MAL/HDP/1255CIPLA LTDQUALITY CHEMICALS LTD - HUMANNIFELAT RETARDNIFEDIPINE20MGCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGAD |INDIA |ORAL SOLID RETARD TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1997
657NDA/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.
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2013
658NDA/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.
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2013
659NDA/MAL/HDP/1264CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUCYCLINE EYE OINTMENTTETRACYCLINE HYDROCHLORIDE1%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 |INDIA |OPHTHALMIC OINTMENTS1.0X5.0 G TUBE,1.0X3.5 G TUBE7/1/2000
660NDA/MAL/HDP/1265GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCOMBIPLEXVITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B61.0 MG + 1.0 MG + 15 MG + 0.5 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2008
661NDA/MAL/HDP/1274SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN250MGNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN |ORAL SOLID ORDINARY CAPSULES1.0X1.0X6.0 CAPSULE BLISTER7/1/2007
662NDA/MAL/HDP/1275REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 10 F.C TABLETSNIFEDIPINE10MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1997
663NDA/MAL/HDP/1276INCEPTA PHARMACUTICALS LIMITEDECHO PHARMACY (U) LIMITEDPANTONIX 40 INJECTIONPANTOPRAZOLE SODIUM SEQUIHYDRATE40MGINCEPTA PHARMACEUTICALS LIMITED- DEWAN IDRIS ROAD, BARA RANGAMATIA, ZIRABO
SAVAR, DHAKA, BANGLADESH
|
BANGLADESH |PARENTERAL ORDINARY AMPOULES1.0X1.0X40.0 MG VIAL 1*10ML AMPOULE OF 0.9% NACL7/1/2013
664NDA/MAL/HDP/1277SANOTI AVENTISLABOREX UGANDA LIMITEDINSUMAN RAPIDINSULIN HUMAN100 IU/MLSANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY | GERMANY |PARENTERAL ORDINARY S C VIALS1.0X5.0 ML VIAL7/1/2015
665NDA/MAL/HDP/1278GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDD-ARTEPPDIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE40MG +320MGGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI |CHINA |ORAL SOLID ORDINARY TABLETS1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X25.0X1.0X9.0 TABLET BLISTER7/1/2013
666NDA/MAL/HDP/1282ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDLOSABERGLOSARTAN POTASSIUM50MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
667NDA/MAL/HDP/1285SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANFUR-750CEFUROXIME750MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X750.0 MG VIAL7/1/2012
668NDA/MAL/HDP/1287SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX- DS 100CEFIXIME100MG/5MLSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2014
669NDA/MAL/HDP/1289METRO PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDTETRACYCLINE HYDROCHLORIDETETRACYCLINE250MGCSPC OUYI PHARMACEUTICAL CO.LTD. LIMITED-NO. 276, WEST ZHONGSTAN ROAD, SHIJIAZHUANG, CHINA | CHINA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X100.0 CAPSULE BLISTER7/1/2013
670NDA/MAL/HDP/1290SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANIX 400 CAPCEFIXIME400MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2013
671NDA/MAL/HDP/1291BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST-300IOPROMIDE300MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |PARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL,1.0X100.0 ML VIAL7/1/2012
672NDA/MAL/HDP/1293ZEE PHARMACEUTICALS LTDZEE PHARMACEUTICALS LIMITEDZEEGRA - 100SILDENAFIL CITRATE100MGTHE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0 TABLET BLISTER7/1/2016
673NDA/MAL/HDP/1294BAYER SCHERING PHARMASURGIPHARM (U) LIMITEDULTRAVIST 370IOPROMIDE370MG/MLBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |PARENTERAL ORDINARY VIALS1.0X100.0 ML VIAL,1.0X50.0 ML VIAL7/1/2012
674NDA/MAL/HDP/1295SHAIGAN PHARMACEUTICALS (PVT) LTDHEALTHCARE LTD.ZEPARALBENDAZOLE200MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/1997
675NDA/MAL/HDP/1298HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDNEUROVIT FORTETHIAMINE MONONITRATE/ PYRIDOXINE/ CYANOCOBALAMIN245.5MG/ 250MG/ 1.4MGHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
676NDA/MAL/HDP/1299SANCE LABORATORIES PVT LTDDELMAW ENTERPRISES LIMITEDSANAXONE PLUS-1000CEFTRIAXONE+SULBACTAM1000MG+500MGSANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.5 G VIAL,1.0X50.0X1.0 VIAL CARTON7/1/2012
677NDA/MAL/HDP/1300KOPRAN LIMITEDTATA UGANDA LIMITEDATENOLOL-100ATENOLOL100MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X16.0X14.0 TABLET BLISTER7/1/1997
678NDA/MAL/HDP/1301HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDCOSAMINE PLUSGLUCOSAMINE SULPHATE + CHONDROITIN SULPHATE250MG + 200MGHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
679NDA/MAL/HDP/1302CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDHIPEN CAPSULESAMOXYCILLIN250MGSPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
680NDA/MAL/HDP/1304MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE PLUS 2GLIMEPIRIDE+ METFORMIN1MG + 500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
681NDA/MAL/HDP/1307MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDARBITEL 40TELMISARTAN40MGMICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
682NDA/MAL/HDP/1312BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDSLIPIZEM- 2.5DIAZEPAM2.5MGBLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA |INDIA |RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES1.0X5.0 SUPPOSITORY BLISTER7/1/2007
683NDA/MAL/HDP/1319REMEDICA LTDGOODMAN INTERNATIONAL LTDZESTAVAL 200 F.C TABLETSALBENDAZOLE200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS50.0X2.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER7/1/1997
684NDA/MAL/HDP/1324MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDTOOTH HEALMULTI INGREDIENTMULTI INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X1.0X18.0 ML BOTTLE7/1/2005
685NDA/MAL/HDP/1328GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN20MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART |BELGIUM |PARENTERAL ORDINARY VIALS1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE)7/1/1997
686NDA/MAL/HDP/1330IPCA LABORATORIES LTDMEDVIN PHARMA LIMITEDRAPICLAV-625AMOXYCILLIN+CLAVULANIC ACID500MG+125MGIPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X2.0 TABLET STRIP,1.0X7.0X3.0 TABLET STRIP7/1/2003
687NDA/MAL/HDP/1331ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDBETADERM N OINTMENTBETAMETHASONE VALERATE + NEOMYCIN0.1%W/W + 0.5%W/WATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/1997
688NDA/MAL/HDP/1335INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDPREGATASPREGABALIN75MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2012
689NDA/MAL/HDP/1338LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDGRISEBEN 500GRISEOFULVIN500 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
690NDA/MAL/HDP/1341AUROLABSWASTIK PHARMACEUTICAL LTDG-FLOXGATIFLOXACIN SESQUIHYDRATE0.3%W/VAUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIA | INDIA |OPHTHALMIC LIQUIDS1.0X5.0 ML VIAL7/1/2016
691NDA/MAL/HDP/1342KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL CEPHALEXIN 250CEPHALEXIN MONOHYDRATE250MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2008
692NDA/MAL/HDP/1343MICRO LABS LTDPHARMA VILLE LIMITEDPRAZIQUANTELPRAZIQUANTEL600MGMICRO LABS LIMITED .,-92, SIPCOT, HOSUR 635126 | MICRO LABS LIMITED, BOMMASANDRA (ML07),-PLOT 121-124, IV PHASE KIADB, BOMMASANDRA IND. AREA, JIGNI LINK ROAD | INDIA |ORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER7/1/2013
693NDA/MAL/HDP/1345ALKEM LABORATORIES LIMITEDABACUS PHARMA (AFRICA) LIMITEDSWICH-200CEFPODOXIME200MGALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
694NDA/MAL/HDP/1346ASTRA PHARMA LTDASTRA PHARMA (U) LIMITEDASIXFUROSEMIDE40MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2010
695NDA/MAL/HDP/1347MICRO LABS LIMITEDLABOREX UGANDA LIMITEDORNILOXORNIDAZOLE + OFLOXACIN500MG + 200MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
696NDA/MAL/HDP/1348TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 500SODIUM VALPROATE (CONTROLLED RELEASE)500MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2009
697NDA/MAL/HDP/1351MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDATORINATORVASTATIN CALCIUM20MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
698NDA/MAL/HDP/1352MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPLATFREECLOPIDOGREL75MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
699NDA/MAL/HDP/1353MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDKITPYLO - CLANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN30MG +500MG + 250MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)7/1/2015
700NDA/MAL/HDP/1355PIRAMAL HEALTHCARE LTDTATA UGANDA LIMITEDSEVOFLURANESEVOFLURANE100% V/VPIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH | INDIA |OTHER SYSTEMIC LIQUID INHALATIONS1.0X250.0 ML BOTTLE7/1/2010
701NDA/MAL/HDP/1359KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENAC-100 SRDICLOFENAC SODIUM100MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA |UGANDA |ORAL SOLID RETARD CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2016
702NDA/MAL/HDP/1360CIPLA LTDQUALITY CHEMICALS LTD - HUMANABAMUNE-L BABYABACAVIR SULPHATE + LAMIVUDINE60MG + 30MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA | INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET CONTAINER7/1/2016
703NDA/MAL/HDP/1361SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDFALCI CAREARTESUNATE120MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE7/1/2016
704NDA/MAL/HDP/1362MICRO LABS LIMITEDLABOREX UGANDA LIMITEDBACTOCLAV-1000AMOXICILLIN + CLAVULANATE875 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X6.0 TABLET STRIP7/1/2013
705NDA/MAL/HDP/1366F. HOFFMANN- LA ROCHE LTDLABOREX UGANDA LIMITEDHERCEPTIN 440MGTRASTUZUMAB440MGF. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGST |SWITZERLAND |PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X440.0 MG VIAL ,2OML VIAL OF SOLVENT7/1/2016
706NDA/MAL/HDP/1367DAWA LIMITEDSUPER MEDIC LTDACEPARACECLOFENAC + PARACETAMOL100 MG + 500 MGDAWA LTD-BABA DOGO ROAD RUARAKA |KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2013
707NDA/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. | UGANDA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2010
708NDA/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 | INDIA |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X2.0X20.8 G SACHET + 1.0 *10.0 TABLET BLISTER7/1/2016
709NDA/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. | UGANDA |PARENTERAL ORDINARY AMPOULES1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE7/1/2010
710NDA/MAL/HDP/1372AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDRLCOMPOUND SODIUM LACTATE (NACL + KCL + CACL )0.115 G + 0.6G + 0.027AXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2014
711NDA/MAL/HDP/1374HILTON PHARMA (PVT) LTDHEALTHCARE LTD.VALODIN -125CEPHADRINE125MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI |PAKISTAN |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2003
712NDA/MAL/HDP/1377OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDWATER FOR INJECTIONWATER FOR INJECTIONN/AOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0 ML AMPOULE7/1/2014
713NDA/MAL/HDP/1380KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDHYCORT CREAMHYDROCORTISONE1%W/WKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/1997
714NDA/MAL/HDP/1381CIPLA LTDQUALITY CHEMICALS LTD - HUMANLAMIVUDINE,/ ZIDOVUDINE TABLETSLAMIVUDINE,+ ZIDOVUDINE150MG+300MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2007
715NDA/MAL/HDP/1382HOVID BERHADUNITED HEALTHCARE DISTRIBUTORS LTDINOX CAPSULESITRACONAZOLE100MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY CAPSULES1.0X7.0X4.0 CAPSULE BLISTER7/1/2012
716NDA/MAL/HDP/1383HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDKETOFEN GELKETOPROFEN2.5%W/WHOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA |TOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G CONTAINER7/1/2013
717NDA/MAL/HDP/1384CIPLA LTDQUALITY CHEMICALS LTD - HUMANLAMIVUDINE AND ZIDOVUDINE TABLETSLAMIVUDINE + ZIDOVUDINE30MG + 60MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
718NDA/MAL/HDP/1387INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLAN-30LANSOPRAZOLE30MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X1.0X5.0X10.0 CAPSULE STRIP7/1/2004
719NDA/MAL/HDP/1389UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDNELSTATNYSTATIN100000 I.U/MLUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA |ORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2010
720NDA/MAL/HDP/1390ASTRA ZENECAMACNAUGHTON LIMITEDCRESTORROSUVASTATIN CALCIUM5MGIPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
721NDA/MAL/HDP/1391UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDUNIVIR 5%ACYCLOVIR5%W/WUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA |TOPICAL EXTERNAL CREAMS1.0X1.0X10.0 G TUBE7/1/2010
722NDA/MAL/HDP/1392ASTRA ZENECAMACNAUGHTON LIMITEDZOLADEXGOSERELIN3.6MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X1.0 PREFILLED SYRINGE CARTON7/1/1997
723NDA/MAL/HDP/1395ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MG IVESOMEPRAZOLE40MG/5MLASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJE | SWEDEN |PARENTERAL ORDINARY VIALS1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL7/1/2010
724NDA/MAL/HDP/1397ASTRAZENECAMACNAUGHTON LIMITEDPLENDILFELODIPINE10MGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2001
725NDA/MAL/HDP/1399CIPLA LTD.QUALITY CHEMICALS LTD - HUMANASTHALINSALBUTAMOL100MCG/DOSECIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE ?II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH | INDIA |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X200.0 METERED DOSE CANNISTER7/1/2010
726NDA/MAL/HDP/1400MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 500METFORMIN HYDROCHLORIDE500MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
(EAST), DISTRICT THANE, 421 0506, DIST. THANE,
MAHARASHTRA, INDIA.
|
INDIA |ORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER7/1/2015
727NDA/MAL/HDP/1402MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDPANFOR SR 1000METFORMIN HYDROCHLORIDE1000MGINVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
(EAST), DISTRICT THANE, 421 0506, DIST. THANE,
MAHARASHTRA, INDIA.
|
INDIA |ORAL SOLID RETARD TABLETS1.0X5.0X20.0 TABLET BLISTER7/1/2015
728NDA/MAL/HDP/1403VHB MEDI SCIENCES LTDLLOYDS PHARMACY LIMITEDDOMAXIN-RD 10MGDOXORUBICIN HCL10MGVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X10.0 MG VIAL7/1/2010
729NDA/MAL/HDP/1406LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCEBAY DRY SYRUPCEFIXIME TRIHYDRATE50MG/5MLLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
730NDA/MAL/HDP/1407PHARMATHEN S.AGOODMAN INTERNATIONAL LTDBELIFAXOMEPRAZOLE20MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE | GREECE |ORAL SOLID ORDINARY CAPSULES1.0X14.0 CAPSULE BOTTLE7/1/1997
731NDA/MAL/HDP/1408TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.ROSUCORROSUVASTATIN20MGTORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P) | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
732NDA/MAL/HDP/1409SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDROMYCINAZITHROMYCIN200MG/5MLNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X15.0 ML BOTTLE7/1/2007
733NDA/MAL/HDP/1411LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDCIPIUMCHLORPHENIRAMINE4MGLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER7/1/2011
734NDA/MAL/HDP/1413BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDPODINE MOUTH WASHPOVIDONE IODINE0.1%W/VBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA |ORAL TOPICAL LIQUIDS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE7/1/2014
735NDA/MAL/HDP/1414UNIQUE PHARMACEUTICALS LABORATORIESPLANET PHARMACEUTICALS UGANDA LTDDICLORAN SR TABLETSDICLOFENAC SODIUM100MGUNIQUE PHARMACEUTICAL LABS LIMITED. .-215-216, 216-219, 304-308, GIDC PANOLI 394116-GUJARAT | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2016
736NDA/MAL/HDP/1415ASTRA ZENECAMACNAUGHTON LIMITEDATACANDCANDESARTAN32MGASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE
|
SWEDEN |ORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2011
737NDA/MAL/HDP/1418NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDAMINOPHYLLINE TABLETSAMINOPHYLLINE100MGNEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
738NDA/MAL/HDP/1419GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDSINOPRIL 10LISINOPRIL10MGGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2005
739NDA/MAL/HDP/1422SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.STAMINCETIRIZINE DIHYDROCHLORIDE10MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2005
740NDA/MAL/HDP/1425LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDL-TRIMCOTRIMOXAZOLE240MG/5MLLEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C, | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2007
741NDA/MAL/HDP/1426LEBEN LABORATORIES PVT.LTDANDYCO PHARMACY (UGANDA) LTDMETROLEBMETRONIDAZOLE200MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
742NDA/MAL/HDP/1427GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENA-50ATENOLOL50MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2011
743NDA/MAL/HDP/1428UNIVERSAL CORPORATION LTDROYAL PHARMA 2011 LIMITEDDINAC-50DICLOFENAC SODIUM50 MGUNIVERSAL CORPORATION LTD.-CLUB ROAD, PAST KIKUYU POST OFFICE, P.O. BOX 1748-00902 KIKUYU TOWN | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
744NDA/MAL/HDP/1431INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDTORTAS 10TORSEMIDE10MGINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
745NDA/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 | INDIA |OTIC DROPS1.0X10.0 ML VIAL7/1/2007
746NDA/MAL/HDP/1433BAYER PHARMA AGSURGIPHARM (U) LIMITEDNORISTERATNORETHISTERONE ENANTATE200MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |PARENTERAL ORDINARY VIALS1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL7/1/1997
747NDA/MAL/HDP/1436MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDCONCOR 10BISOPROLOL HEMIFUMARATE10MGMERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT | WINTHROP PHARMACEUTICALS(PTY) LTD,-315 WATLOO ROAD,WATLOO,PRETORIA,SOUTHAFRICA (FPP SECONDARY PACKAGING,FPP RELEASE/QC TESTING SITE) | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
748NDA/MAL/HDP/1441AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDSODIUM CHLORIDESODIUM CHLORIDE0.9%W/VAXA PARENTERALS LTD-KISHNPUR, JAMALPUR ROORKEE- 247677 | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2014
749NDA/MAL/HDP/1445CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.AXONE 1000CEFTRIAXONE SODIUM1000MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL7/1/2003
750NDA/MAL/HDP/1446RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN B COMPLEXVITAMINS B1 + B2 + B6 + NIACINAMIDE0.5 MG + 0.5MG + 7.5MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2015
751NDA/MAL/HDP/1447EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDVITONA PLUSVITAMINS + MINERALSMULTI-INGREDIENTEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA |EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X2.0X6.0 CAPSULE BLISTER7/1/2014
752NDA/MAL/HDP/1450GLAXOSMITHKLINE LIMITED LIKONIUNITED HEALTHCARE DISTRIBUTORS LTDVOLTAREN EMULGEL 1%DICLOFENAC DIETHYLAMMONIUM1%W/VNOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND |SWITZERLAND |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X50.0 G TUBE7/1/1997
753NDA/MAL/HDP/1451NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN INJECTIONDICLOFENAC25MG/MLNOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. |SWITZERLAND |PARENTERAL ORDINARY AMPOULES1.0X3.0 ML AMPOULE7/1/1997
754NDA/MAL/HDP/1452ASTRA ZENECAMACNAUGHTON LIMITEDZESTORETICLISINOPRIL/HYDROCHLOROTHIAZIDE20MG/12.5MGASTRAZENECA MACCLESFIELD-CHESHIRE |UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/1997
755NDA/MAL/HDP/1454RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDPAINEXPARACETAMOL + ASPIRIN + CAFFEINE500MG + 400MG + 50 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP7/1/2003
756NDA/MAL/HDP/1457NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDDYSEN FORTESECNIDAZOLE1000MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2006
757NDA/MAL/HDP/1458STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDCLAVICIN INJECTIONAMOXICILLIN + POTASSIUM CLAVULANATE1.2GSTRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD
BANGALORE 560076
INDIA
|
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.2 G VIAL7/1/2013
758NDA/MAL/HDP/1459NVS KENYA LTDSURGIPHARM (U) LIMITEDTASIGNA 200NILOTINIB200MGNORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND |ORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER7/1/2014
759NDA/MAL/HDP/1460VENUS REMEDIES LIMITEDAARON PHARMACEUTICALS LTDPARIN EENOXAPARIN80MGVENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) |INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X10.0X2.0 ML PRE- FILLED SYRINGE7/1/2009
760NDA/MAL/HDP/1463ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDARISTOZYME LIQUIDDIASTASE+PEPSIN50MG+10MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE7/1/2015
761NDA/MAL/HDP/1464ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDORNIDAORNIDAZOLE500MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2014
762NDA/MAL/HDP/1465NORVATIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTFAST 50MGDICLOFENAC POTASSIUM50MGMIPHARM S.P.A -VIA BERNARDO QUARANTA, 12-20141, MILANO ITALY. | ITALY |ORAL LIQUID ORDINARY SOLUBLE POWDERS1.0X3.0 SACHET CARTON,9.0X1.0X3.0X3.0 SACHET CARTON7/1/2014
763NDA/MAL/HDP/1468CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOCID CAPSULESOMEPRAZOLE20MG S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID RETARD CAPSULES1.0X10.0X10.0 CAPSULE STRIP7/1/1998
764NDA/MAL/HDP/1469VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 125AMOXICILLIN125MG/5MLVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
765NDA/MAL/HDP/1471PT SAMBE FARMAMEDVIN PHARMA LIMITEDTEMIRALACICLOVIR30MG/GPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |OPHTHALMIC OINTMENTS1.0X3.5 G TUBE7/1/2011
766NDA/MAL/HDP/1472GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDFORTUM INJECTIONCEFTAZIDIME1GMGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONA |ITALY |PARENTERAL ORDINARY VIALS1.0X1.0 G VIAL7/1/1997
767NDA/MAL/HDP/1474GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGODIC GELDICLOFENAC DIETHYLAMINE1%W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE7/1/2016
768NDA/MAL/HDP/1476GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDSEPTOLSILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE1%W/W + 0.20W/WAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2016
769NDA/MAL/HDP/1478AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRASILDENAFIL50MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2001
770NDA/MAL/HDP/1481ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTROGYLMETRONIDAZOLE200MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/1997
771NDA/MAL/HDP/1482SANOFI PASTEURLABOREX UGANDA LIMITEDSTAMARIL PASTEURYELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED)NLT 1000 I.USANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE | SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) | FRANCE |PARENTERAL ORDINARY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE,1.0X10.0X10.0 DOSE VIAL + 1*10*10 DOSE AMPOULE OF NS7/1/1997
772NDA/MAL/HDP/1485UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDDICLOFEN 25DICLOFENAC25MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |RECTAL SYSTEMIC SUPPOSITORIES1.0X2.0X5.0 SUPPOSITORY BLISTER7/1/2011
773NDA/MAL/HDP/1486ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-1AMPICILLIN1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X1.0 G VIAL7/1/2011
774NDA/MAL/HDP/1488ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RECTALDICLOFENAC SODIUM100MGHAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAU | GERMANY |RECTAL SYSTEMIC ADULT SUPPOSITORIES10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP7/1/2000
775NDA/MAL/HDP/1492ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 75 INJECTIONDICLOFENAC SODIUM25MG/MLHAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY. | GERMANY |PARENTERAL ORDINARY AMPOULES1.0X10.0X3.0 ML AMPOULE7/1/1998
776NDA/MAL/HDP/1494FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDPEITEL 0.25%PREDNICARBATE0.25%W/WFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN |TOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/2013
777NDA/MAL/HDP/1495WOCKHARDT LTDSTAR PHARMACEUTICALS LTDPELOX-400PEFLOXACIN400MGWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP7/1/1997
778NDA/MAL/HDP/1497LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE CREAMBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE7/1/1997
779NDA/MAL/HDP/1499GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINEPROMETHAZINE HYDROCHLORIDE25MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN |CHINA |PARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE7/1/2005
780NDA/MAL/HDP/1500MERCK SHARP & DOHME BVPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDATRIPLAEFAVIRENZ+EMTRICITABINE + TENOFOVIR600MG +200MG+300MGPATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA | NETHERLANDS |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2008
781NDA/MAL/HDP/1503MEDICAL UNION PHARMACUITICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT CREAMHYDROCORTISONE+CINCHOCAINE0.5%W/W + 0.5%W/WMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT |EGYPT |TOPICAL EXTERNAL OTHER CREAMS1.0X20.0 G TUBE7/1/2003
782NDA/MAL/HDP/1505GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDSERETIDE EVOHALERSALMETEROL/ FLUTICASONE PROPIONATE25/50 MCGGLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX |
FRANCE |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON7/1/2007
783NDA/MAL/HDP/1506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDWEPOX 2000RECOMBINANT HUMAN ERYTHROPOIETIN2000 IUWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE7/1/2011
784NDA/MAL/HDP/1508IMMUCORSUPER MEDIC LTDWOMNILALBENDAZOLE200MG/5MLDAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2009
785NDA/MAL/HDP/1509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDFEVEREXPARACETAMOL500MGBETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100, | KENYA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2007
786NDA/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 AFRICA |ORAL LIQUID ORDINARY LIQUIDS1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2001
787NDA/MAL/HDP/1514JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE100MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE |SOUTH AFRICA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X6.0 TABLET BLISTER7/1/1997
788NDA/MAL/HDP/1515CIPLA LTD.QUALITY CHEMICALS LTD - HUMANCIPLACEF 1000CEFTRIAXONE1000MGCIPLA LTD C/O OKASA-OKASA PHARMA PVT LTD L-2 ADDITIONAL MIDC SATARA 415004 |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X15.0 ML VIAL 1X1 WFI AMPOULE7/1/2007
789NDA/MAL/HDP/1516WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDURGENDOL PTRAMADOL/ PARACETAMOL37.5MG/ 325MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR
PRADESH - INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
790NDA/MAL/HDP/1517NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDVEST MENTAMU BALMCOMPOUND METHYLSALICYLATEMULTI INGREDIENTNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1998
791NDA/MAL/HDP/1519CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 400BUDESONIDE + FORMOTEROL FUMARATE120 METERED DOSES (400MCG/6MCG)CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA |LUNG ADMINISTRATION METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON7/1/2007
792NDA/MAL/HDP/1522GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDPENAMOXAMOXYCILLIN250MGMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
793NDA/MAL/HDP/1523RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIRENAMPICILLIN125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
794NDA/MAL/HDP/1524RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE125 MG / 5 MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2008
795NDA/MAL/HDP/1525CIPLA LIMITED.QUALITY CHEMICALS LTD - HUMANBENDEXALBENDAZOLE20MG/5MLCIPLA LTD ,,-PLOT NO. 9,10,15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH PIN. 454775 | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2007
796NDA/MAL/HDP/1526FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDGAMALATE B6MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B675MG + 75MG + 37MG + 37MGFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2015
797NDA/MAL/HDP/1527MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAVAMOXICILLIN + CLAVULANATE POTASSIUM200MG + 28.5MG/ 5MLMICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X100.0 ML BOTTLE7/1/2012
798NDA/MAL/HDP/1528MICRO LABS LTDLABOREX UGANDA LIMITEDBACTOCLAV-625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER7/1/2007
799NDA/MAL/HDP/1529BAYER PHARMA AGSURGIPHARM (U) LIMITEDPROVIRONMESTEROLONE25MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1997
800NDA/MAL/HDP/1531CIPLA LTDQUALITY CHEMICALS LTD - HUMANNOVATAXCEFOTAXIME1GMMEDISPRAY LABORATORIES PVT LTD --L-1/1, L-1/2/2, ADDITIONAL MIDC SATARA 415004 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2009
801NDA/MAL/HDP/1532BF BIOSCIENCES LTDHARLEYS UGANDA LIMITEDNOVAPRESSINTERLIPRESSIN1MG/VIALBF BIOSCIENCES LTD. -RAIWIND,PAKISTAN | PAKISTAN |PARENTERAL ORDINARY VIALS1.0X1.0 MG VIAL7/1/2014
802NDA/MAL/HDP/1533OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITED5DGLUCOSE50G/LOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2007
803NDA/MAL/HDP/1535ABACUS PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDFORTIWIN-4FORTIFIED PROCAINE PENICILLIN SODIUM4 M.UREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X4.0 MU VIAL7/1/2011
804NDA/MAL/HDP/1537ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLEALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
|
KENYA |ORAL SOLID ORDINARY TABLETS1.0X20.0X2.0 TABLET BLISTER7/1/2005
805NDA/MAL/HDP/1538ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYZOLE SUSPENSIONALBENDAZOLE200MGELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
|
KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2003
806NDA/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 | UGANDA |ORAL LIQUID ORDINARY LIQUIDS1.0X60.0 ML BOTTLE7/1/1997
807NDA/MAL/HDP/1544GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROMETHAZINE HYDROCHLORIDE B.PPROMETHAZINE HCL25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
808NDA/MAL/HDP/1546UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDLANPROLANSOPRAZOLE30MGUNICHEM LABORATORIES LTD-PLOT NO. 15,16,17,17A & 18, PILERNE INDUSTRIAL ESTATE, PILERNE, BARDEZ, GOA- 403511 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X5.0X2.0X10.0 CAPSULE BLISTER7/1/1999
809NDA/MAL/HDP/1547MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDLUSIA-FNORGESTREL/ ETHINYL ESTRADIOL + FERROUS FUMARATE0.3MG/ 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER7/1/2007
810NDA/MAL/HDP/1550GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDRUBIGELMULTI-INGREDIENTMULTI-INGREDIENTGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
|
INDIA |ORAL TOPICAL GELS AND SOLS1.0X30.0 G TUBE7/1/2007
811NDA/MAL/HDP/1551EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDCALOSHELL-500CALCIUM CARBONATE + VITAMIN D31250MG + 250IUEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2004
812NDA/MAL/HDP/1553EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDVIFEXSALBUTAMOL + BROMHEXINE + GUAIFENESIN1MG/5ML+2MG/5ML+50MG/5MLEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2004
813NDA/MAL/HDP/1554KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL CETIRIZINECETIRIZINE DIHYDROCHLORIDE5MG/5MLKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2010
814NDA/MAL/HDP/1555GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDGALSCRUBCHLORHEXIDINE4%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
|
INDIA |TOPICAL EXTERNAL LIQUIDS1.0X500.0 ML BOTTLE7/1/2008
815NDA/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 | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2014
816NDA/MAL/HDP/1557GLAXOSMITHKLINEUNITED HEALTHCARE DISTRIBUTORS LTDSYNFLORIX VACCINEPNEUMOCOCCAL POLYSACCHARIDE SEROTYPES (1,5,6B,7F,9V,14,23F) + (4,18C,19F) + PROTEIN D+TETANUS TOXOID+DIPTHERIA TOXOID CARRIER PROTEINS AND ALUMINIUM PHOSPHATE1MCG+3MCG+13MCG+8MCG+5MCG+0.5MGGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART |BELGIUM |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE)7/1/2010
817NDA/MAL/HDP/1558PFIZER LABORATORIES (PTY) LTDLABOREX UGANDA LIMITEDGABBRORALAMINOSIDINE SULPHATE250MGPHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS | BELGIUM |ORAL SOLID ORDINARY TABLETS1.0X12.0 TABLET STRIP7/1/1998
818NDA/MAL/HDP/1563GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN125MG/5MLGLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE | FRANCE |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
819NDA/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 | INDIA |ORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2009
820NDA/MAL/HDP/1569ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDKALETRALOPINAVIR+RITONAVIR80MG + 20MGAESICA PHARMACEUTICALS SRL-QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM | UNITED KINGDOM |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X5.0X1.0X60.0 ML BOTTLE7/1/2007
821NDA/MAL/HDP/1571BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDRHOCLONEMONOCLONAL ANTI-D IMMUNOGLOBULIN300MCGBHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
|
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X2.0 ML VIAL (1 DOSE VIAL)7/1/2013
822NDA/MAL/HDP/1574INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMTAS-5AMLODIPINE5MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER7/1/2003
823NDA/MAL/HDP/1575ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL20MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. | ASTRAZENECA MACCLESFIELD-CHESHIRE | UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/1997
824NDA/MAL/HDP/1576ASTRAZENECAMACNAUGHTON LIMITEDZESTRILLISINOPRIL10MGASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA. | ASTRAZENECA MACCLESFIELD-UNITED KINGDOM | UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER7/1/1997
825NDA/MAL/HDP/1577SEARLE PAKISTAN LTDHEALTHCARE LTD.SPIROMIDESPIRONOLACTONE + FRUSEMIDE50MG+20MGTHE SEARLE COMPANY-32-KM MULTAN ROAD, LAHORE | INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET STRIP7/1/2005
826NDA/MAL/HDP/1579PT SANBE FARMAMEDVIN PHARMA LIMITEDPLASMINEXTRANEXAMIC ACID100MG/MLPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE7/1/2011
827NDA/MAL/HDP/1583INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDABZEEALBENDAZOLE200MG/5MLINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2001
828NDA/MAL/HDP/1584UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUCLOXCLOXACILLIN SODIUM500MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2015
829NDA/MAL/HDP/1585WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDUDIHEP FORTEURSODEOXYCHOLIC ACID300MGWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2010
830NDA/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 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X4.0X7.0 TABLET BLISTER7/1/2005
831NDA/MAL/HDP/1589CENTAUR PHARMACEUTICALS PVT LTDGITTOES PHARMACEUTICALS LIMITEDCENTACID SUSPENSIONMAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE40MG+200MG+250MG/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE7/1/1997
832NDA/MAL/HDP/1591CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDCENTIPAR ELIXIRPIPERAZINE CITRATE750ML/5MLCENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA |INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE7/1/1997
833NDA/MAL/HDP/1598GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM 400CIMETIDINE400MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
834NDA/MAL/HDP/1605RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDASPIRIN TABLETSACETYL SALICYLIC ACID300MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER7/1/2001
835NDA/MAL/HDP/1614ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDASTAGRA-50SILDENAFIL50MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X4.0 TABLET BLISTER7/1/2011
836NDA/MAL/HDP/1615AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDAPCALIS SXTADALAFIL20MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X2.0 TABLET BLISTER7/1/2005
837NDA/MAL/HDP/1616GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCEZINCETIRIZINE5MG/5MLAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2011
838NDA/MAL/HDP/1618DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMOXYDARAMOXYCILLIN TRIHYDRATE125MG/5MLDAR AL DAWA-NA'UR PLANT AMMAN |JORDAN |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2009
839NDA/MAL/HDP/1629INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 12.5CARVEDILOL12.5MGINTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
840NDA/MAL/HDP/1631AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDNEVIRAPINE ORAL SUSPENSIONNEVIRAPINE50MG/5MLAUROBINDO PHARMA LTD, UNIT III -SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2007
841NDA/MAL/HDP/1635CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.ORITAXIM 1000MG INJECTIONCEFOTAXIME SODIUM1GMCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X1.0 G VIAL7/1/1997
842NDA/MAL/HDP/1636NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDVIGAMOXMOXIFLOXACIN5MG/MLS.A.ALCON COUVREUR N.V-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM |OPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/2013
843NDA/MAL/HDP/1638AMOUN PHARMACEUTICAL COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDFLADAZOLESECNIDAZOLE500MGAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/2005
844NDA/MAL/HDP/1639GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDPANADOL EXTRA WITH OPTIZORBPARACETAMOL + CAFFEINE500MG + 65MGGLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON7/1/2003
845NDA/MAL/HDP/1640GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDALBEN TABLETSALBENDAZOLE400MGMEDREICH LIMITED - UNIT 3-SURVEY NO. 4/3, AVALAHALLI, ANJANAPURA, OFF KANAKAPURA ROAD, BANGALORE-560062 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X500.0 TABLET BLISTER7/1/1999
846NDA/MAL/HDP/1641UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDUNIENZYME C MPSNICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL25MG+50MG+30MG+20MG+75MGUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
847NDA/MAL/HDP/1642UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDEUCHLOR-1000CHLORAMPHENICOL SODIUM SUCCINNATE B.P1GUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA |PARENTERAL ORDINARY VIALS1.0X1.0 G VIAL7/1/2004
848NDA/MAL/HDP/1645ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTAZOLEMEBENDAZOLE100MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA | INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
849NDA/MAL/HDP/1646BETA HEALTHCARE INTERNATIONAL LTDBETA HEALTHCARE UGANDA LIMITEDBETROZOLE TABLETSMETRONIDAZOLE+DILOXANIDE200MG+250MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BLISTER7/1/2002
850NDA/MAL/HDP/1650NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL CR 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | ITALY |ORAL SOLID RETARD TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2006
851NDA/MAL/HDP/1652TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.VALPARIN CHRONO 300SODIUM VALPROATE300MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2009
852NDA/MAL/HDP/1655UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDUNIGENTYLSECNIDAZOLE500MGUNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2010
853NDA/MAL/HDP/1656ANHIUMAISHA MEDICAL SUPPLIES LIMITEDAZIGYL-500AZITHROMYCIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER7/1/2015
854NDA/MAL/HDP/1660GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOCIM-200CIMEDITINE200MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP7/1/2005
855NDA/MAL/HDP/1661ABBVIE (PTY) LTDMEDICAL ACCESS (UGANDA) LIMITEDALUVIA 100/25LOPINAVIR/ RITONAVIR100MG/25MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET CONTAINER7/1/2007
856NDA/MAL/HDP/1663MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDALCID-PINKALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE400MG+400MG/50MLTORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE7/1/2003
857NDA/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 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1998
858NDA/MAL/HDP/1666SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL 1GLIMEPIRIDE1MGSANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICA |SOUTH AFRICA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
859NDA/MAL/HDP/1669SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL 2GLIMEPIRIDE2MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA | SOUTH AFRICA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
860NDA/MAL/HDP/1670SANOFI AVENTISLABOREX UGANDA LIMITEDAMARYL 4GLIMIPIRIDE4MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA | SOUTH AFRICA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
861NDA/MAL/HDP/1673GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMOXILAMOXYCILLIN250MGGLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE |FRANCE |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER7/1/2005
862NDA/MAL/HDP/1676KOPRAN LIMITEDTATA UGANDA LIMITEDCLOXIN-250CLOXACILLIN250MGKOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
863NDA/MAL/HDP/1679LEBEN LABORATORIES PVT. LTDANDYCO PHARMACY (UGANDA) LTDCIPROLEBCIPROFLOXACIN500MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
864NDA/MAL/HDP/1680NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDH-CORTHYDROCORTISONE0.1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
865NDA/MAL/HDP/1681CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 25LOSARTAN POTASSIUM25MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2003
866NDA/MAL/HDP/1682VIRBAC RSA (PTY) LTDMETRO PHARMACEUTICALS LIMITEDTOFLOX-200OFLOXACIN200MGLINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER7/1/2005
867NDA/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
|
INDIA |ORAL SOLID ORDINARY COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
868NDA/MAL/HDP/1690PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE1MG/MLPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2004
869NDA/MAL/HDP/1691WIDE SPECTRUM ENTERPRISES (U) LIMITEDWIDE SPECTRUM ENTERPRISES (U) LIMITEDZITHRORIVAZITHROMYCIN500MGRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT |EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER7/1/2011
870NDA/MAL/HDP/1692PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCEFODOX 50MG/5ML SUSPENSIONCEFPODOXIME PROXETIL50MG/5MLPHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X50.0 ML BOTTLE7/1/2007
871NDA/MAL/HDP/1693PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDOPTIMAL (0.05%) CREAMTRETINOIN USP0.5MG/1GPHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN | JORDAN |TOPICAL EXTERNAL CREAMS1.0X1.0X30.0 G TUBE7/1/2005
872NDA/MAL/HDP/1697PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDFINALLERGCETIRIZINE DIHYDROCHLORIDE10MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
873NDA/MAL/HDP/1698CIPLA LTDQUALITY CHEMICALS LTD - HUMANAZEE-500AZITHROMYCIN500MGCIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIA |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER7/1/2009
874NDA/MAL/HDP/1701KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDFORMINMETFORMIN HYDROCHLORIDE500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2014
875NDA/MAL/HDP/1702PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDDELORCLOBETASOL PROPIONATE0.05%W/WPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |TOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2005
876NDA/MAL/HDP/1704DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE500MG + 125MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59510 CERKEZKOY, TEKIRDAG,TURKEY | TURKEY |ORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2011
877NDA/MAL/HDP/1708LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDDENTAMOLACETAMINOPHEN500MGLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
|
KENYA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1997
878NDA/MAL/HDP/1709REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDLUCIN CREAMHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/1997
879NDA/MAL/HDP/1711KOPRAN LIMITEDTATA UGANDA LIMITEDAMYN-250AMOXYCILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
880NDA/MAL/HDP/1713MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDLUMITERARTEMETHER + LUMEFANTRINE20 MG + 120 MGMACLEODS PHARMACEUTICALS LTD -BLOCK N2, VILLAGE THEDA, P.O. LODHI MAJRA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH 174101 | OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X8.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER7/1/2007
881NDA/MAL/HDP/1715SHELYS PHARMACEUTICALS LTDBETA HEALTHCARE UGANDA LIMITEDMUCOLYN SYRUPAMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMHEXINE50MG+2MG+5MG+4MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | SHELYS PHARMACEUTICALS LTD,-NEW BAGAMOYO ROAD, MWENGE, PLOT NO 696,BLOCK NO 32, P.O.BOX 3016, DAR ES SALAAM | TANZANIA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/1997
882NDA/MAL/HDP/1716NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRMIN 5SMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA | INDIA |PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
883NDA/MAL/HDP/1719NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRMIN 10 PLUSMULTI-INGREDIENTMULTI-INGREDIENTACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
884NDA/MAL/HDP/1723USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT MULTIVITAMIN DROPSMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA |ORAL LIQUID ORDINARY DROPS1.0X15.0 ML BOTTLE7/1/2000
885NDA/MAL/HDP/1724GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAVAMYS NASAL SPRAYFLUTICASONE FUROATE27.5MCG/ACTUATIONGLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK | UNITED KINGDOM |NASAL TOPICAL SPRAYS WITHOUT GAS1.0X120.0 METERED DOSE CANNISTER7/1/2009
886NDA/MAL/HDP/1725REMEDICA LTDGOODMAN INTERNATIONAL LTDMYCORIL CREAM 1%CLOTRIMAZOLE1%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
887NDA/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 HYDROXIDESMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUM | BELGIUM |PARENTERAL ORDINARY VIALS1.0X0.5 ML VIAL (1 DOSE)7/1/1997
888NDA/MAL/HDP/1727MISSION PHARMAJOINT MEDICAL STORE (UPMB - UCMB)TETRACYCLINE HYDROCLORIDETETRACYCLINE HYDROCHLORIDE3%W/WNANJING BAIJINGYN PHARMACEUTICALS CO.LTD NO-1 HUIZHONG ROAD NANJING ECONOMIC AND TECHNICAL DEVELOPMENT ZONE |CHINA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/2014
889NDA/MAL/HDP/1728ARISTO PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDDELISPRIN 75MGASPIRIN75MGARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046 |INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP7/1/2007
890NDA/MAL/HDP/1730COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN500MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2008
891NDA/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 | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
892NDA/MAL/HDP/1732MICRO LABS LTDLABOREX UGANDA LIMITEDCEFEX-250CEPHALEXIN250MGMICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1999
893NDA/MAL/HDP/1734KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMOMINTCOMPOUND MAGNESIUM TRISILICATE500MGTIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA | INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER7/1/1997
894NDA/MAL/HDP/1738ALCON PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.TEARS NATURALE IINATURAL TEARS15MLALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM |OPHTHALMIC DROPS1.0X15.0 ML BOTTLE7/1/1997
895NDA/MAL/HDP/1741AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEOPRED-PPREDNISOLONE ACETATE + NEOMYCIN SULPHATE+ POLYMYXIN-B5MG/ML +5MG/ML + 1M I.U/MLAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
896NDA/MAL/HDP/1745AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIGENGENTAMYCIN SULPHATE0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
897NDA/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.
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2008
898NDA/MAL/HDP/1748GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAZ-500AZITHROMYCIN500MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X3.0 CAPSULE BLISTER7/1/2011
899NDA/MAL/HDP/1750AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIFLOXNORFLOXACIN0.3%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
900NDA/MAL/HDP/1751AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDOPTIFUCINFUSIDIC ACID1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X5.0 ML AMPOULE7/1/2005
901NDA/MAL/HDP/1754AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPIMOLTIMOLOL MALEATE0.5%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X5.0 ML VIAL7/1/2005
902NDA/MAL/HDP/1755MEMPHIS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDDOPAGON TABLETSBROMOCRIPTINE2.5MGMEMPHIS COMPANY--8 EL SAWAH STREET, CAIRO. EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/1999
903NDA/MAL/HDP/1758AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPICORTPREDNISOLONE ACETATE0.12%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
904NDA/MAL/HDP/1759SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.AMLOPINAMLODIPINE5MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER7/1/2004
905NDA/MAL/HDP/1760AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDNEODEXNEOMYCIN +DEXAMETHASONE0.5%W/V + 0.1%W/VAMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OTIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
906NDA/MAL/HDP/1761EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDATAZOR-RATAZANAVIR + RITONAVIR300 MG + 100 MGEMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET BOTTLE7/1/2014
907NDA/MAL/HDP/1762AMMAN PHARMACEUTICAL INDUSTRIESWIDE SPECTRUM ENTERPRISES (U) LIMITEDAPITROPINATROPINE1%W/VAMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN |OPHTHALMIC DROPS1.0X1.0X10.0 ML VIAL7/1/2005
908NDA/MAL/HDP/1763LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDASPIRIN TABLETS BPACETYL SALICYLIC ACID300MGLABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBI |KENYA |ORAL SOLID ORDINARY TABLETS1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1997
909NDA/MAL/HDP/1764JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDFRESH BURST LISTERINEALCOHOL + THYMOL95 % W/V + 12 MGJOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794
|
SOUTH AFRICA |ORAL LIQUID ORDINARY LIQUIDS1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER7/1/2006
910NDA/MAL/HDP/1765UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDRILIF PLUSACECLOFENAC + PARACETAMOL100MG + 500MGUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
911NDA/MAL/HDP/1766RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCOLDEASE CAPSULESPARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE400MG+30MG+4MG+30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2005
912NDA/MAL/HDP/1767EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES -WIDE SPECTRUM ENTERPRISES (U) LIMITEDPROSTEROLALFUZOSIN HYDROCHLORIDE10MGEVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2013
913NDA/MAL/HDP/1768BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDULTIVA INJECTION 2MGREMIFENTANIL2MGGLAXOSMITHKLINE MANUFACTURING SPA ,.,-STRADA PROVINCIALE ASOLANA, 90-43056, S.POLO DI TORRILE (PARMA) | ITALY |PARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON7/1/1999
914NDA/MAL/HDP/1769GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDENGERIX-B VACCINEHEPATITIS B SURFACE ANTIGEN10MCG/MLGLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART |BELGIUM |PARENTERAL ORDINARY VIALS1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE)7/1/1997
915NDA/MAL/HDP/1771MISSION PHARMA A/SJOINT MEDICAL STORE (UPMB - UCMB)ORAL REHYDRATION SALTS BPMULTI-INGREDIENTMULTI-INGREDIENTMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
|
INDIA |ORAL LIQUID ORDINARY UNIT DOSE POWDERS1.0X100.0X20.5 G SACHET7/1/2010
916NDA/MAL/HDP/1772SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDGESTID TABLETSCOMPOUND MAGNESIUM TRISILICATE385MGSUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET BLISTER7/1/2000
917NDA/MAL/HDP/1773MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT 500LEVOFLOXACIN HEMIHYDRATE500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2005
918NDA/MAL/HDP/1777CIPLA LTD.QUALITY CHEMICALS LTD - HUMANNUZAC 20FLUOXETINE20MGCIPLA LTD ..-PLOT NO. 910 & 15 INDORE SPECIAL ECONOMIC ZONE PHASE II PITHAMPUR DISTRICT DHAR MADHYA PRADESH 454775 | CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2003
919NDA/MAL/HDP/1778PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCONCIL 500MG CAPSULESAMOXYCILLIN TRIHYDRATE500MGPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
|
EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER7/1/1998
920NDA/MAL/HDP/1779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SOLUTIONPOVIDONE IODINE10.0G/100MLBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN |
PAKISTAN |TOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE7/1/2006
921NDA/MAL/HDP/1780RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENETRIM SUSPENSIONCO-TRIMOXAZOLE240MG/5MLRENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKA |UGANDA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE7/1/2000
922NDA/MAL/HDP/1781ASTRAZENECAMACNAUGHTON LIMITEDARIMIDEXANASTROZOLE1MGASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE | UNITED STATES |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2000
923NDA/MAL/HDP/1782GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINEPER 5ML: 15MG + 90MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
924NDA/MAL/HDP/1783LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLAEOVATE OINTMENTBETAMETHASONE VALERATE0.1%W/WLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X1.0X15.0 G TUBE7/1/1997
925NDA/MAL/HDP/1784MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAZICURE-500AZITHROMYCIN500MGMACLEODS PHARMACEUTICALS LIMITED (BLOCK ?N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER7/1/2005
926NDA/MAL/HDP/1785BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDACTION TABLETSACETYL SALICYLATE + CAFFEINE + PARACETAMOL600MG+50MG+300MGBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER7/1/1997
927NDA/MAL/HDP/1786GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGONAC TABLETS (THANE)DICLOFENAC50MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2001
928NDA/MAL/HDP/1790REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNITRIM TABLETCO-TRIMOXAZOLE480MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1997
929NDA/MAL/HDP/1792DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDLIPODARATORVASTATIN20MGDAR AL DAWA-NA'UR PLANT AMMAN |JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
930NDA/MAL/HDP/1793MACNAUNGHTON LIMITEDMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL80MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X60.0 DOSE CANNISTER7/1/2001
931NDA/MAL/HDP/1795KOPRAN LIMITEDTATA UGANDA LIMITEDAMPIK-250AMPICILLIN250MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/1997
932NDA/MAL/HDP/1796AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDZAHA 250AZITHROMYCIN250 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER7/1/2006
933NDA/MAL/HDP/1797KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTDTATA UGANDA LIMITEDAMPICILLIN+CLOXACILLINAMPICILLIN + CLOXACILLIN250 MG + 250 MGKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X10.0X500.0 MG VIAL7/1/2010
934NDA/MAL/HDP/1798INTAS PHARMACEUTICALS LIMITEDNORVIK ENTERPRISES LIMITEDCARDITAS RETARDNIFEDIPINE20MGINTAS PHARMACEUTICALS LTD, VATVA-7/3 G.I.D.C. ESTATE, PHASE-1, B/H DENA BANK VATVA, AHMEDABAD-382 445 GUJARAT, INDIA
| INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA |
INDIA |ORAL SOLID RETARD FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/1997
935NDA/MAL/HDP/1799INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDSECZOL DSSECNIDAZOLE1GMINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2001
936NDA/MAL/HDP/1800MICRO LABS LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAMLONG-10AMLODIPINE5MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2009
937NDA/MAL/HDP/1801LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDLABESTEN PESSARIESCLOTRIMAZOLE100MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI |KENYA |VAGINAL TABLETS1.0X1.0X6.0 PESSARY STRIP7/1/1997
938NDA/MAL/HDP/1803ASTRA ZENECA ABMACNAUGHTON LIMITEDNEXIUM 40MGESOMEPRAZOLE40MGASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLM |SWEDEN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON7/1/2001
939NDA/MAL/HDP/1804TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.LISTRILLISINOPRIL5MGTORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2001
940NDA/MAL/HDP/1805MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 1000MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2014
941NDA/MAL/HDP/1806BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUMOX PAMOXYCILLIN125MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0X2.0 TABLET STRIP7/1/2000
942NDA/MAL/HDP/1807GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAMPICLOX NEONATAL DROPSAMPICILLIN + CLOXACILLIN60 MG / 0.6 ML + 30 MG / 0.6 MLMEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X8.0 ML BOTTLE7/1/1997
943NDA/MAL/HDP/1808ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTACIDMAGNESIUM TRISILICATE370MGASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA |
INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
944NDA/MAL/HDP/1809GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOVIT-6PYRIDOXINE25MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
945NDA/MAL/HDP/1810GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOTRITRIFLUOPERAZINE5MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2010
946NDA/MAL/HDP/1811CIPLA LTDQUALITY CHEMICALS LTD - HUMANDUOVIR TABLETSZIDOVUDINE+ LAMIVUDINE300MG + 150MGCIPLA LTD---PLOT NO. 143 AND L-144A VERNA IND. ESTATE SALCETTE GOA 403 722 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE7/1/2001
947NDA/MAL/HDP/1812RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDREQUIN TABLETSQUININE SULPHATE300MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2001
948NDA/MAL/HDP/1813DAWA LIMITEDSUPER MEDIC LTDMOXAFORTEAMOXICILLIN + FLUCLOXACILLIN125 MG + 125MGDAWA LTD-BABA DOGO ROAD RUARAKA |KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2014
949NDA/MAL/HDP/1816MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDDRESS UP CREAMNEOMYCIN SULPHATE0.5%W/WTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X30.0 G TUBE7/1/1998
950NDA/MAL/HDP/1821BLUE CROSS LABORATORIES LTDSTAR PHARMACEUTICALS LTDMEFTAL 500 TABLETSMEFENAMIC ACID500MGBLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/1997
951NDA/MAL/HDP/1822RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDEPHEDRINEEPHEDRINE HYDROCHLORIDE30MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2005
952NDA/MAL/HDP/1825RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDCOLDEASE SYRUPPARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE120MG+2MG+15MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2005
953NDA/MAL/HDP/1827REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDALBASOL SUSPENSIONALBENDAZOLE200MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X10.0 ML BOTTLE7/1/2006
954NDA/MAL/HDP/1828ASTRAZENECAMACNAUGHTON LIMITEDTENORETATENOLOL + CHLORTHALIDONE50 MG + 12.5 MGASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/1997
955NDA/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. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2011
956NDA/MAL/HDP/1838INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDABZEEALBENDAZOLE400MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER7/1/2004
957NDA/MAL/HDP/1840REMEDICA LTDGOODMAN INTERNATIONAL LTDOVA-MITCLOMIPHENE50MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2011
958NDA/MAL/HDP/1841MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDFUNGNIL CREAMCLOTRIMAZOLE1%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
959NDA/MAL/HDP/1842KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDSUGAQUIN TABLETSCHLOROQUINE PHOSPHATE250MGKAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDA |UGANDA |ORAL SOLID ORDINARY OTHER COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2002
960NDA/MAL/HDP/1843USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDECORIN-75ASPIRIN75MGREMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
961NDA/MAL/HDP/1844GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM800MG /160MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
962NDA/MAL/HDP/1846LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDANTAGIT DS GEL ORANGE FLAVOURALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE400MG + 400MG + 50MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X170.0 ML BOTTLE7/1/2013
963NDA/MAL/HDP/1847LEBEN LABORATORIES PVT. LTD., INDIAANDYCO PHARMACY (UGANDA) LTDMOXILEB-250 CAPSULEAMOXICILLIN250MGLEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2007
964NDA/MAL/HDP/1848LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDPARATALPARACETAMOL500MGLABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
965NDA/MAL/HDP/1849ABACUS PARENTERAL DRUGS LIMITEDABACUS PARENTERAL DRUGS LIMITEDCIFINCIPROFLOXACIN0.2%W/VABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
|
UGANDA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2011
966NDA/MAL/HDP/1850RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDALZOL TABLETSALBENDAZOLE400MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER7/1/2010
967NDA/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 | INDIA |TOPICAL EXTERNAL EMULSION GELS1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE7/1/2011
968NDA/MAL/HDP/1854ROYAL PHARMA 2011 LIMITEDROYAL PHARMA 2011 LIMITEDFUROSEMIDE INJECTIONFUROSEMIDE10MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE7/1/2004
969NDA/MAL/HDP/1855INTERMEDROYAL PHARMA 2011 LIMITEDQUININE SULPHATEQUININE SULPHATE300MGAFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED (755793)-PLOT 9-12,DEWAN & SONS INDUSTRIAL. AREA, VEOOR,PALGHAR-401404. INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2004
970NDA/MAL/HDP/1856COSMOS LTDASTRA PHARMA (U) LIMITEDPROPRANOLOL TABLETS B.P. 40MGPROPRANOLOL HYDROCHLORIDE40MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
971NDA/MAL/HDP/1861GUILIN PHARMACEUTICALS CO LTDSTAR PHARMACEUTICALS LTDSULFAMETHOXAZOLE / TRIMETHOPRIMSULFAMETHOXAZOLE / TRIMETHOPRIM400MG /80MGGUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
972NDA/MAL/HDP/1863AMOUN PHARMACEUTICALS COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDORACURE GELLIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE2 GM+0.1 GMAMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT |ORAL TOPICAL GELS AND SOLS1.0X15.0 G TUBE7/1/2004
973NDA/MAL/HDP/1864NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDPATANOLOLOPATADINE HYDROCHLORIDE0.1%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM |OPHTHALMIC DROPS1.0X5.0 ML VIAL7/1/2009
974NDA/MAL/HDP/1865FDC LTDAIVEEN (U) LIMITEDMYCODERM-C POWDERCLOTRIMAZOLE1%W/WFDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA |TOPICAL EXTERNAL POWDERS1.0X75.0 G CONTAINER7/1/2014
975NDA/MAL/HDP/1866JASSEN-CILAG (PTY) LTDLABOREX UGANDA LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE |SOUTH AFRICA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1997
976NDA/MAL/HDP/1873MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDJANUMETSITAGLIPTIN + METFORMIN HYDROCHLORIDE50MG + 850MGAESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM | UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS1.0X4.0X14.0 TABLET BLISTER7/1/2014
977NDA/MAL/HDP/1877RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMINT-O-COOLDRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE120MG + 250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2007
978NDA/MAL/HDP/1879SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPENIVPHENOXYMETHYL PENICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
979NDA/MAL/HDP/1880SPARSH BIO-TECH PVT. LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCLOXAMPICILLIN + CLOXACILLIN250 MG + 250 MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2004
980NDA/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.
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2004
981NDA/MAL/HDP/1882SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN250MGSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2004
982NDA/MAL/HDP/1887KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMADOLPARACETAMOL500MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
983NDA/MAL/HDP/1889KAMPALA PHARMACEUTICAL INDUSTRIES LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PREDSOLPREDNISOLONE5MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON7/1/1997
984NDA/MAL/HDP/1891MACLEODS PHARMACEUTICAL LTDNORVIK ENTERPRISES LIMITEDLEVOMAC 500LEVOFLOXACIN500MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X20.0X5.0 TABLET BLISTER7/1/2005
985NDA/MAL/HDP/1894KOPRAN LIMITEDTATA UGANDA LIMITEDTRIM-480CO-TRIMOXAZOLE480MGKOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
986NDA/MAL/HDP/1895GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTRIMAGO (PAEDIATRIC)CO-TRIMOXAZOLE100MG/20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2007
987NDA/MAL/HDP/1898WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDZAPACID - 30LANSOPRAZOLE30MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR
PRADESH - INDIA
|
INDIA |ORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER7/1/2001
988NDA/MAL/HDP/1900GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOM 20OMEPRAZOLE20MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP7/1/2007
989NDA/MAL/HDP/1901AJANTA PHARMA LTD 31-0ABACUS PHARMA (AFRICA) LIMITEDIBUMOLIBUPROFEN + PARACETAMOL100MG + 162.5 MG /5MLAJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE |INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2013
990NDA/MAL/HDP/1902KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMODIUMLOPERAMIDE HYDROCHLORIDE2MGKAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
991NDA/MAL/HDP/1903DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 100ARTEMETHER100MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY |PARENTERAL ORDINARY I M AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2007
992NDA/MAL/HDP/1906ACG PHARMAPACK PVT. LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDEFAVIRENZ TABLETS 600MGEFAVIRENZ600MGCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA | UGANDA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
993NDA/MAL/HDP/1907CIPLA LTDQUALITY CHEMICALS LTD - HUMANABACAVIRABACAVIR300MGCIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220, DIST- RAIGAD, MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2004
994NDA/MAL/HDP/1911COSMOS LTDASTRA PHARMA (U) LIMITEDCODEINE PHOSPHATE TABLETS BP 30CODEINE PHOSPHATE30MGCOSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1998
995NDA/MAL/HDP/1912MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDD-WORMALBENDAZOLE200MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/2008
996NDA/MAL/HDP/1914RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCHLORPHENIRAMINECHLORPHENIRAMINE4MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2003
997NDA/MAL/HDP/1915HETERO LABS LTDAIVEEN (U) LIMITEDATAZANAVIR SULPHATE + RITONAVIRATAZANAVIR SULPHATE + RITONAVIR300 MG + 100 MGHETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH , | HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2013
998NDA/MAL/HDP/1918UNIVERSAL CORPORATION LTDHARLEYS UGANDA LIMITEDUNIVIRACYCLOVIR200MGUNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYA |KENYA |ORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET STRIP7/1/2010
999NDA/MAL/HDP/1921SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.ANTIMINLORATIDINE10MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2005
1000NDA/MAL/HDP/1922IPCA LABORATORIES LIMITEDMEDVIN PHARMA LIMITEDAZIFAST-500AZITHROMYCIN500MG IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X3.0 TABLET BLISTER7/1/2007
1001NDA/MAL/HDP/1923GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBETAMETHASONEBETAMETHASONE0.1%W/WGALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
1002NDA/MAL/HDP/1924ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDAMPICILLIN SODIUMAMPICILLIN SODIUM500MGCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL7/1/2013
1003NDA/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 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2014
1004NDA/MAL/HDP/1927REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDINTAPLEX TABLETVITAMIN B COMPOUNDN/AREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
1005NDA/MAL/HDP/1928STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDNEUTRAFLUXALGINIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE200MG + 250MG +250MG +250MG + 125MGSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
1006NDA/MAL/HDP/1929CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDATORVA 40ATORVASTATIN40MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2012
1007NDA/MAL/HDP/1931ASTRAZENECAMACNAUGHTON LIMITEDZOLADEX LAGOSERELIN ACETATE10.8MGASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM |PARENTERAL RETARD PRE-FILLED SYRINGES1.0X10.8 MG IMPLANT7/1/2010
1008NDA/MAL/HDP/1932ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDCANDISTAT CREAMCLOTRIMAZOLE1%W/WELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
|
KENYA |ORAL TOPICAL CREAMS1.0X20.0 G TUBE7/1/2001
1009NDA/MAL/HDP/1934RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENECHLOR SUSPENSIONCHLORAMPHENICOL125MG/5MLRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2001
1010NDA/MAL/HDP/1935NABIQASIM INDUSTRIES (PVT) LTD.JEET PHARMACEUTICALS LIMITEDSULPHA KREAM-NSULPHANILAMIDE15%W/WNABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN |TOPICAL EXTERNAL CREAMS1.0X1.0X80.0 G TUBE7/1/2006
1011NDA/MAL/HDP/1936GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON EXPECTORANTCHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDEMULTINGREDIENTGLAXO WELLCOME (KENYA) LTD-KENYA |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1012NDA/MAL/HDP/1937AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDEFAVIRENZEFAVIRENZ600MGAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2005
1013NDA/MAL/HDP/1940REMEDICA LTDGOODMAN INTERNATIONAL LTDCLOXACILLIN CAPSULESCLOXACILLIN SODIUM250MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER7/1/2001
1014NDA/MAL/HDP/1941CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.RABELOC IVRABEPRAZOLE20MG/VIALCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL7/1/2005
1015NDA/MAL/HDP/1942RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDAMCLORENAMPICILLIN + CLOXACILLIN250 MG + 250 MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X100.0 CAPSULE CONTAINER7/1/2009
1016NDA/MAL/HDP/1943MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDNITROCONTIN 2.6NITROGLYCERIN (CONTROLLED RELEASE)2.6MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA |ORAL SOLID RETARD TABLETS1.0X25.0 TABLET CONTAINER7/1/2009
1017NDA/MAL/HDP/1946WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDSOLUDOL TABLETSDICLOFENAC SODIUM50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR
PRADESH - INDIA
|
INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS10.0X10.0 TABLET STRIP7/1/1998
1018NDA/MAL/HDP/1948PFIZER LABORATORIES PTY LTDLABOREX UGANDA LIMITEDZITHROMAXAZITHROMYCIN DIHYDRATE500MGHAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | PFIZER LABORATORIES (PTY) LTD;--SOUTH AFRICA | SOUTH AFRICA |ORAL SOLID ORDINARY TABLETS1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER7/1/1998
1019NDA/MAL/HDP/1949MACLEODS PHARMACEUTICALS LTDS LTDNORVIK ENTERPRISES LIMITEDTRENAXA 500TRANEXAMIC ACID500MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X6.0 TABLET BLISTER7/1/2011
1020NDA/MAL/HDP/1951MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCLOPI 75CLOPIDOGREL75MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP7/1/2006
1021NDA/MAL/HDP/1952JOHNSON &JOHNSON (PTY) LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNIZORALKETOCONAZOLE20MG/GSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE |SOUTH AFRICA |TOPICAL EXTERNAL LIQUID SOAPS/WASHES1.0X80.0 ML BOTTLE7/1/1997
1022NDA/MAL/HDP/1954: ALKEM LABORATORIES LIMITED?ABACUS PHARMA (AFRICA) LIMITEDRAPEED-20RABEPRAZOLE20MGALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP7/1/2011
1023NDA/MAL/HDP/1956MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN250MGMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
|
INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2006
1024NDA/MAL/HDP/1958MILAN LABORATORIES LTDGITTOES PHARMACEUTICALS LIMITEDMILOXYAMOXYCILLIN125MG/5MLMILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
|
INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2005
1025NDA/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).
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1026NDA/MAL/HDP/1960KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDDIFENACDICLOFENAC SODIUM50MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2003
1027NDA/MAL/HDP/1962BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDNIMBEXCISATRACURIUM BESYLATE2MG/MLGLAXOSMITHKLINE S.P.A -STRADA PROVINCIALE ASOLANA 9 |ITALY |PARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL,1.0X2.5 ML VIAL7/1/1997
1028NDA/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).
|
INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2007
1029NDA/MAL/HDP/1966MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDPARACINPARACETAMOL500MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1030NDA/MAL/HDP/1969NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SR 75MGDICLOFENAC SODIUM75MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA | ITALY |ORAL SOLID RETARD TABLETS1.0X30.0 TABLET CONTAINER7/1/1997
1031NDA/MAL/HDP/1970MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDCETRAMACCETIRIZINE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1032NDA/MAL/HDP/1971GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMPICLOX ORAL SUSPENSIONAMPICILLIN + CLOXACILLIN125 MG/5ML + 125 MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
1033NDA/MAL/HDP/1974SAKAR HEALTH CARE PVT .LTDROYAL PHARMA 2011 LIMITEDCEFROTILCEFUROXIME AXETIL500MGSAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2013
1034NDA/MAL/HDP/1975LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDBET-CODERM NBETAMETHASONE + NEOMYCIN0.1 W/W + 0.5 W/WLINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
|
INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1035NDA/MAL/HDP/1977UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDLOSA-HLOSARTAN + HYDROCHLOROTHIAZIDE50MG + 12.5MGUNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1036NDA/MAL/HDP/1984ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDCIALISTADALAFIL20MGLILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRID | SPAIN |ORAL SOLID ORDINARY TABLETS2.0X2.0 TABLET BLISTER7/1/2004
1037NDA/MAL/HDP/1988KUNMING PHARMACEUTICALS CORPSINO AFRICA MEDICINES & HEALTH LTDARTEMEDINE INJECTIONARTEMETHER80MG/MLKUNMING PHARMACEUTICAL CORP.-QIGONGLI, WEST SURBURB, KUNMING 650106 - YUNNAM PROVINCE, P.R. CHINA | CHINA |PARENTERAL ORDINARY I M AMPOULES1.0X0.5 ML AMPOULE7/1/1999
1038NDA/MAL/HDP/1989FERRER INTERNACIONAL S.ALABOREX UGANDA LIMITEDDERMOFIXSERTACONAZOLE NITRATE2%W/WFERRER INTERNATIONAL, S.A.-C/JOAN BUSCALLA, 1-9.08173 SANT CUGAT DEL VALLES, BARCELONA | SPAIN |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2014
1039NDA/MAL/HDP/1990UNICHEM LABORATORIES LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDTAGERA FORTESECNIDAZOLE1GUNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X1.0X2.0 TABLET BLISTER7/1/2005
1040NDA/MAL/HDP/1997GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDTENA-100ATENOLOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER7/1/2011
1041NDA/MAL/HDP/1998M.J.BIOPHARM PVT LTDTATA UGANDA LIMITEDTEICO 500CEFEPIME500MGM.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X500.0 MG VIAL7/1/2013
1042NDA/MAL/HDP/1999TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CARBATOL 200CARBAMAZEPINE200MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER7/1/2000
1043NDA/MAL/HDP/2000TORRENT PHARAMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.CALCIGARD RETARDNIFEDIPINE(SR)20MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA |ORAL SOLID RETARD TABLETS10.0X10.0 TABLET BLISTER7/1/2000
1044NDA/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 | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X15.0 CAPSULE BLISTER7/1/2008
1045NDA/MAL/HDP/2005AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDKAMAGRA-100SILDENAFIL CITRATE100MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET BLISTER7/1/2005
1046NDA/MAL/HDP/2007GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDB-COX TABLETSVITAMIN B COMPLEXBCP FORMULAAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2001
1047NDA/MAL/HDP/0510GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDLIZOLID-600LINEZOLID600MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X4.0 TABLET STRIP7/1/2004
1048NDA/MAL/HDP/2009COSMOS LTDASTRA PHARMA (U) LIMITEDZITHROXAZITHROMYCIN200MG/5MLCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
1049NDA/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. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER,1.0X10.0X1.0X4.0 TABLET BLISTER7/1/2013
1050NDA/MAL/HDP/0857GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V6 VAGINAL TABLETSCLOTRIMAZOLE100MGGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |VAGINAL TABLETS1.0X6.0 PESSARY STRIP7/1/2000
1051NDA/MAL/HDP/2014SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDCANI-MAKSCLOTRIMAZOLE1%W/W S KANT HEALTHCARE LTD-1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE7/1/2009
1052NDA/MAL/HDP/1099GLENMARK PHARMACEUTICAL LTD.STAR PHARMACEUTICALS LTDMOMATE F CREAMFUSIDIC ACID+MOMETASONE FUROATE2.1%W/W + 0.1W/WGLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESH |INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2012
1053NDA/MAL/HDP/2018CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDORAXIN SYRUPCYPROHEPTADINE+TRICHOLINE CITRATE2MG+275MGCENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1054NDA/MAL/HDP/2019GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOHALHALOPERIDOL10MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
1055NDA/MAL/HDP/2020KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDQUINEQUININE SULPHATE300MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER7/1/1997
1056NDA/MAL/HDP/2021PHARCO PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDPREGVIT ZINCMULTIVITAMIN/MINERALSMULT-INGREDIENTPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
|
EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X12.0X2.0 CAPSULE BLISTER7/1/2000
1057NDA/MAL/HDP/2022MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDTORACTINCYPROHEPTADINE2MG/5MLTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1997
1058NDA/MAL/HDP/2024TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.NEXPRO - 40ESOMEPRAZOLE MAGNESIUM TABLET40MGTORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
1059NDA/MAL/HDP/2025REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDFERRO-B COMPLEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1060NDA/MAL/HDP/2026BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDCORAM 10MGAMLODIPINE BESYLATE10MGBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN |
PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER7/1/2009
1061NDA/MAL/HDP/2027UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDCO-ANGINET 160/12.5MGVALSARTAN + HYDROCHLOROTHIAZIDE160MG + 12.5MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2013
1062NDA/MAL/HDP/2028SEARLE PAKISTAN LIMITEDHEALTHCARE LTD.SELANZ - SRLANSOPRAZOLE30MGSEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY CAPSULES1.0X1.0X7.0 CAPSULE BLISTER7/1/2005
1063NDA/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)
|
INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2014
1064NDA/MAL/HDP/2031GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOZID TABLETSISONIAZID100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2004
1065NDA/MAL/HDP/2033MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDANGIZAAR-50LOSARTAN POTASSIUM50MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2009
1066NDA/MAL/HDP/2035KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDNEOSIDARSULPHADOXINE + PYRIMETHAMINE500MG + 25MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL SOLID ORDINARY TABLETS1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER7/1/2004
1067NDA/MAL/HDP/2036ELI-LILLY (SUISSE) SALABOREX UGANDA LIMITEDHUMULIN REGULARHUMAN INSULIN100IUELI LILLY & COMPANY-LILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221 | LILLY FRANCE SA-FRANCE | FRANCE |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE7/1/1998
1068NDA/MAL/HDP/2040AJANTA PHARMA LIMITEDABACUS PHARMA (AFRICA) LIMITEDARTEFAN 20/120ARTEMETHER + LUMEFANTRINE20 MG + 120 MGAJANTA PHARMA LIMITED PAITHAN-MANUFACTURING UNIT B-4/5/6 MIDC PAITHAN DISTRICT AURANGABAD 431 148 MAHARASTRA STATE INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0X12.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER7/1/2006
1069NDA/MAL/HDP/2041IDAKIMSY MEDS LTDOXYTOCINOXYTOCIN10IUGLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA | GLAND PHARMA LTD-PLOT NO. 42 TO 52, SY NO. 166, 171, 172 & 177, TSIIC, PHASE III, PASHAMYLARAM (V) PATANCHERU (M), MEDAK DISTRICT 502307, TELANGANA STATE | INDIA |PARENTERAL 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
1070NDA/MAL/HDP/2042NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDBURNCURESILVER SULFADIAZINE1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL CREAMS1.0X200.0 G TUBE,1.0X15.0 G TUBE7/1/1997
1071NDA/MAL/HDP/2043COSMOS LTDASTRA PHARMA (U) LIMITEDDIASTOP TABLETSATTAPULGITE/ ALUMINIUM HYDROXIDEN/ACOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X25.0X4.0 TABLET STRIP7/1/1998
1072NDA/MAL/HDP/2045ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDBUPICANBUPIVACAINE0.5% W/VCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARAT |INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2006
1073NDA/MAL/HDP/2046COSMOS LTDASTRA PHARMA (U) LIMITEDLORHISTINALORATADINE10MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
1074NDA/MAL/HDP/2047MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDRITONAVIRRITONAVIR100MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE7/1/2011
1075NDA/MAL/HDP/2049WOCKHARDT LTDSTAR PHARMACEUTICALS LTDKEFSTAR-500CEFUROXIME AXETIL500MGSANCE LABORATORIES PVT LTD-VI/51B, P.B. NO.2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X4.0 TABLET STRIP,1.0X1.0X10.0 TABLET BLISTER7/1/2005
1076NDA/MAL/HDP/2051GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON TABLETSCHLORPHENIRAMINE MALEATE4MGGLAXO WELLCOME (KENYA) LTD-KENYA |KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
1077NDA/MAL/HDP/2053EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDASOMEX-5AMLODIPINE BESILATE5MGEMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2005
1078NDA/MAL/HDP/2055GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDARTESUNARTESUNATE120MGGUILIN PHARMACEUTICAL CO. LTD.-NO. 43 QILIDIAN ROAD, GUILIN 541004 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X120.0 MG VIAL + 1 *2 ML AMPOULE OF 5% SODIUM BICARBONATE SOLUTION + 1*10 ML AMPOULE OF 0.9% SODIUM CHLORIDE7/1/2011
1079NDA/MAL/HDP/2056WOCKHARDT LTDSTAR PHARMACEUTICALS LTDBRO-ZEDEXTERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL1.25MG+ 4 MG+50 MG+2.5 MG/5 MLWOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1080NDA/MAL/HDP/2058MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDQUININE SULPHATEQUININE SULPHATE300MGMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2006
1081NDA/MAL/HDP/2063BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROGYNON FELEVONORGESTREL / ETHINYLESTRADIOL.0.15MG / 0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X1.0X28.0 TABLET BLISTER7/1/1997
1082NDA/MAL/HDP/2066REMEDICA LTDGOODMAN INTERNATIONAL LTDMETHOTREXATEMETHOTREXATE2.5MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1083NDA/MAL/HDP/2067UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDZYNCETCETIRIZINE DIHYDROCHLORIDE10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X5.0X10.0 TABLET BLISTER7/1/1999
1084NDA/MAL/HDP/2068UNICHEM LABORATORIES LTDEUROPA HEALTHCARE (U) LTDDOMADOLTRAMADOL HYDROCHLORIDE50MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/1999
1085NDA/MAL/HDP/2069SK AGE EXPORTSABACUS PHARMA (AFRICA) LIMITEDSK DERMBETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN0.05%W/W + 1%W/W + 0.1%W/W S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2010
1086NDA/MAL/HDP/2071CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR DRY SYRUPCEFALEXIN125MG/5MLCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2000
1087NDA/MAL/HDP/2073SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES VACCINE LIVE ATTENUATED(FREEZE-DRIED)MEASLES VIRUSNOT LESS THAN 1000CCID50/ DOSESERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 DOSE VIAL + 0.5ML AMPOULE OF STERILE WATER FOR INJECTION,1.0X10.0 DOSE VIAL + 5ML AMPOULE OF STERILE WATER FOR INJECTION7/1/1997
1088NDA/MAL/HDP/2074GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOXIN ORAL SUSPENSIONAMOXYCILLIN TRIHYDRATE125MG/5MLMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
1089NDA/MAL/HDP/2075GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOPREDPREDNISOLONE5MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER7/1/2006
1090NDA/MAL/HDP/2076GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMIDEFUROSEMIDE40MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER7/1/2006
1091NDA/MAL/HDP/2077ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDAMBRODILAMBROXOL HYDROCHLORIDE30MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2007
1092NDA/MAL/HDP/2078LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDALCLOX SYRUPCLOXACILLIN SODIUM125MG/5MLLEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA |INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
1093NDA/MAL/HDP/2079GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDNETRAVIRACICLOVIR5%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA | INDIA |TOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE7/1/2005
1094NDA/MAL/HDP/2080GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDBETAMETHASONE VALERATEBETAMETHASONE VALERATE0.1%W/VGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
|
INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2009
1095NDA/MAL/HDP/2083BIOLOGICAL E. LTDGITTOES PHARMACEUTICALS LIMITEDBEVACPURIFIED HEPATITIS B SURFACE ANTIGEN20MCGBIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA |PARENTERAL ORDINARY VIALS1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL)7/1/2015
1096NDA/MAL/HDP/2087ABBVIE LOGISTICS BVMEDICAL ACCESS (UGANDA) LIMITEDNORVIRRITONAVIR100MGABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET BOTTLE7/1/2013
1097NDA/MAL/HDP/2089HOVID BHDUNITED HEALTHCARE DISTRIBUTORS LTDDIABETMIN XR 500MGMETFORMIN HCL EXTENDED RELEASE500MGHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA |ORAL SOLID ORDINARY OTHER COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2013
1098NDA/MAL/HDP/2090RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDCIPRORENCIPROFLOXACIN500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1099NDA/MAL/HDP/2091KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDCAMSTONCLOTRIMAZOLE1%W/WKPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDA |UGANDA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2001
1100NDA/MAL/HDP/2092CIPLA LTD.QUALITY CHEMICALS LTD - HUMANDUOVIR-NLAMIVUDINE + ZIDOVUDINE + NEVIRAPINE150MG + 300MG + 200MGCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE,1.0X60.0 TABLET BOTTLE7/1/2004
1101NDA/MAL/HDP/2093CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.TRIGAN-D TABLETPARACETAMOL + DICYCLOMINE500MG + 20MGCADILA PHARMACEUTICALS LIMITED-1389, TRASAD ROAD, DHOLKA- 382225, DIST: AHMEDAD, GUJARAT STATE, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP7/1/1999
1102NDA/MAL/HDP/2094MICRO LABS LTDLABOREX UGANDA LIMITEDLEVOBACT-750LEVOFLOXACIN HEMIHYDRATE750MGMICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
1103NDA/MAL/HDP/2095GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOMOLPARACETAMOL100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2010
1104NDA/MAL/HDP/2097LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDALCLOXCLOXACILLIN250MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2011
1105NDA/MAL/HDP/2098GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGO QUININEQUININE SULPHATE300MGAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2006
1106NDA/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 |
MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/1998
1107NDA/MAL/HDP/2100MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDORALCON - FLEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE0.15MG + 0.03MG + 75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X28.0 TABLET BLISTER7/1/2007
1108NDA/MAL/HDP/2101COSMOS LTDASTRA PHARMA (U) LIMITEDCARDISPRINACETYL SALICYLIC ACID75MGCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
1109NDA/MAL/HDP/2102MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 625AMOXYCILLIN + CLAVULANATE POTASSIUM500 MG + 125 MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2006
1110NDA/MAL/HDP/2103MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 1000 TABAMOXYCILLIN + CLAVULANATE POTASSIUM875 MG + 125 MGMEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2006
1111NDA/MAL/HDP/2104MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE/NEVIRAPINE /ZIDOVUDINE DISPERSIBLE TABLETSLAMIVUDINE + NEVIRAPINE + ZIDOVUDINE30MG + 50MG + 60MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X60.0 TABLET BOTTLE7/1/2009
1112NDA/MAL/HDP/2111HETERO LABS LTDAIVEEN (U) LIMITEDLOPINAVIR / RITONAVIRLOPINAVIR / RITONAVIR200MG /50MGHETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2011
1113NDA/MAL/HDP/2112MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLOPINAVIR + RITONAVIRLOPINAVIR + RITONAVIR200MG + 50MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2008
1114NDA/MAL/HDP/2114AXA PARENTERALS LTDGITTOES PHARMACEUTICALS LIMITEDAXA-LEVOLEVOFLOXACIN HEMIHYDRATE500MG/100MLAXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA. |
INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML VIAL7/1/2015
1115NDA/MAL/HDP/2116MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDAMLOVAS-10AMLODIPINE BESILATE10MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET STRIP7/1/2005
1116NDA/MAL/HDP/2118AVENTIS PHARMA (PTY) LTD SOUTH AFRICALABOREX UGANDA LIMITEDRIFAFOURE E-275RIFAMPICIN+ISONIAZID+PYRAZINAMIDE+ETHAMBUTOL150MG+75MG+400MG+275MGAVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA | SOUTH AFRICA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X20.0 TABLET BLISTER7/1/2005
1117NDA/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. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0X1.0 G VIAL7/1/2011
1118NDA/MAL/HDP/2123VHB MEDI SCIENCES LTDLLOYDS PHARMACY LIMITEDPLATFIRSTCISPLATIN1MG/MLVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X50.0 ML VIAL7/1/2014
1119NDA/MAL/HDP/2125CIPLA LTDQUALITY CHEMICALS LTD - HUMANBECLATE 100BECLOMETASONE100MCG/DOSECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |NASAL SYSTEMIC METERED-DOSE LIQUIDS1.0X200.0 METERED DOSE CANNISTER7/1/2009
1120NDA/MAL/HDP/2128HILTON PHARMA (PVT) LTDHEALTHCARE LTD.TRANSAMIN INJECTION 500MGTRANEXAMIC ACID500MG/5MLHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI |PAKISTAN |PARENTERAL ORDINARY AMPOULES1.0X10.0X5.0 ML AMPOULE7/1/2005
1121NDA/MAL/HDP/2129DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDCLAVODARAMOXICILLIN/CLAVULANIC ACID500MG/125MGDAR AL DAWA-NA'UR PLANT AMMAN |JORDAN |ORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2011
1122NDA/MAL/HDP/2130IPCA LABORATORIESMEDVIN PHARMA LIMITEDZERODOL-CRACECLOFENAC200MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1123NDA/MAL/HDP/2132AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDLOPINAVIR/ RITONAVIRLOPINAVIR/ RITONAVIR200MG/ 50MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X120.0 TABLET CONTAINER7/1/2010
1124NDA/MAL/HDP/2133NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPIDHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE |DENMARK |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL7/1/1997
1125NDA/MAL/HDP/2134CADILA PHARMACEUTICALS LIMITEDKARURI PHARMACEUTICALS LTD.CEFAMOR-250CEFALEXIN250MGLA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X5.0X20.0 CAPSULE BLISTER7/1/1997
1126NDA/MAL/HDP/2135VHB MEDI SCIENCES LTDLLOYDS PHARMACY LIMITEDSOLITAXCEFTRIAXONE1GVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2010
1127NDA/MAL/HDP/2136MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.SEDIPROCT SUPOSITORYHYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN5MG + 5MG +10MG +10MGMEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT |EGYPT |TOPICAL EXTERNAL SUPPOSITORIES1.0X6.0 SUPPOSITORY STRIP7/1/2003
1128NDA/MAL/HDP/2141CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDINFLAZONEMULTIINGREDIENTN/ACENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2005
1129NDA/MAL/HDP/2144EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDEPICOTILTENOXICAM20MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA |EGYPT |PARENTERAL ORDINARY VIALS1.0X3.0 VIAL CARTON + 1*3*2ML WFI AMPOULE7/1/2014
1130NDA/MAL/HDP/2149BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT DEPOTHYDROXYPROGESTERONE HEXANOATE250MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |PARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/1997
1131NDA/MAL/HDP/2151USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYCOMET 850METFORMIN850MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
1132NDA/MAL/HDP/2154ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDGLYNASEGLIPIZIDE5MGFREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2000
1133NDA/MAL/HDP/2156NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRPID 10 INTRAVENOUS FAT EMULSIONSOYA OIL10%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2011
1134NDA/MAL/HDP/2158NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARELIFE PHARMA AFRICA LIMITEDNIRPIDINTRAVENOUS FAT EMULSION20%W/VACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X500.0 ML BOTTLE7/1/2010
1135NDA/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) | FRANCE |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)7/1/2011
1136NDA/MAL/HDP/2160EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDACEM-500CLARITHROMYCIN500MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1137NDA/MAL/HDP/2161REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX CREAMACICLOVIR5%W/WREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/1997
1138NDA/MAL/HDP/2164ELYS CHEMICAL INDUSTRIES LTDVELVET PHARMA LIMITEDELYCORTHYDROCORTISONE1%W/WELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
1139NDA/MAL/HDP/2165RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDTRAMARENTRAMADOL HYDROCHLORIDE50MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2014
1140NDA/MAL/HDP/2170ARISTO PHARMACEUTICALS PVT LTDNORVIK ENTERPRISES LIMITEDALSARTAN-AMLOSARTAN + AMLODIPINE50MG + 5MGARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X4.0X7.0 TABLET BLISTER7/1/2011
1141NDA/MAL/HDP/1417GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDMILICAL TABLETSCALCIUM CITRATE + VITAMIN D31000MG +200 I.UGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2001
1142NDA/MAL/HDP/2175CIPLA LTDQUALITY CHEMICALS LTD - HUMANPARAFIZZPARACETAMOL500MGCIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE ?II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH | INDIA |ORAL SOLID ORDINARY SOLUBLE TABLETS1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP7/1/2005
1143NDA/MAL/HDP/2176INTAS PHARMACUITICALS LTDNORVIK ENTERPRISES LIMITEDRISPITAS-2RISPERIDONE2MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/2011
1144NDA/MAL/HDP/2178KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL CEFUROXIME-250CEFUROXIME AXETIL250MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2008
1145NDA/MAL/HDP/2180KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAM PEN VPHENOXYMETHYLPENICILLIN125MG/5MLKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA |UGANDA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1146NDA/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 BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART |BELGIUM |ORAL LIQUID ORDINARY LIQUIDS1.0X1.5 ML TUBE (1 DOSE),1.0X50.0X1.5 ML TUBE (1 DOSE)7/1/2013
1147NDA/MAL/HDP/2186KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL DIPHENHYDRAMINE PAEDIATRIC SYRUPDIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE7MG+67.5MG/5MLKOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
|
MALAYSIA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2008
1148NDA/MAL/HDP/2187CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDVOMIZONDANSETRON4MG/2MLCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE7/1/2005
1149NDA/MAL/HDP/2188CIPLA LTDQUALITY CHEMICALS LTD - HUMANPREDNISOLONEPREDNISOLONE5MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2010
1150NDA/MAL/HDP/2189KOTRA PHARMA (M) SDN BHDABACUS PHARMA (AFRICA) LIMITEDAXCEL BETAMETHASONEBETAMETHASONE0.1%W/WKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE,1.0X5.0 G TUBE7/1/2008
1151NDA/MAL/HDP/2191LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDKLOXYCLOXACILLIN250MGLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI |KENYA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/1997
1152NDA/MAL/HDP/2193CIPLA LTD..QUALITY CHEMICALS LTD - HUMANCIPLOX-500CIPROFLOXACIN500MGCIPLA LIMITED.-PLOT NO. L-139, S-103 & M-62, VERNA INDUSTRIAL ESTATE, VERNA SALCETTE, GOA, PIN 403722 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER7/1/2007
1153NDA/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 |
MALAYSIA |TOPICAL EXTERNAL CREAMS1.0X45.0 G TUBE7/1/1997
1154NDA/MAL/HDP/2196PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDMYCOBUTINRIFABUTIN150MGPHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALY |ITALY |ORAL SOLID ORDINARY CAPSULES1.0X30.0 CAPSULE BOTTLE7/1/1998
1155NDA/MAL/HDP/2197LABORATORY&ALLIED LTDHARLEYS UGANDA LIMITEDWHITFIELD'S OINTMENTBENZOIC ACID + SALICYLIC ACID6%W/W + 3%W/WLABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
|
KENYA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE7/1/1997
1156NDA/MAL/HDP/2198TROGE MEDICAL GMBHECHO PHARMACY (U) LIMITEDTRO- CEFTRIAXCEFTRIAXONE SODIUM1GREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0 VIAL CARTON7/1/2014
1157NDA/MAL/HDP/2199MERCK (PTY) LTDUNITED HEALTHCARE DISTRIBUTORS LTDEUTHYROX 50MCGLEVOTHYROXINE SODIUM50MCGMERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER7/1/2013
1158NDA/MAL/HDP/2201SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.CLYCINCLINDAMYCIN PHOSPHATE10MG/MLSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN |TOPICAL EXTERNAL LOTIONS1.0X30.0 ML BOTTLE7/1/2004
1159NDA/MAL/HDP/2206GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDNETRA CORTHYDROCORTISONE ACETATE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
|
INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
1160NDA/MAL/HDP/2208KOTRA PHARMA SDN BDNABACUS PHARMA (AFRICA) LIMITEDAXCEL CEPHALEXINCEPHALEXIN MONOHYDRATE500MGKOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2010
1161NDA/MAL/HDP/2211GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDBENZYL BENZOATEBENZYL BENZOATE25%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
|
INDIA |TOPICAL EXTERNAL EMULSIONS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE7/1/2005
1162NDA/MAL/HDP/2212DENK PHARMABENLE CONSULT LIMITEDCIPRO-DENK 500CIPROFLOXACIN500MGALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081 |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1163NDA/MAL/HDP/2214SINO AFRICA MEDICINES AND HEALTH LTDROYAL PHARMA 2011 LIMITEDGENTAMICIN INJECTIONGENTAMICIN SULPHATE40MG/MLREYOUNG PHARMACEUTICAL CO. LIMITED-NO. 1 RUIYANG ROAD YIYUAN COUNTY, SHANDONG PROVINCE, P. R. CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE7/1/1997
1164NDA/MAL/HDP/2216GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDMETOCLOPRAMIDEMETOCLOPRAMIDE5MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X10.0X2.0 ML AMPOULE7/1/2005
1165NDA/MAL/HDP/2217GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAMINOPHYLINEAMINOPHYLLINE20MGNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X50.0X10.0 ML AMPOULE7/1/2005
1166NDA/MAL/HDP/2219BAYER PHARMA AGSURGIPHARM (U) LIMITEDPRIMOLUT NNORETHISTERONE5MGBAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER7/1/1997
1167NDA/MAL/HDP/2220CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDAMLODAC 5AMLODIPINE BESYLATE5MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER7/1/2003
1168NDA/MAL/HDP/2224VOGEN LABORATORIES LTDBUFFALO HEALTH CARE LTDDURAMOX 500AMOXICILLIN500MGVOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS |ORAL SOLID ORDINARY CAPSULES1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1169NDA/MAL/HDP/2226WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDHEPA-MERZ GRANULESL-ORNITHINE-L-ASPARTATE3G/5GWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA |ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES1.0X10.0X5.0 G SACHET7/1/2004
1170NDA/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 | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1171NDA/MAL/HDP/2232UNITED PHARMACEUTICAL MANUFACTURING CO. LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDUNICASTMONTELUKAST10MGUNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING |JORDAN |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1172NDA/MAL/HDP/2233ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.25MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN |LUNG ADMINISTRATION LIQUID FOR INHALATION1.0X4.0X5.0X2.0 ML VIAL7/1/2011
1173NDA/MAL/HDP/2235WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-NINSULIN HUMAN(RECOMBINANT DNA ORIGIN)100IU/MLWOCKHARDT-WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA | INDIA |PARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL7/1/2006
1174NDA/MAL/HDP/2236NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL 200CARBAMAZEPINE200MGNOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | ITALY |ORAL SOLID ORDINARY TABLETS1.0X5.0X10.0 TABLET BLISTER7/1/1997
1175NDA/MAL/HDP/2237WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-30/70INSULIN HUMAN(RECOMBINANT DNA ORIGIN)100I.U/MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA |PARENTERAL ORDINARY S C VIALS1.0X10.0 ML VIAL,1.0X3.0 ML VIAL7/1/2006
1176NDA/MAL/HDP/2238UNI MEDICO LABSHREEJI PHARMACEUTICALS LIMITEDUMOCLOXAMPICILLIN + CLOXACILLIN125MG +125MGUNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 |INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2015
1177NDA/MAL/HDP/2239NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDTEGRETOL ORAL SUSPENSIONCARBAMAZEPINE20MG/MLDELPHARMA HUNINGUE S.A.S-26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCE | FRANCE |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE7/1/2006
1178NDA/MAL/HDP/2242REMEDICA LTDGOODMAN INTERNATIONAL LTDCYCLOVAX 200 TABLETSACYCLOVIR200MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/1997
1179NDA/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.
|
INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/1997
1180NDA/MAL/HDP/2245RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDX-PELMEBENDAZOLE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER7/1/2008
1181NDA/MAL/HDP/2248GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDTETRACYCLINE OPHTHALMICTETRACYCLINE1%W/WGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA | INDIA |OPHTHALMIC OINTMENTS1.0X3.5 G TUBE,1.0X5.0 G TUBE7/1/2004
1182NDA/MAL/HDP/2249WOCKHARDT LTDABACUS PHARMA (AFRICA) LIMITEDWOSULIN-RINSULIN100MLWOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA |PARENTERAL ORDINARY S C VIALS1.0X3.0 ML VIAL,1.0X10.0 ML VIAL7/1/2006
1183NDA/MAL/HDP/2250GALENTIC PHARMA LTDNORVIK ENTERPRISES LIMITEDCANDIGENCLOTRIMAZOLE1%W/WGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
|
INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2004
1184NDA/MAL/HDP/2252JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDVERMOXMEBENDAZOLE500MGSPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE |SOUTH AFRICA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1.0 TABLET BLISTER7/1/2000
1185NDA/MAL/HDP/2253GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDINDOMETHACININDOMETHACIN25MGNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2005
1186NDA/MAL/HDP/2254MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDBURN CUR CREAMACRIFLAVINE/THYMOLN/ATORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1998
1187NDA/MAL/HDP/2256GLAXOSMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN 457MG/5MLAMOXICILLIN + CLAVULANIC ACID400 MG + 57 MG / 5 MLSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X1.0X70.0 ML BOTTLE7/1/2010
1188NDA/MAL/HDP/2258MYLAN LABORATORIES LIMITED (OTL)KIMSY MEDS LTDTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZTENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZ300MG/300MG/600MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA | GREEN STONE LIMITED-PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONE | QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA. |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X100.0 TABLET BOTTLE,1.0X1.0X30.0 TABLET BOTTLE7/1/2009
1189NDA/MAL/HDP/2262CIPLA LTDQUALITY CHEMICALS LTD - HUMANTENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2010
1190NDA/MAL/HDP/2263OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITEDREDDYS PHARMA LIMITEDCELEMIN 10 PLUSAMINO ACIDS/ELECTROLYTES10%W/V+10%W/VOTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA |PARENTERAL ORDINARY INFUSION BAGS1.0X500.0 ML BOTTLE7/1/2001
1191NDA/MAL/HDP/2265HETERO DRUGS LTDAIVEEN (U) LIMITEDTENOFOVIR/ LAMUVIDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG + 300MGHETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2010
1192NDA/MAL/HDP/2267MYLAN LABORATORIES LIMITED (OTL)KIMSY MEDS LTDTENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINETENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE300MG+300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA | QUESTA CARE LIMITED-PLOT NO 209/7184 HOMABAY RD TERMINUS GATE NO-19, INDUSTRIAL AREA NAIROBI, KENYA. |
INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2007
1193NDA/MAL/HDP/2269DAWA LIMITEDSUPER MEDIC LTDDAWAMOXAMOXYCILLIN TRIHYDRATE125MG/5MLDAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
1194NDA/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 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2006
1195NDA/MAL/HDP/2271EAGLEVET UGANDA LIMITEDMEDVIN PHARMA LIMITEDARTEMETHER 20MG/LUMEFANTRINE 120MGARTEMETHER + LUMEFANTRINE20MG + 120MG IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X3.0X6.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER,1.0X10.0X2.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X4.0X6.0 TABLET BLISTER,1.0X30.0X3.0X6.0 TABLET BLISTER,1.0X30.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X10.0X4.0X6.0 TABLET BLISTER7/1/2010
1196NDA/MAL/HDP/2272AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCLARANTA -500CLARITHROMYCIN500MGAJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X2.0X10.0 TABLET BLISTER7/1/2005
1197NDA/MAL/HDP/2278AVENTIS INTERCONTINENTALLABOREX UGANDA LIMITEDORELOXCEFPODOXIME PROXETIL100MGSANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPI?GNE
|
FRANCE |ORAL SOLID ORDINARY TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2010
1198NDA/MAL/HDP/2281SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDLUMFORTLORATADINE10MGNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1199NDA/MAL/HDP/2282GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDPROPANPROPRANOLOL40MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2011
1200NDA/MAL/HDP/2283SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA TETANUS PERTUSISDIPTHERIA TOXOID+TETANUS TOXOID+B.PERTUSIS ADSORBED ON ALUMINIUM PHOSPATE>25LF(>30IU)+>5LF(>40IU)+<16OU(>4PU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY VIALS1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)7/1/1997
1201NDA/MAL/HDP/2284SURGE LAB (PVT) LIMITEDJEET PHARMACEUTICALS LIMITEDLUMFORT SYRUPLORATADINE5MG/5MLNABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE7/1/2007
1202NDA/MAL/HDP/2287GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL250MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON7/1/1997
1203NDA/MAL/HDP/2289GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCHLORAMPHENICOLCHLORAMPHENICOL250MGNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2005
1204NDA/MAL/HDP/2290MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA |
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2008
1205NDA/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 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2011
1206NDA/MAL/HDP/2292MEDREICH PLCLABOREX UGANDA LIMITEDFLEMING 1200AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE1000MG + 200MGNATCO PHARMA LTD-VIJAYAPUR, NORTH NAGARIJUNA SAGA,INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X5.0X20.0 ML VIAL7/1/2007
1207NDA/MAL/HDP/2293GLOBAL NAPI PHARMACEUTICALSWIDE SPECTRUM ENTERPRISES (U) LIMITEDTIOCONTIOCONAZOLE1%W/WGLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2005
1208NDA/MAL/HDP/2295DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 10ROSUVASTATIN CALCIUM10MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
1209NDA/MAL/HDP/2297DAWA LIMITEDSUPER MEDIC LTDSABULIN SYRUPSALBUTAMOL SULPHATE2MG/5MLDAWA LIMITED -BABA DOGO RWARAKA |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X100.0 ML BOTTLE7/1/2008
1210NDA/MAL/HDP/2298MSN LABORATORIES PRIVATE LIMITEDMETRO PHARMACEUTICALS LIMITEDSAFELEVO 500LEVOFLOXACIN500MGMSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER7/1/2013
1211NDA/MAL/HDP/2299DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDROZITTA 20ROSUVASTATIN CALCIUM20MGDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2013
1212NDA/MAL/HDP/2303MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1213NDA/MAL/HDP/2304MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 10/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE10 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1214NDA/MAL/HDP/2305MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZIAK 2.5/6.25BISOPROLOL + HYDROCHLOROTHIAZIDE2.5 MG + 6.25 MGMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY |GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2014
1215NDA/MAL/HDP/2306BAYER PHARMA AGSURGIPHARM (U) LIMITEDMICROLUTLEVONORGESTREL0.03MGBAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X3.0X35.0 TABLET BLISTER7/1/2010
1216NDA/MAL/HDP/2312REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 625AMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER7/1/2006
1217NDA/MAL/HDP/2313REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAVOMID 375AMOXICILLIN + CLAVULANIC ACID250 MG + 125 MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS2.0X10.0 TABLET BLISTER7/1/2006
1218NDA/MAL/HDP/2314MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDRABEMAC-20RABEPRAZOLE SODIUM20MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET STRIP7/1/2005
1219NDA/MAL/HDP/2315MICRO LABS LTDLABOREX UGANDA LIMITEDGRAMOCEF-O-50CEFIXIME50MG/5MLMICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2006
1220NDA/MAL/HDP/2318MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIAPRIDE-4GLIMEPIRIDE4MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2006
1221NDA/MAL/HDP/2319COSMOS LTDASTRA PHARMA (U) LIMITEDCOSMOLPARACETAMOL120MG/5MLCOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/1998
1222NDA/MAL/HDP/2320GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDERO-125 DRY SYRUPERYTHROMYCIN ESTOLATE125MG/5MLAGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2006
1223NDA/MAL/HDP/2321JOHNSON&JOHNSON PTY LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDBENYLIN CHESTYORCIPRENALINE+BROMHEXINE5MG/5ML+ 4MG/5MLJOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA |ORAL LIQUID ORDINARY LIQUIDS1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2001
1224NDA/MAL/HDP/2322EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANYWIDE SPECTRUM ENTERPRISES (U) LIMITEDTREFLUCANFLUCONAZOLE150MGEGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA |EGYPT |ORAL SOLID ORDINARY CAPSULES1.0X2.0X1.0 CAPSULE STRIP7/1/2007
1225NDA/MAL/HDP/2324SWISS PARENTERALS PVT. LTD.SHREEJI PHARMACEUTICALS LIMITEDSWISSCLOXAAMPICILLIN + CLOXACILLIN250 MG + 250 MGSWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X7.5 ML VIAL7/1/2011
1226NDA/MAL/HDP/2326EMCURE PHARMACEUTICALS LTDHARLEYS UGANDA LIMITEDSYLATE-500ETAMSYLATE50MGEMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X6.0 TABLET STRIP7/1/2004
1227NDA/MAL/HDP/2327AUROBINDO PHARMA LTDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULPHATEABACAVIR SULPHATE300MGAUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X60.0 TABLET CONTAINER7/1/2007
1228NDA/MAL/HDP/2330NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDCOARTEMARTEMETHER + LUMEFANTRINE20MG + 120MGNOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND | BEIJING NOVARTIS PHARMA LTD-31ST YONG'AN ROAD, CHANGPING DISTRICT, BEIJING P.R | NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY | SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X24.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER7/1/2005
1229NDA/MAL/HDP/2333SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII DIPHTHERIA & TETANUS VACCINE ADSORBED(PEDIATRIC)DIPTHERIA TOXOID+TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE>25LF(>30IU)+>5LF(>40IU) ADSORBED ON ?1.5MGSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE)7/1/1997
1230NDA/MAL/HDP/2334SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII MEASLES MUMPS & RUBELLAMEASLES VIRUS+MUMPS VIRUS+RUBELLA VIRUSNLT 1000 CCID50+NLT 5000 CCID50 +NLT1000 CCID50SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT7/1/1997
1231NDA/MAL/HDP/2335GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDAGOBEN TABLETS(THANE)MEBENDAZOLE100MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY CHEWABLE TABLETS10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2001
1232NDA/MAL/HDP/2337AUROBINDOM PHARMA LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDAUROXETIL-500CEFUROXIME AXETIL500MGAUROBINDO 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 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X10.0 TABLET BLISTER7/1/2007
1233NDA/MAL/HDP/2338GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULINAMOXICILLIN + CLAVULANIC ACID200 MG + 28.5 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE7/1/2003
1234NDA/MAL/HDP/2339AUROBINDO PHARMA LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDKOACT-375AMOXICILLIN + CLAVULANATE POTASSIUM250 MG + 125 MGAUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH | INDIA |ORAL SOLID ORDINARY TABLETS1.0X4.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER7/1/2007
1235NDA/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 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X5.0 TABLET BLISTER7/1/2007
1236NDA/MAL/HDP/2346AUROBINDOM PHARMA LIMITEDGITTOES PHARMACEUTICALS LIMITEDABACAVIR SULFATE ORAL SOLUTIONABACAVIR SULPHATE20MG/MLAUROBINDO PHARMA LTD, UNIT III -SURVEY NO. 313, 314 BACHUPALLY (VILLAGE) QUTHUBULLAPUR (MANDAL) RR DISTRICT HYDERABAD ANDHRA PRADESH 500090 | INDIA |ORAL LIQUID ORDINARY LIQUIDS1.0X240.0 ML BOTTLE7/1/2008
1237NDA/MAL/HDP/2348SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDHEPATITIS B VACCINE(RDNA) ADULTHEPATITIS B VACCINE(RDNA) ADULT20MCG/MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY I M VIALS1.0X10.0X10.0 ML VIAL (10 DOSE VIAL),1.0X50.0X1.0 ML VIAL (1 DOSE VIAL)7/1/2005
1238NDA/MAL/HDP/2350ASTRA ZENECA ABMACNAUGHTON LIMITEDPULMICORT TURBUHALERBUDESONIDE200MCGASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN |LUNG ADMINISTRATION METERED-DOSE INHALER1.0X100.0 DOSE CANNISTER7/1/2001
1239NDA/MAL/HDP/2352REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDCOLDCAP DAY TIMEPARACETAMOL/PSEUDOEPHEDRINE HCL/CAFFEINE500MG+30MG+30MGREGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA |ORAL SOLID ORDINARY CAPSULES1.0X1.0X12.0 CAPSULE BLISTER7/1/2007
1240NDA/MAL/HDP/2353ASTRA ZENECAMACNAUGHTON LIMITEDNEXIUMESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE)10MGASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN |ORAL SOLID ORDINARY GRANULES1.0X28.0 SACHET CARTON7/1/2013
1241NDA/MAL/HDP/2354STRIDES SHASUN LIMITEDDELMAW ENTERPRISES LIMITEDLAMIVUDINE + ZIDOVUDINELAMIVUDINE + ZIDOVUDINE150MG + 300MGSTRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X60.0 TABLET BOTTLE7/1/2006
1242NDA/MAL/HDP/2356GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDQUININEQUININE DIHYDROCHLORIDE600MG/2MLNINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X2.0 ML AMPOULE7/1/2005
1243NDA/MAL/HDP/2359REMEDICA LTDGOODMAN INTERNATIONAL LTDASPIREM 75ASPIRIN75MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X2.0X28.0 TABLET BLISTER7/1/2007
1244NDA/MAL/HDP/2361REMEDICA LTDGOODMAN INTERNATIONAL LTDCLAREM 500CLARITHROMYCIN500MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2007
1245NDA/MAL/HDP/2362GALENTIC PHARMA( INDIA)PVT LTDNORVIK ENTERPRISES LIMITEDCANDISTATIN OINTMENTNYSTATIN100,000I.UGALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
|
INDIA |TOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE7/1/2009
1246NDA/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 | CHINA |PARENTERAL ORDINARY AMPOULES1.0X100.0X2.0 ML AMPOULE7/1/2005
1247NDA/MAL/HDP/2364MEDICO REMEDIES PVT LTDMAISHA MEDICAL SUPPLIES LIMITEDVOXEL-500LEVOFLOXACIN500MGMEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2015
1248NDA/MAL/HDP/2366UNIQUE PHARMACEUTICALS LTDTATA UGANDA LIMITEDIFICIPRO INJECTIONCIPROFLOXACIN200MG/100MLUNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116 | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2005
1249NDA/MAL/HDP/2367REMEDICA LTDGOODMAN INTERNATIONAL LTDFELEXIN 125CEPHALEXIN MONOHYDRATE125MG/5MLREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/2007
1250NDA/MAL/HDP/2368REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDDERMIDEX CREAMMICONAZOLE NITRATE2%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1251NDA/MAL/HDP/2369ARISTO PHARMACEUTICALSNORVIK ENTERPRISES LIMITEDTRANLOK 500MG INJECTIONTRANEXAMIC ACID500MG/5MLARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA |PARENTERAL ORDINARY AMPOULES1.0X5.0X5.0 ML AMPOULE7/1/2010
1252NDA/MAL/HDP/2371PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIZONE CREAMFUSIDIC ACID + BETAMETHASONE VALERATE20MG/G+1MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1253NDA/MAL/HDP/2373INDOCO REMEDIES LTDTATA UGANDA LIMITEDCLOBEN SKIN CREAMCLOTRIMAZOLE/ BECLOMETASONE1%W/W/ 0.025%W/WINDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNA |INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1254NDA/MAL/HDP/2374COSMOS LTDASTRA PHARMA (U) LIMITEDPYRAZINAMIDE TABLETSPYRAZINAMIDE500MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP7/1/1997
1255NDA/MAL/HDP/2375GLAXO SMITHLINE LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTDCLAVULIN 1GAMOXICILLIN + CLAVULANIC ACID875 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X1.0X7.0 TABLET BLISTER7/1/2010
1256NDA/MAL/HDP/2376INDOCO REMEDIES LTDTATA UGANDA LIMITEDMETCHEK-500METFORMIN500MGINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1257NDA/MAL/HDP/2378GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTINAMOXICILLIN + CLAVULANIC ACID1000 MG + 200 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |PARENTERAL ORDINARY DRY VIALS1.0X10.0X1.2 G VIAL7/1/1997
1258NDA/MAL/HDP/2379PT SANBE FARMAMEDVIN PHARMA LIMITEDPUMPITOROMEPRAZOLE40MGPT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG |INDONESIA |PARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT7/1/2014
1259NDA/MAL/HDP/2383GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTINAMOXICILLIN + CLAVULANIC ACID500 MG + 100 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |PARENTERAL ORDINARY DRY VIALS1.0X10.0X25.0 ML VIAL7/1/1997
1260NDA/MAL/HDP/2384PHARMA INTERNATIONAL COOMAB UGANDA LIMITEDCLARIX 500CLARITHROMYCIN500MGPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2007
1261NDA/MAL/HDP/2385COSMOS LIMITEDASTRA PHARMA (U) LIMITEDCOZEPAM 5MGDIAZEPAM5MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2000
1262NDA/MAL/HDP/2386HILTON PHARMA (PVT) LTDHEALTHCARE LTD.NEOGABGABAPENTIN100MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI |PAKISTAN |ORAL SOLID ORDINARY CAPSULES1.0X10.0 CAPSULE BLISTER7/1/2005
1263NDA/MAL/HDP/2387DAWA LIMITEDSUPER MEDIC LTDVERMOUTMEBENDAZOLE100MG/5MLDAWA LIMITED -BABA DOGO RWARAKA |KENYA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2010
1264NDA/MAL/HDP/2388DAFRA PHARMA LTDLABOREX UGANDA LIMITEDDAFRACLAVAMOXYCILLIN + POTASSIUM CLAVULANATE400MG + 57MGBILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG | TURKEY |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X70.0 ML BOTTLE7/1/2011
1265NDA/MAL/HDP/2390BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDP-ALAXINDIHYDROARTEMISININ/ PIPERAQUINE PHOSPHATE80MG /640MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE7/1/2008
1266NDA/MAL/HDP/2391BIOMATRIX HEALTHCARE PVT LTDROYAL PHARMA 2011 LIMITEDHEADAID TABLETSASPIRIN + CAFFEINE + PARACETAMOL300MG + 30MG + 250MGMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP7/1/1997
1267NDA/MAL/HDP/2395A.MENARINI INDUSTRIE FARMACEUTICHE S.R.ISTAR PHARMACEUTICALS LTDFASTUM GELKETOPROFEN2.5%W/WA. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA SETTE SANTI 3, 50131 FIRENZE-ITALY | ITALY |TOPICAL EXTERNAL GELS AND SOLS1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE7/1/2005
1268NDA/MAL/HDP/2399SUN PHARMACEUTICAL INDUSTRIES LIMITEDSTAR PHARMACEUTICALS LTDVOLINIMULTI INGREDIENTMULTI INGREDIENTSUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIA | INDIA |TOPICAL EXTERNAL OTHER GELS/SOLS1.0X1.0X30.0 G TUBE7/1/2005
1269NDA/MAL/HDP/2400PHARMA INTERNATIONAL COMPANYOMAB UGANDA LIMITEDTOPIDIC 2%FUSIDIC ACID20MG/GPHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2007
1270NDA/MAL/HDP/2401MEGA LIFESCIENCES (AUSTRALIA) PTY LTDABACUS PHARMA (AFRICA) LIMITEDENATNATURAL VITAMIN E400IUMEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 |THAILAND |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER7/1/2005
1271NDA/MAL/HDP/2404UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDLOSAR 50LOSARTAN POTASSIUM50MGUNICHEM LABORATORIES LTD---VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1272NDA/MAL/HDP/2408RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRON TONICMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE7/1/2001
1273NDA/MAL/HDP/2409TORRENT PHARMACEUTICALS LTDKARURI PHARMACEUTICALS LTD.DEPLATTCLOPIDOGREL75MGTORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2004
1274NDA/MAL/HDP/2410RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDDOXYRENDOXYCYCLINE100MGRENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER7/1/2007
1275NDA/MAL/HDP/2411STEDMAN PHARMACEUTICALS PVT. LTDVEERAM HEALTHCARE (U) LIMITEDDREZPOVIDONE IODINE + METRONIDAZOLE5%W/W + 1%W/WSTEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE7/1/2010
1276NDA/MAL/HDP/2414SPARSH BIO-TECH PVT LTDABACUS PHARMA (AFRICA) LIMITEDSPAMCILAMPICILLIN125MG/5MLSPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1998
1277NDA/MAL/HDP/2415CENTAUR PHARMACEUTICALS LTDGITTOES PHARMACEUTICALS LIMITEDSOLINA TABLETSDIAZEPAM5MGCENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/1997
1278NDA/MAL/HDP/2420INDOCO REMEDIES LTDTATA UGANDA LIMITEDLIDOCAINE INJ.BPLIDOCAINE2% W/VINDOCO REMEDIES LTD-L-32,33 AND VERNA INDUSTRIAL ESTATE VERNA ? SALCATTE GOA, 403722 INDIA | INDIA |PARENTERAL ORDINARY OTHER VIALS1.0X20.0 ML VIAL7/1/2006
1279NDA/MAL/HDP/2421INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDTAMIGEN EYE/EAR DROPSGENTAMICIN SULPHATE0.3%W/VINDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722 | INDIA |OPHTHALMIC DROPS1.0X5.0 ML BOTTLE,1.0X10.0 ML BOTTLE7/1/2006
1280NDA/MAL/HDP/2422INDOCO REMEDIES LIMITEDTATA UGANDA LIMITEDTAMIGEN-S EYE/EAR DROPSGENTAMICIN SULPHATE+DEXAMETHASONE0.3%W/V+0.1%W/VINDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722 | INDIA |OTHER SYSTEMIC DROPS1.0X5.0 ML BOTTLE7/1/2006
1281NDA/MAL/HDP/2423MEDLEY PHARMACEUTICALSMEDVIN PHARMA LIMITEDATORIN ATORVASTATIN10MGMEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1282NDA/MAL/HDP/2426MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPROBEX SYRUPMULTI-INGREDIENTMULTI-INGREDIENTTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/2000
1283NDA/MAL/HDP/2427NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDCLONEMCLOTRIMAZOLE1%W/WNEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1997
1284NDA/MAL/HDP/2428ERIS LTDBENLE CONSULT LIMITEDCLOTRI-DENK 1% CREAMCLOTRIMAZOLE1%W/WRUBIEPHARM ARZNEIMITTEL GMHH--BRUDER-GRIMU, STRABE 62, GERMANY
|
GERMANY |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/1998
1285NDA/MAL/HDP/2429ERIS LTDBENLE CONSULT LIMITEDCLOTRI-DENK 100 VAGINALCLOTRIMAZOLE100MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY |VAGINAL TABLETS1.0X6.0 PESSARY CARTON7/1/1998
1286NDA/MAL/HDP/2431CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 200BUDESONIDE + FORMOTEROL FUMARATE200MCG/ 6MCGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA |LUNG ADMINISTRATION METERED-DOSE INHALER1.0X1.0 CANNISTER CARTON7/1/2007
1287NDA/MAL/HDP/2432CADILA HEALTH CARE LTDABACUS PHARMA (AFRICA) LIMITEDFORMONIDE 100BUDESONIDE + FORMOTEROL FUMARATE100MCG+6MCGCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA |LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER1.0X120.0 METERED DOSE CANNISTER7/1/2007
1288NDA/MAL/HDP/2434STRIDES SHASUN LIMITED .DELMAW ENTERPRISES LIMITEDSOLCEROMEPRAZOLE40MGSTRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD
BANGALORE 560076
INDIA
|
INDIA |PARENTERAL ORDINARY DRY VIALS1.0X10.0 ML VIAL7/1/2009
1289NDA/MAL/HDP/2437DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDRISDONERISPERIDONE1MG/MLDAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN |ORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2012
1290NDA/MAL/HDP/2438INTAS, PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHIFENACACECLOFENAC100MGINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2006
1291NDA/MAL/HDP/2450BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDTODAY PESSARYNONOXYNOL-95%W/VBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA |VAGINAL TABLETS1.0X5.0 PESSARY BLISTER7/1/2011
1292NDA/MAL/HDP/2451ACINO PHARMA AGGOODMAN INTERNATIONAL LTDOLFEN 75 SRDICLOFENAC SODIUM75 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH | SWITZERLAND |ORAL SOLID RETARD TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2004
1293NDA/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 NAIROBI |KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2007
1294NDA/MAL/HDP/2455ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 600/750 LACTABARTESUNATE + MEFLOQUINE200 MG + 250 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH | SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2004
1295NDA/MAL/HDP/2458XEPA SOUL PATTISON (M) SDN BHDDELMAW ENTERPRISES LIMITEDPRISTINEX 2% CREAMKETOCONAZOLE2%W/WXEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA |TOPICAL EXTERNAL CREAMS2.0X15.0 G TUBE7/1/2006
1296NDA/MAL/HDP/2459MYLAN LABS LTDNORVIK ENTERPRISES LIMITEDP2LEVONORGESTREL0.75MGMYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA. | MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213 | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X2.0 TABLET BLISTER7/1/2007
1297NDA/MAL/HDP/2460COSMOS LTDASTRA PHARMA (U) LIMITEDBENZHEXOL TABLETS 2MGBENZHEXOL HCL2MGCOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA |ORAL SOLID ORDINARY TABLETS1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2000
1298NDA/MAL/HDP/2461UMEDICA LABORATORIES PVT LTDVITACARE LIMITEDUMERAN SR - 100DICLOFENAC100MGUMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1299NDA/MAL/HDP/2462REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDHISTALIN SYRUPCHLORPHENIRAMINE MALEATE/PROMETHAZINE/DIPHENHYDRAMINE/EPHEDRINE/AMMONIUM CHLORIDE/SODIUM CITRATE1.0MG+ 2.5MG+5.0MG+7.5MG+90.0MG+48.0MG/ 5ML.REGAL PHARMACEUTICALS LTD..-PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN7/1/1997
1300NDA/MAL/HDP/2467CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDNOKLOTCLOPIDOGREL75MGCADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2003
1301NDA/MAL/HDP/2470GLAXOSMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDEURAXCROTAMITON10%W/WNOVATIS CONSUMER HEALTH INC -ZYMA SA-CH- 1260 NYON SWITZERLAND |SWITZERLAND |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2004
1302NDA/MAL/HDP/2471GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.1% NASAL DROPSXYLOMETAZOLINE0.1%W/VNOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND |SWITZERLAND |NASAL SYSTEMIC DROPS1.0X10.0 ML BOTTLE7/1/2003
1303NDA/MAL/HDP/2472NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDTRAN-GELDICLOFENAC DIETHYLAMMONIUM1%W/WNEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL GELS AND SOLS1.0X30.0 G TUBE,1.0X20.0 G TUBE7/1/2011
1304NDA/MAL/HDP/2473MICRO LABS LTDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDNUGRELCLOPIDOGREL75MGMICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2010
1305NDA/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) | FRANCE |PARENTERAL ORDINARY PRE-FILLED SYRINGES1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE)7/1/1997
1306NDA/MAL/HDP/2475WIN-MEDICURE LTDSURGIPHARM (U) LIMITEDURGENDOL INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLWIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA |PARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE7/1/2001
1307NDA/MAL/HDP/1627GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDID-V GELCLOTRIMAZOLE2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |VAGINAL GELS AND SOLS1.0X30.0 G TUBE7/1/2004
1308NDA/MAL/HDP/2478WIN-MEDICARE PVT LTDSURGIPHARM (U) LIMITEDDICLOMOL PLUSPARACETAMOL+DICLOFENAC500MG+50MGWIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH -INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1309NDA/MAL/HDP/2480DAFRA PHARMA LTDLABOREX UGANDA LIMITEDARTESIANE 40ARTEMETHER40MG/MLROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
1310NDA/MAL/HDP/2481GALENTIC PHARMA (PVT)LTDNORVIK ENTERPRISES LIMITEDNETRACORTHYDROCORTISONE1%W/WGALENTIC PHARMA PVT LIMITED-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI MUMBAI | INDIA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X20.0 G TUBE7/1/2005
1311NDA/MAL/HDP/2496MACLEODS PDHARMACEUTICALS LTNORVIK ENTERPRISES LIMITEDZETIVAS 20ATORVASTATIN/EZETIMIBE20MG/10MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2008
1312NDA/MAL/HDP/2497CIPLA LTDQUALITY CHEMICALS LTD - HUMANNEVIMUNENEVIRAPINE50MG/5MLCIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,
SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA |
INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2004
1313NDA/MAL/HDP/2498MACLEODS PDHARMACEUTICALS LTNORVIK ENTERPRISES LIMITEDZETIVAS 10ATORVASTATIN/EZETIMIBE10MG/10MGMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2008
1314NDA/MAL/HDP/2500MACLEODS PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDCHLORAMPHENICOL SODIUM SUCCINATE INJECTION BPCHLORAMPHENICOL SODIUM SUCCINATE1GMACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL7/1/2007
1315NDA/MAL/HDP/2502ROYAL GROUPABACUS PHARMA (AFRICA) LIMITEDPROBETA N EYE DROPBETAMETHASONE + NEOMYCIN0.1%W/V+0.5%W/VATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN |OPHTHALMIC DROPS1.0X7.5 ML VIAL7/1/1997
1316NDA/MAL/HDP/2504LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDRESTOCINPARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL500MG+ 2MG+ 2MG + 30MGLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X50.0X1.0X4.0 TABLET STRIP7/1/2008
1317NDA/MAL/HDP/2506WOCKHARDT LTDSTAR PHARMACEUTICALS LTDNADOXINNADIFLOXACIN1%W/WWOCKHARDT LTD -VILLAGE KUNJHAL P.O BAROTIWALA DIST SOLAN HIMACHAL PRADESH |INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X20.0 G TUBE7/1/2011
1318NDA/MAL/HDP/2507CIPLA LTDQUALITY CHEMICALS LTD - HUMANEXERMET 1000METFORMIN HCL1000MGCIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TAL | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2007
1319NDA/MAL/HDP/2508GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDHYOSCINEHYOSCINE20MG/MLNINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANG |CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2011
1320NDA/MAL/HDP/2509BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDOPELE LOTIONBENZYL BENZOATE25%W/VBETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL LOTIONS1.0X50.0 ML BOTTLE7/1/1997
1321NDA/MAL/HDP/2510PANACEA BIOTEC LTDVITACARE LIMITEDGIROORDNIDAZOLE500MGPANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH ? 173 205 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X2.0X10.0 TABLET BLISTER7/1/2013
1322NDA/MAL/HDP/2511BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITEDULTIVA INJECTION 5MGREMIFENTANIL5MGGLAXOSMITHKLINE MANUFACTURING SPA ,.,-STRADA PROVINCIALE ASOLANA, 90-43056, S.POLO DI TORRILE (PARMA) | ITALY |PARENTERAL ORDINARY DRY VIALS1.0X1.0 VIAL CARTON7/1/1999
1323NDA/MAL/HDP/2513REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNIPEN DRY SYRUPPHENOXYMETHYLPENICILLIN125MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X100.0 ML BOTTLE7/1/1997
1324NDA/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 10280 |THAILAND |ORAL SOLID ORDINARY CAPSULES1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER7/1/2009
1325NDA/MAL/HDP/2521MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDMOTINORMDOMPERIDONE10MGMEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1326NDA/MAL/HDP/2522MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPANTAZ TABLETSPANTOPRAZOLE40MGMEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI
CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210
|
INDIA |ORAL SOLID ORDINARY ENTERIC-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1327NDA/MAL/HDP/2523NEM LABORATORIES PRIVATE LIMITEDRENE PHARMACY LTDSULPHUR OINTMENTSULPHUR10%W/WNEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI |INDIA |TOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/1997
1328NDA/MAL/HDP/2524MEDLEY PHARMACEUTICALS LTDMEDVIN PHARMA LIMITEDPRIMODIL-5AMLODIPINE BESYLATE5MGMEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI
CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1329NDA/MAL/HDP/2525ERIS LTDBENLE CONSULT LIMITEDDICLO-DENK 100 RETARDDICLOFENAC SODIUM100MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY |ORAL SOLID RETARD TABLETS10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER7/1/1998
1330NDA/MAL/HDP/2526REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDUNISTEN COMBI PACKCLOTRIMAZOLE500MG & 1 %W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |VAGINAL COMBINATION PACK TABLETS1.0X1.0 PESSARY BLISTER + 1*20G TUBE7/1/2009
1331NDA/MAL/HDP/2527CIPLA LTD.QUALITY CHEMICALS LTD - HUMANACIVIR CREAMACICLOVIR5%W/WCIPLA LTD-VERNA INDUSTRIAL ESTATE, GOA | INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE,1.0X5.0 G TUBE7/1/1998
1332NDA/MAL/HDP/2528LABORATORY AND ALLIED LTDHARLEYS UGANDA LIMITEDLABESTENCLOTRIMAZOLE1%W/WLABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI |KENYA |TOPICAL EXTERNAL CREAMS1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE7/1/1997
1333NDA/MAL/HDP/2529GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDG-CEFTRIACEFTRIAXONE1GGUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI |CHINA |PARENTERAL ORDINARY DRY VIALS1.0X1.0 G VIAL + 10 ML AMPOULE WFI,1.0X1.0X50.0 G VIAL,1.0X1.0 VIAL CARTON7/1/2012
1334NDA/MAL/HDP/2545NORVATIS PHARMA AG- SWITZERLANDLABOREX UGANDA LIMITEDTOBREXTOBRAMYCIN0.3%W/VALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM |OPHTHALMIC DROPS1.0X5.0 ML BOTTLE7/1/1997
1335NDA/MAL/HDP/2549ASTRA LIFE CARE (INDIA) PVT LTDASTRA PHARMA (U) LIMITEDAZY-250AZITHROMYCIN250MGASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2011
1336NDA/MAL/HDP/2552AJANTA PHARMA LTDABACUS PHARMA (AFRICA) LIMITEDCAROFITVITAMIN C/ VITAMIN A/ ZINC SULPHATE150MG/10MG/75MGAJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2005
1337NDA/MAL/HDP/1815GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDSUPIROCIN OINTMENTMUPIROCIN2%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |TOPICAL EXTERNAL OTHER OINTMENTS1.0X15.0 G TUBE7/1/2003
1338NDA/MAL/HDP/1919GLENMARK PHARMACEUTICAL LTDSTAR PHARMACEUTICALS LTDCANDIDERM CREAMBECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN0.025%W/W+1%W/W+0.1%W/WGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA |TOPICAL EXTERNAL CREAMS1.0X5.0 G TUBE,1.0X15.0 G TUBE7/1/1999
1339NDA/MAL/HDP/2555COSMOS LTDASTRA PHARMA (U) LIMITEDPHENOBARBITONE TABLETS BP 30MGPHENOBARBITONE30MGCOSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER7/1/1998
1340NDA/MAL/HDP/2556GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDTRUVADAEMTRICITABINE/TENOFOVIR200MG/300MGPATHEON INC-ADDRESS: 2100 SYNTEX COURT, MISSISSAUGA, ONTARIO L5N 7K9
COUNTRY: CANADA
| TAKEDA GMBH-16515 ORANIENBURG GERMANY | ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICA |
UNITED STATES |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/2005
1341NDA/MAL/HDP/2557REMEDICA LTDGOODMAN INTERNATIONAL LTDEPSITRON 25 TABLETSCAPTOPRIL25MGREMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1999
1342NDA/MAL/HDP/2558RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDMYCOREN SUSPENSIONNYSTATIN100000 I.U/ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA |
UGANDA |ORAL TOPICAL SUSPENSIONS1.0X30.0 ML BOTTLE7/1/2007
1343NDA/MAL/HDP/2559RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDERYTHRORENERYTHROMYCIN STEARATE250MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER7/1/2007
1344NDA/MAL/HDP/2561PHARMATHEN LTDGOODMAN INTERNATIONAL LTDLANOMYCINAMIKACIN SULPHATE500MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE | GREECE |PARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE7/1/1997
1345NDA/MAL/HDP/2565CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDTRAMAZAC INJECTIONTRAMADOL HYDROCHLORIDE50MG/MLCADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA |PARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE,1.0X5.0X2.0 ML AMPOULE7/1/2001
1346NDA/MAL/HDP/2567CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCIPROBID-500CIPROFLOXACIN500MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | S.KANT HEALTHCARE LIMITED--PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIA | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328 - 1330, VILLAGE MANPURA, TEHSIL BADDI, DIST. SOLAN, HIMACHAL PRADESH - 174101 | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/1997
1347NDA/MAL/HDP/2568GLAXO WELLCOME (KENYA) LTDUNITED HEALTHCARE DISTRIBUTORS LTDZINNATCEFUROXIME AXETIL500MGGLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON7/1/1997
1348NDA/MAL/HDP/2569SANOFI AVENTISLABOREX UGANDA LIMITEDNO-SPADROTAVERINE HYDROCHLORIDE40MG/2MLCHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO. LTD CSANYIKVOLGY SITE-CSANYIKVOLGY, P.O.BOX 565.3510, MISKOLC, HUGARY | HUNGARY |PARENTERAL ORDINARY AMPOULES1.0X2.0 ML AMPOULE7/1/1998
1349NDA/MAL/HDP/2570REMEDICA LTDGOODMAN INTERNATIONAL LTDAMOXAPEN 250 CAPSULESAMOXYCILLIN250MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY CAPSULES10.0X10.0 CAPSULE BLISTER,100.0X10.0 CAPSULE BLISTER7/1/1997
1350NDA/MAL/HDP/2571GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDCO-METHERARTEMETHER + LUMEFANTRINE180 MG + 1080 MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE7/1/2010
1351NDA/MAL/HDP/2575HILTON PHARMA (PVT) LTDHEALTHCARE LTD.MYTEKAMONTELUKAST SODIUM10MGHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI |PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X2.0X7.0 TABLET BLISTER7/1/2005
1352NDA/MAL/HDP/2576RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEQUINE TABLETSCHLOROQUINE PHOSPHATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA |
UGANDA |ORAL SOLID ORDINARY TABLETS1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/2000
1353NDA/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.) | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1354NDA/MAL/HDP/2578REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDMAGNOMINT TABLETSMAGNESIUM TRISILICATE+ALUMINIUM HYDROXIDE250MG+120MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER7/1/1997
1355NDA/MAL/HDP/2579ACINO PHARMA AGGOODMAN INTERNATIONAL LTDARTEQUIN 300/375 LACTABARTESUNATE + MEFLOQUINE300 MG + 375 MGACINO PHARMA AG-DORNACHERSTRASSE 114, CH-4147 AESCH | SWITZERLAND |ORAL SOLID ORDINARY TABLETS1.0X6.0 TABLET BLISTER7/1/2005
1356NDA/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 | KENYA |ORAL SOLID ORDINARY TABLETS1.0X50.0X2.0 TABLET STRIP7/1/1998
1357NDA/MAL/HDP/2592METRO PHARMACEUTICALS LIMITEDMETRO PHARMACEUTICALS LIMITEDINDOMETHACININDOMETHACIN25MGCSPC OUYI PHARMACEUTICAL CO.LTD. LIMITED-NO. 276, WEST ZHONGSTAN ROAD, SHIJIAZHUANG, CHINA | CHINA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2011
1358NDA/MAL/HDP/2593E DENK OHGBENLE CONSULT LIMITEDATENOLOL DENK 50ATENOLOL50MGARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2005
1359NDA/MAL/HDP/2594GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDFEFFERROUS SULPHATE + FOLIC ACID200MG + 0.4MGAGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER7/1/2009
1360NDA/MAL/HDP/2597E DENK OHGBENLE CONSULT LIMITEDPARA DENK 250PARACETAMOL250MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANY | BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY | GERMANY |RECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP7/1/2005
1361NDA/MAL/HDP/2600IND SWIFT LTDPLANET PHARMACEUTICALS UGANDA LTDCLARIE-ODCLARITHROMYCIN(EXTENTED RELEASE)500MGIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X1.0X7.0 TABLET BLISTER7/1/2008
1362NDA/MAL/HDP/2603CIPLA LTDQUALITY CHEMICALS LTD - HUMANVIRADAYTENOFOVIR + EMTRICITABINE + EFAVIRENZ300 MG + 200 MG + 600 MGCIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET BOTTLE7/1/2011
1363NDA/MAL/HDP/2604USV PRIVATE LIMITEDABACUS PHARMA (AFRICA) LIMITEDGROVIT SYRUPMULTI-INGREDIENTMULTI-INGREDIENTSAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2000
1364NDA/MAL/HDP/2610GITTOES PHARMACEUTICALS LIMITEDGITTOES PHARMACEUTICALS LIMITEDATROPINEATROPINE1MG/MLNINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN |CHINA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
1365NDA/MAL/HDP/2612RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDRENIRONMULTI-INGREDIENTMULTI-INGREDIENTRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY CAPSULES3.0X10.0 CAPSULE BLISTER7/1/2005
1366NDA/MAL/HDP/2615ASTRA ZENECA ABMACNAUGHTON LIMITEDSYMBICORT TURBUHALERBUDESONIDE+FORMOTEROL160MCG+4.5MCG/DOSEASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN |LUNG ADMINISTRATION METERED-DOSE POWDER INHALER1.0X60.0 DOSE CANNISTER7/1/2001
1367NDA/MAL/HDP/2617BLUE CROSS LABORATORIES LIMITEDSTAR PHARMACEUTICALS LTDBLUDROX TABLETS DISPERSABLECEFADROXIL250MGBLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET STRIP7/1/2001
1368NDA/MAL/HDP/2628MICRO LABS LTDLABOREX UGANDA LIMITEDAZILIDE-500AZITHROMYCIN500MGMICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X3.0 TABLET BLISTER7/1/2004
1369NDA/MAL/HDP/2647DENK PHARMABENLE CONSULT LIMITEDIBUPROFEN DENK 400MGIBUPROFEN400MGDENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1370NDA/MAL/HDP/2648E DENK OHGBENLE CONSULT LIMITEDPARA DENK 125PARACETAMOL125MGRUBIEPHARM ARZNEIMITTEL GMHH -GERMANY | BENE-ARZNEIMITTEL GMBH-HERTERICHSTR. 1,81479 MUENCHEN, GERMANY | GERMANY |RECTAL SYSTEMIC SUPPOSITORIES1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP7/1/2005
1371NDA/MAL/HDP/2650DENK PHARMABENLE CONSULT LIMITEDVIT-B-DENKTHIAMINE HCL + PYRIDOXINE HCL100MG + 200MGDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 M?NCHEN, G?LLSTR. 1, 84529 TITTMONING, GERMANY | GERMANY |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER7/1/2005
1372NDA/MAL/HDP/2651REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDRINAVIT SYRUPMULTIVITAMINMULTI-INGREDIENTREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE7/1/1997
1373NDA/MAL/HDP/2652SANOFI - AVENTISLABOREX UGANDA LIMITEDFLAGENTYL TABLETSSECNIDAZOLE500MGFAMAR LYON-29 AVENUE CHARLES DE GAULLE SAINT |FRANCE |ORAL SOLID ORDINARY TABLETS1.0X4.0 TABLET BLISTER7/1/1997
1374NDA/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 | INDIA |TOPICAL EXTERNAL CREAMS1.0X10.0 G TUBE7/1/2007
1375NDA/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 PHARMACEUTICALS -HEAD OFFICE 36 6TH DISTRICT NASR CITY CAIRO EGYPT PLANT ABUSULTAN ISMAILIA |EGYPT |ORAL LIQUID ORDINARY LIQUIDS1.0X30.0 ML BOTTLE7/1/2006
1376NDA/MAL/HDP/2657SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.XEPILCARBAMAZEPINE200MGSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X10.0X5.0 TABLET BLISTER7/1/1997
1377NDA/MAL/HDP/2670ELDA INTERNATIONAL DMCCREDDYS PHARMA LIMITEDSENSINILLIDOCAINE2%W/VCLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARAT |INDIA |PARENTERAL ORDINARY VIALS1.0X5.0 ML VIAL,1.0X20.0 ML VIAL,1.0X30.0 ML VIAL,1.0X5.0X20.0 ML VIAL7/1/2005
1378NDA/MAL/HDP/2671CIPLA LTD..QUALITY CHEMICALS LTD - HUMANDUOLIN RESPULESIPRATROPIUM BROMIDE & SALBUTAMOL500MG + 2.5 MG /2.5MLCIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA |LUNG ADMINISTRATION LIQUID FOR INHALATION4.0X5.0X2.5 ML VIAL7/1/2005
1379NDA/MAL/HDP/2673PHARMATHEN LTDGOODMAN INTERNATIONAL LTDSTRADUMELALLOPURINOL300MGPHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE | GREECE |ORAL SOLID ORDINARY TABLETS1.0X28.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE7/1/1997
1380NDA/MAL/HDP/2675LEBEN LABORATORIES PVT LTDANDYCO PHARMACY (UGANDA) LTDLIBITUS PLUS SYRUPTERBUTALINE/ BROMHEXINE/ GUAIPHENESIN1.25MG/ 4MG/ 50 MGLEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA |INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/2011
1381NDA/MAL/HDP/2678CIPLA LTD.QUALITY CHEMICALS LTD - HUMANFORCAN-150FLUCONAZOLE150MGCIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA |ORAL SOLID ORDINARY CAPSULES1.0X5.0 CAPSULE BLISTER7/1/2004
1382NDA/MAL/HDP/2679CIPLA LTD.QUALITY CHEMICALS LTD - HUMANALERID SYRUPCETIRIZINE HYDROCHLORIDE5MG/5ML CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA. |
INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X30.0 ML BOTTLE7/1/2006
1383NDA/MAL/HDP/2680RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMPIREN CAPSULESAMPICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA |
UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER7/1/2007
1384NDA/MAL/HDP/2681RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDAMOXIRENAMOXICILLIN TRIHYDRATE250MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA |
UGANDA |ORAL SOLID ORDINARY CAPSULES1.0X1000.0 CAPSULE CONTAINER7/1/2007
1385NDA/MAL/HDP/2683RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDVITAMIN CASCORBIC ACID100MG RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA |
UGANDA |ORAL SOLID ORDINARY CHEWABLE TABLETS1.0X1000.0 TABLET CONTAINER7/1/2005
1386NDA/MAL/HDP/2685RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENEDOL(SUSPENSION)PARACETAMOL120MG/5ML RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA |
UGANDA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE7/1/2007
1387NDA/MAL/HDP/2686DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMOXYDAR FORTEAMOXICILLIN TRIHYDRATE250MG/5MLDAR AL DAWA-NA'UR PLANT AMMAN |JORDAN |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2009
1388NDA/MAL/HDP/2687M.J BIOPHARM PVT LTDTATA UGANDA LIMITEDTEICO 1000CEFEPIME1000MGM.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI |INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1000.0 MG VIAL7/1/2013
1389NDA/MAL/HDP/2688ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMOXYN-250AMOXICILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER7/1/2011
1390NDA/MAL/HDP/2690ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-250AMPICILLIN250MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA |ORAL SOLID ORDINARY CAPSULES1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER7/1/2011
1391NDA/MAL/HDP/2691ABACUS PHARMA (A) LTD.ABACUS PHARMA (AFRICA) LIMITEDAMPIMAX-500AMPICILLIN500MGREYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X50.0X500.0 MG VIAL7/1/2011
1392NDA/MAL/HDP/2696BHARAT SERUMS AND VACCINES LTDABACUS PHARMA (AFRICA) LIMITEDAMPHOTRETAMPHOTERICIN B50MGBHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501 |INDIA |PARENTERAL ORDINARY VIALS1.0X1.0 VIAL CARTON7/1/2012
1393NDA/MAL/HDP/2697REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDLUCIN OINTMENTHYDROCORTISONE1%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
1394NDA/MAL/HDP/2699CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDCARVIL 12.5CARVEDILOL12.5 MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS10.0X10.0 TABLET BLISTER7/1/2005
1395NDA/MAL/HDP/2702CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDEUGLIM 2GLIMEPIRIDE2MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2004
1396NDA/MAL/HDP/2704MACLEODS PHARMACEUTICALS LTDROYAL PHARMA 2011 LIMITEDPRIMACORT-100HYDROCORTISONE SODIUM SUCCINATE100MGMACLEODS PHARMACEUTICALS LTD-MAHIM ROAD, NEAR KULDEEP NAGAR REGAR(W0 MAHARASHTRA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X1.0X100.0 MG VIAL7/1/2005
1397NDA/MAL/HDP/2705ASTRAZENECAMACNAUGHTON LIMITEDPULMICORT NEBULISERBUDESONIDE0.5MG/MLASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN |LUNG ADMINISTRATION LIQUID FOR INHALATION1.0X4.0X5.0X2.0 ML VIAL7/1/2011
1398NDA/MAL/HDP/2706SOLVAY PHARMACEUTICALS BVHARLEYS UGANDA LIMITEDDUSPATALINMEBEVERINE HCL135MGSOLVAY PHARMACEUTICALS PV-VEERVEG 12 8121 AA 0187
NETHERLAND |
NETHERLANDS |ORAL SOLID ORDINARY TABLETS1.0X10.0X5.0 TABLET BLISTER7/1/2008
1399NDA/MAL/HDP/2707KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDKAMCLOXACLOXACILLIN250MGKAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA |UGANDA |ORAL SOLID ORDINARY CAPSULES100.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,10.0 CAPSULE CONTAINER7/1/1997
1400NDA/MAL/HDP/2708MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDHYPER TABLETSPROPRANOLOL HYDROCHLORIDE40MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER7/1/2000
1401NDA/MAL/HDP/2710GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTDUNITED HEALTHCARE DISTRIBUTORS LTDAUGMENTIN BDAMOXICILLIN + CLAVULANIC ACID500 MG + 125 MGSMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM |ORAL SOLID ORDINARY TABLETS1.0X14.0 TABLET BLISTER7/1/1997
1402NDA/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 | INDIA |PARENTERAL ORDINARY VIALS1.0X20.0 ML VIAL7/1/2014
1403NDA/MAL/HDP/2714NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDANAFRANILCLOMIPRAMINE25MGNOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA | ITALY |ORAL SOLID ORDINARY TABLETS1.0X30.0 TABLET CONTAINER7/1/1997
1404NDA/MAL/HDP/2715MYLAN LABORATORIES LIMITEDKIMSY MEDS LTDLAMIVUDINELAMIVUDINE150MGMYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X1.0X60.0 TABLET CONTAINER7/1/2008
1405NDA/MAL/HDP/2717CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDOCUMYCIN EYE OINTMENTCHLORAMPHENICOL1%W/WCENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA | INDIA |OPHTHALMIC OINTMENTS1.0X3.5 G TUBE7/1/2000
1406NDA/MAL/HDP/2718SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.GYNOMINZZSHAIGAN PHARMACEUTICALS (PVT) LIMITED-14 KM ADYALA RD, RAWALPINDI, PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X2.0 TABLET BLISTER7/1/1997
1407NDA/MAL/HDP/2720SEDICO PHARMACEUTICAL CO.WIDE SPECTRUM ENTERPRISES (U) LIMITEDFLUCAMOX 250MG POWDER FOR ORAL SUSPENSIONAMOXICILLIN +FLUCLOXACILLIN125MG/5ML+125MG/5MLSEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT | EGYPT |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X80.0 ML BOTTLE7/1/2007
1408NDA/MAL/HDP/2721MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRIMAFEN TABLETIBUPROFEN + PARACETAMOL400MG + 325MGTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2007
1409NDA/MAL/HDP/2722MACK BROWN PHARMACEUTICALS PVT LIMITEDSHURIK LTDNO SORESCHOLINE SALICYLATE/LIDOCAINE8.7%W/W+2%W/WTORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL TOPICAL GELS AND SOLS1.0X10.0 G TUBE7/1/2007
1410NDA/MAL/HDP/2723TABROS PHARMAHEALTHCARE LTD.DURAGESIC TABLETPARACETAMOL + ORPHENADRINE450MG+35MGTABROS PHARMA-L-20/B SECTOR 22 FB INDUSTRIAL AREA KARACHI PAKISTAN |PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/1997
1411NDA/MAL/HDP/2730MISSION PHARMA A/S INDIAJOINT MEDICAL STORE (UPMB - UCMB)TRICLOVERAMEDROXYPROGESTERONE ACETATE150MG/MLPT TUNGGAI IDAMAN ABDI,-J1.JEND.YANI NO.7 JAKARTA TIMUR | INDONESIA |PARENTERAL ORDINARY I M VIALS1.0X20.0X1.0 ML VIAL7/1/2010
1412NDA/MAL/HDP/2734DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTDGAMA PHARMACEUTICALS (U) LIMITEDAMLODAR-10AMLODIPINE BESILATE10MGDAR AL DAWA-NA'UR PLANT AMMAN |JORDAN |ORAL SOLID ORDINARY CAPSULES1.0X2.0X14.0 CAPSULE BLISTER7/1/2009
1413NDA/MAL/HDP/2737SHAIGAN PHARMACEUTICALS LTDHEALTHCARE LTD.SENEX FORTESECNIDAZOLE1GSHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN |ORAL SOLID ORDINARY TABLETS1.0X1.0X2.0 TABLET BLISTER7/1/2004
1414NDA/MAL/HDP/2738WIN-MEDICARE LTDSURGIPHARM (U) LIMITEDHEPA-MERZ INFUSIONL-ORNITHINE- L-ASPARTATE5MG/MLWIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA |PARENTERAL ORDINARY I V VIALS1.0X5.0X10.0 ML VIAL7/1/2001
1415NDA/MAL/HDP/2739REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL TABLETHYOSCINE BUTYLBROMIDE10MGREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER7/1/2001
1416NDA/MAL/HDP/2742MARCK BIOSCIENCES LTDPHARMA VILLE LIMITEDSTERILIZED WATER FOR INJECTION BPSTERILIZED WATER FOR INJECTION BPMULTI-INGREDIENTMARCK BIOSCIENCES LIMITED. .-PLOT 876, NH NO. 8, HARIYALA, KHEDA-387411, GUJARAT | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X10.0X5.0X10.0 ML BOTTLE
1417NDA/MAL/HDP/2743BEIJING HOLLEY COTEC PHARMA CHINASUPER PHARMACEUTICALS LIMITEDDUO-COTECXINDIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE40MG + 320MGKBN- ZHEJIANG PHARMACEUTICAL CO. LTD-NO. 340 YUNHAI ROAD JIAXING ECONOMIC DEVELOPMENT ZONE, JIAXING CITY, ZHEJIANG PROVINCE | CHINA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER,1.0X30.0X9.0 TABLET BLISTER7/1/2005
1418NDA/MAL/HDP/2745RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDRENFORMINMETFORMIN HYDROCHLORIDE500MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2015
1419NDA/MAL/HDP/2746ERIS LTDBENLE CONSULT LIMITEDACYCLOVIR DENK 200ACYCLOVIR200MGDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY |ORAL SOLID ORDINARY TABLETS1.0X25.0 TABLET BLISTER7/1/2000
1420NDA/MAL/HDP/2751CADILA PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.FLUDAC CAPSULESFLUOXETINE HCL20MGCADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE |INDIA |ORAL SOLID ORDINARY CAPSULES1.0X20.0 CAPSULE BLISTER7/1/1997
1421NDA/MAL/HDP/2753MACK BROWN PHARMECEUTICALS PVT LTDSHURIK LTDPRASILMETOCLOPRAMIDE HYDROCHLORIDE10MGTORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2009
1422NDA/MAL/HDP/2754FDC LTDAIVEEN (U) LIMITEDZATHRIN 500AZITHROMYCIN DIHYDRATE500MGFDC LIMITED -PLOT NO. L121 B VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0X1.0X3.0 TABLET BLISTER,1.0X50.0X1.0X1.0X3.0 TABLET BLISTER7/1/2016
1423NDA/MAL/HDP/2756PFIZER LABORATORIES LTDLABOREX UGANDA LIMITEDCYTOTECMISOPROSTOL200MCGPIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND NE 613YA |UNITED KINGDOM |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X2.0X14.0 TABLET BLISTER7/1/2010
1424NDA/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 | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE7/1/1997
1425NDA/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 | INDIA |ORAL LIQUID ORDINARY SYRUPS1.0X200.0 ML BOTTLE7/1/2004
1426NDA/MAL/HDP/2767MISSION PHARMA A/S INDIAJOINT MEDICAL STORE (UPMB - UCMB)PHENOXYMETHYLPENICILLIN TABLETS BPPHENOXYMETHYLPENICILLIN250MGMEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
|
INDIA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2010
1427NDA/MAL/HDP/2773REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDBISPANOL ELIXIRHYOSCINE-N-BUTYLBROMIDE5MG/5MLREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA, NAIROBI, KENYA | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE7/1/2004
1428NDA/MAL/HDP/2774ACINO PHARMA AGGOODMAN INTERNATIONAL LTDBACTIFLOX NEO 500CIPROFLOXACIN500MGACINO PHARMA AG.-DORNACHERSTRASSE 114, CH-4147 AESCH, SWITZERLAND | SWITZERLAND |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2005
1429NDA/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 BHARUCH |INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,14.0X10.0 TABLET BLISTER7/1/1997
1430NDA/MAL/HDP/2779BROOKES PHARMACEUTICAL LABORATORIES LHARLEYS UGANDA LIMITEDPYODINE SURGICAL SCRUBPOVIDONE IODINE7.5%W/VBROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN |
PAKISTAN |TOPICAL EXTERNAL LIQUIDS1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE,1.0X500.0 ML BOTTLE7/1/2006
1431NDA/MAL/HDP/2781INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDCARVETAS 6.25CARVEDILOL6.25MGINTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER7/1/2011
1432NDA/MAL/HDP/2782INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDKWINILQUININE DIHYDROCHLORIDE300MG/MLINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA |PARENTERAL ORDINARY AMPOULES20.0X5.0X2.0 ML AMPOULE7/1/1998
1433NDA/MAL/HDP/2783NOVARTIS PHARMA AGSURGIPHARM (U) LIMITEDVOLTAREN SUPPOSITORIES 25MGDICLOFENAC SODIUM25MGDELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE |RECTAL SYSTEMIC SUPPOSITORIES1.0X1.0X10.0 SUPPOSITORY STRIP7/1/2006
1434NDA/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)
|
INDIA |ORAL LIQUID ORDINARY SUSPENSIONS1.0X100.0 ML BOTTLE7/1/2009
1435NDA/MAL/HDP/2788RENE INDUSTRIES LIMITEDRENE INDUSTRIES LIMITEDMULTIVITAMIN TABLETSMULTIINGREDIENTN/ARENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X1000.0 TABLET CONTAINER7/1/2010
1436NDA/MAL/HDP/2790UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 20ATORVASTATIN20MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0 TABLET BLISTER7/1/2003
1437NDA/MAL/HDP/2792UNICHEM LABORATORIES LIMITED?EUROPA HEALTHCARE (U) LTDTG-TOR 10ATORVASTATIN10MGUNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 |INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X10.0 TABLET BLISTER7/1/2003
1438NDA/MAL/HDP/2793GILEAD SCIENCE INCMEDICAL ACCESS (UGANDA) LIMITEDVIREADTENOFOVIR DISOPROXIL FUMARATE300MGPATHEON YM INC. TORONTO- TORONTO, CANADA | ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICA | TAKEDA GMBH,PLANT ORANIENBURG-LEHNITZSTRASSE 70-98,16515,ORANIENBURG-GERMANY | CANADA |ORAL SOLID ORDINARY TABLETS1.0X1.0X30.0 TABLET BOTTLE7/1/2004
1439NDA/MAL/HDP/2796ASTRA PHARMA (UK) LTDASTRA PHARMA (U) LIMITEDBENZYLPENICILLIN INJECTIONBENZYLPENICILLIN SODIUM1,000,000I.UCSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG)CO. LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY, HEBEI PROVINCE(WORKSHOP 406 AND 407) | CHINA |PARENTERAL ORDINARY DRY VIALS1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON7/1/2001
1440NDA/MAL/HDP/2797RENE INDUSTRIES LTDRENE INDUSTRIES LIMITEDLUMARENARTEMETHER + LUMEFANTRINE20 MG + 120 MGRENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA |ORAL SOLID ORDINARY TABLETS1.0X3.0X8.0 TABLET BLISTER7/1/2010
1441NDA/MAL/HDP/2800NOVO NORDISKSTAR PHARMACEUTICALS LTDACTRAPID HM PENFILLHUMAN INSULIN100 I.U/MLNOVO NORDISK PHARMA-NOVO ALLE |DENMARK |PARENTERAL ORDINARY PRE-FILLED PENS1.0X1.5 ML PREFILLED PEN,1.0X3.0 ML PREFILLED PEN7/1/1997
1442NDA/MAL/HDP/2802CENTAUR PHARMACEUTICALS PRIVATE LIMITEDGITTOES PHARMACEUTICALS LIMITEDTASOLCLOBETASOL0.05%W/WCENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 |INDIA |TOPICAL EXTERNAL CREAMS1.0X15.0 G TUBE7/1/2005
1443NDA/MAL/HDP/2805REMEDICA LTDGOODMAN INTERNATIONAL LTDNIFELAT 20R TABLETSNIFEDIPINE20MGREMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER7/1/1997
1444NDA/MAL/HDP/2807GUILIN PHARMACEUTICALS CO.LTDSTAR PHARMACEUTICALS LTDASAQ GPSCARTESUNATE + AMODIAQUINE100 MG + 270 MGGUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA |CHINA |ORAL SOLID ORDINARY TABLETS1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER7/1/2011
1445NDA/MAL/HDP/2809BLISS GVS PHARMA LIMITEDDELMAW ENTERPRISES LIMITEDMAITRIPEG 150OBP/ PEG 1000BP1280MG/ 320MGBLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA |VAGINAL TABLETS1.0X5.0 PESSARY STRIP7/1/2008
1446NDA/MAL/HDP/2811REGAL PHARMACEUICALS LTDREGAL PHARMA (U) LTDSULPHUR OINTMENTSULPHUR PRECIPITATED10%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X25.0 G TUBE7/1/2001
1447NDA/MAL/HDP/2812DAFRA PHARMA LTDLABOREX UGANDA LIMITEDCO-ARTESIANEBETA ARTEMETHER + LUMEFANTRINE180 MG/60ML + 1080 MG/60MLMANUFACTURING PACKAGING FARMACIA APPELHOF OUDEHASK-NETHERLANDS |NETHERLANDS |ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS1.0X60.0 ML BOTTLE7/1/2005
1448NDA/MAL/HDP/2813REGAL PHARMACEUTICALS LTDREGAL PHARMA (U) LTDINTACYCLINE SKIN OINTMENTTETRACYCLINE HYDROCHLORIDE3%W/WREGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE7/1/1997
1449NDA/MAL/HDP/2814THE ARAB DRUG COMPANYGOODMAN INTERNATIONAL LTDVENTAL PLUSSALBUTAMOL + BECLOMETHASONE DIPROPIONATE0.1MG + 0.05MG/ PUFFTHE ARAB DRUG COMPANY-5-EL MASSANEI ST AL AMEREYA CAIRO |EGYPT |LUNG ADMINISTRATION METERED-DOSE INHALER1.0X200.0 DOSE CANNISTER7/1/2014
1450NDA/MAL/HDP/2816CADILA HEALTH CARE LIMITEDABACUS PHARMA (AFRICA) LIMITEDCATENOL-100 TABLETSATENOLOL100MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS10.0X10.0 TABLET BLISTER7/1/1997
1451NDA/MAL/HDP/2821LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDDIOLIN-MGLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS5MG+500MGLINCOLN PHARMACEUTICAL LIMITED..-LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2011
1452NDA/MAL/HDP/2826GLAXO SMITH KLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPIRITON SYRUPCHLORPHENIRAMINE MALEATE4MG/10ML GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBI | KENYA |ORAL LIQUID ORDINARY SYRUPS1.0X100.0 ML BOTTLE,1.0X2.0 L BOTTLE7/1/1997
1453NDA/MAL/HDP/2830MEDIPHARM SALES LIMITEDMEDIPHARM INDUSTRIES (E.A) LTDQUINIMIX MIXTUREQUININE HYDROCHLORIDE100MG/5MLMEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD (BWEYOGERERE) | UGANDA |ORAL LIQUID ORDINARY LIQUIDS1.0X100.0 ML BOTTLE7/1/2003
1454NDA/MAL/HDP/2835LINCOLN PHARMACEUTICALS LTDMETRO PHARMACEUTICALS LIMITEDSOLUDINE-MPOVIDONE IODINE / METRONIDAZOLE5%W/W / 1%W/WLINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
|
INDIA |TOPICAL EXTERNAL OINTMENTS1.0X20.0 G TUBE,1.0X125.0 G TUBE7/1/2011
1455NDA/MAL/HDP/2838MODI MUNDI PHARMA PVT LTDSURGIPHARM (U) LIMITEDDILCONTIN XL 120CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE120MGMODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA |ORAL SOLID RETARD FILM-COATED TABLETS1.0X10.0X10.0 TABLET STRIP7/1/2010
1456NDA/MAL/HDP/2848MSD (PTY) LIMITED SAPHILLIPS PHARMACEUTICALS (UGANDA) LIMITEDDIPROGENTA OINTMENTBETAMETHASONE /GENTAMICIN SULPHATE0.5MG/G+1.0MG/GSCHERING-PLOUGH LABONV-INDUSTRIE PARK 30, B-220 HEIST-OP-DEN-BERG, BELGIUM | CANADA |TOPICAL EXTERNAL OINTMENTS1.0X15.0 G TUBE,1.0X30.0 G TUBE7/1/2001
1457NDA/MAL/HDP/2850MEDICAL UNION PHARMACEUTICALSKARURI PHARMACEUTICALS LTD.DISPERCAMPIROXICAM20MGMEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT |EGYPT |PARENTERAL ORDINARY AMPOULES1.0X2.0X3.0X1.0 ML AMPOULE7/1/2007
1458NDA/MAL/HDP/2867SERUM INSTITUTE OF INDIA LTD.NORVIK ENTERPRISES LIMITEDSII RABIVAXRABIES VACCINE2.5I.U/MLSERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA |PARENTERAL ORDINARY AMPOULES1.0X1.0 ML AMPOULE7/1/2005
1459NDA/MAL/HDP/2868CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDLOSACAR 50LOSARTAN POTASSIUM50MGCADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X7.0 TABLET BLISTER7/1/2003
1460NDA/MAL/HDP/2869GLAXO SMITHKLINE LTDUNITED HEALTHCARE DISTRIBUTORS LTDPRIORIX VACCINEMEASLES + MUMPS + RUBELLA103.0CCID50 + 103.7CCID50 + 103.0CCID50GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSART | BELGIUM |PARENTERAL ORDINARY DRY VIALS1.0X0.5 ML VIAL (1 DOSE)7/1/2010
1461NDA/MAL/HDP/2873INTAS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDHELIGO KITTINIDAZOLE/CLARITHROMYCIN/LANSOPRAZOLE500MG+ 250MG+30MGINTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA |ORAL SOLID ORDINARY TABLETS1.0X7.0X6.0 TABLET BLISTER7/1/2001
1462NDA/MAL/HDP/2875GLAXOSMITHKLINE LIMITED-UNITED HEALTHCARE DISTRIBUTORS LTDOTRIVIN 0.05% NASAL DROPSXYLOMETAZOLINE0.05%W/VNOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND |SWITZERLAND |NASAL TOPICAL DROPS1.0X10.0 ML BOTTLE7/1/2003
1463NDA/MAL/HDP/2877MARCK BIOSCIENCES LIMITEDPHARMA VILLE LIMITEDCANDICANFLUCONAZOLE0.2%W/VMARCK PARENTERALS (INDIA) LTD-PLOT NO. 876, N.H,NO.8,VIL, HANYALA, KHEDA 387411,GURAJAT, INDIA | INDIA |PARENTERAL ORDINARY INFUSION VIALS/BOTTLES1.0X100.0 ML BOTTLE7/1/2005
1464NDA/MAL/HDP/2878PHARCO PHARMACEUTICALS LTDWIDE SPECTRUM ENTERPRISES (U) LIMITEDFARCOCIN CREAMGENTAMYCIN SULPHATE0.1%W/WPHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
|
EGYPT |TOPICAL EXTERNAL CREAMS1.0X20.0 G TUBE7/1/2000
1465NDA/MAL/HDP/2879CADILA HEALTHCARE LTDABACUS PHARMA (AFRICA) LIMITEDOFLIN-200OFLOXACIN200MGCADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X20.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,10.0X1.0X10.0 TABLET BLISTER7/1/2004
1466NDA/MAL/HDP/2880REMEDICA LTDGOODMAN INTERNATIONAL LTDCARBIMAZOLE 5CARBIMAZOLE5MGREMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL | CYPRUS |ORAL SOLID ORDINARY TABLETS1.0X10.0X10.0 TABLET BLISTER7/1/2010
1467NDA/MAL/HDP/2882TATA UGANDA LIMITEDTATA UGANDA LIMITEDHYOSCINE BROMIDEHYOSCINE BROMIDE2OMG/MLGLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043 |INDIA |PARENTERAL ORDINARY AMPOULES1.0X10.0X1.0 ML AMPOULE7/1/2009
1468NDA/MAL/HDP/2885MACLEODS PHARMACEUTICALS LTDNORVIK ENTERPRISES LIMITEDFORECOX-TRACRIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL150MG + 75MG+ 400MG + 275MGMACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | OXALIS LABS LIMITED-VILLAGE THEDA, P.O LODHIMAJRA, TEHSIL,BADDI, DIST.SOLAN, INDIA | INDIA |ORAL SOLID ORDINARY TABLETS1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER7/1/2005
1469NDA/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)
|
INDIA |ORAL SOLID ORDINARY FILM-COATED TABLETS1.0X1000.0 TABLET CONTAINER7/1/2009
1470NDA/MAL/HDP/2888VHB MEDI SCIENCES LTDLLOYDS PHARMACY LIMITEDSUCCICORTHYDROCORTISONE SODIUM SUCCINATE100MG/VIALVHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA |PARENTERAL ORDINARY DRY VIALS1.0X100.0 MG VIAL7/1/2013
1471NDA/MAL/HDP/2890KPI INDUSTRIES(1996) LTEDKAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITEDBETASOL N