| NDA/MAL/HDP/0002 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | X-SONE-N | DEXAMETHASONE+NEOMYCIN | 0.1W/V+ 0.35W/V | ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0003 | UNI MEDICO LAB | SHREEJI PHARMACEUTICALS LIMITED | UMOXIL CLAV 625 | AMOXICILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | UNI MEDICOLABS-21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/0004 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | INRAB 20 | RABEPRAZOLE SODIUM | 20 MG | AUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK,
POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR
| INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0005 | STALLION LABORATORIES PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | ALPRAZEC 0.25 | ALPRAZOLAM | 0.25MG | ACME FORMULATION PVT LTD -ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X4.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0006 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIAMIDE | GLIBENCLAMIDE + METFORMIN HYDROCHLORIDE | 5MG,500MG | HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/0007 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | PROCIP SYRUP | CYPROHEPTADINE HYDROCHLORIDE | 2MG/5ML | 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 SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0008 | STALLION LABORATORIES PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | OMEPRIC | OMEPRAZOLE DELAYED-RELEASE | 20MG | ACME FORMULATION PVT LTD.-ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID RETARD CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0009 | STALLION LABORATORIES PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | DINASOD-100 | DICLOFENAC | 100MG | ACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0010 | STALLION LABORATORIES PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | 02-LON | OFLOXACIN + ORNIDAZOLE | 200MG + 500MG | ACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0012 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | PENGESIC SR | TRAMADOL HYDROCHLORIDE SR | 100MG | HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0014 | HOVID BHD (IPOH SITE) | UNITED HEALTHCARE DISTRIBUTORS LTD | MONTELAIR 10MG TABLET | MONTELUKAST | 10MG | HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0016 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | CODIMEX-CT TABLETS | CETIRIZINE DIHYDROCHLORIDE | 10MG | REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0017 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | HYCORT | HYDROCORTISONE | 100MG | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X7.5 ML VIAL |
| NDA/MAL/HDP/0021 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | QUINS | QUININE DIHYDROCHLORIDE | 300MG/ML | SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2.0 ML AMPOULE,1.0X2.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0022 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | QUININE SULPHATE | QUININE SULPHATE | 300MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0024 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMPICLOXA | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0025 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | AMLOAS-5 | AMLODIPINE | 5MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220,TALUKA BAVLA DIST AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0026 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | AMLOAS-10 | AMLODIPINE | 10MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0028 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | HYPERLOK-50 | ATENOLOL | 50MG | ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0029 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | HYPERLOK-100 | ATENOLOL | 100MG | ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0030 | UNOSOURCE PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | TRADMIN | TRAMADOL HYDROCHLORIDE | 50MG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
| INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0031 | MANKIND PHARM LTD | TATA UGANDA LIMITED | CEFTATIME-SB 1.5 | CEFTRIAXONE+SULBACTAM | 1000MG+500MG | MANKIND PHARMA LTD--VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.5 G VIAL |
| NDA/MAL/HDP/0033 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYVATE CREAM | BETAMETHASONE VALERATE | 0.1%W/W | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0036 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | DOCETAXEL FOR INJECTION | DOCETAXEL | 40MG/ML | NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
| INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL + 1*6ML SOLVENT FOR RECONSTITUTION |
| NDA/MAL/HDP/0037 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | L-ASPASE | L-ASPARGINASE | 1000 I.U | NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
| INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0038 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | ARZI 200 | DACARBAZINE | 200MG | NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
| INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/0039 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | NZYTOP | ETOPOSIDE INJECTION USP | 100MG | NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
| INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/0041 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RECIM | CIMETIDINE | 200MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0042 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | CISPLATIN | CISPLATIN | 1MG/ML | NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
| INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML VIAL |
| NDA/MAL/HDP/0043 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMADOL JUNIOR | PARACETAMOL | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0044 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | NAPRO-TAX | PACLITAXEL | 6MG/ML | NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506
MAHARASTRA, INDIA.
| INDIA | PARENTERAL ORDINARY OTHER VIALS | 1.0X1.0X20.0 ML VIAL |
| NDA/MAL/HDP/0045 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOMOL | PARACETAMOL | 500MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0046 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | ABINGEM | GEMCITABINE | 1G | NAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/0047 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LAMIHOPE ET | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 600MG + 300MG + 300MG | MACLEODS PHARMACEUTICALS LIMITED (BLOCK ?N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/0051 | H. LUNDBECK A/S | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CLOPIXOL ACUPHASE | ZUCLOPENTHIXOL ACETATE | 50MG/ML | H. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY | DENMARK | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0052 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DISPERCAM | PIROXICAM | 0.5%W/V | MEDICAL UNION PHARMACEUTICALS CO -36 DR MOHAMED HASSAN EL GAMAL ST. 6TH DISTRICT NASR CITY, CAIRO | EGYPT | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/0053 | H. LUNDBECK A/S | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLUANXOL DEPOT | FLUPENTIXOL DECANOATE | 20MG/ML | H. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK | PARENTERAL RETARD AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0054 | GOOD DAY PHARMACY LIMITED | GOOD DAY PHARMACY LIMITED | FUNGOAL | CLOTRIMAZOLE | 1%W/W | KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/0055 | H.LUNDBECK A/S | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CLOPIXOL DEPOT | ZUCLOPENTHIXOL DECANOATE | 200MG/ML | H. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN | DENMARK | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0056 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | DYNAPAR QPS | DICLOFENAC | 4%W/V | TROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL SPRAYS WITHOUT GAS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/0058 | NIRMA LIMITED. | SUPER MEDIC LTD | WATER FOR INJECTION B.P. | WATER FOR INJECTION | N/A | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/0059 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | VAGIBACT CREAM | CLINDAMYCIN PHOSPHATE | 2%W/W | NABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
| PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X40.0 G TUBE + 1 APPLICATOR |
| NDA/MAL/HDP/0060 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GONAL-F PEN 300 IU/0,5 ML (22 ?G/0,5 ML) | FOLLITROPIN ALFA | 22 ?G/0,5 ML | MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION |
| NDA/MAL/HDP/0063 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | ABACAVIR SULPHATE + LAMIVUDINE | ABACAVIR SULFATE + LAMIVUDINE | 600MG + 300MG | HETERO 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 TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/0064 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GONAL-F PEN 450 IU/ IE 0,75 ML (33 ?G) | FOLLITROPIN ALFA | 33?G/ 0.7ML | MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY CARTRIDGES | 1.0X1.0 CARTRIDGE PREFILLED PEN + 12 NEEDLES FOR INJECTION |
| NDA/MAL/HDP/0065 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | ALENDRONATE 70MG | ALENDRONATE SODIUM | 70MG | HOVID BHD-LOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMOR | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/0067 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | ARTEES | ?-? ARTEETHER | 75MG/ML | SAKAR HEALTHCARE PVT LTD --406, SILVER OAKS COMMERCIAL COMPLEX, | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X3.2 ML AMPOULE |
| NDA/MAL/HDP/0069 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | LIPITOR | ATORVASTATIN | 10MG | PFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/0070 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | LIPITOR | ATORVASTATIN | 20MG | PFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/0071 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SUMAFIX 100 | SUMATRIPTAN SUCCINATE | 100MG | AUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/0072 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | AMTERICIN | AMPHOTERICIN | 50MG | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 MG VIAL |
| NDA/MAL/HDP/0073 | NAARI LTD | ECHO PHARMACY (U) LIMITED | FASILE-ONE | LEVONORGESTREL TABLETS BP | 1.5MG | NAARI 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 TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/0075 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | SYNRIAM | ARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE | 150 MG + 750 MG | SUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/0077 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | X-SONE | DEXAMETHASONE SODIUM PHOSPHATE | 0.1 % W/V | ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0079 | MYLAN LABORATORIES LIMITED. | NORVIK ENTERPRISES LIMITED | REVOKE 72 | LEVONORGESTREL | 750MCG | MYLAN 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, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/0080 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABWATER | STERILE WATER FOR IRRIGATION | N/A | ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | PARENTERAL ORDINARY OTHER INFUSIONS | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/0081 | ANKUR DRUGS AND PHARMA LTD | JOINT MEDICAL STORE (UPMB - UCMB) | VEXAPEN-625 | AMOXICILLIN + CLAVULANATE | 500 MG + 125 MG | ANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) ? 174 101(INDIA)
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0082 | ANKUR DRUGS AND PHARMA LTD | JOINT MEDICAL STORE (UPMB - UCMB) | CEPOVEX-50 | CEFPODOXIME PROXETIL | 50MG | ANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) ? 174 101(INDIA)
| INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/0083 | MYLAN LABORATORIES LIMITED. | NORVIK ENTERPRISES LIMITED | ZINNIA-F | LEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE | 150MCG + 30MCG + 75MG | MYLAN 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, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/0084 | ANKUR DRUGS AND PHARMA LTD | JOINT MEDICAL STORE (UPMB - UCMB) | VEXIME CP-625 | CEFUROXIME AXETIL + POTASSIUM CLAVULANATE | 500MG + 125MG | ANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) ? 174 101(INDIA)
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/0085 | HETERO LABS LTD UNIT IX | ABACUS PHARMA (AFRICA) LIMITED | PIOGEN-30 | PIOGLITAZONE HYDROCHLORIDE | 30MG | HETERO 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0086 | ANKUR DRUGS AND PHARMA LTD | JOINT MEDICAL STORE (UPMB - UCMB) | VEXAPEN -228.5 | AMOXICILLIN + CLAVULANATE | 200 MG + 28.5 MG | ANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) ? 174 101(INDIA)
| INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0087 | ANKUR DRUGS AND PHARMA LTD | JOINT MEDICAL STORE (UPMB - UCMB) | VEXAPEN CP-457 | AMOXICILLIN + CLAVULANATE | 400 MG + 57 MG | ANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) ? 174 101(INDIA)
| INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0088 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | D-LYTE CO-PACK | ANHYDROUS GLUCOSE/SODIUM CHLORIDE/TRISODIUM CITRATE/POTASSIUM CHLORIDE | (2.7G/0.52G/0.58G/0.3G)/20MG | 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 COMBINATION PACK POWDERS/GRANULES | 4.0X500.0 ML SACHET + 1*10 BLISTERS,10.0X200.0 ML SACHET + 1*10 BLISTERS,2.0X1000.0 ML SACHET + 1*10 BLISTERS |
| NDA/MAL/HDP/0089 | ANKUR DRUGS AND PHARMA LTD | JOINT MEDICAL STORE (UPMB - UCMB) | CEPOVEX-200 | CEFPODOXIME PROXETIL | 200MG | ANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) ? 174 101(INDIA)
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0093 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | LORAS | LORATADINE | 10MG | ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0096 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | LIPOR | ATORVASTATIN | 20MG | ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/0097 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | SAFELEVO 750 | LEVOFLOXACIN | 750MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0098 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | ATOREM 10 | ATORVASTATIN | 10MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0099 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | CARBAS | CARBAMAZEPINE | 200MG | ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0101 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTETRA CAPSULES (THANE) | TETRACYCLINE HYDROCHLORIDE | 250MG | AGOG 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 CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0102 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | SILMELT 100 | SILDENAFIL CITRATE | 100MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/0103 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | ATOREM 20 | ATORVASTATIN | 20MG | MSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0104 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | SILMELT 50 | SILDENAFIL CITRATE | 50MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/0105 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOSPRIN TABLETS | ACETYL SALICYLIC ACID | 300MG | AGOG 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 TABLETS | 10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0106 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | SAFELEVO | LEVOFLOXACIN | 500MG/100ML | MARCK BIOSCIENCES -PLOT NO 876, NH NO 8 HARIYALA KHEDA- 387411 GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0107 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | ASUNRA | DEFERASIROX | 400MG | NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE | SWITZERLAND | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X5.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/0110 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | SAFETELMI 40 | TELMISARTAN | 40MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0111 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | SAFETELMI 80 | TELMISARTAN | 80MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0112 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE 5MG/160MG | AMLODIPINE + VALSARTAN | 5 MG + 160 MG | NOVARTIS 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 TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/0114 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | BREATHEZY 4 | MONTELUKAST SODIUM | 4MG | MSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0116 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | BREATHEZY CW 5 | MONTELUKAST SODIUM | 5MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0117 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF 1.5G | CEFUROXIME SODIUM | 1.5G | ALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.5 G VIAL |
| NDA/MAL/HDP/0118 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF 750MG | CEFUROXIME SODIUM | 750MG | ALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL |
| NDA/MAL/HDP/0119 | DAWA LIMITED | SUPER MEDIC LTD | DACOLD | CAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSUDOEPHEDRINE | 30MG+4MG+400MG+30MG | DAWA LIMITED -BABA DOGO RWARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0124 | DAWA LIMITED | SUPER MEDIC LTD | AMPECIN | AMPICILLIN TRIHYDRATE | 125MG/5ML | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0125 | DAWA LIMITED | SUPER MEDIC LTD | SULPHUR OINTMENT | SULPHUR | 10%W/W | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/0126 | DAWA LIMITED | SUPER MEDIC LTD | WHITFIELD'S | BENZOIC ACID + SALICYLIC ACID | 6.0%W/W +3.0%W/W | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/0127 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | CORYCARDON | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300MG + 12.5MG | ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0128 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | CORYCARDON | IRBESARTAN + HYDROCHLOROTHIAZIDE | 150MG + 12.5MG | ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0129 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | PIOGEN | PIOGLITAZONE HYDROCHLORIDE | 15MG | HETERO 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0130 | CADILA PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TRIGAN -D | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0131 | ABBOT LABORATORIES S.A. (PTY) LTD | HARLEYS UGANDA LIMITED | KLACID P125 | CLARITHROMYCIN | 125MG/5ML | ABBOTT 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/GRANULES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0132 | ABBOT LABORATORIES S.A. (PTY) LTD | HARLEYS UGANDA LIMITED | KLACID 500MG | CLARITHROMYCIN | 500MG | ABBOTT 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 TABLETS | 1.0X10.0 TABLET BLISTER,1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/0133 | ABBOT LABORATORIES S.A. (PTY) LTD | HARLEYS UGANDA LIMITED | KLACID P250 | CLARITHROMYCIN | 250MG/5ML | ABBOTT 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/GRANULES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0139 | ANGLIAN NUTRITION PRODUCTS COMPANY | SUPER MEDIC LTD | MOXAFORTE | FLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE | 250MG + 250MG | DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0141 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | NYCOSTAT SUSPENSION | NYSTATIN | 100,000 I.U/ML | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/0142 | PFIZER LAB LTD | LABOREX UGANDA LIMITED | PREVENAR 13 | PNEUMOCOCCAL 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 6B | WYETH PHARMACEUTICALS INC-401 N MIDDLETOWN RD PEARL RIVER NY 10965 | UNITED STATES | PARENTERAL ORDINARY VIALS | 1.0X0.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/0143 | UNIMED INDIA | METAPLUS (U) LIMITED | SPECTRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | UNIMED INDIA.-UNI-MED HOUSE, 86,MAROL COOPORATIVE INDUSTRIAL ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0144 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | NEXQUIN 500 | LEVOFLOXACIN | 500MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0145 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | TELKAST 10 | MONTELUKAST SODIUM | 10MG | MSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0146 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | CEF2 250 | CEFUROXIME AXETIL | 250MG | MEDREICH LIMITED UNIT-5-PLOT 45 A & B, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, TELANGANA INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0147 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | CEF 2 500 | CEFUROXIME AXETIL | 500MG | MEDREICH LIMITED UNIT-5-PLOT 45 A & B, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, TELANGANA INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0148 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | SYNCLAV 1000 | AMOXICILLIN + CLAVULANATE POTASSIUM | 875 MG + 125 MG | MEDREICH 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 TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/0149 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | SYNCLAV 625 | AMOXICILLIN + POTASSIUM CLAVULANATE | 500 MG + 125 MG | MEDREICH 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 TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/0150 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | SYNCLAV 228 | AMOXYCILLIN + CLAVULANATE POTASSIUM | 200 MG + 28.5 MG | MEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
| INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/0151 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | CARDITEL 80 | TELMISARTAN | 80MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0152 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | RYCARDON 150 | IRBESARTAN | 150MG | 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0153 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | RYCARDON 300 | IRBESARTAN | 300MG | 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0155 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ASTHATOR 10 | MONTELUKAST SODIUM | 10MG | TORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0157 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RECODIN | CODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE | 10MG + 4MG /5ML | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0158 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | KIPEL 10 | MONTELUKAST SODIUM | 10MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0161 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | TRAMAREN | TRAMADOL HYDROCHLORIDE | 50MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0162 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | COSYP-D LINCTUS | DEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE | 10MG +4MG /5ML | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0163 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | PHENAREN | PROMETHAZINE HYDROCHLORIDE | 5MG/5ML | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/0164 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | RENPRESS | PROPRANOLOL | 40MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0166 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | X-PEL | MEBENDAZOLE | 100MG/5ML | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/0168 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FEBUDAY | FEBUXOSTAT | 80MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0169 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ROSUVAX 10 | ROSUVASTATIN | 10MG | ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/0174 | GLAXO SMITHKLINE LTD | ERIS LTD | FLIXOTIDE 50 | FLUTICASONE PROPIONATE | 50MCG | GLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3
09400 ARANDA DE DUERO
BURGOS
SPAIN
| SPAIN | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/0175 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | XARELTO 10MG | RIVAROXABAN | 10MG | BAYER HEALTHCARE AG,-D-51368, LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0177 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | ILET B2 | GLIMEPIRIDE+METFORMIN HYDROCHLORIDE | 2MG+500 MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0178 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | COLDCAP DAYTIME AND NIGHT TIME CAPSULE | DAY 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 CAPSULES | 1.0X3.0X8.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0182 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FEBUDAY 40 | FEBUXOSTAT | 40MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0186 | WIDE SPECTRUM ENTERPRISES (U) LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BBC SPRAY | BENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE | 1.5%W/V+0.15%W/V+0.0413%W/V | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL TOPICAL SPRAYS WITHOUT GAS | 1.0X25.0 ML BOTTLE |
| NDA/MAL/HDP/0187 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KAPRON TABLET | TRANEXAMIC ACID | 500 MG | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0189 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | NEVIMUNE TABLETS | NEVIRAPINE | 200MG | CIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/0191 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CLEDOMOX 228.5 | AMOXICILLIN + CLAVULANATE | 200 MG + 28.5 MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/0192 | AMOUN PHARMACEUTICALS COMPANY | BOOTS PHARMACEUTICALS LIMITED | AMOCOMB CREAM | NEOMYCIN + TRIAMCINOLONE ACETONIDE + GRAMICIDIN | 0.25GM + 0.1G + 100000IU + 0.025G/100G | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0193 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | CLEDOMOX 625 | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/0196 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | DUOVIR | LAMIVUDINE/ZIDOVUDINE | 150MG/300MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | UGANDA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/0197 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | EFAVIR-600 | EFAVIRENZ | 600MG | CIPLA 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 TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/0198 | CIPLA LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | NEVIRAPINE TABLETS 200 MG | NEVIRAPINE | 200MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/0201 | GLAXO SMITH KLINE LTD | ERIS LTD | FLIXOTIDE 125 | FLUTICASONE PROPIONATE | 125MCG | GLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3
09400 ARANDA DE DUERO
BURGOS
SPAIN
| SPAIN | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/0203 | GLAXOSMITHLINE LTD | ERIS LTD | SERETIDE EVOHALER 250 | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG + 250MCG | GLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/0204 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | TIVICAY | DOLUTEGRAVIR SODIUM | 50MG | GLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOM | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/0205 | MACLEODS PHARMACEUTICALS LTDS LTD | NORVIK ENTERPRISES LIMITED | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/0206 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | CARDITEL 40 | TELMISARTAN | 40MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0207 | MACLEODS PHARMACEUTICAL LTD | NORVIK ENTERPRISES LIMITED | LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 300MG +300MG | MACLEODS 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 TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/0209 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | ABACAVIR SULPHATE ORAL SOLUTION | ABACAVIR SULPHATE | 20MG/ML | HETERO LABS LTD, UNIT III-KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X240.0 ML BOTTLE |
| NDA/MAL/HDP/0210 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | HEPATICUM | SILYMARIN | 140MG | MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0212 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | HEPATICUM | SILYMARIN | 1G/100ML | MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/0213 | AUROBINDO PHARMA LTD (UNIT VI) | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROPODOX 200 | CEFPODOXIME | 200MG | AUROBINDO 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 TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0217 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | PALETHER | ARTEMETHER | 80MG/ML | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | PARENTERAL ORDINARY I M AMPOULES | 2.0X3.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0221 | DAWA LIMITED | SUPER MEDIC LTD | AMPICLO-DAWA | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0222 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | AVIR-200 | ACYCLOVIR | 500MG | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0223 | ABACUS PHARMA LTD | ABACUS PARENTERAL DRUGS LIMITED | TOPCID-150 | RANITIDINE | 150MG | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0225 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | DIKON PLUS | DICLOFENAC/SALICYLATE/MENTHOL/LINSEED | 1%W/W+10%W/W+5%W/W+3%W/W | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G CONTAINER |
| NDA/MAL/HDP/0227 | AMOUM PHARMACEUTICALS LTD | BOOTS PHARMACEUTICALS LIMITED | CYRINOL SYRUP | PHOLCODINE+EPHEDRINE HCL +CARBINOXAMINE MALEATE | 4MG+7MG+2MG /5ML | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/0228 | KOPRAN LIMITED | TATA UGANDA LIMITED | TRIM-960 | TRIMETHOPRIM/SULFAMETHOXAZOLE | 160MG/800MG | KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0230 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | COMBIART | ARTHEMETHER + LUMEFANTRINE | 20MG +120MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X24.0 TABLET BLISTER |
| NDA/MAL/HDP/0232 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | BRANTA | LOSARTAN POTASSIUM + AMLODIPINE BESILATE | 50MG + 5MG | TORRENT PHARMACEUTICALS LTD .,-AHMEDABAD-MEHSANA HIGHWAY, TALUKA-KADI, DIST. MEHSANA, INDRAD-382721, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0233 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | CEFIMED 400 | CEFIXIME TRIHYDRATE | 400MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/0235 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | AXETINE 500 | CEFUROXIME AXETIL | 500MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0236 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | CLOB | CLOTRIMAZOLE | 1%W/W | INDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/0237 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | KOMEFAN 280 | ARTEMETHER + LUMEFANTRINE | 40 MG + 240 MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/0239 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | KOMEFAN 140 | ARTEMETHER + LUMEFANTRINE | 20 MG+ 120 MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/0243 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | LAMOZID | LAMIVUDINE + ZIDOVUDINE | 150MG +300MG | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/0245 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | EUGLIM 4 | GLIMEPIRIDE | 4MG | CADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0248 | EAGLEVET UGANDA LIMITED | MEDVIN PHARMA LIMITED | PANTONEX DR-40 | PANTOPRAZOLE | 40 MG | IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
| INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0250 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | DIKON | DICLOFENAC | 1%W/W | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G CONTAINER |
| NDA/MAL/HDP/0251 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LAMIVUDINE/ZIDOVUDINE/NEVIRAPINE | LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE | 150MG + 300MG + 200MG | MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101,MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/0252 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VAST-40 | ATORVASTATIN | 40MG | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0254 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR 5 | BISOPROLOL HEMIFUMARATE | 5MG | MERCK 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0255 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | CAPETERO 150 | CAPECITABINE | 150MG | HETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/0256 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | CAPETERO 500 | CAPECITABINE | 500MG | HETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X120.0 TABLET CONTAINER |
| NDA/MAL/HDP/0257 | SANOFI AVENTS FRANCE | LABOREX UGANDA LIMITED | CORDARONE | AMIODARONE HYDROCHLORIDE | 200MG | SANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE
| FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0261 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | LOSAGEN -100 | LOSARTAN POTASSIUM | 100MG | 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 FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0266 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | BENZATHINE PENICILLIN INJECTION | BENZATHINE PENICILLIN | 2.400.000 IU | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON |
| NDA/MAL/HDP/0267 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | PENVIR 750 | FAMCICLOVIR | 750MG | 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0269 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VOMISTAT-8 | ONDANSETRON | 8MG | LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0270 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | LEVIN 500MG | LEVOFLOXACIN HEMIHYDRATE | 500MG | 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 FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0271 | BIOLOGICAL E. LTD | GITTOES PHARMACEUTICALS LIMITED | BETT | TETANUS VACCNE ADSORBED | 40 I.U | BIOLOGICAL 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 AMPOULES | 1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML VIAL (10 DOSES) |
| NDA/MAL/HDP/0272 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | LEVIN 250 | LEVOFLOXACIN | 250MG | HETERO 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0273 | MICRO LABS LTD | LABOREX UGANDA LIMITED | PULMOCEF-1500 | CEFUROXIME | 1500MG | MICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/0275 | GLAXO SMITHLINE LIMITED | ERIS LTD | ZENTEL | ALBENDAZOLE | 400MG | GLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD-39 HAWKINS AVENUE, EPPING INDUSTRIAL, CAPE TOWN, 7460, SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/0276 | MICRO LABS LTD | LABOREX UGANDA LIMITED | MELANOV 80 | GLICLAZIDE | 80MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0278 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CHLORPROMAZINE TABLETS B.P 100MG | CHLORPROMAZINE HYDROCHLORIDE | 100MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0283 | DAWA LIMITED | SUPER MEDIC LTD | AMPICLO-DAWA | AMPICILLIN + CLOXACILLIN | 125 MG + 125 MG | DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0284 | GLAXO SMITHLINE LIMITED | ERIS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 1000 MG + 200 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | PARENTERAL ORDINARY DRY VIALS | 10.0X1.2 G VIAL |
| NDA/MAL/HDP/0287 | GOOD DAY PHARMACY LIMITED | GOOD DAY PHARMACY LIMITED | POWER HEAT | METHYL SALICYLATE BP | 15000MG | KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/0288 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | DUXCOSPAN | HYOSCINE BUTYL BROMIDE | 10MG | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0289 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | TETRAS | TETRACYCLINE HYDROCHLORIDE | 250MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0290 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | NATOA | MEBENDAZOLE | 100MG | LABORATORY & 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 TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0292 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | NAZANEEN ANTACID SUSPENSION | ALUMINUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 3.75 G/ 200 ML + 2.724 G/ 200 ML + 0.399 G/ 200 ML | MILAN LABS PVT LTD-63-67 JAWAHAR CO.OP. INDUSTRIAL ESTATE KAMOTHE,NAVI MUMBAI | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/0296 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PRAZITEL TABLETS | PRAZIQUANTEL | 600MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0298 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | SEFIXI-50 DRY SYRUP | CEFIXIME | 50MG | SAKAR 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/DROPS | 1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/0301 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | MONTE - H 10 | MONTELUKAST SODIUM | 10MG | HETERO 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0303 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | ABACAVIR SULPHATE | ABACAVIR SULPHATE | 300MG | HETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/0304 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | DARUNAVIR | DARUNAVIR | 400MG | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/0305 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | CEFAX-250 DRY SYRUP | CEFALEXIN | 250MG/5ML | SAKAR 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 POWDERS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0308 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | CEFAX-250 | CEFALEXIN | 250MG | SAKAR 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 CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0310 | YURIA PHARM EAST AFRICA LIMITED | YURIA PHARM EAST AFRICA LIMITED | LATREN | PENTOXIFYLLINE | 0.5MG/ML | YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/0311 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | FENTANYL | FENTANYL CITRATE | 50MCG/ML | MARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0312 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CLOXISPA ORAL SOLUTION 125 | CLOXACILLIN | 125MG/5ML | SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0314 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | SUXAMETHONIUM CHLORIDE SOLUTION FOR INJECTION | SUXAMETHONIUM CHLORIDE | 50MG/ML | MARTINDALE PHARMA -BAMPTON ROAD, HAROLD HILL,ROMFORD,RM3844 | UNITED KINGDOM | ORAL LIQUID ORDINARY LIQUIDS | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0316 | YURIA PHARM EAST AFRICA LIMITED | YURIA PHARM EAST AFRICA LIMITED | OFLOXACIN-UF | OFLOXACIN | 2MG/ML | YURIA-PHARM, LTD. -18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.. | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/0317 | YURIA PHARM EAST AFRICA LIMITED | YURIA PHARM EAST AFRICA LIMITED | CIPROFLOXACIN-UF | CIPROFLOXACIN | 2MG/ML | YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0318 | DAWA LIMITED | SUPER MEDIC LTD | SABULIN | SALBUTAMOL | 4MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0320 | DAWA LIMITED | SUPER MEDIC LTD | DAZOLE | CLOTRIMAZOLE | 1%W/W | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/0322 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-5 | NEBIVOLOL HCL | 5MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0326 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | OSTEBON | CALCIUM + COLECALCIFEROL | 250MG + 125 IU | ARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/0327 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | FLEXILOR 8 | LORNOXICAM | 8MG | GLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0328 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | FLEXILOR P | LORNOXICAM + PARACETAMOL | 4MG + 500MG | GLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0330 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASBUTOL-4 | SALBUTAMOL | 4MG | ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0331 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVOKILZ 500 | LEVOFLOXACIN | 500MG | AUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0332 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ROSUVAX 20 | ROSUVASTATIN CALCIUM | 20MG | ASTRA 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 TABLETS | 1.0X2.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/0333 | KOPRAN LIMITED | TATA UGANDA LIMITED | CLAVAMYN-625 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500MG +125MG | KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0335 | GOOD DAY PHARMACY LIMITED | GOOD DAY PHARMACY LIMITED | NEOMYCIN SULPHATE CREAM USP | NEOMYCIN SULPHATE CREAM USP | 0.5%WW | KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE |
| NDA/MAL/HDP/0336 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | AS-DP TABLETS | DICYCLOMINE HCL + PARACETAMOL | 20MG+500MG | ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0337 | IND-SWIFT | TATA UGANDA LIMITED | SWAZI *500 | AZITHROMYCIN | 500MG | IND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/0338 | KOPRAN LIMITED | TATA UGANDA LIMITED | KORAB 20 | RABEPRAZOLE SODIUM | 20MG | KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0339 | IND-SWIFT | TATA UGANDA LIMITED | SWAZI *250 | AZITHROMYCIN | 250MG | IND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/0340 | GOOD DAY PHARMACY LIMITED | GOOD DAY PHARMACY LIMITED | SONADAY | CLOBETASOL-17-BUTYRATE + GENTAMYCIN SULPHATE + MICONAZOLE NITRATE | 0.05%W/W+0.1%W/W+2%W/W | KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0341 | IND SWIFT LTD | TATA UGANDA LIMITED | TELSWIFT- H 40 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | IND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0342 | IND SWIFT LTD | TATA UGANDA LIMITED | TELSWIFT- H 80 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | IND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/0343 | GOOD DAY PHARMACY LIMITED | GOOD DAY PHARMACY LIMITED | WHITFIELD'S OINTMENT B.P | BENZOIC ACID + SALICYLIC ACID | 6% W/W + 3% W/W | KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/0348 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | XBETA | BETAMETHASONE SODIUM PHOSPHATE | 0.1%W/V | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0349 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | CLAXY 1.2 G | COAMOXICLAV | 1.2G | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.2 G VIAL |
| NDA/MAL/HDP/0350 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CETRIREN | CETIRIZINE HYDROCHLORIDE | 10MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0351 | MANKIND PHARM LTD | TATA UGANDA LIMITED | DEPREGDINA | LEVONORGESTREL | 1.5MG | ACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/0352 | HARLEYS UGANDA LIMITED | HARLEYS UGANDA LIMITED | ANLODIN TABLET 5MG | AMLODIPINE | 5MG | Y.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0353 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DEROX-10 | AMLODIPINE BESILATE | 10MG | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X3.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0354 | KOPRAN LIMITED | TATA UGANDA LIMITED | LEVOKOP | LEVOFLOXACIN | 500MG | KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0355 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | BICO VITA | THIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE | 10MG + 0.1MG + 1MG + 10MG | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0356 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | LEVO DENK 50O | LEVOFLOXACIN HEMIHYDRATE | 500MG | ROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0358 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | STREPTOCIN | STREPTOMYCIN SULPHATE | 1GM | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/0360 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | NEXIUM 20MG | ESOMEPRAZOLE | 20MG | ASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON |
| NDA/MAL/HDP/0361 | I CARE PHARMA LIMITED | VITACARE LTD | ATROPINE INJECTION | ATROPINE | IMG/ML | WUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINA | CHINA | PARENTERAL ORDINARY I V AMPOULES | 1.0X5.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/0362 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | BUPI | BUPIVACAINE | 5 MG/ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/0363 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | AGYCIN | AZITHROMYCIN | 250MG | BLISS 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 TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/0364 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | HALDOL | HALOPERIDOL | 5MG/ML | JANSSEN PHARMACEUTICAL NV-TURNHOUTSEWEG 30
B-2340 BEERSE
BELGIUM
| BELGIUM | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0365 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | SULFRAN- DS | TRIMETHOPRIM/SULFAMETHOXAZOLE | 160MG/800MG | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0366 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | AGYCIN 500 | AZITHROMYCIN | 500MG | BLISS 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 TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/0367 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | BG-ZOLE -400 | ALBENDAZOLE | 400MG | BLISS 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 CHEWABLE TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/0368 | ROTEX MEDICA GBH ARZNEIMITTELI | GITTOES PHARMACEUTICALS LIMITED | QUININE DI HYDROCHLORIDE INJECTION | QUININE DIHYDROCHLORIDE | 300MG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0369 | ABBOT LABORATORIES S.A. (PTY) LTD | HARLEYS UGANDA LIMITED | KLACID 250MG | CLARITHROMYCIN | 250MG | ABBOTT 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 TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0370 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-H | NEBIVOLOL + HYDROCHLOROTHIAZIDE | 5MG + 12.5MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0372 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEZYNCET | LEVOCETIRIZINE | 5MG | UNICHEM 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 TABLETS | 1.0X2.0X10.0 TABLET BLISTER,5.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0376 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-D | AMLODIPINE + HYDROCHLOROTHIAZIDE | 2.5 MG + 12.5 MG | EMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0377 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | DUINUM | CLOMIFENE | 50MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0379 | I CARE PHARMA LIMITED | VITACARE LTD | AMINOPHYLLINE INJECTION | AMINOPHYLLINE | 250MG/10ML | WUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINA | CHINA | PARENTERAL ORDINARY I V VIALS | 1.0X10.0X10.0 ML VIAL |
| NDA/MAL/HDP/0380 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | AVERNOL | CARVEDILOL | 6.25NG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0381 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | EFAVIRENZ/EMTRICITABINE/TENOFOVIR | EFAVIRENZ + EMTRICITABINE + TENOFOVIR | 600MG + 200MG + 300MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/0382 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | KETAMINE FRESENIUS | KETAMINE HYDROCHLORIDE | 50MG/ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY VIALS | 1.0X10.0X10.0 ML VIAL |
| NDA/MAL/HDP/0383 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | MANNITOL FRESENIUS | MANNITOL | 20%W/V | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BAG |
| NDA/MAL/HDP/0384 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | PANCURONIUM BROMIDE FRESENIUS | PANCURONIUM BROMIDE | 4MG/2ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0385 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASFORMIN | METFORMIN HYDROCHLORIDE | 500MG | ASTRA 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0386 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | LOMOH-80 | ENOXAPARIN SODIUM | 80MG/ 0.8ML | EMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/0388 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AZUCLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0389 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | SANMOL INFUSION IV | PARACETAMOL | 1000MG/100ML | PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0390 | PT NOVELL PHARMACEUTICAL LABORATORIES | ECHO PHARMACY (U) LIMITED | TUSSIGON | DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE/CHLORPHENAMINE/GUAIFENESIN | 10MG/30MG/2MG/100MG | PT NOVELL PHARMACEUTICAL LABORATORIES -J1 WANAHERANG NO. 35, TLAJUNG UDIK, GUNUNG
PUTRI, BORGO 16962
INDONESIA | INDONESIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0393 | NAARI LTD | ECHO PHARMACY (U) LIMITED | MISO-KARE | MISOPROSTOL | 200MCG | NAARI 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 TABLETS | 1.0X3.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/0394 | LEBEN LABORATORIES PVT.LTD | ANDYCO PHARMACY (UGANDA) LTD | DOXYLEB | DOXYCYCLINE | 100MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0397 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-LT | AMLODIPINE + LOSARTAN POTASSIUM | 2.5 MG + 50 MG | EMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0400 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IBSOL 1.2 | MESALAMINE DELAYED RELEASE | 1.2GM | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0401 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | L MONTUS | LEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM | 5MG + 10MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0402 | IVEE AQUA EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYSONE OPHTHALMIC SUSPENSION | HYDROCORTISONE ACETATE | 1%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC SUSPENSIONS | 5.0 ML VIAL |
| NDA/MAL/HDP/0403 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | SUPRIDOL | TRAMADOL HYDROCHLORIDE | 50MG/ML | NEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0404 | GLAXOSMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ACTIFED WET COUGH & COLD | TRIPLORIDINE HCL/PSEUDOEPHEDRINE/GUAIPHENESIN | 1.25MG/30MG/100MG | GLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN |
| NDA/MAL/HDP/0405 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | CHEMLET | LETROZOLE | 2.5MG | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0406 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | EVATOCIN | OXYTOCIN | 10 I.U./ ML | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0407 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | NEOROF | PROPOFOL | 1%W/V | NEON 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 AMPOULES | 1.0X20.0 ML AMPOULE |
| NDA/MAL/HDP/0408 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | ALGIC - P | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0409 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | TYDE-S* | CHLORAMPHENICOL SODIUM SUCCINATE | 1G/VIAL | NEON 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 VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/0410 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | LDNIL 20 | ROSUVASTATIN CALCIUM | 20MG | MSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0411 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | JADELLE SINE | LEVONORGESTREL | 150MG | BAYER OY-PANSIONATE 47 20210 TURKU FINLAND | FINLAND | PARENTERAL RETARD IMPLANTS | 1.0X3.0X1.0 IMPLANT STRIP |
| NDA/MAL/HDP/0412 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | LDNIL 5 | ROSUVASTATIN CALCIUM | 5MG | MSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0413 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | XSPAS | HYOSCINE BUTYLBROMIDE | 20MG/ML | NEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0415 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | RELEX | DIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL | 14.03MG+138MG+57.03MG+0.90MG | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0416 | NORVATIS PHARMA SERVICES | SURGIPHARM (U) LIMITED | RAMIZID 5 | RAMIPRIL | 5MG | LEK S.A-95 - 010 STRYK?W, PODLIPIE 16, POLAND | POLAND | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0418 | ASTRA ZENECA | MACNAUGHTON LIMITED | KOMBIGLYZE XR 5MG/1000 | SAXAGLIPTIN + METFORMIN | 5MG + 1000MG | ASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA | UNITED STATES | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/0419 | ASTRAZENECA | MACNAUGHTON LIMITED | KOMBIGLYZE XR 2.5MG/1000MG | SAXAGLIPTIN + METFORMIN | 2.5MG + 1000MG | ASTRAZENECA PHARMACEUTICALS LP.-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620 USA | UNITED STATES | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/0421 | MSN LABORATORIES LTD | STAR PHARMACEUTICALS LTD | PREGASAFE 150 | PREGABALIN | 150MG | MSN LABORATORIES LTD-PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0422 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | PARAFLAM | IBUPROFEN + PARACETAMOL | 100MG + 162.5MG /5ML | 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 SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0423 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTRAM | TRAMADOL | 50MG | AGOG 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 CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0424 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CHLORPROMAZINE TABLETS B.P 25MG | CHLORPROMAZINE | 25MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0426 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE | LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE | 150MG +300MG + 200MG | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/0427 | MICRO LABS LTD | LABOREX UGANDA LIMITED | AMLOZAAR -H | LOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE | 50MG + 5MG + 12.5MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0428 | MICRO LABS LTD | LABOREX UGANDA LIMITED | MICROMOX-400 | MOXIFLOXACIN | 400MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/0429 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | FLEXON MR | IBUPROFEN + PARACETAMOL + CHLORZOXAZONE | 400MG + 325MG + 250MG | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0430 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO ACECLO PLUS | ACECLOFENAC+PARACETAMOL | 100MG+500MG | ARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X15.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0432 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | K MAC ORAL SOLUTION | POTASSIUM CITRATE + MAGNESIUM CITRATE | 22MG + 7.5MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/0433 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | PROANES MCT/LCT | PROPOFOL | 1%W/V | PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X5.0X20.0 ML AMPOULE |
| NDA/MAL/HDP/0434 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | PROHIBIN | OMEPRAZOLE | 20MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/0435 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | LIGNOCAINE HCL FRESENIUS | LIGNOCAINE HYDROCHLORIDE | 2%W/V | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY VIALS | 1.0X10.0X20.0 ML VIAL |
| NDA/MAL/HDP/0436 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | SANBE HEST 130 | POLY (0-2-HYDROXYETHYL) STARCH | 30G | PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA | INDONESIA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/0437 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | NALOXONE HCL NEONATAL FRESENIUS | NALOXONE HYDROCHLORIDE | 0.02MG/ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0438 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | SANBE HEST 200 | POLY (0-2-HYDROXYETHYL) STARCH | MW 200,000 | PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA | INDONESIA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/0439 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | NALOXONE HCL FRESENIUS 0.4MG/1ML | NALOXONE HYDROCHLORIDE | 0.4MG/1ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0444 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | NEOSTIGMINE METHYLSUIPHATE FRESENIUS | NEOSTIGMINE METHYLSULPHATE | 2.5MG\ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0449 | PHILLIPS PHARMACEUTICALS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMINOGUARD GRANULES | CYANOCOBALAMIN | 5MCG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY GRANULES | 1.0X10.0X5.0 G SACHET |
| NDA/MAL/HDP/0452 | I CARE PHARMA LIMITED | VITACARE LTD | CALCIUM GLUCONATE INJECTION | CALCIUM GLUCONATE INJECTION | 1G/10ML | GRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCE | CHINA | PARENTERAL ORDINARY INFUSION AMPOULES | 1.0X10.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/0453 | PHILLIPS PHARMACEUTICALS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMINOGUARD LIQUID | AMINO ACIDS + MULTIVITAMINS | MULTI INGREDIENTS | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/0454 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | LEVOCIN INFUSION | LEVOFLOXACIN HEMIHYDRATE | 500 MG | PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0456 | LEBEN LABORATORIES PVT. LTD | ANDYCO PHARMACY (UGANDA) LTD | METROLEB | METRONIDAZOLE | 125MG/5ML | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0458 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE 5MG/80MG | AMLODIPINE + VALSARTAN | 5 MG + 80 MG | NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE,NOVARTIS FARMACEUTICA SA,-BARBERA DEL VALLES BARCELONA SPAIN | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/0460 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | AMBRODIL | AMBROXOL HYDROCHLORIDE | 7.5MG/ML | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/0461 | BEXIMCO PHARMACEUTICALS LTD | KIMSY MEDS LTD | BEXITROL-F HFA 25/125 | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG+125MCG | BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH | BANGLADESH | TOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/0462 | BEXIMCO PHARMACEUTICALS LTD | KIMSY MEDS LTD | DECOMIT 50 HFA | BECLOMETHASONE | 50MCG | BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH | BANGLADESH | TOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/0463 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | TOPHEN | PHENYTOIN | 100MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0465 | BEXIMCO PHARMACEUTICALS LTD | KIMSY MEDS LTD | DECOMIT 100 HFA | BECLOMETHASONE DIPROPIONATE | 200MCG | BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH | BANGLADESH | TOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/0466 | BEXIMCO PHARMACEUTICALS LTD | KIMSY MEDS LTD | ALPHIN DS | ALBENDAZOLE | 400MG | BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X50.0 TABLET BLISTER,1.0X50.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/0467 | DAWA PHARMACEUTICALS LIMITED | SUPER MEDIC LTD | CURAMOL PLUS | PARACETAMOL/CAFFEINE | 500MG/60MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 50.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/0468 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | CEFUAXIT 750 | CEFUROXIME | 750MG | NECTAR LIFESCIENCES LIMITED-VILL. BHATOLIKALAN, ADJOININGJHARMJRI,
P.O BAROTIWALA DIST SOLAN H.P 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL + 10ML WFI AMPOULE |
| NDA/MAL/HDP/0470 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NOVOMIX 30 FLEXPEN | INSULIN ASPART | 100I.U/ML | NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD | DENMARK | PARENTERAL ORDINARY DRY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN |
| NDA/MAL/HDP/0471 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NOVORAPID FLEXPEN | INSULIN ASPART | 100 I.U/ML | NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD | DENMARK | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN |
| NDA/MAL/HDP/0472 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | BCG VACCINE (FREEZE DRIED) | BCG VACCINE(FREEZE DRIED) | 1.33*100000 C.F.U/0.1ML | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 ML VIAL,1.0X0.5 ML VIAL |
| NDA/MAL/HDP/0475 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | TINI-500 | TINIDAZOLE | 500MG | LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X25.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/0477 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VOMISTAT-4 | ONDANSETRON | 4MG | LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0480 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | EFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMERATE 600/300/300 MG | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 600MG+300MG+300MG | CIPLA 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, VERN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/0481 | BIOCON LTD | ABACUS PHARMA (AFRICA) LIMITED | ERYPRO SAFE 4000 | RECOMBINANT HUMAN ERYTHROPOETIN ALPHA | 4,000 IU/ML | BIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA
| INDIA | PARENTERAL ORDINARY CARTRIDGES | 1.0X1.0 ML CARTRIDGE |
| NDA/MAL/HDP/0482 | LEBEN LABORATORIES PVT. LTD | ANDYCO PHARMACY (UGANDA) LTD | AZILEB-500 | AZITHROMYCIN | 500MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/0483 | FOUNTIL LIFE SCIENCES PVT LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ULGICID TABLETS | ALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE+ MAGNESIUM TRISILICATE + SIMETICONE | 200MG + 250MG + 250MG + 250MG + 125MG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0484 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | PILPLAN PLUS | ETHINYL ESTRADIOL + LEVONORGESTREL / FERROUS FUMARATE | 0.03MG+0.15MG/75MG | BAYER SCHERING PHARMA AG.-13342, BERLIN | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X3.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/0486 | LEBEN LABORATORIES PVT. LTD | ANDYCO PHARMACY (UGANDA) LTD | ADIFLAM-SR | DICLOFENAC SODIUM | 100MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0487 | BIOCON LTD | ABACUS PHARMA (AFRICA) LIMITED | BASALOG | INSULIN GLARGINE | 100IU/ML | BIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA
| INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X3.0 ML PRE- FILLED SYRINGE,1.0X3.0 ML VIAL |
| NDA/MAL/HDP/0489 | LEBEN LABORATORIES PVT.LTD | ANDYCO PHARMACY (UGANDA) LTD | CEBAY-200 DT | CEFIXIME | 200MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0490 | SISONKE | LABOREX UGANDA LIMITED | ORELOX | CEFPODOXIME | 200MG | SANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPI?GNE
| FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0491 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABCHLOR EYE DROPS | CHLORAMPHENICOL | 0.5% W/V | ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0492 | BEXIMCO PHARMACEUTICALS LTD | KIMSY MEDS LTD | ZOLFIN | ACECLOFENAC | 100MG | BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X15.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/0493 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | PRASUSAFE 10 | PRASUGREL | 10MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0494 | BEXIMCO PHARMACEUTICALS LIMITED | KIMSY MEDS LTD | INFORMET 500 | METFORMIN HYDROCHLORIDE | 500MG | BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0496 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | MYPRODOL | PARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE | 250MG + 200MG + 10MG | ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0497 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | KEMOXYL DRY SUSPENSION | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0498 | BEXIMCO PHARMACEUTICALS LTD | KIMSY MEDS LTD | EVO 500 | LEVOFLOXACIN | 500MG | BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0499 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | BANEOCIN OINTMENT | BACITRACIN ZINC+NEOMYCIN SULPHATE | 250I.U + 5000I.U | MERCK KGAA & CO.-HOSSLGASSE 20 9800 SPITTAL DRAU/ AUSTRIA | AUSTRIA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/0502 | STEDMAN PHARMACEUTICALS LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ GARGLE | IODINATED POVIDONE | 2%W/V | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0504 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | BANEOCIN POWDER | BACITRACIN/NEOMYCIN SULPHATE | 250/5000I.U/5MG | PHARMAZEUTISCHE FABRIK MONTAVIT GES M.B.H-SALZBERGSTRABE 96 6060 ABSAM/ TYROL,AUSTRIA | AUSTRIA | TOPICAL EXTERNAL POWDERS | 1.0X10.0 G CONTAINER |
| NDA/MAL/HDP/0505 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | 75MG | MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0506 | REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD | HEALTHCARE LTD. | OPTA-ATROPINE EYE DROPS | ATROPINE SULPHATE | 1%W/V | REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0507 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FILDILOL 12.5 | CARVEDILOL | 12.5 MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0508 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASTARGAN | PROMETHAZINE HYDROCHLORIDE | 25MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0509 | FOURRTS (INDIA) LABORATORIES (PVT) LTD | DELMAW ENTERPRISES LIMITED | FILDILOL 25 | CARVEDILOL | 25MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0510 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | LIZOLID-600 | LINEZOLID | 600MG | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/0511 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | 150MG + 200MG + 300MG | STRIDES ARCOLAB LIMITED .-PLOT 9-12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR, MAHARASHTRA 401404 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/0512 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FILSTAT 10 | ATORVASTATIN CALCIUM | 10MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0515 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FILSTAT 20 | ATORVASTATIN | 20MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0517 | SANOFI AVENTIS KENYA LTD | LABOREX UGANDA LIMITED | SHANVAC -B | R- DNA HEPATITIS -B SURFACE ANTIGEN PURIFIED | 20MCG/ML | SHANTHA BIOTECHNICS LTD -SURVEY NO. 274, ATHVELLI VILLAGE, MEDCHAL MANDAL ? 501401, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X35.0X1.0 ML VIAL (1 ADULT DOSE),1.0X35.0X0.5 ML VIAL (1 PEDIATRIC DOSE) |
| NDA/MAL/HDP/0518 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CYCLOREN | ACICLOVIR | 200MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0520 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FILSTAT 40 | ATORVASTATIN CALCIUM | 40MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0521 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PAN 40 | PANTOPRAZOLE SODIUM | 40MG | ALKEM LABORATORIES LTD .- VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0522 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | VAZORTAN 50 | LOSARTAN POTASSIUM | 50MG | MEDLEY 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0524 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | XAFEN-60 | FEXOFENADINE HYDROCHLORIDE | 60MG | MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0526 | LEBEN LABORATORIES LTD | ANDYCO PHARMACY (UGANDA) LTD | AMILEB- 25 | AMITRIPTYLINE | 25MG | LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA? 444 104 (MS).
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/0527 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | XAFEN-120 | FEXOFENADINE HYDROCHLORIDE | 120MG | MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0528 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLARY 500 | CLARITHROMYCIN | 500MG | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0529 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | MOXIKIND-CV | AMOXICILLIN + CLAVULANIC ACID | 200 MG + 28.5 MG | MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML CONTAINER |
| NDA/MAL/HDP/0530 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | XAFEN-180 | FEXOFENADINE HYDROCHLORIDE | 180 MG | MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0531 | LEBEN LABORATORIES LTD | ANDYCO PHARMACY (UGANDA) LTD | ENDERM-GM | CLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE | 0.05%W/W + 0.10%W/W + 2.0%W/W | LEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/0532 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | SARTAN-50 | LOSARTAN POTASSIUM | 50MG | LINCOLN 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0533 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | TELKAST 5 | MONTELUKAST SODIUM | 5MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0534 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | MOXIKIND-CV 375 | AMOXICILLIN + POTASSIUM CLAVULANATE | 250 MG + 125 MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/0536 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | MOXIKIND-CV 625 | AMOXICILLIN + POTASSIUM CLAVULANATE | 500 MG + 125 MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/0538 | MICRO LABS LTD | LABOREX UGANDA LIMITED | XONADINE 180 | FEXOFENADINE HYDROCHLORIDE | 180 MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0539 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | TELKAST 4 | MONTELUKAST SODIUM | 4MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0540 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | HYDRICORT | HYDROCORTISONE SODIUM SUCCINATE | 100MG | LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X100.0 MG VIAL |
| NDA/MAL/HDP/0541 | MICRO LABS LTD | LABOREX UGANDA LIMITED | XONADINE 120 | FEXOFENADINE HYDROCHLORIDE | 120MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0542 | DAWA LIMITED | SUPER MEDIC LTD | PHENBITAL | PHENOBARBITAL | 30MG | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0543 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GLIMERYL 2 | GLIMEPIRIDE | 2MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0544 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | DOLOWIN PLUS | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0548 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNICAST | MONTELUKAST | 5MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITY | JORDAN | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0549 | ABOTT LABORATORIES S.A (PTY) LTD | HARLEYS UGANDA LIMITED | HIDRASEC | RACECADOTRIL | 100 MG | LABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE | FRANCE | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0550 | DAWA LIMITED | SUPER MEDIC LTD | DA-ZEPAM | DIAZEPAM | 5MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0551 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | REDAMOX | AMOXICILLIN + CLAVULANIC ACID | 125 MG/ 5 ML + 31.25 MG/ 5 ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0552 | ABOTT LABORATORIES S.A (PTY) LIMITED | HARLEYS UGANDA LIMITED | HIDRASEC INFANTS | RACECADOTRIL | 10 MG | LABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE | FRANCE | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X16.0 SACHET CARTON |
| NDA/MAL/HDP/0553 | BHARAT SERUMS AND VACCINES LTD | GITTOES PHARMACEUTICALS LIMITED | EQUIRAB | RABIES ANTISERUM | 1000IU/ 5ML | BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
| INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL (5 DOSE VIAL) |
| NDA/MAL/HDP/0555 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | CARZEPIN | CARBAMAZEPINE | 200MG | HOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0556 | ABOTT LABORATORIES S.A (PTY) LTD | HARLEYS UGANDA LIMITED | HIDRASEC CHILDREN | RACECADOTRIL | 30 MG | LABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE | FRANCE | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X30.0 SACHET CARTON |
| NDA/MAL/HDP/0557 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | REDAMOX 312.5 | AMOXICILLIN + POTASSIUM CLAVULANATE | 250 MG/5 ML + 62.5 MG/5 ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0558 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABGENTA EYE DROPS | GENTAMICIN SULPHATE | 0.3% W/V | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/0559 | HOVID BHD | MEDICAL ACCESS (UGANDA) LIMITED | DIABETMIN RETARD | METFORMIN HYDROCHLORIDE | 850MG | HOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIA | MALAYSIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0560 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GLIMERYL 1 | GLIMEPIRIDE | 1MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITY | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0562 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM COTRI | CO-TRIMOXAZOLE | 240MG/5ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 100.0 ML BOTTLE,60.0 ML BOTTLE |
| NDA/MAL/HDP/0563 | IND SWIFT LTD | TATA UGANDA LIMITED | EZO 40 | ESOMEPRAZOLE MAGNESIUM | 40MG | IND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0565 | YURIA PHARM LTD | YURIA PHARM EAST AFRICA LIMITED | AMINOCAPROIC ACID-UF | AMINOCARPROIC ACID | 5G/100ML | YURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE. | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0566 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | CEFROTIL SUSPENSION | CEFUROXIME AXETIL | 125MG/5ML | SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/0567 | KOTRA PHARMA SDN BDN | UNITED HEALTHCARE DISTRIBUTORS LTD | VAXCEL CEFTRIAZONE 500MG | CEFTRIAXONE | 500MG | KOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/0568 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | FLUOXIREN | FLUOXETINE | 20MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0569 | KOTRA PHARMA SDN BDN | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCELLRIDIN LINCTUS | PHOLCODINE | 10MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE |
| NDA/MAL/HDP/0570 | BHARAT SERUMS AND VACCINES LIMITED, | GITTOES PHARMACEUTICALS LIMITED | TETGLOB 250 I.U | HUMAN TETANUS IMMUNOGLOBULIN | 250IU | BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
| INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X1.0X2.0 ML VIAL (1 DOSE VIAL) |
| NDA/MAL/HDP/0571 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL KAOPEC | LIGHT KAOLIN + PECTIN (CITRUS) | 1G + 20MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/0572 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | AZARGA | BRINZOLAMIDE + TIMOLOL | 10MG/ML + 5MG/ML | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/0573 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL PARACETAMOL-250 | PARACETAMOL | 250MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0575 | MICRO LABS LTD | LABOREX UGANDA LIMITED | MICROMOX | MOXIFLOXACIN | 400MG/100ML | AHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0576 | GLAXO SMITH KLINE LTD | ERIS LTD | DUODART | DUTASTERIDE + TAMSULOSIN | 0.5MG,0.4MG | CATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY | GERMANY | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/0580 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLUCAP | MULTINGREDIENT | MULTINGREDIENT | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0582 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ACECLO SERA | ACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE | 100MG + 500MG + 15MG | ARISTO PHARMACEUTICALS PVT LTD-VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0584 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | TRIGLIMIPREX 1 | GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE | 1MG+15MG+500MG | ARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0585 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DOMPERON | DOMPERIDONE | 1MG/ML | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/0586 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | ONSETT | ONDANSETRON | 2MG/ML | CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE |
| NDA/MAL/HDP/0587 | CADILA PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | CADIGREL | CLOPIDOGREL | 75MG | CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0588 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROFORT | PREDNISOLONE ACETATE | 1%W/V | AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIA | INDIA | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/0589 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | TRIGLIMIPREX 2 | GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE | 2MG+15MG+500MG | ARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0590 | BHARAT SERUMS AND VACCINES LTD | GITTOES PHARMACEUTICALS LIMITED | ASNA ANTIVENOM C | B.GABONICA/B.ARIENTANS/ B.NASICORNIS/ DENDROASPIS/ POLYEPIS/D.ANGUSTICEPS/ N.NIVEA /N.NLGRCOLLIS/N.HAJE | 25/25/20/25/25/25/25/25/20/25/20/25 I.U | BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
| INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0592 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROCHROME | CROMOLYN SODIUM | 2%W/V | AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIA | INDIA | OPHTHALMIC LIQUIDS | 1.0X10.0 ML CONTAINER |
| NDA/MAL/HDP/0593 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | PANTOP-D | PANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES | 20MG+10MG | ARISTO PHARMACEUTICALS PVT LTD .-MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/0594 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROVISC-2ML PFS | HYPROMELLOSE OPHTHALMIC SOLUTION USP | 2%W/V | AUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA | INDIA | OPHTHALMIC VIALS | 1.0X2.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/0595 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ORNOF | ORNIDAZOLE + OFLOXACIN | 500MG + 200MG | ARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0596 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL-H | TELMISARTAN/HYDROCHLOROTHIAZIDE | 40MG/12.5MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0598 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LIPICURE-20 | ATORVASTATIN | 20MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0599 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O-400 | CEFIXIME | 400MG | MICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/0600 | DENK PHARM GMBH&CO.KG | BENLE CONSULT LIMITED | CARVEDI-DENK 6.25 | CARVEDILOL | 6.25MG | ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0603 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | GROMIN SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/0605 | DENK PHARM GMBH&CO.KG | BENLE CONSULT LIMITED | CARVEDI-DENK 25 | CARVEDILOL | 25MG | ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0608 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | LOPINAVIR AND RITONAVIR TABLETS 200MG/50MG | LOPINAVIR + RITONAVIR | 200MG + 50MG | CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X120.0 TABLET BOTTLE |
| NDA/MAL/HDP/0609 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | CLOPI-DENK 75 | CLOPIDOGREL BESYLATE | 75MG | ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0610 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | PYLOR KIT | LANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE | 30MG + 250MG + 500MG | LINCOLN 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 TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS) |
| NDA/MAL/HDP/0611 | GALPHA LABORATORIES LTD | AIVEEN (U) LIMITED | GALCIPRO 500 | CIPROFLOXACIN HYDROCHLORIDE | 500MG | GALPHA LABORATORIES LIMITED-VILLAGE ? THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0614 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 126 MG/ 5 ML + 31.25 MG/ 5 ML | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0615 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | VALSAR 80 | VALSARTAN | 80MG | HETERO 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0617 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | SILVEX | SILVER SULFADIAZINE + CHLORHEXIDINE | 1%W/W + 0.2%W/W | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0618 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | VALSAR 160 | VALSARTAN | 160MG | HETERO 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0619 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | D10 | GLUCOSE | 10%W/V | ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/0621 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | ALZER | DONEPEZIL HYDROCHLORIDE | 10MG | HETERO 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0623 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | GELCID | MAGNESIUM SULPHATE | 50%W/V | LINCOLN PHARMACEUTICALS LTD--11 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0X10.0 ML AMPOULE,1.0X10.0X5.0X5.0 ML AMPOULE IN BLISTER PACK |
| NDA/MAL/HDP/0625 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | VERORAB | RABIES VACCINE | 1 DOSE | SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE | FRANCE | PARENTERAL ORDINARY VIALS | 1.0X1.0 DOSE VIAL |
| NDA/MAL/HDP/0626 | KPI INDUSTRIES(1996) LTED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CARDIPAC-10 | AMLODIPINE BESILATE | 10MG | KPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0627 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AMOXIKID | AMOXICILLIN TRIHYDRATE | 125MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0630 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NEO LORIDIN | DESLORATADINE | 5MG | CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0633 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | CIPROCIN | CIPROFLOXACIN | 0.3%W/V | ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0634 | MEDLEY PHARMACEUTICALS | MEDVIN PHARMA LIMITED | TRISOLIV | ANDROGRAPHOLIDES/TRICHOLINE CITRATE | 50MCG+50MG/ML | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/0635 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-AMIN | AMINOPHYLLINE | 100MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0636 | MYLAN LABORATORIES LIMITED. | NORVIK ENTERPRISES LIMITED | REVOKE-1.5 | LEVONORGESTREL | 1.5MG | MYLAN 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, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/0637 | NABIQASIM INDUSTRIES (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | ZUDICORT | FUSIDIC ACID + BETAMETHASONE VALERATE | 20MG + 1MG/G | NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0638 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABLOL-5 EYE DROPS | TIMOLOL MALEATE | 0.5% W/V | ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0639 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | RHEUMATIC CREAM | MULTI-INGREDIENT | MULTI-INGREDIENT | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0640 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | BIODROXIL 250MG/5ML | CEFADROXIL (ANHYDROUS) | 250MG/5ML | SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/0641 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | GYNAZOLE | CLOTRIMAZOLE | 2%W/W | LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/0642 | SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES. | SURGIPHARM (U) LIMITED | BIODROXIL 125MG/5ML | CEFADROXIL (ANHYDROUS) | 125MG/5ML | SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/0643 | NAARI LTD | ECHO PHARMACY (U) LIMITED | MISOPRO | MISOPROSTOL | 200MCG | NAARI 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 TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/0647 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | BIODROXIL 1000MG TABLETS | CEFADROXIL (ANHYDROUS) | 1000MG | SANDOZ GMBH-BIOCHEMIESTRA?E 10 A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/0651 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | BIODROXIL 500MG | CEFADROXIL (ANHYDROUS) | 500MG | SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0652 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS | VILDAGLIPTIN | 50MG | NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS BARBERA -SPAIN | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/0654 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS MET | VILDAGLIPTIN / METFORMIN | 50MG/500MG | NORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/0657 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS MET | VILDAGLIPTIN / METFORMIN | 50MG / 850MG | NORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0658 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | GALVUS MET | VILDAGLIPTIN/ METFORMIN | 50MG/1000MG | NORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0662 | PHARMAVET LTD | DELMAW ENTERPRISES LIMITED | RECTIN 100 | INDOMETHACIN | 100MG | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/0663 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GLYCERIN | GLYCERIN | 1G | BLISS 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 SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/0665 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | IRBIS-H 150 | IRBESARTAN | 150MG | 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 TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0666 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | IRBIS-H 300 | IRBESARTAN | 300MG | 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 TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0667 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXEL MICONAZOLE | MICONAZOLE NITRATE | 2%W/W | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/0668 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | TELI 40 | TELMISARTAN | 40MG | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0669 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXEL FUNGICORT CREAM | MICONAZOLE NITRATE + HYDROCORTISONE | 2% W/W + 1% W/W | KOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/0670 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | FLUNAZ-200 | FLUCONAZOLE | 200MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0671 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL LIGNOCAINE | LIDOCAINE | 2%W/W | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/0672 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGONOR TABLETS | NORFLOXACIN | 400MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0674 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGODAPS-100 | DAPSONE | 100MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0675 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL METRONIDAZOLE 400 | METRONIDAZOLE | 400MG | KOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
| MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0676 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | ONSETT 4 | ONDANSETRON | 4MG | CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0677 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | DOPAMET | METHYLDOPA | 250MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0678 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL HYDROCORTISONE CREAM | HYDROCORTISONE | 1%W/W | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE |
| NDA/MAL/HDP/0679 | AGOG PHARMA | GITTOES PHARMACEUTICALS LIMITED | MEFENA-250 CAPSULES | MEFENAMIC ACID | 250MG | AGOG 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 CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0681 | GENNOVA BIOPHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ELAXIM 40 | TENECTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR) | 40MG/VIAL | EMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X40.0 MG VIAL , 1*8 ML VIAL OF WFI |
| NDA/MAL/HDP/0685 | FERRER INTERNACIONAL S.A | LABOREX UGANDA LIMITED | SOMAZINA | CITICOLINE | 1000MG | FERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONA | SPAIN | PARENTERAL RETARD I M AMPOULES | 1.0X5.0X4.0 ML AMPOULE |
| NDA/MAL/HDP/0687 | FERRER INTERNACIONAL S.A | LABOREX UGANDA LIMITED | SOMAZINA | CITICOLINE | 1000MG | FERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X6.0X10.0 ML SACHET |
| NDA/MAL/HDP/0688 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | HBB | HYOSCINE BUTYLBROMIDE | 10MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0689 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGONAL | NALIDIXIC ACID | 500MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0690 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | HEALTHEASE CREAM | BECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL | 0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/W | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/0691 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLMAT-20 | OLMESARTAN MEDOXOMIL | 20 MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0692 | DAWA LIMITED | SUPER MEDIC LTD | DAWACLOX -250 | CLOXACILLIN SODIUM | 250MG | DAWA LIMITED -BABA DOGO RWARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/0693 | DAWA LIMITED | SUPER MEDIC LTD | MOXACIL -250 | AMOXYCILLIN TRIHYDRATE | 250MG | DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/0694 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | DT ZINC-20 TABLETS | ZINC SULPHATE | 20MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON |
| NDA/MAL/HDP/0696 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | RITONAVIR | RITONAVIR | 100MG | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/0698 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | WHITFIELD'S OINTMENT | BENZOIC ACID+SALICYLIC CID | 6%W/W + 3%W/W | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/0700 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | VAXIRAB N | INACTIVATED RABIES VIRUS(PITMAN MOORE STRAIN) | >2.5 I.U | CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL + 1ML AMPOULE OF WFI(1 DOSE VIAL) |
| NDA/MAL/HDP/0702 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | SEPTOCIN | STREPTOMYCIN SULPHATE | 1GM | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 G VIAL |
| NDA/MAL/HDP/0703 | GOOD DAY PHARMACY LIMITED | GOOD DAY PHARMACY LIMITED | DICLODAY GEL | DICLOFENAC DIETHYLAMINE+ LINSEED OIL+ METHYL SALICYLATE +MENTHOL | 11.6MG + 30MG + 100MG + 50MG | KREMOINT 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 SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/0704 | HETERO LABS LTD UNIT IX | ABACUS PHARMA (AFRICA) LIMITED | M-FLOX | MOXIFLOXACIN HYDROCHLORIDE | 400MG | HETERO 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0705 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ACICLOVIR | ACICLOVIR | 5%W/W | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/0706 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | ROVAS 5 | ROSUVASTATIN | 5MG | INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0707 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | PENVIR 500 | FAMCICLOVIR | 500MG | HETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0710 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | ROVAS 20 | ROSUVASTATIN | 20MG | INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0712 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | ZENTEL | ALBENDAZOLE | 100MG/5ML | FARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCE | FRANCE | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X20.0 ML BOTTLE |
| NDA/MAL/HDP/0713 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PANTO-DENK 20 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 20MG | ADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/0715 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | PANTO-DENK 40 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40MG | ADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/0716 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | GLYMET-1 | GLIMEPIRIDE+METFORMIN HYDROCHLORIDE | 1MG + 500MG | LINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0718 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | GLYMET-2 | GLIMEPIRIDE+METFORMIN HYDROCHLORIDE | 2MG + 500MG | LINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0719 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | WEPOX 4000 | RECOMBINANT HUMAN ERYTHROPOIETIN | 4000 I.U | WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.4 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/0720 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | JUSDEE 400 DROPS | COLECALCIFEROL | 400 I.U/ML | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/0721 | MISSION PHARMA | METRO PHARMACEUTICALS LIMITED | ARH-A | ARTEMETHER | 80MG/ML | LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE |
| NDA/MAL/HDP/0722 | FDC LTD | AIVEEN (U) LIMITED | IOTIM 0.5% | TIMOLOL MALEATE | 0.5% W/V | FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/0724 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | NIZORAL | KETOCONAZOLE | 200MG | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0725 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | SPASMOTROY 40 | DROTAVERINE HYDROCHLORIDE | 40MG | TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0726 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | T DOL RAPID | TRAMADOL HYDROCHLORIDE | 50MG | TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0727 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | STOMACH FIT SYRUP | BISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL | 140MG+9MG+0.15MG+0.2/5ML | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X225.0 ML BOTTLE |
| NDA/MAL/HDP/0733 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZYNAC | ACECLOFENAC | 100MG | CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0734 | ANHIU | MAISHA MEDICAL SUPPLIES LIMITED | OMMED -20 | OMEPRAZOLE | 20MG | MEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/0736 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | MABRON 50 | TRAMADOL HYDROCHLORIDE | 50MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0737 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | TAXOTERE 80MG | DOCETAXEL TRIHYDRATE | 80MG/4ML | SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
| GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X4.0 ML VIAL |
| NDA/MAL/HDP/0738 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | CIPRIND-500 | CIPROFLOXACIN | 500MG | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X200.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0739 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | TAXOTERE 20MG | DOCETAXEL TRIHYDRATE | 20MG/ML | SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOESCHST,BRUNINGSTRASSEN BUIDING,H65065926, FRANKFURT AM MAIN | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0 ML VIAL |
| NDA/MAL/HDP/0740 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | COTRIM | CO-TRIMOXAZOLE | 960MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X17.0X6.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0741 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | MEDOCIPRIN | CIPROFLOXACIN | 500MG | MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0742 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | BROT | METFORMIN HYDROCHLORIDE | 500MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0743 | INTRACIN PHARMACEUTICAL PVT LTD | VEERAM HEALTHCARE (U) LIMITED | TRY-PZ | PIPERACILLIN+TAZOBACTAM | 5MG+500MG | INTRACIN PHARMACEUTICAL PVT LTD-C-1, B -53, G.I.D.C ESTATE, NADIAD ? 387001 GUJARAT, INDIA., | INDIA | PARENTERAL ORDINARY VIALS | 1.0X30.0 ML VIAL |
| NDA/MAL/HDP/0745 | CADILA HEALTHCARE LTD | KARURI PHARMACEUTICALS LTD. | TELI 80 | TELMISARTAN | 80MG | B. BRAUN MELSUNGEN - MISTELWEG-1389, TRABAD ROAD, DHOLKA 387 810, DISTRICT AHMEDABAD, GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0746 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | DTS-Z KIT | TABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSE | TABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75G | COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
| KENYA | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X4.0X10.3 G SACHET + 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0747 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORALYTE ORANGE CO-PACK | GLUCOSE ANHYDROUS + SODIUM CHLORIDE + TRISSODIUM CITRATE DEHYDRATE + POTASSIUM CHLORIDE / ZINC SULPHATE | 13.5G + 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 FORMS | 1.0X20.8 G SACHET + 60 ML BOTTLE |
| NDA/MAL/HDP/0748 | BAYER PHARMA | SURGIPHARM (U) LIMITED | XARELTO 15MG | RIVAROXABAN | 15MG | BAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/0749 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEROGRAM 1000 | MEROPENEM | 1000MG | AURONEXT PHARMA PVT LTD.-A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/0750 | BAYER PHARMA | SURGIPHARM (U) LIMITED | XARELTO 20MG | RIVAROXABAN | 20MG | BAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/0751 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | DOLOWIN | ACECLOFENAC | 100MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0752 | FERRER INTERNACIONAL S.A | LABOREX UGANDA LIMITED | NUCLEO C.M.P FORTE | CYTIDINE + URIDINE | 10MG + 6MG | FERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONA | SPAIN | PARENTERAL ORDINARY DRY PRE-FILLED PENS | 1.0X3.0 ML AMPOULE + 1 *2ML CLEAR GLASS AMPOULES FOR SOLVENT |
| NDA/MAL/HDP/0753 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MEROGRAM 500 | MEROPENEM | 500MG | AURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/0754 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | TORAS DENK 10 | TORASEMIDE | 10MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0755 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | T- DOL | TRAMADOL HYDROCHLORIDE | 50MG/ML | TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0756 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TOLFREE 100 | TOLPERISONE | 100MG | CADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0757 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TOLFREE 150 | TOLPERISONE | 150MG | CADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0759 | MICRO LABS LTD | LABOREX UGANDA LIMITED | COTRIMOXAZOLE | COTRIMOXAZOLE | 960MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0760 | STRIDES | SUPER PHARMACEUTICALS LIMITED | CEFAX | CEFTRIAXONE | 1G | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.0 G VIAL |
| NDA/MAL/HDP/0761 | BEIJING HOLLEY COTEC PHARMA CHINA | SUPER PHARMACEUTICALS LIMITED | BENZILIN | BENZATHINE BENZYLPENICILLIN | 2.4MEGA/VIAL | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X2.4 MU VIAL |
| NDA/MAL/HDP/0764 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORVADIL 5 | AMLODIPINE | 5MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0765 | PHARM ACCESS AFRICA LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | LEVOPLANT | LEVONORGESTREL | 75MG | SHANGHAI DAHUA PHARMACEUTICAL CO. LTD-CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAI | CHINA | PARENTERAL RETARD IMPLANTS | 1.0X10.0X2.0 ROD IMPLANT |
| NDA/MAL/HDP/0768 | FDC LTD | AIVEEN (U) LIMITED | PYRIMON EYE DROP | DEXAMETHASONE/CHLORAMPHENICOL | 1%W/V + 0.1%W/V | FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/0769 | BEIJING HOLLEY COTEC PHARMA CHINA | SUPER PHARMACEUTICALS LIMITED | AMPIL-1000 | AMPICILLIN | 1G | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON |
| NDA/MAL/HDP/0770 | BEIJING HOLLEY COTEC PHARMA CHINA | SUPER PHARMACEUTICALS LIMITED | AMPIL-500 | AMPICILLIN | 500MG | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X500.0 MG VIAL |
| NDA/MAL/HDP/0772 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIGABA - 150 | PREGABALIN | 150MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0774 | CADILA HEALTHCARE LTD | KARURI PHARMACEUTICALS LTD. | NODON | NEBIVOLOL | 10MG | CADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0775 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIGABA - 75 | PREGABALIN | 75MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0776 | FREDUN PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | FREMOL TABLETS | PARACETAMOL TABLETS | 500MG | FREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0779 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | VITAFIL Z | CHROMIUM + ZINC + THIAMINE + RIBOFLAVINE + PYRIDOXINE + FOLIC ACID + NICOTINAMIDE + ASCORBIC ACID | 1.667MG + 42MG + 12MG + 11.5MG + 3.6MG + 1.2MG + 52.5MG + 165MG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0780 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ATORVA TABLETS | ATORVASTATIN | 10MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X1.0X7.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0781 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | TRICOLD | PARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE/CAFFEINE ANHYDROUS/CHLORPHENIRAMINE | 500MG/10MG/30MG/2MG | TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/0783 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | CYPOLIVE | CYPROHEPTADINE HYDROCHLORIDE | 4 MG | TRIVENI 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 TABLETS | 1.0X2.0X50.0 TABLET BLISTER |
| NDA/MAL/HDP/0784 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | HEMOSAN | FERROUS FUMERATE | 300MG | COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
| KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0786 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | DERMA 1 | GRISEOFULVIN | 500MG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0787 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | BACTOCLAV DRY SYRUP | AMOXICILLIN + CLAVULANIC ACID | 250 MG + 62.5 MG/5 ML | MICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0788 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | TRIDANTIN | NITROFURANTOIN | 100 MG | TRIVENI FORMULATIONS LIMITED .- PLOT NO 52,53-54,63-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAN MANDAL KRISHNA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0792 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | AS-V | PHENOXYMETHYL PENICILLIN | 250MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0794 | REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD | HEALTHCARE LTD. | AMYGYDEX | TOBRAMYCIN/DEXAMETHASONE | 3MG+1MG/ML | REMINGTON PHARMACEUTICALS (PVT) LTD-18KM, MULTAN ROAD, LAHORE 53800, PAKISTAN | PAKISTAN | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/0795 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOPEN-250 | PHENOXYMETHYL PENICILLIN POTASSIUM | 250MG | MILAN 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0796 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | AMLO-H 5 | AMLODIPINE BESILATE | 5MG | HETERO 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0797 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | AFINITOR 5MG | EVEROLIMUS | 5MG | NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BLISTER |
| NDA/MAL/HDP/0798 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | AMLO-H 10 | AMLODIPINE BESILATE | 10MG | 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0799 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | AFINITOR 10MG | EVEROLIMUS | 10MG | NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BLISTER |
| NDA/MAL/HDP/0802 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE HCT 5MG/ 160MG/12.5MG | AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE | 5MG+ 160MG+ 12.5MG | NOVARTIS 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 TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/0806 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | SQUARE ZINC | ZINC SULPHATE | 20MG | SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0808 | PIRAMAL HEALTHCARE LTD | TATA UGANDA LIMITED | ISOFLURANE | ISOFLURANE | 250ML | PIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH | INDIA | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0809 | BRICVED LTD | BOOTS PHARMACEUTICALS LIMITED | PARAPAED | PARACETAMOL | 120MG/5ML | PINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND | IRELAND | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0811 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | DOLOWIN -SR | ACECLOFENAC | 200MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0812 | BRICVED LTD | BOOTS PHARMACEUTICALS LIMITED | FENPAED | IBUPROFEN | 100MG/5ML | PINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND | IRELAND | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0814 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | CANCYT | CYTARABINE | 100MG/5ML | NAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/0815 | NAPROD LIFE SCIENCES PVT LTD | AIVEEN (U) LTD - WILSON ROAD | ABINGEM-200 | GEMCITABINE | 200MG | NAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X200.0 MG VIAL |
| NDA/MAL/HDP/0816 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | GLIMEPIRIDE DENK 2 | GLIMEPIRIDE | 2MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0820 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | FIXIME 400MG | CEFIXIME | 400MG | NKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0821 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | GLIMEPIRIDE DENK 3 | GLIMEPIRIDE | 3MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0822 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CLOXCIN-500 | CLOXACILLIN SODIUM | 500MG | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 G VIAL |
| NDA/MAL/HDP/0823 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TRAP TABLETS | TRAMADOL HCL + PARACETAMOL | 37.5MG+325MG | CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0827 | GALPHA LABORATORIES LTD | AIVEEN (U) LIMITED | CLANOXY 1.2 | AMOXICILLIN + CLAVULANATE | 1000 MG + 200 MG | GALPHA LABORATORIES LTD-AT: ALKEM LABORATORIES LTD PLOT 167/2 MAHATMA UDYOG NAGAR AMALIYA DAMAN 396210 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 ML VIAL 1*20ML VIAL OF WFI |
| NDA/MAL/HDP/0830 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EUTHYROX 25 MCG | LEVOTHYROXINE SODIUM | 25 MCG | MERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER |
| NDA/MAL/HDP/0832 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EUTHYROX 100MCG | LEVOTHYROXINE | 100MCG | MERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER |
| NDA/MAL/HDP/0834 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VOMI-6 | DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE | 10MG + 10MG | LINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0835 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | AGOBIS | BISACODYL | 5MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0836 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | CALBONE-500 | CALCIUM CARBONATE + COLECALCIFEROL | 1250MG + 250 I.U | LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0841 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ETHOMID | ETHIONAMIDE | 250MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0842 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | SAC | SECNIDAZOLE | 1000MG | LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/0843 | MACLEODS PHARMACEUTICAL LTD | NORVIK ENTERPRISES LIMITED | COXERIN | CYCLOSERINE | 250MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/0845 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | OLEVO-500 | LEVOFLOXACIN | 500 MG | LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0846 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | MOXIMAC | MOXIFLOXACIN | 400MG | MACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/0848 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | MACROZIDE 500 | PYRAZINAMIDE | 500MG | MACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/0849 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | MONOPAS-4G | PARA-AMINOSALICYLATE SODIUM | 60%W/W | MACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 | INDIA | ORAL SOLID RETARD GRANULES | 1.0X30.0X4.0 G SACHET |
| NDA/MAL/HDP/0850 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | LCT KIT | LANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE | 30MG + 250MG + 500MG | LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS) |
| NDA/MAL/HDP/0852 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | KAPOCIN-1G | CAPREOMYCIN | 1000MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON |
| NDA/MAL/HDP/0854 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | IBICAR-50 | BECLOMETASONE | 50MCG PER ACTUATION | GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
| INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/0855 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | LAZINE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0856 | MACLEODS PHARMACEUTICAL LTD | NORVIK ENTERPRISES LIMITED | KANAMAC-1000 | KANAMYCIN | 1G | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1000.0 MG VIAL |
| NDA/MAL/HDP/0857 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID-V6 VAGINAL TABLETS | CLOTRIMAZOLE | 100MG | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP |
| NDA/MAL/HDP/0858 | ASTRAZENECA | MACNAUGHTON LIMITED | PLENDIL | FELODIPINE | 5MG | ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/0860 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | FLOXSAFE 400 | MOXIFLOXACIN HYDROCHLORIDE | 400MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/0861 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | PROZINE | PROMETHAZINE | 25MG/ML | SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 2.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0862 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | IBICAR- 200 | BECLOMETASONE | 200MCG PER ACTUATION | GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
| INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/0864 | HETERO LABS LTD UNIT IX | ABACUS PHARMA (AFRICA) LIMITED | PANTIN-40 | PANTOPRAZOLE SODIUM | 40 MG | HETERO 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0866 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | LIZOLID | LINEZOLID | 2MG/ML | AMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0867 | HETERO LABS LTD UNIT IX | ABACUS PHARMA (AFRICA) LIMITED | PANTIN-20 | PANTOPRAZOLE SODIUM | 20MG | HETERO 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0868 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | VARMIKA-500 | AMIKACIN | 500MG | SAKAR 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 AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0869 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | LARTRM | ARTEMETHER | 80MG/ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0870 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | TROY-K | PHYTOMENADIONE | 10MG/ML | TROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0871 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | DEXA | DEXAMETHASONE SODIUM | 4MG/ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 2.0X6.0X2.0 ML VIAL |
| NDA/MAL/HDP/0873 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | OXYTOCIN INJECTION | OXYTOCIN | 10I.U/ML | NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0874 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | LEBASMA-4 | SALBUTAMOL | 4MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0877 | LEBEN LABORATORIES LTD | ANDYCO PHARMACY (UGANDA) LTD | ANTAGIT DS GEL MINT FLAVOUR | DRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 400MG + 400MG + 50MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X170.0 ML BOTTLE |
| NDA/MAL/HDP/0879 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | TRIBEES FORTE FILM COATED TABLETS | THIAMINE + PYRIDOXINE + CYANOCOBALAMIN | 200MG + 50MG +1000MCG | COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
| KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0882 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOVANCE 500MG/2.5MG | METFORMIN + GLIBENCLAMIDE | 500MG + 2.5MG | MERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/0883 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOVANCE 500MG/5MG | METFORMIN + GLIBENCLAMIDE | 500MG + 5MG | MERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/0889 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | DNS | SODIUM CHLORIDE + GLUCOSE | 0.9%W/V + 5% W/V | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/0892 | ASTRA ZENECA | MACNAUGHTON LIMITED | ONGLYZA | SAXAGLIPTIN | 2.5MG | BRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620
USA | UNITED STATES | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/0894 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | GIAGRA 100 | SILDENAFIL CITRATE | 100MG | HETERO 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 TABLETS | 1.0X4.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0895 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | HYORTH | SODIUM HYALURONATE | 10MG/1ML | VIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/0897 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | DEBRIDACE | PAPAIN + UREA | 521700UNITS+100MG/G | VIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0898 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | LOSAGEN 50 | LOSARTAN POTASSIUM | 50MG | 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 FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0899 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | VIRIAXONE | CEFTRIAXONE | 1G | INJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 10 ML VIAL WFI |
| NDA/MAL/HDP/0900 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | LAPSONE | DAPSONE | 100MG | ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0902 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOPINE SR | NIFEDIPINE | 20MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0903 | GLAXO WELLCOME(KENYA) LTD | ERIS LTD | ZANTAC | RANITIDINE | 50MG/2ML | GLAXO SMITHKLINE MANUFACTURING S.P.A .-STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA) | ITALY | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0904 | ASTRA ZENECA | MACNAUGHTON LIMITED | ONGLYZA | SAXAGLIPTIN | 5MG | BRISTOL-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 TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/0905 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | NECPOD | CEFPODOXIME PROXETIL | 200MG | NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0906 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | IONSIL | SILVER NITRATE | 0.2%W/W | VIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0907 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | CEFUAXIT | CEFUROXIME AXETIL | 250MG | NECTAR LIFE SCIENCES LTD--UNIT VI BHATOLIKALAN DIST SOLAN H.P | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0908 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | HYOPT PLUS | SODIUM HYALURONATE | 11.9MG/0.85ML | VIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.85 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/0909 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | FIXINECT | CEFIXIME | 100MG | NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0911 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | HEALACE | RECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B | 100MCG/G | VIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0913 | NOVARTIS PHARMA | SURGIPHARM (U) LIMITED | FEMARA | LETROZOLE | 2.5MG | NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0914 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | OSTEOTIDE | TERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION | 250MCG/ML | VIRCHOW BIOTECH PVT LTD -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT ANDHRA PRADESH | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X3.0 ML VIAL |
| NDA/MAL/HDP/0915 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | CURAM | AMOXICILLIN + CLAVULANIC ACID | 875 MG + 125 MG | SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/0920 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | BUPITROY HEAVY | BUPIVACAINE HYDROCHLORIDE | 5MG/ML | TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0X4.0 ML VIAL |
| NDA/MAL/HDP/0926 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | BACTOCLAV-375 | AMOXICILLIN +CLAVULANATE POTASSIUM | 250MG + 125MG | MICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0928 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | INSTACLOP 75 | CLOPIDOGREL | 75MG | AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/0929 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | DUOQUIN | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG +320MG | IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER |
| NDA/MAL/HDP/0931 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ARH JUNIOR | ALPHA-BETA ARTEETHER | 75MG/ML | SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X3.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/0937 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VALAZYD H 92.5 | VALSARTAN/HYDROCHLOROTHIAZIDE | 80MG/12.5MG | CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0938 | FEROZSONS LABORATORIES LTD | TOP UNIVERSAL MEDICARE LIMITED | ESOMEGA 20MG | ESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS | 20MG | FEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0939 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ARH | ALPHA -BETA ARTEETHER | 150MG /2ML | SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X3.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0940 | FEROZSONS LABORATORIES LTD | TOP UNIVERSAL MEDICARE LIMITED | ESOMEGA 40MG | ESOMEPRAZOLE AS MAGNESSIUM TRIHYDRATE PELLETS | 40MG | FEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0941 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZAHA | AZITHROMYCIN | 200MG/5ML | AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/0942 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ARH FORTE | ALPHA -BETA ARTEETHER | 225MG/ 3ML | SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X3.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/0943 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | STREPTOMYCIN INJECTION BP | STREPTOMYCIN | 1G | MACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0X1.0 G VIAL |
| NDA/MAL/HDP/0945 | CLARIS LIFE SCIENCES LIMITED | REDDYS PHARMA LIMITED | ZOFEX | OFLOXACIN | 2 MG/ML | CLARIS OTSUKA LIMITED-VILLAGE ? VASANA ? CHACHARWADIP,
TAL: SANAND, AHMADABAD
| INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0946 | ASTRAZENECA | MACNAUGHTON LIMITED | TENORETIC | ATENOLOL + CHLORTHALIDONE | 100 MG + 25 MG | ASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/0948 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | LORHISTINA SYRUP 5MG/5ML | LORATADINE | 5MG/5ML | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/0949 | JULPHAR GULF PHARMACEUTICAL INDUSTRIES | GAMA PHARMACEUTICALS (U) LIMITED | VANCOLON | VANCOMYCIN | 0.5G/VIAL | JULPHAR GULF PHARMACEUTICAL INDUSTRIES-DIGDIGA AREA, AIR PORT ROAD P.O BOX 977 RAS-AL KHAIMAH UAE | UNITED ARAB EMIRATES | PARENTERAL ORDINARY I V VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/0950 | JULPHAR GULF PHARMACEUTICAL INDUSTRIES | GAMA PHARMACEUTICALS (U) LIMITED | EPOTIN | ERYTHROPOIETIN | 4000I.U | JULPHAR GULF PHARMACEUTICAL INDUSTRIES-DIGDIGA AREA, AIR PORT ROAD P.O BOX 977 RAS-AL KHAIMAH UAE | UNITED ARAB EMIRATES | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0 PREFILLED SYRINGE CARTON |
| NDA/MAL/HDP/0951 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | NORAD | STERILE NORADRENALINE CONCENTRATE | 2MG/2ML | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY S C AMPOULES | 1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0952 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | EFECATAL | CEFTRIAXONE | 1G | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/0953 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | CIZCAN | CISPLATIN | 10MG/10ML | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/0954 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | ANAWIN | BUPIVACAINE | 50MG/20ML | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL RETARD OTHER VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/0955 | I CARE PHARMA LIMITED | VITACARE LTD | INDOX | INDOMETHACIN USP | 25MG | WUHAN GRAND PHARMACEUTICAL GROUP.CO.LTD-NO.5 GUTIAN ROAD WUHAN HUBEL PR OF CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0956 | I CARE PHARMA LIMITED | VITACARE LTD | GENTAMICIN INJECTION BP | GENTAMICIN | 80MG/2ML | GRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCE | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0957 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | LYRED SYRUP | VITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC | 2500 IU + 10 IU + 50MG + 35MCG + 3MG | TORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/0958 | I CARE PHARMA LIMITED | VITACARE LTD | FUROSEMIDE | FUROSEMIDE | 10MG/2ML | GRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCE | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0959 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN DISPERSIBLE 20/120 | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/0960 | I CARE PHARMA LIMITED | VITACARE LTD | VITAMIN B COMPLEX INJECTION | VITAMIN B1+VITAMIN B6+ VITAMIN B2+VITAMIN B5+ NICOTINAMIDE | 20MG+2MG+27.4MG+1MG+30MG | WUHAN GRAND PHARMACEUTICALS GROUP CO.LTD-M/S NO. 5 GUTIAN RD, WUHAN, HUBEI CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0963 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APMOD | ARTESUNATE+AMODIAQUINE | 50MG+135MG | AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/0964 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APMOD 25 / 67.5 | ARTESUNATE + AMODIAQUINE | 25 MG + 67.5 MG | AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/0966 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLOFENAC DT | DICLOFENAC SODIUM | 50MG | SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0967 | I CARE PHARMA LIMITED | VITACARE LTD | STREPTOMYCIN | STREPTOMYCIN | 1G | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/0969 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-2.5 | AMLODIPINE BESILATE | 2.5MG | EMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0971 | I CARE PHARMA LIMITED | VITACARE LTD | BENZYLPENICILLIN INJECTION | BENZYL PENICILLIN SODIUM | 1MU | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY I M VIALS | 1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON |
| NDA/MAL/HDP/0972 | PHARCO PHARMACEUTICALS COMPANY LTD | ECHO PHARMACY (U) LIMITED | AZOMYCIN | AZITHROMYCIN DIHYDRATE | 200 MG/5ML | PHARCO 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/DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/0974 | SQUARE CEPHALOSPORINS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CEF-3 | CEFIXIME | 100MG/5ML | SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/0975 | PHARCO PHARMACEUTICALS | ECHO PHARMACY (U) LIMITED | CETRAK SYRUP | CETIRIZINE DIHYDROCHLORIDE | 5MG/5ML | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/0977 | PHARCO PHARMACEUTICALS | ECHO PHARMACY (U) LIMITED | CETRAK | CETIRIZINE DIHYDROCHLORIDE | 10MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0978 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | AMBROX 75 SR CAPSULE | AMBROXOL | 75MG | SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0980 | PHARCO PHARMACEUTICALS | ECHO PHARMACY (U) LIMITED | AZOMYCIN | AZITHROMYCIN | 250MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0981 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | CLOFENAC SR TABLETS | DICLOFENAC SODIUM | 100MG | HOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0982 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASMETO-10 | METOCLOPRAMIDE | 10MG | ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/0983 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ANADOL CAPSULES | TRAMADOL HYDROCHLORIDE | 50MG | SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0984 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | JOVAN T20 | TADALAFIL | 20MG | CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0986 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CONVENTIN | GABAPENTIN | 100MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/0987 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ALATROL TABLETS | CETIRIZINE | 10MG | SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0988 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | CADITOR 20 | ATORVASTATIN | 20MG | CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0990 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FUSIDERM CREAM | FUSIDIC ACID | 2%W/W | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/0995 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | FLUCOMOL | PARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE | 250MG + 5MG + 10MG + 2MG | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/0997 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GENUPHIL | GLUCOSAMINE SULPHATE SODIUM CHLORIDE+METHYLSULPHONYLMETHANE+CHONDROITIN SULPHATE | 375MG+375MG+300MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/0998 | ROYAL GROUP | HARLEYS UGANDA LIMITED | QUININE DIHYDROCHLORIDE INJECTION | QUININE DIHYDROCHLORIDE | 600MG/2ML | GRAND PHARMACEUTICAL (CHINA) CO. LTD--LAKE ROAD NELL JINYINHU ECOLOGICAL PARKDONG XI HU DISTRICT, WUHAN, HEBEI PROVINCE. | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/0999 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | THIOEVA | THIOTIC ACID | 600MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1000 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | TROYCURIUM | ATRACURIUM | 10MG/ML | TROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE |
| NDA/MAL/HDP/1001 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | THIOTACID ACID | THIOTIC ACID | 300MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1002 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CIPROCIN T 750 | CIPROFLOXACIN | 750MG | SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1003 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZEFICAM | LORNOXICAM | 8MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1006 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TRIPRIDE-2 | GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN | 2MG+15MG+500MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1007 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ZINCOS DISPERSIBLE TABLETS 20MG | ZINC SULPHATE | 20MG | COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
| KENYA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1009 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | BUPITROY 0.5% | BUPIVACAINE | 5MG/ML | TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/1010 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASDOPA TABLETS | METHYLDOPA | 250MG | ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1011 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | DABORAL SYRUP | AMINOSIDINE | 125MG/5ML | COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA
NAIROBI - KENYA
| KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/1012 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | LOX 2% | LIDOCAINE | 2% W/V | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY OTHER VIALS | 1.0X20.0 ML VIAL, 1.0X50.0 ML VIAL |
| NDA/MAL/HDP/1013 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | THIOSOL | THIOPENTAL SODIUM | 500MG | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X20.0 ML VIAL |
| NDA/MAL/HDP/1014 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | TIDAZOL TABLETS | TINIDAZOLE | 500MG | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
| KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1015 | DAWA LIMITED | SUPER MEDIC LTD | ORACEF | CEFALEXIN | 250MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1016 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ASCORBIC ACID | ASCORBIC ACID | 200MG | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1017 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYCLOX | AMPICILLIN/CLOXACILLIN | 125MG/125MG | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
| KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1018 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM CHLOR | CHLORAMPHENICOL | 250MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 100.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/1020 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | PA-12 | PARACETAMOL SUSTAINED RELEASE | 1000MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID RETARD LAYERED TABLETS | 1.0X10.0X1.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/1022 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CONVENTIN | GABAPENTIN | 300MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1023 | MYLAN LABORATORIES LIMITED. | NORVIK ENTERPRISES LIMITED | ZINNIA P | LEVONORGESTREL + ETHINYLESTRADIOL | 150MCG + 30MCG | MYLAN 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, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/1025 | SANOFI ?AVENTIS DEUTSCHLAND | LABOREX UGANDA LIMITED | INSUMAN COMB 30 | INSULIN HUMAN | 100IU/ML | SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
| GERMANY | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X3.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/1026 | BIOCON LTD | ABACUS PHARMA (AFRICA) LIMITED | INSUGEN R (REGULAR) | INSULIN HUMAN | 100 IU/ML | BIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROAD | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/1027 | BIOCON LTD | ABACUS PHARMA (AFRICA) LIMITED | INSUGEN-N (NPH) | INSULIN HUMAN | 100 IU/ML | BIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROAD | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/1028 | BIOCON LTD | ABACUS PHARMA (AFRICA) LIMITED | INSUGEN -30/70 (BIPHASIC) | INSULIN HUMAN | 30/70I.U/ML | BIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROAD | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/1030 | LABORATORIOS SALVAT SA | LABOREX UGANDA LIMITED | MALACUR | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG+320MG | ELDER PHARMACEUTICALS LTD -PLOT NO. C-11/1, INDUSTRIAL AREA, SELAQUI, DEHRADUN-248197, UTTRAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/1031 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MOXIFLOX | MOXIFLOXACIN | 400MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/1032 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ARTHFREE 20 | LEFLUNOMIDE | 20MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1033 | FAES FARMA S.A | LABOREX UGANDA LIMITED | DYNAMOGEN | GLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE | 3MG +1G | FAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X20.0X10.0 ML SACHET |
| NDA/MAL/HDP/1034 | VOGEN LABORATORIES LTD | BUFFALO HEALTH CARE LTD | DURAMOX | AMOXICILLIN | 250MG/5ML | VOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1035 | GUILIN PHARMACEUTICAL CO.LTD | STAR PHARMACEUTICALS LTD | G-CIPROX | CIPROFLOXACIN | 500MG | GUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1037 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LAMIVUDINE + TENOFOVIR | LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE | 300MG+300MG | AUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK,
POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/1038 | SQUARE CEPHALOSPORINS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CEF-3 | CEFIXIME TRIHYDRATE | 200MG | SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1040 | SQUARE CEPHALOSPORINS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CEF-3 DS | CEFIXIME TRIHYDRATE | 400MG | SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1041 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | REPOITIN | RECOMBINANT HUMAN ERYTHROPOIETIN | 4000 I.U/1ML | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X1.0X1.0 ML VIAL |
| NDA/MAL/HDP/1042 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS-H 80/12.5 | TELMISARTAN +HYDROCHLOROTHIAZIDE | 80MG +12.5 MG | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1043 | SQUARE CEPHALOSPORINS LTD | GAMA PHARMACEUTICALS (U) LIMITED | FLEXI 100 | ACECLOFENAC | 100MG | SQUARE PHARMACEUTICALS LTD-KALIAKOIR | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1044 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANGINET 80MG | VALSARTAN | 80MG | UNITED 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1045 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ZIMAX 500 | AZITHROMYCIN | 500MG | SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/1047 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EXOFEN 180MG | FEXOFENADINE | 180MG | UNITED 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 TABLETS | 1.0X1.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/1048 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EXOFEN 120MG | FEXOFENADINE | 120MG | UNITED 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 TABLETS | 1.0X1.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/1049 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | AGOVATE | BETAMETHASONE VALERATE | 0.1%W/W | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1050 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | AMTAS-10 | AMLODIPINE | 10MG | INTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1051 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIVAL 300MG | SODIUM VALPROATE | 300MG | UNITED 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 TABLETS | 1.0X50.0 TABLET CONTAINER |
| NDA/MAL/HDP/1052 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | MICLOGEN | MICONAZOLE NITRATE+NEOMYCIN SULPHATE+CLOBETASOL PROPIONATE | 2.0%W/W+0.5%W/W+0.05%W/W | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1053 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN-125 DT | AMOXICILLIN | 125MG | MILAN 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 TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1054 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-250 | AZITHROMYCIN | 250MG | AGOG 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 CAPSULES | 1.0X1.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1055 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | ROZITTA 40 | ROSUVASTATIN CALCIUM | 40MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1056 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | AGOVATE-N OINTMENT | BETAMETHASONE + NEOMYCIN | 0.1%W/W + 0.5% W/W | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE |
| NDA/MAL/HDP/1057 | NECTAR LIFESCIENCES LTD | SUPER MEDIC LTD | FIXINECT-200MG | CEFIXIME | 200MG | NECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL.
NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1061 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | BISALAX | BISACODYL | 5MG | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1062 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | VANCONEX-CP | VANCOMYCIN | 500MG | VENUS REMEDIES LIMITED-UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP
PHASE I BHATOLI BADDI (HP) 173205
INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/1063 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VIRECTA | SILDENAFIL CITRATE | 100MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/1064 | VENUS REMEDIES LTD | AARON PHARMACEUTICALS LTD | OXOL | OXALIPLATIN | 2MG/ML | VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/1065 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | SLIPIZEM-5 | DIAZEPAM | 5MG | BLISS 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 SUPPOSITORIES | 1.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/1067 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | IBUPARA | IBUPROFEN+PARACETAMOL | 200MG+ 250MG/10ML | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1069 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | K-ONE INJECTION | PHYTOMENADIONE | 10MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/1071 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CO-ANGINET 160/25MG | VALSARTAN + HYDROCHLOROTHIAZIDE | 160 MG + 25 MG | UNITED 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1072 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CO-ANGINET 80/12.5MG | VALSARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .-57 UBAYBIN MUAATH STREET AL RAGEEM-SAHAB, AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1073 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | IBICAR-250 | BECLOMETASONE | 250MCG PER ACTUATION | GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
| INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/1074 | NECTAR LIFESCIENCES LTD | SUPER MEDIC LTD | CEFUAXIT | CEFUROXIME | 500MG | NECTAR 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 TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1075 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | NECPIME | CEFEPIME | 1000MG | NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION |
| NDA/MAL/HDP/1076 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNICAST 4MG | MONTELUKAST SODIUM | 4MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1077 | NECTAR LIFESCIENCES LTD | AIVEEN (U) LIMITED | NECTRAM | CEFTRIAXONE | 1G | NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL + 1*10 ML WFI AMPOULE |
| NDA/MAL/HDP/1078 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LEVOBACT INFUSION | LEVOFLOXACIN HEMIHYDRATE | 500MG | AHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1079 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOG-QUINE SYRUP | QUININE HYDROCHLORIDE | 100MG/5ML | 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 SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1080 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF 250 TABLETS | CEFUROXIME AXETIL | 250MG | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1081 | BRICVED LTD | BOOTS PHARMACEUTICALS LIMITED | ACIDEX | SODIUM BICARBONATE + SODIUM ALGINATE + CALCIUM CARBONATE | 267MG + 500MG + 160MG /10ML | PINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND | IRELAND | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/1082 | DAWA LIMITED | SUPER MEDIC LTD | DACOF PAEDIATRIC | DIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL | 75MG + 28.5MG + 0.55MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1083 | GALPHA LABORATORIES LTD | AIVEEN (U) LIMITED | CHOCOFER SYRUP | IRON + FOLIC ACID | 50MG + 0.5MG /5ML | GALPHA LABORATORIES LIMITED-VILLAGE ? THANA BADDI, TEHSIL BADDI
SOLAN HIMACHAL PRADESH-173 205 INDIA
| INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/1084 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-CPM | CHLORPHENIRAMINE MALEATE | 4MG | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1086 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | SYNOGEN TABLETS | DIACEREIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE | 50MG +250MG + 750MG | NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA ? INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1087 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCYCLINE | TETRACYCLINE | 3%W/W | AGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1088 | GALPHA LABORATORIES LTD | AIVEEN (U) LIMITED | RESTUM | CEFUROXIME SODIUM | 750MG | ALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL |
| NDA/MAL/HDP/1093 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMARATE | 200MG+300MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/1094 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O-100 | CEFIXIME | 100MG/5ML | MICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1095 | MICRO LABS LTD | LABOREX UGANDA LIMITED | EROSTINE-20 | EBASTINE | 20MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1098 | IDA FOUNDATION | KIMSY MEDS LTD | PRAZIQUANTEL | PRAZIQUANTEL USP | 600MG | MICRO LABS LTD ..PLOT NO.S-155 TO S-159 & N1,PHASE 111 & IV,VERNA SALCETTE GOA,403722 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/1099 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | MOMATE F CREAM | FUSIDIC ACID+MOMETASONE FUROATE | 2.1%W/W + 0.1W/W | GLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/1100 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOVIR SKIN CREAM | ACICLOVIR | 5% W/W | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X5.0 G TUBE |
| NDA/MAL/HDP/1101 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O 100 | CEFIXIME | 100MG | MICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1102 | MATRIX UGANDA LTD | ROYAL PHARMA 2011 LIMITED | OVUREX | CLOMIPHENE | 50MG | Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1103 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOCIN CREAM | NEOMYCIN SULPHATE | 0.5% W/W | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1104 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | LIPIDUCE 10 | ATORVASTATIN | 10MG | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/1105 | DAWA LIMITED | SUPER MEDIC LTD | DERMAZINE PLUS | SILVER SULPHADIAZINE AND CHLORHEXIDINE GLUCONATE | 1%W/W / 10.0%W/W | DAWA LIMITED -BABA DOGO RWARAKA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1106 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DIACEREIN | DIACEREIN | 50MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1107 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | HEPATITIS B VACCINE(RDNA) (PAEDIATRIC)) | HEPATITIS B VACCINE(RDNA) | 10MCG /0.5ML | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X25.0X5.0 ML VIAL (10 DOSES),1.0X10.0X0.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/1109 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-CPM | CHLORPHENIRAMINE MALEATE | 2MG/5ML | DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/1111 | DAWA LIMITED | SUPER MEDIC LTD | FAST-ACT GEL | DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS | 1.16%W/W + 10%W/W + 3%W/W + 5%W/W | DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1112 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | ZIDOVUDINE CAPSULES | ZIDOVUDINE | 100MG | AUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHU | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/1113 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ALCID-YELLOW | MULTI-INGREDIENT | MULTI-INGREDIENT | TORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE |
| NDA/MAL/HDP/1114 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | TRANGEL ULTRA | DICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN | 10MG/80MG/60MG/0.15MG | NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA ? INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G CONTAINER |
| NDA/MAL/HDP/1116 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | VITAL ESSENTIAL BALM | MENTHOL + CAMPHOR + PEPPERMINT OIL + EUCALYPTUS OIL + CLOVE OIL+ CINNAMON +WINTER GREEN OIL | 140MG + 140MG + 80MG +80MG +40MG +40MG +120MG | NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA ? INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X24.0 G CONTAINER |
| NDA/MAL/HDP/1117 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | TETRACYCLINE EYE OINTMENT USP 1% | TETRACYCLINE | 1%W/W | NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA ? INDIA | INDIA | OPHTHALMIC OINTMENTS | 1.0X20.0X3.5 G TUBE |
| NDA/MAL/HDP/1122 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABCHLOR EAR DROPS | CHLORAMPHENICOL | 5%W/V | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OTIC DROPS | 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL |
| NDA/MAL/HDP/1123 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPAR | PARACETAMOL | 500 MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/1124 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGO SCRUB | CHLORHEXIDINE GLUCONATE | 4%W/V | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/1125 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROXONE 1000 | CEFTRIAXONE | 1000MG | A-UNIT VI, SY. NO 329/39, 329/ | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/1127 | FEROZSONS LABORATORIES LTD | TOP UNIVERSAL MEDICARE LIMITED | CLARION TABLETS 500MG | CLARITHROMYCIN | 500MG | FEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
| PAKISTAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1128 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | BTC KIT | FLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE | 150MG + 1G + 1G | LINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY COMBINATION PACK TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1130 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | KLARO-500 | CLARITHROMYCIN TABLETS | 500MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1132 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | M-CALZ | CALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL | 1000MG+100MG+4MG+200.I.U | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1133 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | MEDICOL SUSPENSION | CHLORAMPHENICOL | 125MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1136 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | AGOSCAB APPLICATION | BENZYL BENZOATE | 25%W/W | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL EMULSIONS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1138 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGO-CALAMINE | CALAMINE | 15%W/W | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL LOTIONS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1139 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | AGOVATE | BETAMETHASONE | 0.1%W/W | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1140 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | AGOVATE-N | BETAMETHASONE+NEOMYCIN SULPHATE | 0.1%W/W+0.5%W/W | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1141 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | CALBONE | CALCIUM CARBONATE + COLECALCIFEROL | 250MG+125MG/5ML | SAKAR 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 SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1142 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | CANDIZOL | CLOTRIMAZOLE | 1%W/W | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1143 | LINCOLN P'CALS LTD | METRO PHARMACEUTICALS LIMITED | LOSA-H | LOSARTAN + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1145 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | HILAC | LACTULOSE | 68%W/V | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/1147 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | VALAZYD | VALSARTAN | 80MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1148 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ODIMONT 10 | MONTELUKAST | 10MG | CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
| INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1149 | UNIVERSAL CORPORATION LTD | DELMAW ENTERPRISES LIMITED | NEUROBA | GABAPENTIN | 300MG | UNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1154 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | BACQURE | IMIPENEM + CILASTATIN | 500MG + 500MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED-INDUSTRIAL AREA NO.3, A.B. ROAD DEWAS, 455001 (MP), INDIA.
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 ML VIAL |
| NDA/MAL/HDP/1156 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | FUNGICIP | CLOTRIMAZOLE | 1%W/W | CIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1157 | Y.S.P INDUSTRIES (M) SDN BHD | ROYAL PHARMA 2011 LIMITED | TRETINON | TRETINOIN | 0.05%W/W | Y.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1158 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | TRAMADOL | TRAMADOL | 50MG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1159 | Y.S.P INDUSTRIES (M) SDN BHD | ROYAL PHARMA 2011 LIMITED | VOREN | DICLOFENAC SODIUM | 50MG | Y.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA | MALAYSIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X10.0X10.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/1160 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | DAFRACLAV | AMOXYCILLIN + CLAVULANIC ACID | 875MG+125MG | BILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/1162 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | WINKLOT | CLOPIDOGREL | 75MG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1163 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | FRUSEMIDE | FUROSEMIDE | 40MG | NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA ? INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1164 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | PIROXICAM | PIROXICAM | 20MG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1166 | PANACEA BIOTEC LTD | ABACUS PHARMA (AFRICA) LIMITED | DOLZERO | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1167 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | METOCLOPRAMIDE INJECTION | METOCLOPRAMIDE | 5MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/1168 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-CORT CREAM | HYDROCORTISONE | 1%W/W | DAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1169 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | NEBI 5 | NEBIVOLOL HYDROCHLORIDE | 5MG | ARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1171 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | BETNEW EYE / EAR DROP | BETAMETHASONE+NEOMYCIN | 0.1%W/W+0.5%W/W | CIRON DRUGS & PHARMACEUTICALS PVT LTD.-N-118 MIDC TARAPUR BOISAR DIST THANE 401 506 MAHARASTHTRA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/1172 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 20MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL,1.0X30.0 ML VIAL |
| NDA/MAL/HDP/1176 | AMOUN PHARMACEUTICALS COMPANY | BOOTS PHARMACEUTICALS LIMITED | FUNGISAFE | TERBINAFINE HYDROCHLORIDE | 1%W/W | AMOUN 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 CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1178 | HETERO DRUGS LTD | ABACUS PHARMA (AFRICA) LIMITED | TENOFOVIR | TENOFOVIR DISOPROXIL FUMARATE | 300MG | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/1179 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | OVITRELLE | CHORIOGONADOTROPIN ALFA | 250MCG/0.5ML | MERCK SERONO SA-1170 AUBONNE(SWITZERLAND),MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY | SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 PREFILLED SYRINGE CARTON |
| NDA/MAL/HDP/1180 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ZIF TIMED RELEASED CAPSULES | DRIED FERROUS SULPHATE+ZINC SULPHATE MONOHYDRATE+FOLIC ACID | 150MG+61.8MG+0.5MG | SQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID RETARD CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1182 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | ASTHATOR 5 | MONTELUKAST SODIUM | 5MG | TORRENT PHARMACEUTICALS LIMITED-VILLAGE .BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P), INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1184 | DAWA LIMITED | SUPER MEDIC LTD | DACOF MUCOLYTIC | SALBUTAMOL + BROMHEXINE + GUAIPHENESIN + MENTHOL | 2.0MG + 4.0MG +100MG + 1.0MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1185 | DAWA LIMITED | SUPER MEDIC LTD | DACOF DRY | DIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL | 12.5MG + 6.5MG + 1.10MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1186 | DAWA LIMITED | SUPER MEDIC LTD | DACOF EXPECTORANT | DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL | 14.0MG + 135.0MG + 57.0MG + 1.10MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1187 | GALPHA LABORATORIES LTD | AIVEEN (U) LIMITED | KEFTAZ-1000 | CEFTAZIDIME | 1 G | ALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION |
| NDA/MAL/HDP/1194 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | PISA | PIPERACILLIN + TAZOBACTAM | 4000MG/VIAL + 500MG/VIAL | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X30.0 ML VIAL |
| NDA/MAL/HDP/1195 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | ALTRINE | CETIRIZINE | 5MG/5ML | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/1196 | UNIVERSAL CORPORATION LTD | DELMAW ENTERPRISES LIMITED | ACNESOL | TRETINOIN | 0.05%W/W | UNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/1202 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | QUINIMIX SYRUP | QUININE HYDROCHLORIDE | 100MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1205 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | EFAVIRENZ | EFAVIRENZ | 600MG | MYLAN 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 TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/1206 | THE METHOLATUM CO. LTD | HARLEYS UGANDA LIMITED | DEEP RELIEF | IBUPROFEN + MENTHOL | 5%W/W + 3% W/W | THE MENTHOLATUM CO. LTD. -1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDE | UNITED KINGDOM | TOPICAL EXTERNAL OTHER GELS/SOLS | 1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER |
| NDA/MAL/HDP/1208 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | VISCO LIQUID | ALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE | 100 MG + 250 MG + 125 MG + 50 MG | ARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/1209 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL-80 | TELMISARTAN | 80MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1211 | ASTRA ZENECA | MACNAUGHTON LIMITED | BRILINTA | TICAGRELOR | 90MG | ASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1212 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | GLINTHER | ARTEMETHER | 80MG/ML | GUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI | CHINA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/1214 | FERRER INTERNACIONAL S.A | LABOREX UGANDA LIMITED | NUCLEO C.M.P FORTE | CYTIDINE+URIDINE | 5MG+3MG | FERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1215 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GYNANFORT VAGINAL PESSARY | METRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN | 500MG+65,000I.U+100,000I.U | BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | VAGINAL SUPPOSITORIES | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1217 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | INSUMAN BASAL | RECOMBINANT HUMAN INSULIN | 100 IU/ML | SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
| GERMANY | PARENTERAL ORDINARY VIALS | 1.0X5.0X3.0 ML CARTRIDGE,1.0X5.0 ML VIAL |
| NDA/MAL/HDP/1218 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GSUNATE-50 | ARTESUNATE | 50MG | BLISS INDASI LIFESCINCES PRIVATE LIMITED - -PLOT 73-76 SILVER INDUSTRIAL ESTATE,
BHIMPORE, DAMAN 396 210, INDIA
| INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X6.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/1219 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | TORAS-DENK 5 | TORASEMIDE | 5MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1220 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART | ARTEMETHER + LUMEFANTRINE | 180 MG + 1080 MG | BLISS 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 SUSPENSIONS | 1.0X60.0 ML BLISTER |
| NDA/MAL/HDP/1223 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | WHITFIELD'S OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6%W/W + 3%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X25.0 G TUBE |
| NDA/MAL/HDP/1224 | KOTRAPHARMA (M) SDN.BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | VAXCEL CEFTRIAXONE | CEFTRIAXONE | 1G | KOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/1225 | AMOUN PHARMACEUTICAL COMPANY | BOOTS PHARMACEUTICALS LIMITED | MOSEDIN PLUS SR | PSEUDOEPHEDRINE HYDROCHLORIDE + LORATADINE | 120MG + 5MG | AMOUN 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 CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1226 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | SALBUTAMOL | SALBUTAMOL | 4MG | STRIDES ARCOLAB LIMITED .-DEWAN & SONS IND. AREA, VEOOR, PALGHAR, MAHARASTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1227 | AMOUN PHARMACEUTICALS COMPANY | BOOTS PHARMACEUTICALS LIMITED | FUNGISAFE | TERBINAFINE HCL | 250MG | AMOUN 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 TABLETS | 1.0X7.0 TABLET STRIP |
| NDA/MAL/HDP/1228 | ASTRA LIFECARE (INDIA) PVT. LTD | ASTRA PHARMA (U) LIMITED | LUMETHER | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/1230 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | LOXAMP | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1231 | NORVIK ENTERPRISES LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOX 125 | AMOXYCILLIN | 125MG/5ML | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1232 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOCILLIN 125 | AMPICILLIN | 125 MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1234 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | BISACODYL TABLETS BP | BISACODYL | 5MG | MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
| INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1238 | PHARMACARE LIMITED | BETA HEALTHCARE UGANDA LIMITED | SEPTRIN INJECTION | CO-TRIMOXAZOLE | 480MG/5ML | DRAXIS PHARMA INC.- QUEBEC, CANADA | CANADA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/1239 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | PECTYLIN-C | DIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM HYDROCHLORIDE+SODIUM CITRATE+MENTHOL | 14MG+135MG+57MG+1.1MG | IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1240 | BRICVED LTD | BOOTS PHARMACEUTICALS LIMITED | CETIRIZINE HYDRCHLORIDE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | PINEWOOD LABORATORIES LTD. -BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND | IRELAND | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/1242 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | TOPHEN-100 | PHENYTOIN | 100MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1243 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | LEVO DENK 250 | LEVOFLOXACIN HEMIHYDRATE | 250MG | ROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1244 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | FLEXILOR SR | LORNOXICAM | 16MG | GLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1245 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | FLEXILOR P8 | LORNOXICAM + PARACETAMOL | 8MG + 500MG | GLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1246 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | GLEMONT CT 4 | MONTELUKAST | 4MG | GLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1247 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | PROCIP | CYPROHEPTADINE | 4MG | AGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1250 | STRIDES ARCOLAB LIMITED | DELMAW ENTERPRISES LIMITED | STRIMOL EXTRA | PARACETAMOL+CAFFEINE | 500MG+30MG | STRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAWADICROSS ANEKAL TALUK BANYALURE-562106 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1252 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ZOY | SILDENAFIL | 50MG | TORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1254 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSATRIM TABLETS | CO-TRIMOXAZOLE | 480MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/1255 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | NIFELAT RETARD | NIFEDIPINE | 20MG | CIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGAD | INDIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1256 | SIRMAXO CHEMICALS PVT LTD | SUPER MEDIC LTD | SANIQUAD PVP T | POVIDONE IODINE | 10%W/W | SIRMAXO CHEMICALS PVT LTD-PLOT NO. E-35. TARAPRU MIDC BOISAR, THANE, MUMBAI, INDIA | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X1000.0 ML BOTTLE |
| NDA/MAL/HDP/1258 | GLAXO WELLCOME(KENYA),LTD | ERIS LTD | MYOGLIN CAPSULES | CHLORZOXAZONE/PARACETAMOL | 250MG/300MG | GLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1259 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | CARDOZ- 6.25 | CARVEDILOL | 6.25MG | IPCA LABORATORIES LIMITED -SEJAVTA VILLAGE, DIST. RATLAM (M.P) 457002 INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1260 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | DIABETA | GLIBENCLAMIDE | 5MG | BLISS 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1264 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | OCUCYCLINE EYE OINTMENT | TETRACYCLINE HYDROCHLORIDE | 1%W/W | CENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE,1.0X3.5 G TUBE |
| NDA/MAL/HDP/1265 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | COMBIPLEX | VITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B6 | 1.0 MG + 1.0 MG + 15 MG + 0.5 MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1272 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR) | GAMA PHARMACEUTICALS (U) LIMITED | MEBO HERBAL OINTMENT | B-SITOSTEROL | 0.25%W/W | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA, P.O.BOX:
997,
RAS AL KHAIMAH,
U.A.E.
| UNITED ARAB EMIRATES | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/1274 | SURGE LAB (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | ROMYCIN | AZITHROMYCIN | 250MG | NABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN | ORAL SOLID ORDINARYCAPSULES | 1.0X1.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1275 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | NIFELAT 10 F.C TABLETS | NIFEDIPINE | 10MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1277 | SANOTI AVENTIS | LABOREX UGANDA LIMITED | INSUMAN RAPID | INSULIN HUMAN | 100 IU/ML | SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY | GERMANY | PARENTERAL ORDINARY S C VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/1278 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | D-ARTEPP | DIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE | 40MG +320MG | GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER |
| NDA/MAL/HDP/1282 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | LOSABERG | LOSARTAN POTASSIUM | 50MG | THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1287 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANIX- DS 100 | CEFIXIME | 100MG/5ML | SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/1290 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANIX 400 CAP | CEFIXIME | 400MG | SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1291 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | ULTRAVIST-300 | IOPROMIDE | 300MG/ML | BAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL |
| NDA/MAL/HDP/1293 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEEGRA - 100 | SILDENAFIL CITRATE | 100MG | THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1294 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | ULTRAVIST 370 | IOPROMIDE | 370MG/ML | BAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML VIAL,1.0X50.0 ML VIAL |
| NDA/MAL/HDP/1295 | SHAIGAN PHARMACEUTICALS (PVT) LTD | HEALTHCARE LTD. | ZEPAR | ALBENDAZOLE | 200MG | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1297 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | OLMY 40 | OLMESARTAN | 40MG | CADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1298 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | NEUROVIT FORTE | THIAMINE MONONITRATE/ PYRIDOXINE/ CYANOCOBALAMIN | 245.5MG/ 250MG/ 1.4MG | HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1299 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANAXONE PLUS-1000 | CEFTRIAXONE+SULBACTAM | 1000MG+500MG | SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.5 G VIAL |
| NDA/MAL/HDP/1300 | KOPRAN LIMITED | TATA UGANDA LIMITED | ATENOLOL-100 | ATENOLOL | 100MG | KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X16.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1301 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | COSAMINE PLUS | GLUCOSAMINE SULPHATE + CHONDROITIN SULPHATE | 250MG + 200MG | HOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1302 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | HIPEN CAPSULES | AMOXYCILLIN | 250MG | SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1304 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIAPRIDE PLUS 2 | GLIMEPIRIDE+ METFORMIN | 1MG + 500MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1307 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ARBITEL 40 | TELMISARTAN | 40MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1310 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEEMYCIN-300 | CLINDAMYCIN | 300MG | THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1312 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | SLIPIZEM- 2.5 | DIAZEPAM | 2.5MG | BLISS 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 SUPPOSITORIES | 1.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/1315 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZESOZ-20 | ESOMEPRAZOLE | 20MG | THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1319 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ZESTAVAL 200 F.C TABLETS | ALBENDAZOLE | 200MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 50.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1324 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | TOOTH HEAL | MULTI INGREDIENT | MULTI INGREDIENT | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X18.0 ML BOTTLE |
| NDA/MAL/HDP/1325 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LAMIVUDINE + ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 150MG + 300MG | MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/1326 | IDA | KIMSY MEDS LTD | CO-TRIMOXAZOLE 480MG | CO-TRIMOXAZOLE | 480MG | MEDOPHARM--34-B, INDUSTRIAL AREA, MALUR 563 160 KARNATAKE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X100.0 TABLET BLISTER |
| NDA/MAL/HDP/1328 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | ENGERIX-B VACCINE | HEPATITIS B SURFACE ANTIGEN | 20MCG/ML | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X10.0X1.0 ML VIAL (1 DOSE),1.0X25.0X1.0 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/1329 | STRIDES SHASUN LIMITED . | DELMAW ENTERPRISES LIMITED | VITAVITE | MULTI-INGREDIENT | VITAMINS AND MINERALS | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1330 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | RAPICLAV-625 | AMOXYCILLIN+CLAVULANIC ACID | 500MG+125MG | IPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X2.0 TABLET STRIP,1.0X7.0X3.0 TABLET STRIP |
| NDA/MAL/HDP/1331 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM N OINTMENT | BETAMETHASONE VALERATE + NEOMYCIN | 0.1%W/W + 0.5%W/W | ATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE |
| NDA/MAL/HDP/1334 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | 30MG | MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER,1.0X30.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/1335 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | PREGATAS | PREGABALIN | 75MG | INTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1336 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | 45MG | MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER, CAPSULE CONTAINER |
| NDA/MAL/HDP/1337 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | FOURTS B | THIAMINE +RIBOFLAVIN + PYRIDOXINE + NICOTINAMIDE + FOLIC ACID + ASCORBIC ACID + COLECALCIFEROL + ACETYL CYSTEINE + GLYCINE + GLUTAMIC ACID + CHROMIUM + VANADIUM + ZINC + SELENIUM | 10MG + 10MG + 3MG + 50MG + 1MG + 75MG + 400IU + 25MG +25MG +MG +200MCG + 100MCG + 55MG +100MCG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1338 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | GRISEBEN 500 | GRISEOFULVIN | 500 MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1341 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | G-FLOX | GATIFLOXACIN SESQUIHYDRATE | 0.3%W/V | AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIA | INDIA | OPHTHALMIC LIQUIDS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/1342 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL CEPHALEXIN 250 | CEPHALEXIN MONOHYDRATE | 250MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1344 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | LIDOCAINE | LIDOCAINE | 2%W/V | NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANG | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/1345 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | SWICH-200 | CEFPODOXIME | 200MG | ALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1346 | ASTRA PHARMA LTD | ASTRA PHARMA (U) LIMITED | ASIX | FUROSEMIDE | 40MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1347 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | ORNILOX | ORNIDAZOLE + OFLOXACIN | 500MG + 200MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1348 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | VALPARIN CHRONO 500 | SODIUM VALPROATE (CONTROLLED RELEASE) | 500MG | TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1351 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | ATORIN | ATORVASTATIN CALCIUM | 20MG | MEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1352 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | PLATFREE | CLOPIDOGREL | 75MG | MEDLEY 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1353 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | KITPYLO - C | LANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN | 30MG +500MG + 250MG | MEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS) |
| NDA/MAL/HDP/1354 | PFIZER LABS LIMITED | LABOREX UGANDA LIMITED | ARTHROTEC | DICLOFENAC SODIUM + MISOPROSTOL | 50MG + 200MCG | PIRAMAL HEALTHCARE UK LTD--WHALTON ROAD MORPETH NORTHUMBERLAND NE613 YA UK
| UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1355 | PIRAMAL HEALTHCARE LTD | TATA UGANDA LIMITED | SEVOFLURANE | SEVOFLURANE | 100% V/V | PIRAMAL ENTERPRISES LTD, INDIA-DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH | INDIA | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/1356 | GLAXO SMITH KLINE LTD | ERIS LTD | REQUIP PD 24 HOUR 2 MG | ROPINIROLE | 2MG | GLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/1357 | GLAXO SMITH KLINE LTD | ERIS LTD | REQUIP PD 24 HOUR 4 MG | ROPINIROLE | 4MG | GLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/1359 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | DIFENAC-100 SR | DICLOFENAC SODIUM | 100MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID RETARD CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1360 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | ABAMUNE-L BABY | ABACAVIR SULPHATE + LAMIVUDINE | 60MG + 30MG | CIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/1361 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | FALCI CARE | ARTESUNATE | 120MG | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE |
| NDA/MAL/HDP/1362 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | BACTOCLAV-1000 | AMOXICILLIN + CLAVULANATE | 875 MG + 125 MG | MICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET STRIP |
| NDA/MAL/HDP/1367 | DAWA LIMITED | SUPER MEDIC LTD | ACEPAR | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1368 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | D5 | GLUCOSE | 5%W/V | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/1369 | MEDIPHARM (EA) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORALYTE CO-PACK ORANGE FLAVOUR | DT ZINC-20 + ORAL REHYDRATION SALTS (ORS) | 20G | AGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X2.0X20.8 G SACHET + 1.0 *10.0 TABLET BLISTER |
| NDA/MAL/HDP/1370 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | STERILIZED WATER FOR INJECTION | WATER FOR INJECTION | NEUTRAL | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE |
| NDA/MAL/HDP/1374 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | VALODIN -125 | CEPHADRINE | 125MG/5ML | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1375 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | VALODIN CAPSULES | CEPHADRINE | 250MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X4.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1377 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | WATER FOR INJECTION | WATER FOR INJECTION | N/A | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/1380 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | HYCORT CREAM | HYDROCORTISONE | 1%W/W | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/1381 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | LAMIVUDINE,/ ZIDOVUDINE TABLETS | LAMIVUDINE,+ ZIDOVUDINE | 150MG+300MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/1382 | HOVID BERHAD | UNITED HEALTHCARE DISTRIBUTORS LTD | INOX CAPSULES | ITRACONAZOLE | 100MG | HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X7.0X4.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1383 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | KETOFEN GEL | KETOPROFEN | 2.5%W/W | HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G CONTAINER |
| NDA/MAL/HDP/1384 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | LAMIVUDINE AND ZIDOVUDINE TABLETS | LAMIVUDINE + ZIDOVUDINE | 30MG + 60MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/1387 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LAN-30 | LANSOPRAZOLE | 30MG | INTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X5.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/1389 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | NELSTAT | NYSTATIN | 100000 I.U/ML | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL TOPICAL SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/1390 | ASTRA ZENECA | MACNAUGHTON LIMITED | CRESTOR | ROSUVASTATIN CALCIUM | 5MG | IPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1391 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | UNIVIR 5% | ACYCLOVIR | 5%W/W | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X10.0 G TUBE |
| NDA/MAL/HDP/1392 | ASTRA ZENECA | MACNAUGHTON LIMITED | ZOLADEX | GOSERELIN | 3.6MG | ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 PREFILLED SYRINGE CARTON |
| NDA/MAL/HDP/1393 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANFUR | CEFUROXIME | 500MG | SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1394 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANPIME -1000 | CEFEPIME | 1000MG | SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X15.0 ML VIAL |
| NDA/MAL/HDP/1395 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | NEXIUM 40MG IV | ESOMEPRAZOLE | 40MG/5ML | ASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJE | SWEDEN | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL |
| NDA/MAL/HDP/1397 | ASTRAZENECA | MACNAUGHTON LIMITED | PLENDIL | FELODIPINE | 10MG | ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/1399 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ASTHALIN | SALBUTAMOL | 100MCG/DOSE | CIPLA 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 INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/1400 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANFOR SR 500 | METFORMIN HYDROCHLORIDE | 500MG | INVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
(EAST), DISTRICT THANE, 421 0506, DIST. THANE,
MAHARASHTRA, INDIA.
| INDIA | ORAL SOLID RETARD TABLETS | 1.0X5.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/1402 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | PANFOR SR 1000 | METFORMIN HYDROCHLORIDE | 1000MG | INVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH
(EAST), DISTRICT THANE, 421 0506, DIST. THANE,
MAHARASHTRA, INDIA.
| INDIA | ORAL SOLID RETARD TABLETS | 1.0X5.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/1403 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | DOMAXIN-RD 10MG | DOXORUBICIN HCL | 10MG | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 MG VIAL |
| NDA/MAL/HDP/1404 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | NAPRODOX-10 | DOXORUBICIN HCL | 100MG | NAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/1406 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | CEBAY DRY SYRUP | CEFIXIME TRIHYDRATE | 50MG/5ML | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1407 | PHARMATHEN S.A | GOODMAN INTERNATIONAL LTD | BELIFAX | OMEPRAZOLE | 20MG | PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE | GREECE | ORAL SOLID ORDINARY CAPSULES | 1.0X14.0 CAPSULE BOTTLE |
| NDA/MAL/HDP/1408 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | ROSUCOR | ROSUVASTATIN | 20MG | TORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1409 | SURGE LAB (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | ROMYCIN | AZITHROMYCIN | 200MG/5ML | NABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/1411 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | CIPIUM | CHLORPHENIRAMINE | 4MG | LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/1413 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | PODINE MOUTH WASH | POVIDONE IODINE | 0.1%W/V | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL TOPICAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/1415 | ASTRA ZENECA | MACNAUGHTON LIMITED | ATACAND | CANDESARTAN | 32MG | ASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE
| SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1417 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | MILICAL TABLETS | CALCIUM CITRATE + VITAMIN D3 | 1000MG +200 I.U | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1418 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | AMINOPHYLLINE TABLETS | AMINOPHYLLINE | 100MG | NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1419 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SINOPRIL 10 | LISINOPRIL | 10MG | GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1420 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | SODIUM CHLORIDE + GLUCOSE | SODIUM CHLORIDE + GLUCOSE | 0.9%W/V + 5%W/V | IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI | KENYA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/1422 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | BINOZYT 500MG | AZITHROMYCIN MONOHYDRATE | 500MG | SANDOZ SRL LTD-LIVEZENI STREET 7A540472 TARGU MURES ROMANIA | ROMANIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/1423 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | CURAM | AMOXYCILLIN + POTASSIUM CLAVULANATE | 500MG+125MG | SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1425 | LEBEN LABORATORIES PVT.LTD | ANDYCO PHARMACY (UGANDA) LTD | L-TRIM | COTRIMOXAZOLE | 240MG/5ML | LEBEN LABORATORIES PVT. LTD-L-4, PHASE ?III, M.I.D.C, | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1426 | LEBEN LABORATORIES PVT.LTD | ANDYCO PHARMACY (UGANDA) LTD | METROLEB | METRONIDAZOLE | 200MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1427 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | TENA-50 | ATENOLOL | 50MG | AGOG 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1431 | INTAS PHARMACUITICALS LTD | NORVIK ENTERPRISES LIMITED | TORTAS 10 | TORSEMIDE | 10MG | INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1432 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CHLORAMPHENICOL EAR DROPS | CHLORAMPHENICOL | 5%W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | OTIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1433 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NORISTERAT | NORETHISTERONE ENANTATE | 200MG | BAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY VIALS | 1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL |
| NDA/MAL/HDP/1436 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CONCOR 10 | BISOPROLOL HEMIFUMARATE | 10MG | MERCK 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1445 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | AXONE 1000 | CEFTRIAXONE SODIUM | 1000MG | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL |
| NDA/MAL/HDP/1446 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | VITAMIN B COMPLEX | VITAMINS B1 + B2 + B6 + NIACINAMIDE | 0.5 MG + 0.5MG + 7.5MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1447 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VITONA PLUS | VITAMINS + MINERALS | MULTI-INGREDIENT | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1449 | SHAIGAN PHARMACEUTICALS (PVT) LTD | HEALTHCARE LTD. | ZEPAR SUSPENSION | ALBENDAZOLE | 200MG/5ML | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/1450 | GLAXOSMITHKLINE LIMITED LIKONI | UNITED HEALTHCARE DISTRIBUTORS LTD | VOLTAREN EMULGEL 1% | DICLOFENAC DIETHYLAMMONIUM | 1%W/V | NOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND | SWITZERLAND | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE,1.0X50.0 G TUBE |
| NDA/MAL/HDP/1451 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN INJECTION | DICLOFENAC | 25MG/ML | NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | SWITZERLAND | PARENTERAL ORDINARY AMPOULES | 1.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/1452 | ASTRA ZENECA | MACNAUGHTON LIMITED | ZESTORETIC | LISINOPRIL/HYDROCHLOROTHIAZIDE | 20MG/12.5MG | ASTRAZENECA MACCLESFIELD-CHESHIRE | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1453 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZESOZ-40 | ESOMEPRAZOLE | 40MG | MADRAS PHARMACEUTICALS -137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI ? 600 096, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1454 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | PAINEX | PARACETAMOL + ASPIRIN + CAFFEINE | 500MG + 400MG + 50 MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/1455 | IDA | KIMSY MEDS LTD | LIDOCAINE HCL 5% & DEXTROSE 7.5% INJECTION | LIDOCAINE HCL 5%+DEXTROSE 7.5% | 50MG +75MG/ML | GLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/1456 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | SUCRAFIL O GEL | SUCRALFATE + OXETACAINE | 10MG + 0.2MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/1457 | NABIQASIM INDUSTRIES (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | DYSEN FORTE | SECNIDAZOLE | 1000MG | NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1458 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | CLAVICIN INJECTION | AMOXICILLIN + POTASSIUM CLAVULANATE | 1.2G | STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD
BANGALORE 560076
INDIA
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.2 G VIAL |
| NDA/MAL/HDP/1459 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | TASIGNA 200 | NILOTINIB | 200MG | NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1460 | VENUS REMEDIES LIMITED | AARON PHARMACEUTICALS LTD | PARIN E | ENOXAPARIN | 80MG | VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X2.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/1461 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | CLAVICIN | AMOXICILLIN + POTASSIUM CLAVULANATE | 500MG + 100MG | STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD
BANGALORE 560076
INDIA
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X600.0 MG VIAL |
| NDA/MAL/HDP/1463 | ARISTO PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ARISTOZYME LIQUID | DIASTASE+PEPSIN | 50MG+10MG | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/1464 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ORNIDA | ORNIDAZOLE | 500MG | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1465 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTFAST | DICLOFENAC POTASSIUM | 50MG | MIPHARM S.P.A -VIA BERNARDO QUARANTA, 12-20141, MILANO ITALY. | ITALY | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X3.0 G SACHET |
| NDA/MAL/HDP/1466 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | MATADOR | LEVOFLOXACIN | 500MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/1468 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | OCID CAPSULES | OMEPRAZOLE | 20MG | CADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA, S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | ORAL SOLID RETARD CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/1469 | VOGEN LABORATORIES LTD | BUFFALO HEALTH CARE LTD | DURAMOX 125 | AMOXICILLIN | 125MG/5ML | VOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1471 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | TEMIRAL | ACICLOVIR | 30MG/G | PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE |
| NDA/MAL/HDP/1472 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | FORTUM INJECTION | CEFTAZIDIME | 1GM | GLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONA | ITALY | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/1474 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGODIC | DICLOFENAC DIETHYLAMINE | 1%W/W | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/1476 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | SEPTOL | SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE | 1%W/W + 0.20W/W | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1478 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA | SILDENAFIL | 50MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1481 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASTROGYL | METRONIDAZOLE | 200MG | ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1482 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | STAMARIL PASTEUR | YELLOW FEVER VIRUS 17D-204 STRAIN(LIVE ATTENUATED) | NLT 1000 I.U | SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) | FRANCE | PARENTERAL ORDINARY VIALS | 1.0X1.0 DOSE VIAL + 0.5ML OF SOLVENT IN PRE-FILLED SYRINGE |
| NDA/MAL/HDP/1484 | SHAIGAN PHARMACEUTICALS LTD | HEALTHCARE LTD. | CLYCIN.V | CLINDAMYCIN | 2%W/W | SHAIGAN PHARMACEUTICALS (PVT) LIMITED-14 KM ADYALA RD, RAWALPINDI, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL OTHER CREAMS | 1.0X40.0 G TUBE + APPLICATOR |
| NDA/MAL/HDP/1485 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DICLOFEN 25 | DICLOFENAC | 25MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X10.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/1486 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPIMAX-1 | AMPICILLIN | 1G | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 G VIAL |
| NDA/MAL/HDP/1487 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | SCHERIPROCT SUPPOSITORIES | PREDNISOLONE CAPROATE/ CINCHOCAINE HYDROCHLORIDE | 1.3MG/ 1MG | BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY | ITALY | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X12.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/1488 | ERIS LTD | BENLE CONSULT LIMITED | DICLO-DENK 100 RECTAL | DICLOFENAC SODIUM | 100MG | HAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAU | GERMANY | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/1491 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | BILTRICIDE TABLETS | PRAZIQUANTEL | 600MG | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER,1.0X10.0 TABLET BOTTLE |
| NDA/MAL/HDP/1492 | ERIS LTD | BENLE CONSULT LIMITED | DICLO-DENK 75 INJECTION | DICLOFENAC SODIUM | 25MG/ML | HAUPT PHARMA WULFING GMBH;--BETHELNER LANDSTR. 18, 31028 GRONAULLEIRE, GERMANY. | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/1494 | FERRER INTERNACIONAL S.A | LABOREX UGANDA LIMITED | PEITEL 0.25% | PREDNICARBATE | 0.25%W/W | FERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN | SPAIN | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/1495 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | PELOX-400 | PEFLOXACIN | 400MG | WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1497 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LAEOVATE CREAM | BETAMETHASONE VALERATE | 0.1%W/W | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE |
| NDA/MAL/HDP/1499 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROMETHAZINE | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/1500 | MERCK SHARP & DOHME BV | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ATRIPLA | EFAVIRENZ+EMTRICITABINE + TENOFOVIR | 600MG +200MG+300MG | PATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA | NETHERLANDS | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/1501 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | CURAQUIN SYRUP | QUININE HYDROCHLORIDE | 100MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1503 | MEDICAL UNION PHARMACUITICALS | KARURI PHARMACEUTICALS LTD. | SEDIPROCT CREAM | HYDROCORTISONE+CINCHOCAINE | 0.5%W/W + 0.5%W/W | MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | TOPICAL EXTERNAL OTHER CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1505 | GLAXOSMITHKLINE | ERIS LTD | SERETIDE EVOHALER | SALMETEROL/ FLUTICASONE PROPIONATE | 25/50 MCG | GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X1.0 CANNISTER CARTON |
| NDA/MAL/HDP/1506 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | WEPOX 2000 | RECOMBINANT HUMAN ERYTHROPOIETIN | 2000 IU | WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/1508 | DAWA LIMITED | SUPER MEDIC LTD | WOMNIL | ALBENDAZOLE | 200MG/5ML | DAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/1509 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | FEVEREX | PARACETAMOL | 120MG/5ML | BETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100, | KENYA | ORAL SOLID ORDINARY SUSPENSION | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/1510 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LISTERINE ANTISEPTIC | THYMOL + ALCOHOL 95% | 12.78MG/20ML + 5.60ML/ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/1513 | ANKUR DRUGS AND PHARMA LTD | JOINT MEDICAL STORE (UPMB - UCMB) | VEXACEF | CEFTRIAXONE | 1G | ANKUR DRUGS AND PHARMA LTD-WHITE TO OFF WHITE VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NELAGARH DIST. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/1514 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERMOX | MEBENDAZOLE | 100MG | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/1516 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | URGENDOL P | TRAMADOL/ PARACETAMOL | 37.5MG/ 325MG | WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR
PRADESH - INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1517 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | VEST MENTAMU BALM | COMPOUND METHYLSALICYLATE | MULTI INGREDIENT | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1519 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | FORMONIDE 400 | BUDESONIDE + FORMOTEROL FUMARATE | 120 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 INHALER | 1.0X1.0 CANNISTER CARTON |
| NDA/MAL/HDP/1520 | CLARIS INJECTABLES LTD | REDDYS PHARMA LIMITED | FLUCANOL | FLUCONAZOLE | 2MG/ML | CLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML VIAL |
| NDA/MAL/HDP/1522 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | PENAMOX | AMOXYCILLIN | 250MG | MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/1523 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMPIREN | AMPICILLIN | 125MG/5ML | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1524 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN | AMOXICILLIN TRIHYDRATE | 125 MG / 5 ML | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1525 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | BENDEX | ALBENDAZOLE | 20MG/5ML | CIPLA LTD-VERNA INDUSTRIAL ESTATE, GOA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/1526 | FERRER INTERNACIONAL S.A | LABOREX UGANDA LIMITED | GAMALATE B6 | MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B6 | 75MG + 75MG + 37MG + 37MG | FERRER INTERNACIONAL S.A --FOR LABORATORIOS NOVAG S.A GRAN VIA CARLOS III 94 08028 BARCELONA | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1527 | MICRO LABS LTD | LABOREX UGANDA LIMITED | BACTOCLAV | AMOXICILLIN + CLAVULANATE POTASSIUM | 200MG + 28.5MG/ 5ML | MICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1528 | MICRO LABS LTD | LABOREX UGANDA LIMITED | BACTOCLAV-625 | AMOXYCILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | MICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1529 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | PROVIRON | MESTEROLONE | 25MG | BAYER WEIMAR GMBH & CO. KG-DOBEREINERSTRASSE 20 D-99427 WEIMAR, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1531 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | NOVATAX | CEFOTAXIME | 1GM | MEDISPRAY LABORATORIES PVT LTD --L-1/1, L-1/2/2, ADDITIONAL MIDC SATARA 415004 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/1532 | BF BIOSCIENCES LTD | TOP UNIVERSAL MEDICARE LIMITED | NOVAPRESSIN | TERLIPRESSIN | 1MG/VIAL | BF BIOSCIENCES LTD. -RAIWIND,PAKISTAN | PAKISTAN | PARENTERAL ORDINARY VIALS | 1.0X1.0 MG VIAL |
| NDA/MAL/HDP/1533 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | 5D | GLUCOSE | 50G/L | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/1535 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | FORTIWIN-4 | FORTIFIED PROCAINE PENICILLIN SODIUM | 4 M.U | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X4.0 MU VIAL |
| NDA/MAL/HDP/1537 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYZOLE | ALBENDAZOLE | 200MG | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1538 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYZOLE SUSPENSION | ALBENDAZOLE | 200MG | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
| KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/1539 | KWALITY AFRO ASIA LIMITED | KWALITY AFRO ASIA LIMITED | K-TRIM | SULFAMETHOXAZOLE + TRIMETHOPRIM | 200MG + 40MG | KWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROAD | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1540 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | NAT-E 400 | VITAMIN E | 400I.U | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE BOTTLE |
| NDA/MAL/HDP/1543 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | PROMAZINE ELIXIR | PROMETHAZINE HYDROCHLORIDE | 5MG/ML | MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/1544 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | PROMETHAZINE HYDROCHLORIDE B.P | PROMETHAZINE HCL | 25MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1546 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LANPRO | LANSOPRAZOLE | 30MG | UNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1547 | MYLAN LABORATORIES LIMITED. | NORVIK ENTERPRISES LIMITED | LUSIA-F | NORGESTREL/ ETHINYL ESTRADIOL + FERROUS FUMARATE | 0.3MG/ 0.03MG + 75MG | MYLAN 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, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/1549 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | PREDNICOL EYE DROPS | PREDNISOLONE/CHLORAMPHENICOL | 5MG/2MG | REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1550 | GALENTIC PHARMA( INDIA)PVT LTD | NORVIK ENTERPRISES LIMITED | RUBIGEL | MULTI-INGREDIENT | MULTI-INGREDIENT | GALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
| INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/1551 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | CALOSHELL-500 | CALCIUM CARBONATE + VITAMIN D3 | 1250MG + 250IU | EMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1552 | BLUE CROSS LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | BLUDROX TABLETS, DISPERSIBLE | CEFADROXIL | 125MG | BLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1553 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | VIFEX | SALBUTAMOL + BROMHEXINE + GUAIFENESIN | 1MG/5ML+2MG/5ML+50MG/5ML | EMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1554 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL CETIRIZINE | CETIRIZINE DIHYDROCHLORIDE | 5MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/1555 | GALENTIC PHARMA( INDIA)PVT LTD | NORVIK ENTERPRISES LIMITED | GALSCRUB | CHLORHEXIDINE | 4%W/W | GALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
| INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/1556 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | DOMI UP | ONDASENTRON | 2MG/ML | LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE, NEAR KHATRAJ CHOLADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/1557 | GLAXOSMITHKLINE | ERIS LTD | SYNFLORIX VACCINE | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPES (1,5,6B,7F,9V,14,23F) + (4,18C,19F) + PROTEIN D+TETANUS TOXOID+DIPTHERIA TOXOID CARRIER PROTEINS AND ALUMINIUM PHOSPHATE | 1MCG+3MCG+13MCG+8MCG+5MCG+0.5MG | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X100.0X0.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/1558 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | GABBRORAL | AMINOSIDINE SULPHATE | 250MG | PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS | BELGIUM | ORAL SOLID ORDINARY TABLETS | 1.0X12.0 TABLET STRIP |
| NDA/MAL/HDP/1559 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DOLOMOL | PARACETAMOL | 500MG | LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1563 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AMOXIL | AMOXYCILLIN | 125MG/5ML | GLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1565 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | SALBUT SYRUP 2MG/5ML | SALBUTAMOL | 2MG/5ML | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1566 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | VITAVIT | MULTI-INGREDIENT | MULTI-INGREDIENT | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1568 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM | AMOXICILLIN AND CLAVULANATE POTASSIUM | 156.25MG | ALKEM LABORATORIES LTD-PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1569 | ABBVIE (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | KALETRA | LOPINAVIR+RITONAVIR | 80MG + 20MG | ABBOTT LABORATORIES LTD-QUEENSBOROUGH, KENT ME11 SEL | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X160.0 ML BOTTLE |
| NDA/MAL/HDP/1570 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM AMOXY | AMOXYCILLIN | 125MG/5ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1571 | BHARAT SERUMS AND VACCINES LTD | GITTOES PHARMACEUTICALS LIMITED | RHOCLONE | MONOCLONAL ANTI-D IMMUNOGLOBULIN | 300MCG | BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 ML VIAL (1 DOSE VIAL) |
| NDA/MAL/HDP/1574 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | AMTAS-5 | AMLODIPINE | 5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1575 | ASTRAZENECA | MACNAUGHTON LIMITED | ZESTRIL | LISINOPRIL | 20MG | ASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-CHESHIRE | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1576 | ASTRAZENECA | MACNAUGHTON LIMITED | ZESTRIL | LISINOPRIL | 10MG | ASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-UNITED KINGDOM | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1577 | SEARLE PAKISTAN LTD | HEALTHCARE LTD. | SPIROMIDE | SPIRONOLACTONE + FRUSEMIDE | 50MG+20MG | SEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTAN | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1579 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | PLASMINEX | TRANEXAMIC ACID | 100MG/ML | PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/1581 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PANTOTAB | PANTOPRAZOLE | 40MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1582 | LINCON PHARMCUETICALS LIMITED | METRO PHARMACEUTICALS LIMITED | CEEPRO-500 | CIPROFLOXACIN | 500MG | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1583 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | ABZEE | ALBENDAZOLE | 200MG/5ML | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/1584 | UNI MEDICO LAB | SHREEJI PHARMACEUTICALS LIMITED | UCLOX | CLOXACILLIN SODIUM | 500MG | UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/1585 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | UDIHEP FORTE | URSODEOXYCHOLIC ACID | 300MG | WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1588 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TOZAAR-H | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | TORRENT PHARMACEUTICALS LIMITED -AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/1589 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | CENTACID SUSPENSION | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE | 40MG+200MG+250MG/5ML | CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE |
| NDA/MAL/HDP/1591 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | CENTIPAR ELIXIR | PIPERAZINE CITRATE | 750ML/5ML | CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/1598 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOCIM 400 | CIMETIDINE | 400MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1605 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | ASPIRIN TABLETS | ACETYL SALICYLIC ACID | 300MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/1614 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASTAGRA-50 | SILDENAFIL | 50MG | ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1615 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APCALIS SX | TADALAFIL | 20MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1616 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | CEZIN | CETIRIZINE | 5MG/5ML | 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 SYRUPS | 1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/1618 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | AMOXYDAR | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1620 | IRAN MEDICAL GROUP COMPANY | UNEED GLOBAL GROUP LIMITED | LORAXONE | CEFTRIAXONE | 1000MG | EXIR PHARMACEUTICAL FACTORY-2ND KM, BORUJERD, RU | IRAN | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL |
| NDA/MAL/HDP/1627 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID-V GEL | CLOTRIMAZOLE | 2%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | VAGINAL GELS AND SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/1629 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | CARVETAS 12.5 | CARVEDILOL | 12.5MG | INTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1631 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | NEVIRAPINE ORAL SUSPENSION | NEVIRAPINE | 50MG/5ML | AUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1632 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 1.2G | AMOXICILLIN SODIUM + CLAVULANATE POTASSIUM | 1000MG +200MG | ALKEMS LABORATORIES LIMITED-PLOT 167/1 MAHATMA GHANDHI, UDYOG NAGAR, DABHEL, AMALIYA DAMAN- 396 210
UTTARANCHAL, INDIA.
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/1635 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ORITAXIM 1000MG INJECTION | CEFOTAXIME SODIUM | 1GM | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/1636 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | VIGAMOX | MOXIFLOXACIN | 5MG/ML | S.A.ALCON COUVREUR N.V-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/1638 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FLADAZOLE | SECNIDAZOLE | 500MG | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1639 | GLAXO SMITHLINE LIMITED | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL EXTRA | PARACETAMOL + CAFFEINE | 500MG + 65MG | GLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON |
| NDA/MAL/HDP/1641 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | UNIENZYME C MPS | NICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL | 25MG+50MG+30MG+20MG+75MG | UNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1642 | UMEDICA LABORATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | EUCHLOR-1000 | CHLORAMPHENICOL SODIUM SUCCINNATE B.P | 1G | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/1645 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASTAZOLE | MEBENDAZOLE | 100MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1646 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | BETROZOLE TABLETS | METRONIDAZOLE+DILOXANIDE | 200MG+250MG | BETA 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 TABLETS | 1.0X30.0 TABLET BLISTER |
| NDA/MAL/HDP/1650 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TEGRETOL CR 200 | CARBAMAZEPINE | 200MG | NOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | ITALY | ORAL SOLID RETARD TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1651 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | MEGATRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE, 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1652 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | VALPARIN CHRONO 300 | SODIUM VALPROATE | 300MG | TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1655 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | UNIGENTYL | SECNIDAZOLE | 500MG | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1656 | ANHIU | MAISHA MEDICAL SUPPLIES LIMITED | AZIGYL-500 | AZITHROMYCIN | 500MG | MEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1660 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCIM-200 | CIMEDITINE | 200MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1661 | ABBVIE (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | ALUVIA 100/25 | LOPINAVIR/ RITONAVIR | 100MG/25MG | ABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/1663 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ALCID-PINK | ALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE | 400MG+400MG/50ML | TORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE |
| NDA/MAL/HDP/1665 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOXIN CAPSULES | AMOXICILLIN TRIHYDRATE | 250MG | MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1666 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | AMARYL 1 | GLIMEPIRIDE | 1MG | SANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1669 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | AMARYL 2 | GLIMEPIRIDE | 2MG | AVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1670 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | AMARYL 4 | GLIMIPIRIDE | 4MG | AVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1673 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AMOXIL | AMOXYCILLIN | 250MG | GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE | FRANCE | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1675 | MERCK SHARP & DOHME BV | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | GARDASIL | QUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18) | (20MCG+40MCG+40MCG+20MCG)/0.5ML | MERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA | UNITED STATES | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE),1.0X10.0X0.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/1676 | KOPRAN LIMITED | TATA UGANDA LIMITED | CLOXIN-250 | CLOXACILLIN | 250MG | KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1677 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ZIDOVUDINE | ZIDOVUDINE | 300MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/1678 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | HYDROCORTISONE SODIUM SUCCINATE | HYDROCORTISONE SODIUM SUCCINATE | 100MG/VIAL | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X100.0 MG VIAL |
| NDA/MAL/HDP/1679 | LEBEN LABORATORIES PVT. LTD | ANDYCO PHARMACY (UGANDA) LTD | CIPROLEB | CIPROFLOXACIN | 500MG | LEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1680 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | H-CORT | HYDROCORTISONE | 0.1%W/W | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1681 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | LOSACAR 25 | LOSARTAN POTASSIUM | 25MG | CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1682 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | TOFLOX-200 | OFLOXACIN | 200MG | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1683 | Y.S.P INDUSTRIES (M) SDN BHD | ROYAL PHARMA 2011 LIMITED | VOREN PLUS | DICLOFENAC | 10MG/ML | Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN | MALAYSIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE,1.0X45.0 G TUBE |
| NDA/MAL/HDP/1684 | LINCOLN PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | IBUN-200 | IBUPROFEN | 200MG | LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1686 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | QUININE SULPHATE | QUININE SULPHATE | 300MG | LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1687 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ALLDOX | DOXYCYLINE | 100MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1690 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | FINALLERG | CETIRIZINE DIHYDROCHLORIDE | 1MG/ML | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1691 | WIDE SPECTRUM ENTERPRISES (U) LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZITHRORIV | AZITHROMYCIN | 500MG | RIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1692 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFODOX 50MG/5ML SUSPENSION | CEFPODOXIME PROXETIL | 50MG/5ML | PHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/1693 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | OPTIMAL (0.05%) CREAM | TRETINOIN USP | 0.5MG/1G | PHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN | JORDAN | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE |
| NDA/MAL/HDP/1694 | GLAXO WELLCOME(KENYA),LTD | ERIS LTD | BETNOVATE CREAM | BETAMETHASONE VALERATE | 0.1%W/W | GLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM | UNITED KINGDOM | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/1697 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | FINALLERG | CETIRIZINE DIHYDROCHLORIDE | 10MG | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1698 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | AZEE-500 | AZITHROMYCIN | 500MG | CIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/1701 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FORMIN | METFORMIN HYDROCHLORIDE | 500MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1702 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | DELOR | CLOBETASOL PROPIONATE | 0.05%W/W | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/1704 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | DAFRACLAV | AMOXYCILLIN + POTASSIUM CLAVULANATE | 500MG + 125MG | BILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/1705 | IND-SWIFT | TATA UGANDA LIMITED | METSWIFT | METFORMIN | 500MG | IND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1707 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | FEBRICOL TABLETS | PARACETAMOL / PSEUDOEPHEDRINE / CHLORPHENIRAMINE | 500MG / 30MG /2MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BLD -1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1708 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | DENTAMOL | ACETAMINOPHEN | 500MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1709 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | LUCIN CREAM | HYDROCORTISONE | 1%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE |
| NDA/MAL/HDP/1711 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMYN-250 | AMOXYCILLIN | 250MG | KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/1712 | I CARE PHARMA LIMITED | VITACARE LTD | AMPICILLIN SODIUM | AMPICILLIN SODIUM | 500MG | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/1713 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LUMITER | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.,OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X8.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER |
| NDA/MAL/HDP/1714 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | REMICOL EAR DROPS | CHLORAMPHENICOL | 1%W/V | REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | OTIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/1715 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | MUCOLYN SYRUP | AMMONIUM CHLORIDE+CHLORPHENIRAMINE+DEXTROMETHORPHAN+BROMHEXINE | 50MG+2MG+5MG+4MG | BETA 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/KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1723 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GROVIT MULTIVITAMIN | MULTI-INGREDIENT | MULTI-INGREDIENT | SAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/1724 | GLAXOSMITHKLINE LTD | ERIS LTD | AVAMYS NASAL SPRAY | FLUTICASONE FUROATE | 27.5MCG/ACTUATION | GLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK | UNITED KINGDOM | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/1725 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | MYCORIL CREAM 1% | CLOTRIMAZOLE | 1%W/W | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1726 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | HAVRIX 720 | INACTIVATED HEPATITIS A VIRUS ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED | 720 ELISA UNITS ADSORBED ON 0.25MG ALUMINIUM HYDROXIDE | SMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUM | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X0.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/1727 | MISSION PHARMA | JOINT MEDICAL STORE (UPMB - UCMB) | TETRACYCLINE HYDROCLORIDE | TETRACYCLINE HYDROCHLORIDE | 3%W/W | NANJING BAIJINGYN PHARMACEUTICALS CO.LTD NO-1 HUIZHONG ROAD NANJING ECONOMIC AND TECHNICAL DEVELOPMENT ZONE | CHINA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1728 | ARISTO PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | DELISPRIN 75MG | ASPIRIN | 75MG | ARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP |
| NDA/MAL/HDP/1730 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ZITHROX | AZITHROMYCIN | 500MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/1731 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MEDIVEN-S OINTMENT | BETAMETHASONE VALERATE + SALICYLIC ACID | 0.05%W/W + 3%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1732 | MICRO LABS LTD | LABOREX UGANDA LIMITED | CEFEX-250 | CEPHALEXIN | 250MG | MICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1734 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMOMINT | COMPOUND MAGNESIUM TRISILICATE | 500MG | TIL 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 TABLETS | 10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1736 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | KLERIMED | CLARITHROMYCIN | 500MG | MEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/1738 | ALCON PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | TEARS NATURALE II | NATURAL TEARS | 15ML | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/1739 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | MELOX | MELOXICAM | 15MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1741 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEOPRED-P | PREDNISOLONE ACETATE + NEOMYCIN SULPHATE+ POLYMYXIN-B | 5MG/ML +5MG/ML + 1M I.U/ML | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1743 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | DAPRIL | LISINOPRIL DIHYDRATE | 10MG | MEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1745 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APIGEN | GENTAMYCIN SULPHATE | 0.3%W/V | AMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1746 | MISSION PHARMA A/S | JOINT MEDICAL STORE (UPMB - UCMB) | PRAZIQUANTEL | PRAZIQUANTEL USP | 600MG | CSPC OUYI PHARMACEUTICAL CO.LTD. LIMITED-NO. 276, WEST ZHONGSTAN ROAD, SHIJIAZHUANG, CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1747 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | PRESARTAN H 50 | LOSARTAN 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 TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1748 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-500 | AZITHROMYCIN | 500MG | AGOG 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 CAPSULES | 1.0X3.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1749 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VITAMIN B COMPLEX | VITAMIN B COMPLEX | N/A | LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/1750 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APIFLOX | NORFLOXACIN | 0.3%W/V | AMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1751 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OPTIFUCIN | FUSIDIC ACID | 1%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/1754 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APIMOL | TIMOLOL MALEATE | 0.5%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL |
| NDA/MAL/HDP/1755 | MEMPHIS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DOPAGON TABLETS | BROMOCRIPTINE | 2.5MG | MEMPHIS COMPANY--8 EL SAWAH STREET, CAIRO. EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1756 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APRICROM | SODIUM CROMOGLYCATE | 2%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1758 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APICORT | PREDNISOLONE ACETATE | 0.12%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1760 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEODEX | NEOMYCIN +DEXAMETHASONE | 0.5%W/V + 0.1%W/V | AMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OTIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1761 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ATAZOR-R | ATAZANAVIR + RITONAVIR | 300 MG + 100 MG | EMCURE PHARMACEUTICALS LTD .-PLOT NO. P-2 IT-BT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/1762 | AMMAN PHARMACEUTICAL INDUSTRIES | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APITROPIN | ATROPINE | 1%W/V | AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN | JORDAN | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1763 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | ASPIRIN TABLETS BP | ACETYL SALICYLIC ACID | 300MG | LABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1764 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FRESH BURST LISTERINE | ALCOHOL + THYMOL | 95 % W/V + 12 MG | JOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794
| SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER |
| NDA/MAL/HDP/1765 | UMEDICA LABORATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | RILIF PLUS | ACECLOFENAC + PARACETAMOL | 100MG + 500MG | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1766 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | COLDEASE CAPSULES | PARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE | 400MG+30MG+4MG+30MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1767 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | PROSTEROL | ALFUZOSIN HYDROCHLORIDE | 10MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1768 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | ULTIVA INJECTION 2MG | REMIFENTANIL | 2MG | GLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONA | ITALY | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/1769 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | ENGERIX-B VACCINE | HEPATITIS B SURFACE ANTIGEN | 10MCG/ML | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X10.0X0.5 ML VIAL (1 DOSE),1.0X25.0X0.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/1770 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | DIOVAN 160MG TABLETS | VALSARTAN | 160MG | NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X28.0 TABLET STRIP |
| NDA/MAL/HDP/1771 | MISSION PHARMA A/S | JOINT MEDICAL STORE (UPMB - UCMB) | ORAL REHYDRATION SALTS BP | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X100.0X20.5 G SACHET |
| NDA/MAL/HDP/1772 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | GESTID TABLETS | COMPOUND MAGNESIUM TRISILICATE | 385MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/1773 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LEVOBACT 500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/1777 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | NUZAC 20 | FLUOXETINE | 20MG | CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1778 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FARCONCIL 500MG CAPSULES | AMOXYCILLIN TRIHYDRATE | 500MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1779 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | PYODINE SOLUTION | POVIDONE IODINE | 10.0G/100ML | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE |
| NDA/MAL/HDP/1780 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENETRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | RENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/1781 | ASTRAZENECA | MACNAUGHTON LIMITED | ARIMIDEX | ANASTROZOLE | 1MG | ASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE | UNITED STATES | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1782 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | CO-METHER | ARTEMETHER + LUMEFANTRINE | PER 5ML: 15MG + 90MG | 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 SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/1783 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LAEOVATE OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X15.0 G TUBE |
| NDA/MAL/HDP/1784 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | AZICURE-500 | AZITHROMYCIN | 500MG | MACLEODS PHARMACEUTICALS LIMITED (BLOCK ?N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/1785 | BETA HEALTHCARE | BETA HEALTHCARE UGANDA LIMITED | ACTION TABLETS | ACETYL SALICYLATE + CAFFEINE + PARACETAMOL | 600MG+50MG+300MG | BETA 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 TABLETS | 1.0X200.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X110.0 TABLET STRIP,1.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/1786 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGONAC TABLETS (THANE) | DICLOFENAC | 50MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1790 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNITRIM TABLET | CO-TRIMOXAZOLE | 480MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1792 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | LIPODAR | ATORVASTATIN | 20MG | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1793 | MACNAUNGHTON LIMITED | MACNAUGHTON LIMITED | SYMBICORT TURBUHALER | BUDESONIDE+FORMOTEROL | 80MCG+4.5MCG/DOSE | ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X60.0 DOSE CANNISTER |
| NDA/MAL/HDP/1795 | KOPRAN LIMITED | TATA UGANDA LIMITED | AMPIK-250 | AMPICILLIN | 250MG | KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/1796 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZAHA 250 | AZITHROMYCIN | 250 MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/1797 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | AMPICILLIN+CLOXACILLIN | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL |
| NDA/MAL/HDP/1798 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | CARDITAS RETARD | NIFEDIPINE | 20MG | INTAS 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 TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1799 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | SECZOL DS | SECNIDAZOLE | 1GM | INTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1800 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMLONG-10 | AMLODIPINE | 5MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1801 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LABESTEN PESSARIES | CLOTRIMAZOLE | 100MG | LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | VAGINAL TABLETS | 1.0X1.0X6.0 PESSARY STRIP |
| NDA/MAL/HDP/1803 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | NEXIUM 40MG | ESOMEPRAZOLE | 40MG | ASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON |
| NDA/MAL/HDP/1804 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | LISTRIL | LISINOPRIL | 5MG | TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1805 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | JANUMET | SITAGLIPTIN + METFORMIN HYDROCHLORIDE | 50MG + 1000MG | AESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1806 | BLUE CROSS LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | BLUMOX P | AMOXYCILLIN | 125MG | BLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/1807 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AMPICLOX NEONATAL DROPS | AMPICILLIN + CLOXACILLIN | 60 MG / 0.6 ML + 30 MG / 0.6 ML | MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X8.0 ML BOTTLE |
| NDA/MAL/HDP/1808 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASTACID | MAGNESIUM TRISILICATE | 370MG | ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1809 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIT-6 | PYRIDOXINE | 25MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1810 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTRI | TRIFLUOPERAZINE | 5MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1811 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | DUOVIR TABLETS | ZIDOVUDINE+ LAMIVUDINE | 300MG + 150MG | CIPLA 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 TABLETS | 1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/1812 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REQUIN TABLETS | QUININE SULPHATE | 300MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1813 | DAWA LIMITED | SUPER MEDIC LTD | MOXAFORTE | AMOXICILLIN + FLUCLOXACILLIN | 125 MG + 125MG | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1815 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | SUPIROCIN OINTMENT | MUPIROCIN | 2%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL OTHER OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1816 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | DRESS UP CREAM | NEOMYCIN SULPHATE | 0.5%W/W | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/1821 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | MEFTAL 500 TABLETS | MEFENAMIC ACID | 500MG | BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1822 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | EPHEDRINE | EPHEDRINE HYDROCHLORIDE | 30MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1824 | NABIQASIM INDUSTRIES (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | GLANDIN E2 GEL | DINOPROSTONE | 0.5MG | NABIQASIM INDUSTRIES (PVT) LTD?-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.
| PAKISTAN | TOPICAL EXTERNAL GELS AND SOLS | 1.0X3.0 G TUBE WITH STERILE CATHETER |
| NDA/MAL/HDP/1825 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | COLDEASE SYRUP | PARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG+2MG+15MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1826 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | LOGICAN-200 | FLUCONAZOLE | 200MG | WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X4.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1827 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | ALBASOL SUSPENSION | ALBENDAZOLE | 200MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/1828 | ASTRAZENECA | MACNAUGHTON LIMITED | TENORET | ATENOLOL + CHLORTHALIDONE | 50 MG + 12.5 MG | ASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1832 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | DICLOAS | DICLOFENAC SODIUM | 50MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X5.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1833 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASMOX | AMOXICILLIN | 500MG | ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1838 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | ABZEE | ALBENDAZOLE | 400MG | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/1839 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | FEVEREX | PARACETAMOL | 500MG | BETA 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 TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1840 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | OVA-MIT | CLOMIPHENE | 50MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1841 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | FUNGNIL CREAM | CLOTRIMAZOLE | 1%W/W | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1842 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | SUGAQUIN TABLETS | CHLOROQUINE PHOSPHATE | 250MG | KAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDA | UGANDA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1843 | USV LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ECORIN-75 | ASPIRIN | 75MG | REMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1844 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | SULFAMETHOXAZOLE / TRIMETHOPRIM | SULFAMETHOXAZOLE / TRIMETHOPRIM | 800MG /160MG | GUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1846 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | ANTAGIT DS GEL ORANGE FLAVOUR | ALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE | 400MG + 400MG + 50MG | LEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X170.0 ML BOTTLE |
| NDA/MAL/HDP/1847 | LEBEN LABORATORIES PVT. LTD., INDIA | ANDYCO PHARMACY (UGANDA) LTD | MOXILEB-250 CAPSULE | AMOXICILLIN | 250MG | LEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE ?III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1848 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | PARATAL | PARACETAMOL | 500MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1849 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | CIFIN | CIPROFLOXACIN | 0.2%W/V | ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1850 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ALZOL TABLETS | ALBENDAZOLE | 400MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/1851 | PHILLIPS PHARMACEUTICALS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CAPSIFENAC GEL | CAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE | 0.438 G + 0.335 G + 0.135 G + 0.918 G | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL EMULSION GELS | 1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE |
| NDA/MAL/HDP/1852 | RANBAXY LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | VERCEF ORAL SUSPENSION | CEFACLOR | 125MG/5ML | RANBAXY LABORATORIES-LABORATORIES LIMITED INDUSTRIAL AREA 3 DEWAS 455001 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1853 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AERIUS ORAL SOLUTION | DESLORATADINE | 0.5MG/ML | MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA,SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG | BELGIUM/SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X150.0 ML BOTTLE |
| NDA/MAL/HDP/1856 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PROPRANOLOL TABLETS B.P. 40MG | PROPRANOLOL HYDROCHLORIDE | 40MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1861 | GUILIN PHARMACEUTICALS CO LTD | STAR PHARMACEUTICALS LTD | SULFAMETHOXAZOLE / TRIMETHOPRIM | SULFAMETHOXAZOLE / TRIMETHOPRIM | 400MG /80MG | GUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1863 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ORACURE GEL | LIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE | 2 GM+0.1 GM | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL TOPICAL GELS AND SOLS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1864 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | PATANOL | OLOPATADINE HYDROCHLORIDE | 0.1%W/V | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/1865 | FDC LTD | AIVEEN (U) LIMITED | MYCODERM-C POWDER | CLOTRIMAZOLE | 1%W/W | FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | TOPICAL EXTERNAL POWDERS | 1.0X75.0 G CONTAINER |
| NDA/MAL/HDP/1866 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | NIZORAL | KETOCONAZOLE | 20MG/G | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1867 | RENE PHARMACY(R) LTD.. | RENE PHARMACY LTD | LEVATEX TABLETS | LEVAMISOLE HYDROCHLORIDE | 40MG | CYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015 | INDIA | ORAL SOLID ORDINARY TABLETS | 500.0 TABLET CONTAINER,1.0X10.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/1868 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | ZIDOVUDINE | ZIDOVUDINE | 300MG | AUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK,
POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/1869 | MERCK SHARP & DOHME BV | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | STOCRIN 200 | EFAVIRENZ | 200MG | ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA,MERCK SHARP & DOHME.-WAADERWAG 39, POSTBUS 581. 2003 PC HAARLEM | NETHERLANDS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X90.0 TABLET BOTTLE |
| NDA/MAL/HDP/1873 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | JANUMET | SITAGLIPTIN + METFORMIN HYDROCHLORIDE | 50MG + 850MG | AESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1877 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | MINT-O-COOL | DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE | 120MG + 250MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1879 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPENIV | PHENOXYMETHYL PENICILLIN | 250MG | SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1880 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1881 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX | AMOXYCILLIN | 250MG | SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1882 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCIL | AMPICILLIN | 250MG | SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1886 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM QUIN TABLETS | CHLOROQUINE PHOSPHATE | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1887 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMADOL | PARACETAMOL | 500MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1888 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM QUIN SYRUP | CHLOROQUINE PHOSPHATE | 80MG/5ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1889 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM PREDSOL | PREDNISOLONE | 5MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON |
| NDA/MAL/HDP/1891 | MACLEODS PHARMACEUTICAL LTD | NORVIK ENTERPRISES LIMITED | LEVOMAC 500 | LEVOFLOXACIN | 500MG | MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/1892 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LEVOMAC 250 | LEVOFLOXACIN | 250MG | MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/1893 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | TRIKA 0.25 TABLETS | ALPRAZOLAM | 0.25MG | UNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1894 | KOPRAN LIMITED | TATA UGANDA LIMITED | TRIM-480 | CO-TRIMOXAZOLE | 480MG | KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1895 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO (PAEDIATRIC) | CO-TRIMOXAZOLE | 100MG/20MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1898 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | ZAPACID - 30 | LANSOPRAZOLE | 30MG | WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR
PRADESH - INDIA
| INDIA | ORAL SOLID ORDINARY CAPSULES | 3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1899 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | TUSPRESS COUGH SUPPRESSANT | MULTI-INGREDIENT | MULTI-INGREDIENT | INDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1900 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOM 20 | OMEPRAZOLE | 20MG | AGOG 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 CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/1901 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | IBUMOL | IBUPROFEN + PARACETAMOL | 100MG + 162.5 MG /5ML | AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1902 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMODIUM | LOPERAMIDE HYDROCHLORIDE | 2MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1903 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | ARTESIANE 100 | ARTEMETHER | 100MG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY I M AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/1905 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | OXYTOCIN INJECTION | OXYTOCIN | 10I.U/ML | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE,1.0X100.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/1906 | ACG PHARMAPACK PVT. LTD | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | EFAVIRENZ TABLETS 600MG | EFAVIRENZ | 600MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/1907 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | ABACAVIR | ABACAVIR | 300MG | CIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220, DIST- RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/1908 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | OLMY 20 | OLMESARTAN | 20MG | CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1911 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CODIENE PHOSPHATE TABLETS BP 30 | CODEINE PHOSPHATE | 30MG | COSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1912 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | D-WORM | ALBENDAZOLE | 200MG | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1914 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CHLORPHENIRAMINE | CHLORPHENIRAMINE | 4MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1915 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | ATAZANAVIR SULPHATE + RITONAVIR | ATAZANAVIR SULPHATE + RITONAVIR | 300 MG + 100 MG | HETERO 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 TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/1918 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | UNIVIR | ACYCLOVIR | 200MG | UNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET STRIP |
| NDA/MAL/HDP/1919 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDIDERM CREAM | BECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN | 0.025%W/W+1%W/W+0.1%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/1920 | STRIDES ARCOLAB LTD | ROYAL PHARMA 2011 LIMITED | ASCORBIC ACID TABLET | ASCORBIC ACID | 100MG | STRIDES ARCO LAB LTD-K.R.S GARDENS SURAGAJAKKANAHALLI,INDLAWADI CROSS ANEKAL TALUK,BANGALORE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/1922 | IPCA LABORATORIES LIMITED | MEDVIN PHARMA LIMITED | AZIFAST-500 | AZITHROMYCIN | 500MG | IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/1923 | GALENTIC PHARMA (PVT)LTD | NORVIK ENTERPRISES LIMITED | BETAMETHASONE | BETAMETHASONE | 0.1%W/W | GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1924 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | AMPICILLIN SODIUM | AMPICILLIN SODIUM | 500MG | CSPC ZHONGNUO (SHIJIAZHUANG) PHARMACEUTICAL CO LTD-NO. 47 FENGSHOU ROAD SHIJIAZHUANG,CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X500.0 MG VIAL |
| NDA/MAL/HDP/1925 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | G - ALFENAC- P | ACECLOFENAC + PARACETAMOL | 100MG + 500MG | BLISS 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 TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1927 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | INTAPLEX TABLET | VITAMIN B COMPOUND | N/A | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1928 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | NEUTRAFLUX | ALGINIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE | 200MG + 250MG +250MG +250MG + 125MG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1929 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ATORVA 40 | ATORVASTATIN | 40MG | CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1931 | ASTRAZENECA | MACNAUGHTON LIMITED | ZOLADEX LA | GOSERELIN ACETATE | 10.8MG | ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | PARENTERAL RETARD PRE-FILLED SYRINGES | 1.0X10.8 MG IMPLANT |
| NDA/MAL/HDP/1932 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | CANDISTAT CREAM | CLOTRIMAZOLE | 1%W/W | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
| KENYA | ORAL TOPICAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1934 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENECHLOR SUSPENSION | CHLORAMPHENICOL | 125MG/5ML | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1935 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | SULPHA KREAM-N | SULPHANILAMIDE | 15%W/W | NABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X1.0X80.0 G TUBE |
| NDA/MAL/HDP/1936 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PIRITON EXPECTORANT | CHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDE | MULTINGREDIENT | GLAXO WELLCOME (KENYA) LTD-KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1937 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ | EFAVIRENZ | 600MG | AUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/1938 | YURIA PHARM EAST AFRICA LIMITED | YURIA PHARM EAST AFRICA LIMITED | INFULGAN | PARACETAMOL | 10MG/ML | YURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE. | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE |
| NDA/MAL/HDP/1940 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CLOXACILLIN CAPSULES | CLOXACILLIN SODIUM | 250MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1941 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | RABELOC IV | RABEPRAZOLE | 20MG/VIAL | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/1942 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | AMCLOREN | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/1943 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | NITROCONTIN 2.6 | NITROGLYCERIN (CONTROLLED RELEASE) | 2.6MG | MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID RETARD TABLETS | 1.0X25.0 TABLET CONTAINER |
| NDA/MAL/HDP/1946 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | SOLUDOL TABLETS | DICLOFENAC SODIUM | 50MG | WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR
PRADESH - INDIA
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1948 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 500MG | HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1949 | MACLEODS PHARMACEUTICALS LTDS LTD | NORVIK ENTERPRISES LIMITED | TRENAXA 500 | TRANEXAMIC ACID | 500MG | MACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/1951 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | CLOPI 75 | CLOPIDOGREL | 75MG | MACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1952 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NIZORAL | KETOCONAZOLE | 20MG/G | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X80.0 ML BOTTLE |
| NDA/MAL/HDP/1953 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | RANTAB-150 | RANITIDINE | 150MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1954 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | RAPEED-20 | RABEPRAZOLE | 20MG | ALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1955 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | MILCILLIN | AMPICILLIN | 250MG | MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1956 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | MILOXY | AMOXYCILLIN | 250MG | MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/1957 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | MILCILLIN | AMPICILLIN | 125MG/5ML | MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
| INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1958 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | MILOXY | AMOXYCILLIN | 125MG/5ML | MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
| INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1959 | MILAN LABERATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | BETRIM 480 | CO-TRIMOXAZOLE | 480MG | MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1960 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | DIFENAC | DICLOFENAC SODIUM | 50MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1961 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | MUILTIZEBEX | VITAMIN A + CHOLECALCIFEROL + THIAMINE + RIBOFLAVINE + PYRIDOXINE + NICOTINAMIDE | 2500 IU + 200IU + 1MG +1MG + 0.5MG +15MG | TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/1962 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | NIMBEX | CISATRACURIUM BESYLATE | 2MG/ML | GLAXOSMITHKLINE S.P.A -STRADA PROVINCIALE ASOLANA 9 | ITALY | PARENTERAL ORDINARY VIALS | 2.5 ML VIAL,1.0X10.0 ML VIAL |
| NDA/MAL/HDP/1963 | MILAN LABERATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | DICLOFENAC GEL | DICLOFENAC | 1%W/W | MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
| INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X35.0 G TUBE |
| NDA/MAL/HDP/1964 | MILAN LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | CLONEX | CLOTRIMAZOLE | 1%W/W | MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
| INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1966 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | PARACIN | PARACETAMOL | 500MG | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1969 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SR 75MG | DICLOFENAC SODIUM | 75MG | NOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA | ITALY | ORAL SOLID RETARD TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/1970 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | CETRAMAC | CETIRIZINE | 10MG | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1971 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMPICLOX ORAL SUSPENSION | AMPICILLIN + CLOXACILLIN | 125 MG/5ML + 125 MG/5ML | MILAN 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/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/1974 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | CEFROTIL | CEFUROXIME AXETIL | 500MG | SAKAR 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 TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1975 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | BET-CODERM N | BETAMETHASONE + NEOMYCIN | 0.1 W/W + 0.5 W/W | LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
| INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/1976 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | OROGEL | CHOLINE SALICYLATE+LIGNOCAINE HCL+BENZALKONIUM CHL | 8.7%W/W+2%W/W+0.01%W/W | CENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/1977 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | LOSA-H | LOSARTAN + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | UNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1984 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | CIALIS | TADALAFIL | 20MG | LILLY SA, AVDA DE LA INDUSTRIA-LILLY SA, AVDA DE LA INDUSTRIA, 30 28108 ALCOBENDAS - MADRID | SPAIN | ORAL SOLID ORDINARY TABLETS | 2.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1985 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | PROXIMEXA ORAL SUSPENSION 250MG/5ML | CEFUROXIME AXETIL | 250MG/5ML | GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/1987 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FOMYCETIN | CHLORAMPHENICOL | 250MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/1989 | FERRER INTERNACIONAL S.A | LABOREX UGANDA LIMITED | DERMOFIX | SERTACONAZOLE NITRATE | 2%W/W | FERRER INTERNACIONAL,S.A.-GRAN VIA CARLOS III 94 BARCELONA (ESPANA /SPAIN) | SPAIN | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/1990 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TAGERA FORTE | SECNIDAZOLE | 1G | UNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/1992 | UNIQUE PHARMACEUTICAL LABORATORIES | TATA UGANDA LIMITED | UNIKPEF | PEFLOXACIN | 400MG | J.B CHEMICALS-ANKLESHWAR, GUJARAT 393002 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1994 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | PANUM 40 | PANTOPRAZOLE | 40MG | J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/1997 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | TENA-100 | ATENOLOL | 100MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/1998 | M.J.BIOPHARM PVT LTD | TATA UGANDA LIMITED | TEICO 500 | CEFEPIME | 500MG | M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/1999 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | CARBATOL 200 | CARBAMAZEPINE | 200MG | TORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2000 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | CALCIGARD RETARD | NIFEDIPINE(SR) | 20MG | TORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA | ORAL SOLID RETARD TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2003 | GLAXO SMITHKLINE LTD(ITALY) | ERIS LTD | PROTEDEX 1G | CEFTRIAXONE | 1G | GLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONA | ITALY | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/2004 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | R.B.TONE | FERROUS GLUCONATE + VITAMIN C + VITAMIN B12 + VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + CALCIUM PANTOTHENATE + VITAMIN B3 + FOLIC ACID + DIBASIC CA PO4 + ZINC SULPHATE | 200MG + 38MG + 4MCG + 3MG + 2.5MG + 1MG + 2.5MG + 1MG + 2.5MG + 23MG + 0.5MG + 100MG + 33MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X15.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2005 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | KAMAGRA-100 | SILDENAFIL CITRATE | 100MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/2007 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | B-COX TABLETS | VITAMIN B COMPLEX | BCP FORMULA | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2008 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | CANDID -B- CREAM | CLOTRIMAZOLE + BECLOMETASONE DIPROPRIONATE CREAM | 1%W/W + 0.025%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2009 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ZITHROX | AZITHROMYCIN | 200MG/5ML | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/2011 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | SIFE 50 | SILDENAFIL CITRATE | 50MG | HETERO 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 TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/2012 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | CANDID -B- LOTION | CLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE | 1% + 0.025% | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL LOTIONS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/2014 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | CANI-MAKS | CLOTRIMAZOLE | 1%W/W | S KANT HEALTHCARE LTD-1802-1805 GIDC OHASE II VAPS-396195, GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE |
| NDA/MAL/HDP/2016 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | CANDID CREAM | CLOTRIMAZOLE | 1%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2018 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | ORAXIN SYRUP | CYPROHEPTADINE+TRICHOLINE CITRATE | 2MG+275MG | CENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2019 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOHAL | HALOPERIDOL | 10MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2020 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | QUINE | QUININE SULPHATE | 300MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER |
| NDA/MAL/HDP/2021 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | PREGVIT ZINC | MULTIVITAMIN/MINERALS | MULT-INGREDIENT | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X12.0X2.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2022 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | TORACTIN | CYPROHEPTADINE | 2MG/5ML | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2024 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | NEXPRO - 40 | ESOMEPRAZOLE MAGNESIUM TABLET | 40MG | TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2025 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | FERRO-B COMPLEX SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2026 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | CORAM 10MG | AMLODIPINE BESYLATE | 10MG | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2027 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CO-ANGINET 160/12.5MG | VALSARTAN + HYDROCHLOROTHIAZIDE | 160MG + 12.5MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2028 | SEARLE PAKISTAN LIMITED | HEALTHCARE LTD. | SELANZ - SR | LANSOPRAZOLE | 30MG | SEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X7.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2031 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | AGOZID TABLETS | ISONIAZID | 100MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2033 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANGIZAAR-50 | LOSARTAN POTASSIUM | 50MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2035 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | NEOSIDAR | SULPHADOXINE + PYRIMETHAMINE | 500MG + 25MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/2036 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | HUMULIN REGULAR | HUMAN INSULIN | 100IU | ELI LILLY & COMPANY-LILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221,LILLY FRANCE SA-FRANCE | FRANCE | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/2037 | MERCK SHARP & DOHME BV | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | STOCRIN 50 | EFAVIRENZ | 50MG | ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA,MERCK SHARP & DOHME.-WAADERWAG 39, POSTBUS 581. 2003 PC HAARLEM | NETHERLANDS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2039 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | RANITIDINE INJECTION USP | RANITIDINE | 25MG/ML | NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2040 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN 20/120 | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0X12.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/2041 | IDA | KIMSY MEDS LTD | OXYTOCIN | OXYTOCIN | 10IU | GLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/2042 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | BURNCURE | SILVER SULFADIAZINE | 1%W/W | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X200.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/2043 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | DIASTOP TABLETS | ATTAPULGITE/ ALUMINIUM HYDROXIDE | N/A | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/2045 | ELDA INTERNATIONAL DMCC | REDDYS PHARMA LIMITED | BUPICAN | BUPIVACAINE | 0.5% W/V | CLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/2046 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | LORHISTINA | LORATADINE | 10MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2047 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | RITONAVIR | RITONAVIR | 100MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2050 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | ISOPTO CARPINE 2% | PILOCARPINE | 2%W/V | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/2051 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PIRITON TABLETS | CHLORPHENIRAMINE MALEATE | 4MG | GLAXO WELLCOME (KENYA) LTD-KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2053 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ASOMEX-5 | AMLODIPINE BESILATE | 5MG | EMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2055 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | ARTESUN | ARTESUNATE | 120MG | GUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X120.0 MG VIAL + 1 *2 ML AMPOULE OF 5% SODIUM BICARBONATE SOLUTION + 1*10 ML AMPOULE OF 0.9% SODIUM CHLORIDE |
| NDA/MAL/HDP/2056 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | BRO-ZEDEX | TERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL | 1.25MG+ 4 MG+50 MG+2.5 MG/5 ML | WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2058 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | QUININE SULPHATE | QUININE SULPHATE | 300MG | MACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2061 | RENE PHARMACY(R) LTD.. | RENE PHARMACY LTD | ADSOCARB TABLETS | ACTIVATED CHARCOAL | 250MG | CYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/2063 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MICROGYNON FE | LEVONORGESTREL / ETHINYLESTRADIOL. | 0.15MG / 0.03MG | BAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/2066 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | METHOTREXATE | METHOTREXATE | 2.5MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2067 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | ZYNCET | CETIRIZINE DIHYDROCHLORIDE | 10MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2068 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | DOMADOL | TRAMADOL HYDROCHLORIDE | 50MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2069 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | SK DERM | BETAMETHASONE + CLOTRIMOXAZOLE + GENTAMYCIN | 0.05%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 CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/2070 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MIRENA | LEVONORGESTREL | 52MG | BAYER OY-PANSIONATE 47 20210 TURKU FINLAND | FINLAND | PARENTERAL RETARD IMPLANTS | 1.0X1.0 IMPLANT CARTON |
| NDA/MAL/HDP/2071 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | CEFAMOR DRY SYRUP | CEFALEXIN | 125MG/5ML | CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2073 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII MEASLES VACCINE LIVE ATTENUATED(FREEZE-DRIED) | MEASLES VIRUS | NOT LESS THAN 1000CCID50/ DOSE | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 DOSE VIAL + 0.5ML AMPOULE OF STERILE WATER FOR INJECTION,1.0X10.0 DOSE VIAL + 5ML AMPOULE OF STERILE WATER FOR INJECTION |
| NDA/MAL/HDP/2074 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOXIN ORAL SUSPENSION | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | MILAN 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/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2075 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOPRED | PREDNISOLONE | 5MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2076 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOMIDE | FUROSEMIDE | 40MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2077 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | AMBRODIL | AMBROXOL HYDROCHLORIDE | 30MG/5ML | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2078 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | ALCLOX SYRUP | CLOXACILLIN SODIUM | 125MG/5ML | LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2079 | GALENTIC PHARMA (PVT)LTD | NORVIK ENTERPRISES LIMITED | NETRAVIR | ACICLOVIR | 5%W/W | GALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE |
| NDA/MAL/HDP/2080 | GALENTIC PHARMA( INDIA)PVT LTD | NORVIK ENTERPRISES LIMITED | BETAMETHASONE VALERATE | BETAMETHASONE VALERATE | 0.1%W/V | GALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
| INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/2081 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | COMPOUND SODIUM LACTATE | SODIUM LACTATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE+ CALCIUM CHLORIDE DIHYDRATE | 0.32G+0.6G+0.04+0.027/100ML | IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 | KENYA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/2083 | BIOLOGICAL E. LTD | GITTOES PHARMACEUTICALS LIMITED | BEVAC | PURIFIED HEPATITIS B SURFACE ANTIGEN | 20MCG | BIOLOGICAL 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 VIALS | 1.0X35.0X1.0 ML VIAL (1 DOSE VIAL),1.0X24.0X10.0 ML VIAL (10 DOSE VIAL) |
| NDA/MAL/HDP/2085 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CHLORHEXIDINE GLUCONATE SOLUTION | CHLORHEXIDINE GLUCONATE | 20%W/V | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | TOPICAL EXTERNAL LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN,1.0X5.0 L JERRYCAN |
| NDA/MAL/HDP/2086 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | BENDAS | ALBENDAZOLE | 200MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, SARKEJ BAVLA HIGHWAY RAJODA AHMEDABAD 382220, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/2087 | ABBVIE LOGISTICS BV | MEDICAL ACCESS (UGANDA) LIMITED | NORVIR | RITONAVIR | 100MG | ABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/2089 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIABETMIN XR 500MG | METFORMIN HCL EXTENDED RELEASE | 500MG | HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2090 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | CIPROREN | CIPROFLOXACIN | 500MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2091 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CAMSTON | CLOTRIMAZOLE | 1%W/W | KPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2092 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | DUOVIR-N | LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE | 150MG + 300MG + 200MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/2093 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TRIGAN-D TABLET | PARACETAMOL + DICYCLOMINE | 500MG + 20MG | CADILA PHARMACEUTICALS LTD ...-1389 DHOKA GUIJARAT STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2094 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LEVOBACT-750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2095 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL | PARACETAMOL | 100MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2097 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | ALCLOX | CLOXACILLIN | 250MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2098 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGO QUININE | QUININE SULPHATE | 300MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2099 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | HYDROCORTISONE 1% CREAM | HYDROCORTISONE | 1%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2100 | MYLAN LABORATORIES LIMITED. | NORVIK ENTERPRISES LIMITED | ORALCON - F | LEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE | 0.15MG + 0.03MG + 75MG | MYLAN 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, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/2101 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CARDISPRIN | ACETYL SALICYLIC ACID | 75MG | COSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/2102 | MEDREICH PLC | LABOREX UGANDA LIMITED | FLEMING 625 | AMOXYCILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | MEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2103 | MEDREICH PLC | LABOREX UGANDA LIMITED | FLEMING 1000 TAB | AMOXYCILLIN + CLAVULANATE POTASSIUM | 875 MG + 125 MG | MEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2104 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | 30MG + 50MG + 60MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/2105 | MEDREICH PLC | LABOREX UGANDA LIMITED | FLEMING 156MG/5ML | AMOXYCILLIN + CLAVULANATE POTASSIUM | 125 MG + 31.5 MG/5 ML | MEDREICH LIMITED ?UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR
BANGALORE-560 049, INDIA
| INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2107 | MEDREICH PLC | LABOREX UGANDA LIMITED | AMEDIN 10 | AMLODIPINE | 10 MG | MEDREICH STERILAB LIMITED--AVAILAHALI, BANGALORE-560 062 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X14.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/2108 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYMOX CAPSULES 250MG | AMOXYCILLIN | 250MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | CAPSULE BLISTER, AMPOULE AMPOULE, CAPSULE CONTAINER |
| NDA/MAL/HDP/2111 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | LOPINAVIR / RITONAVIR | LOPINAVIR / RITONAVIR | 200MG /50MG | HETERO 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 TABLETS | 1.0X120.0 TABLET CONTAINER |
| NDA/MAL/HDP/2112 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 200MG + 50MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET CONTAINER |
| NDA/MAL/HDP/2114 | AXA PARENTERALS LTD | GITTOES PHARMACEUTICALS LIMITED | AXA-LEVO | LEVOFLOXACIN HEMIHYDRATE | 500MG/100ML | AXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA. | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML VIAL |
| NDA/MAL/HDP/2115 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASTRIM | CO-TRIMOXAZOLE | 480MG | ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2116 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | AMLOVAS-10 | AMLODIPINE BESILATE | 10MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2118 | AVENTIS PHARMA (PTY) LTD SOUTH AFRICA | LABOREX UGANDA LIMITED | RIFAFOURE E-275 | RIFAMPICIN+ISONIAZID+PYRAZINAMIDE+ETHAMBUTOL | 150MG+75MG+400MG+275MG | AVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/2120 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MEGAPIME | CEFEPIME | 1G | ALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL |
| NDA/MAL/HDP/2122 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYMOL | PARACETAMOL | 120MG/5ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE, 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2123 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | PLATFIRST | CISPLATIN | 1MG/ML | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL |
| NDA/MAL/HDP/2124 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYMOX | AMOXYCILLIN | 125MG/5ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | ML BOTTLE |
| NDA/MAL/HDP/2125 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | BECLATE 100 | BECLOMETASONE | 100MCG/DOSE | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/2128 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | TRANSAMIN INJECTION 500MG | TRANEXAMIC ACID | 500MG/5ML | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/2129 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | CLAVODAR | AMOXICILLIN/CLAVULANIC ACID | 500MG/125MG | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2130 | IPCA LABORATORIES | MEDVIN PHARMA LIMITED | ZERODOL-LA | ACECLOFENAC | 200MG | IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2132 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LOPINAVIR/ RITONAVIR | LOPINAVIR/ RITONAVIR | 200MG/ 50MG | AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET CONTAINER |
| NDA/MAL/HDP/2133 | NOVO NORDISK | STAR PHARMACEUTICALS LTD | ACTRAPID | HUMAN INSULIN | 100 I.U/ML | NOVO NORDISK PHARMA-NOVO ALLE | DENMARK | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/2135 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | SOLITAX | CEFTRIAXONE | 1G | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/2136 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | SEDIPROCT SUPOSITORY | HYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN | 5MG + 5MG +10MG +10MG | MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | TOPICAL EXTERNAL SUPPOSITORIES | 1.0X6.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/2137 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | SEPRODERM OINTMENT | SALICYLIC ACID + SULPHUR COMPOUND | 3.6 + 2.4 MG | REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2141 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | INFLAZONE | MULTIINGREDIENT | N/A | CENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/2143 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GRISEOFIL | GRISEOFULVIN | 500MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2144 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPICOTIL | TENOXICAM | 20MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X3.0 VIAL CARTON + 1*3*2ML WFI AMPOULE |
| NDA/MAL/HDP/2145 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | METFIL 500 | METFORMIN | 500MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/2147 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | DICLOFEN -50 | DICLOFENAC | 50MG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2149 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | PRIMOLUT DEPOT | HYDROXYPROGESTERONE HEXANOATE | 250MG | BAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/2150 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | HUMULIN MIXTURE | HUMAN INSULIN | 70/30 I.U | LILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,-INDIANA 46285 USA | UNITED STATES | PARENTERAL ORDINARY S C VIALS | 1.0X4.0 ML VIAL,1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/2151 | USV LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLYCOMET 850 | METFORMIN | 850MG | FREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2154 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLYNASE | GLIPIZIDE | 5MG | FREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2159 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | VAXIGRIP | INFLUENZA VIRUS STRAINS H1N1 + H3N2 + B | 15MCG + 15MCG + 15MCG | SANOFI 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 SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE) |
| NDA/MAL/HDP/2160 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ACEM-500 | CLARITHROMYCIN | 500MG | EMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2161 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CYCLOVAX CREAM | ACICLOVIR | 5%W/W | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/2164 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYCORT | HYDROCORTISONE | 1%W/W | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | TOPICAL EXTERNAL OINTMENTS | 1X15.0GM TUBE |
| NDA/MAL/HDP/2165 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | TRAMAREN | TRAMADOL HYDROCHLORIDE | 50MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2167 | BAYER AG | SURGIPHARM (U) LIMITED | MYCOSPOR SOLUTION | BIFONAZOLE | 10MG | BAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANY | GERMANY | TOPICAL EXTERNAL LIQUIDS | 1.0X15.0 ML BOTTLE,1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/2168 | ROTEX MEDICA GBH ARZNEIMITTELI | GITTOES PHARMACEUTICALS LIMITED | HYDROCORTISONE INJECTION | HYDROCORTISONE SODIUM SUCCINATE | 100MG | ROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAU | GERMANY | PARENTERAL ORDINARY DRY VIALS | 1.0X8.0 ML VIAL |
| NDA/MAL/HDP/2170 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ALSARTAN-AM | LOSARTAN + AMLODIPINE | 50MG + 5MG | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2171 | IDA | KIMSY MEDS LTD | CO-TRIMOXAZOLE | CO-TRIMOXAZOLE | 100MG/200 MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2173 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLEVO-500 | LEVOFLOXACIN | 500MG | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/2175 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | PARAFIZZ | PARACETAMOL | 500MG | CIPLA 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 TABLETS | 1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/2176 | INTAS PHARMACUITICALS LTD | NORVIK ENTERPRISES LIMITED | RISPITAS-2 | RISPERIDONE | 2MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2177 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM ERYMYCIN | ERYTHROMYCIN ESTOLATE | 125MG/5ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2178 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL CEFUROXIME-250 | CEFUROXIME AXETIL | 250MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2179 | BEIJING HOLLEY COTEC PHARMA CHINA | SUPER PHARMACEUTICALS LIMITED | PENICIN | BENZYLPENICILLIN | 1MEGA | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON |
| NDA/MAL/HDP/2180 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM PEN V | PHENOXYMETHYLPENICILLIN | 125MG/5ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2181 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM PHEN | PHENOXYMETHYLPENICILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,250.0 TABLET CONTAINER |
| NDA/MAL/HDP/2183 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | OCID I.V. | OMEPRAZOLE | 40MG/VIAL | CADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/2184 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM QUIN MIXTURES | QUININE | 100MG/5ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2185 | GLAXOSMITHKLINE LTD | ERIS LTD | ROTARIX | LIVE ATTENUATED RIX4414 STRAIN OF HUMAN ROTAVIRUS OF THE G1P[8] TYPE | NOT LESS THAN 10? CCID?? OF THE RIX4414 STRAIN | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.5 ML TUBE (1 DOSE) |
| NDA/MAL/HDP/2186 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL DIPHENHYDRAMINE PAEDIATRIC SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE | 7MG+67.5MG/5ML | KOTRA PHARMA-BHD
1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA
| MALAYSIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2187 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | VOMIZ | ONDANSETRON | 4MG/2ML | CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE |
| NDA/MAL/HDP/2188 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | PREDNISOLONE | PREDNISOLONE | 5MG | CIPLA 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2189 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL BETAMETHASONE | BETAMETHASONE | 0.1%W/W | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE |
| NDA/MAL/HDP/2191 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | KLOXY | CLOXACILLIN | 250MG | LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2194 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | CALCIUM D SYRUP | CALCIUM CARBONATE/VITAMIN D | 250MG+125IU/5ML | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/2195 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | EUDERM CREAM | UREA | 10%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X45.0 G TUBE |
| NDA/MAL/HDP/2196 | PFIZER LABORATORIES LTD | LABOREX UGANDA LIMITED | MYCOBUTIN | RIFABUTIN | 150MG | PHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALY | ITALY | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE BOTTLE |
| NDA/MAL/HDP/2197 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | WHITFIELD'S OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6%W/W + 3%W/W | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2199 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EUTHYROX 50MCG | LEVOTHYROXINE SODIUM | 50MCG | MERCK KGAA - -FRANKFRUTER STRASSE 250, D-64293,DARMSTADT- GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER |
| NDA/MAL/HDP/2203 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | MYCORIL 100 VAGINAL TABLETS | CLOTRIMAZOLE | 100MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | VAGINAL TABLETS | 1.0X2.0X3.0 PESSARY STRIP |
| NDA/MAL/HDP/2204 | IND SWIFT LTD | TATA UGANDA LIMITED | ATSTAT | ATORVASTATIN | 100MG | IND SWIFT LTD-GBU JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2205 | IND SWIFT LTD | TATA UGANDA LIMITED | C-SWIFT | CETIRIZINE HCL | 10MG | IND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2206 | GALENTIC PHARMA( INDIA)PVT LTD | NORVIK ENTERPRISES LIMITED | NETRA CORT | HYDROCORTISONE ACETATE | 1%W/W | GALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
| INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2208 | KOTRA PHARMA SDN BDN | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL CEPHALEXIN | CEPHALEXIN MONOHYDRATE | 500MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2211 | GALENTIC PHARMA (PVT)LTD | NORVIK ENTERPRISES LIMITED | BENZYL BENZOATE | BENZYL BENZOATE | 25%W/W | GALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701
INDIA
| INDIA | TOPICAL EXTERNAL EMULSIONS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE |
| NDA/MAL/HDP/2212 | DENK PHARMA | BENLE CONSULT LIMITED | CIPRO-DENK 500 | CIPROFLOXACIN | 500MG | ALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081 | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2216 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | METOCLOPRAMIDE | METOCLOPRAMIDE | 5MG/ML | NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2217 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AMINOPHYLINE | AMINOPHYLLINE | 20MG | NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X50.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/2218 | LEBEN LABORATORIES LTD | ANDYCO PHARMACY (UGANDA) LTD | ZINECTIL-100 | CHLORPROMAZINE | 100MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2219 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | PRIMOLUT N | NORETHISTERONE | 5MG | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/2220 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | AMLODAC 5 | AMLODIPINE BESYLATE | 5MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2223 | ROYAL PHARMA | ROYAL PHARMA 2011 LIMITED | BENZATHINE PENICILLIN INJECTION | BENZATHINE PENICILLIN | 2400000 I.U | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X2.4 MU VIAL |
| NDA/MAL/HDP/2224 | VOGEN LABORATORIES LTD | BUFFALO HEALTH CARE LTD | DURAMOX 500 | AMOXICILLIN | 500MG | VOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2226 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | HEPA-MERZ GRANULES | L-ORNITHINE-L-ASPARTATE | 3G/5G | WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X10.0X5.0 G SACHET |
| NDA/MAL/HDP/2230 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | NEUTRAFLUX CHERRY FLAVOUR | ALGNIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE | 200MG +250MG + 250MG + 250MG + 125MG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/2231 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | PIRITEX WITH CODEINE | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2232 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | UNICAST | MONTELUKAST | 10MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2233 | ASTRAZENECA | MACNAUGHTON LIMITED | PULMICORT NEBULISER | BUDESONIDE | 0.25MG/ML | ASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X4.0X5.0X2.0 ML VIAL |
| NDA/MAL/HDP/2235 | WOCKHARDT LTD | TATA UGANDA LIMITED | WOSULIN-N | INSULIN HUMAN(RECOMBINANT DNA ORIGIN) | 100IU/ML | WOCKHARDT-WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X3.0 ML VIAL,1.0X10.0 ML VIAL |
| NDA/MAL/HDP/2236 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TEGRETOL 200 | CARBAMAZEPINE | 200MG | NOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2237 | WOCKHARDT LTD | TATA UGANDA LIMITED | WOSULIN-30/70 | INSULIN HUMAN(RECOMBINANT DNA ORIGIN) | 100I.U/ML | WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X3.0 ML VIAL |
| NDA/MAL/HDP/2238 | UNI MEDICO LAB | SHREEJI PHARMACEUTICALS LIMITED | UMOCLOX | AMPICILLIN + CLOXACILLIN | 125MG +125MG | UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2239 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TEGRETOL ORAL SUSPENSION | CARBAMAZEPINE | 20MG/ML | DELPHARMA HUNINGUE S.A.S-26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCE | FRANCE | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/2240 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | DIOVAN 80 | VALSARTAN | 80MG | NOVARTISPHARMA AG -LICHTSTRASSE 35
CH-4056 BASEL
SWITZERLAND,
AND
NOVARTISPHARMA STEIN AG SCHAFFHAUSERSTRASSE
4332 STEIN
SWITZERLAND
| SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X28.0 TABLET STRIP |
| NDA/MAL/HDP/2241 | IVEE AQUA EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYPHENOCOL EYE DROPS | CHLORAMPHENICOL | 0.5%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC DROPS | 5.0 ML VIAL,10.0 ML VIAL |
| NDA/MAL/HDP/2242 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CYCLOVAX 200 TABLETS | ACYCLOVIR | 200MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2243 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | SIMDOL TABLETS | PARACETAMOL | 500MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2244 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYDEXNICOL EYE DROPS | DEXAMETHASONE/CHLORAMPHENICOL | 0.1% & 1%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/2245 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | X-PEL | MEBENDAZOLE | 100MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2247 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ESOMAC | ESOMEPRAZOLE | 20MG | OKASA PHARMA PVT LTD-L-2, ADDITIONAL M.I.D.C. AREA, SATARA SATARA-415004, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2248 | GALENTIC PHARMA (PVT)LTD | NORVIK ENTERPRISES LIMITED | TETRACYCLINE OPHTHALMIC | TETRACYCLINE | 1%W/W | GALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA | INDIA | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE,1.0X5.0 G TUBE |
| NDA/MAL/HDP/2249 | WOCKHARDT LTD | TATA UGANDA LIMITED | WOSULIN-R | INSULIN | 100ML | WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X3.0 ML VIAL,1.0X10.0 ML VIAL |
| NDA/MAL/HDP/2250 | GALENTIC PHARMA LTD | NORVIK ENTERPRISES LIMITED | CANDIGEN | CLOTRIMAZOLE | 1%W/W | GALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
| INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2252 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERMOX | MEBENDAZOLE | 500MG | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/2253 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | INDOMETHACIN | INDOMETHACIN | 25MG | NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2254 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | BURN CUR CREAM | ACRIFLAVINE/THYMOL | N/A | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2256 | GLAXOSMITH KLINE LTD | ERIS LTD | AUGMENTIN 457MG/5ML | AMOXICILLIN + CLAVULANIC ACID | 400 MG + 57 MG / 5 ML | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/2258 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | TENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZ | TENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZ | 300MG/300MG/600MG | MYLAN 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 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET BOTTLE,1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2262 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | CIPLA 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 TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2263 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CELEMIN 10 PLUS | AMINO ACIDS/ELECTROLYTES | 10%W/V+10%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/2264 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | ARTEMETHER INJECTION | ARTEMETHER | 80MG/ML | GLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESH | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/2265 | HETERO DRUGS LTD | ABACUS PHARMA (AFRICA) LIMITED | TENOFOVIR/ LAMUVIDINE | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE | 300MG + 300MG | HETERO 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 TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2267 | MYLAN LABORATORIES LIMITED. | KIMSY MEDS LTD | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE | TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE | 300MG+300MG | MYLAN 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 TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2269 | DAWA LIMITED | SUPER MEDIC LTD | DAWAMOX | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2270 | UNIQUE PHARMACEUTICAL LABORATORIES | TATA UGANDA LIMITED | ZITHROCIN 500 | AZITHROMYCIN | 500MG | J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, G.I.D.C. INDUSTRIAL AREA, ANKLESHWAR, GUJARAT 393002 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/2271 | EAGLEVET UGANDA LIMITED | MEDVIN PHARMA LIMITED | ARTEMETHER 20MG/LUMEFANTRINE 120MG | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X3.0X6.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER,1.0X10.0X2.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X4.0X6.0 TABLET BLISTER,1.0X30.0X3.0X6.0 TABLET BLISTER,1.0X30.0 |
| NDA/MAL/HDP/2272 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CLARANTA -500 | CLARITHROMYCIN | 500MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2274 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | PARACETAMOL TABLETS 500MG | PARACETAMOL | 500MG | ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2276 | MEDREICH PLC | LABOREX UGANDA LIMITED | FUNGRAL | KETOCONAZOLE | 200MG | MEDRIECH STERILAB LTD,BANGALORE-MEDRIECH STERILAB LTD, AVALAHALLI BANGALORE 560062 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2278 | AVENTIS INTERCONTINENTAL | LABOREX UGANDA LIMITED | ORELOX | CEFPODOXIME PROXETIL | 100MG | SANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPI?GNE
| FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2280 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | BETADROP-N | BETAMETHASONE + NEOMYCIN | 0.1 %W/V + 0.5 %W/V | REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS | 1.0X7.5 ML VIAL |
| NDA/MAL/HDP/2281 | SURGE LAB (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | LUMFORT | LORATADINE | 10MG | NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2282 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | PROPAN | PROPRANOLOL | 40MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2283 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII DIPHTHERIA TETANUS PERTUSIS | DIPTHERIA TOXOID+TETANUS TOXOID+B.PERTUSIS ADSORBED ON ALUMINIUM PHOSPATE | >25LF(>30IU)+>5LF(>40IU)+<16OU(>4PU) ADSORBED ON ?1.5MG | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE) |
| NDA/MAL/HDP/2284 | SURGE LAB (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | LUMFORT SYRUP | LORATADINE | 5MG/5ML | NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2285 | MEDREICH PLC | LABOREX UGANDA LIMITED | BRUMED | IBUPROFEN | 100MG/5ML | MEDRIECH STERILAB LTD-AVALAHALLI BANGALORE-560 049, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2287 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | ZINNAT | CEFUROXIME AXETIL | 250MG | GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON |
| NDA/MAL/HDP/2289 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CHLORAMPHENICOL | CHLORAMPHENICOL | 250MG | NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/2290 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE + ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 150MG + 300MG | MYLAN 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 TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/2291 | HETERO DRUGS LTD | ABACUS PHARMA (AFRICA) LIMITED | VALOVIR | VALACYCLOVIR | 500MG | HETERO 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2292 | MEDREICH PLC | LABOREX UGANDA LIMITED | FLEMING 1200 | AMOXYCILLIN + CLAVULANATE POTASSIUM | 100 MG + 200 MG | NATCO PHARMA LTD-VIJAYAPUR, NORTH NAGARIJUNA SAGA,INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X5.0X20.0 ML VIAL |
| NDA/MAL/HDP/2293 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TIOCON | TIOCONAZOLE | 1%W/W | GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2295 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | ROZITTA 10 | ROSUVASTATIN CALCIUM | 10MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2296 | ERIS LTD | BENLE CONSULT LIMITED | RANI-DENK 150 | RANITIDINE | 150MG | DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CONTAINER |
| NDA/MAL/HDP/2297 | DAWA LIMITED | SUPER MEDIC LTD | SABULIN SYRUP | SALBUTAMOL SULPHATE | 2MG/5ML | DAWA LIMITED -BABA DOGO RWARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2298 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | SAFELEVO 500 | LEVOFLOXACIN | 500MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2299 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | ROZITTA 20 | ROSUVASTATIN CALCIUM | 20MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2303 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZIAK 5/6.25 | BISOPROLOL + HYDROCHLOROTHIAZIDE | 5 MG + 6.25 MG | MERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2304 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZIAK 10/6.25 | BISOPROLOL + HYDROCHLOROTHIAZIDE | 10 MG + 6.25 MG | MERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2305 | MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ZIAK 2.5/6.25 | BISOPROLOL + HYDROCHLOROTHIAZIDE | 2.5 MG + 6.25 MG | MERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2306 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MICROLUT | LEVONORGESTREL | 0.03MG | BAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X35.0 TABLET BLISTER |
| NDA/MAL/HDP/2307 | THE ARAB P'CAL MANUFACTIRING CO. | GOODMAN INTERNATIONAL LTD | ZOCIN SUSPENSION | AZITHROMYCIN | 200MG/5ML | ARAB PHARMACEUTICAL MANUFACTURING INDUSTRIES --KING ABDULAH 2ND STREET / INDUSTRIAL AREA BUILDING NO. 1 AL-BUHAIRAH / SULT-JORDAN | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X15.0 ML BOTTLE,1.0X22.5 ML BOTTLE |
| NDA/MAL/HDP/2312 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CLAVOMID 625 | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2313 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CLAVOMID 375 | AMOXICILLIN + CLAVULANIC ACID | 250 MG + 125 MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2314 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | RABEMAC-20 | RABEPRAZOLE SODIUM | 20MG | MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2315 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O-50 | CEFIXIME | 50MG/5ML | MICRO 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/DROPS | 1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2317 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASMOL | PARACETAMOL | 500MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2318 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIAPRIDE-4 | GLIMEPIRIDE | 4MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2319 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSMOL | PARACETAMOL | 120MG/5ML | COSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2320 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | ERO-125 | ERYTHROMYCIN ESTOLATE | 125MG/5ML | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2321 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN CHESTY | ORCIPRENALINE+BROMHEXINE | 5MG/5ML+ 4MG/5ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2322 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TREFLUCAN | FLUCONAZOLE | 150MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X1.0 CAPSULE STRIP |
| NDA/MAL/HDP/2323 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ALPRIM | CO-TRIMOXAZOLE | 240MG/5ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE, 1.0X5.0 L JERRYCAN |
| NDA/MAL/HDP/2324 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | SWISSCLOXA | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X7.5 ML VIAL |
| NDA/MAL/HDP/2325 | IDA FOUNDATION | KIMSY MEDS LTD | PARAMOMYCIN | PARAMOMYCIN | 375MG/ML | GLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2326 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | SYLATE-500 | ETAMSYLATE | 50MG | EMCURE PHARMACEUTICALS LTD-LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI BRAHMANA JAMMU (J&K) 18113 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X6.0 TABLET STRIP |
| NDA/MAL/HDP/2327 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | ABACAVIR SULPHATE | ABACAVIR SULPHATE | 300MG | AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/2330 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | COARTEM | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | NOVARTIS 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, | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X24.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER |
| NDA/MAL/HDP/2333 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII DIPHTHERIA & TETANUS VACCINE ADSORBED(PEDIATRIC) | DIPTHERIA TOXOID+TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE | >25LF(>30IU)+>5LF(>40IU) ADSORBED ON ?1.5MG | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0 ML VIAL (20 DOSES),1.0X5.0 ML VIAL (10 DOSES),1.0X0.5 ML AMPOULE (1 DOSE) |
| NDA/MAL/HDP/2334 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII MEASLES MUMPS & RUBELLA | MEASLES VIRUS+MUMPS VIRUS+RUBELLA VIRUS | NLT 1000 CCID50+NLT 5000 CCID50 +NLT1000 CCID50 | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 DOSE VIAL + 0.5ML OF THE DILUENT |
| NDA/MAL/HDP/2335 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | AGOBEN TABLETS(THANE) | MEBENDAZOLE | 100MG | AGOG 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 TABLETS | 10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2337 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROXETIL-500 | CEFUROXIME AXETIL | 500MG | A-UNIT VI, SY. NO 329/39, 329/ | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2338 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 200 MG + 28.5 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/2339 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KOACT-375 | AMOXICILLIN + CLAVULANATE POTASSIUM | 250 MG + 125 MG | AUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/2342 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KOACT-625 | AMOXICILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | AUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/2346 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | ABACAVIR SULFATE ORAL SOLUTION | ABACAVIR SULPHATE | 20MG/ML | AUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X240.0 ML BOTTLE |
| NDA/MAL/HDP/2348 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | HEPATITIS B VACCINE(RDNA) ADULT | HEPATITIS B VACCINE(RDNA) ADULT | 20MCG/ML | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X10.0X10.0 ML VIAL (10 DOSE VIAL),1.0X50.0X1.0 ML VIAL (1 DOSE VIAL) |
| NDA/MAL/HDP/2349 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | D-LYTE | ANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + POTASSIUM CHLORIDE | 2.7G + 0.52G/ 200ML + 0.58G/ 200ML + 0.30G/ 200ML | 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 UNIT DOSE POWDERS | 1.0X200.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X500.0 ML SACHET |
| NDA/MAL/HDP/2350 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | PULMICORT TURBUHALER | BUDESONIDE | 200MCG | ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X100.0 DOSE CANNISTER |
| NDA/MAL/HDP/2352 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | COLDCAP DAY TIME | PARACETAMOL/PSEUDOEPHEDRINE HCL/CAFFEINE | 500MG+30MG+30MG | REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X12.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2353 | ASTRA ZENECA | MACNAUGHTON LIMITED | NEXIUM | ESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE) | 10MG | ASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | ORAL SOLID ORDINARY GRANULES | 1.0X28.0 SACHET CARTON |
| NDA/MAL/HDP/2354 | STRIDES ARCOLAB LIMITED | DELMAW ENTERPRISES LIMITED | LAMIVUDINE + ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 150MG + 300MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/2356 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | QUININE | QUININE DIHYDROCHLORIDE | 600MG/2ML | NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2357 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | TRABILIN- 50 CAPSULES | TRAMADOL | 50MG | MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2359 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ASPIREM 75 | ASPIRIN | 75MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/2360 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | FUNGISTIN PESSARIES | NYSTATIN | 100000 IU | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | INDIA | VAGINAL TABLETS | 1.0X14.0 PESSARY PACK,5.0X3.0 PESSARY STRIP,1.0X100.0 PESSARY CONTAINER |
| NDA/MAL/HDP/2361 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CLAREM 500 | CLARITHROMYCIN | 500MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2362 | GALENTIC PHARMA( INDIA)PVT LTD | NORVIK ENTERPRISES LIMITED | CANDISTATIN OINTMENT | NYSTATIN | 100,000I.U | GALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701
INDIA
| INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/2363 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | GENTAMICIN SULPHATE | GENTAMICIN SULPHATE | 80MG/2ML | NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2364 | MEDICO REMEDIES PVT LTD | MAISHA MEDICAL SUPPLIES LIMITED | VOXEL-500 | LEVOFLOXACIN | 500MG | MEDICO REMEDIES PVT LIMITED-8 & 9 DEWAN & SONS, UDYOG NAGAR PALGAR, DISTRICT THANE MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2365 | STRIDES ARCOLAB LIMITED | DELMAW ENTERPRISES LIMITED | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | 30MG+50MG+60MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/2366 | UNIQUE PHARMACEUTICALS LTD | TATA UGANDA LIMITED | IFICIPRO INJECTION | CIPROFLOXACIN | 200MG/100ML | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2367 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | FELEXIN 125 | CEPHALEXIN MONOHYDRATE | 125MG/5ML | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2368 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DERMIDEX CREAM | MICONAZOLE NITRATE | 2%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2370 | IVEE AQUA EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYBETANEOCIN EYE DROPS | BETAMETHASONE + ENOMYCIN | 0.1 %W/V + 0.35 %W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/2371 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | TOPIZONE CREAM | FUSIDIC ACID + BETAMETHASONE VALERATE | 20MG/G+1MG/G | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2373 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | CLOBEN SKIN CREAM | CLOTRIMAZOLE/ BECLOMETASONE | 1%W/W/ 0.025%W/W | INDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2374 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PYRAZINAMIDE TABLETS | PYRAZINAMIDE | 500MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2375 | GLAXO SMITHLINE LIMITED | ERIS LTD | CLAVULIN 1G | AMOXICILLIN + CLAVULANIC ACID | 875 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2376 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | METCHEK-500 | METFORMIN | 500MG | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2377 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | R-LOC TABLETS | RANITIDINE | 150MG | CADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2378 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AUGMENTIN | AMOXICILLIN + CLAVULANIC ACID | 1000 MG + 200 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.2 G VIAL |
| NDA/MAL/HDP/2379 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | PUMPITOR | OMEPRAZOLE | 40MG | PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG | INDONESIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT |
| NDA/MAL/HDP/2381 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | SIMTRIM-480 TABLETS | CO-TRIMOXAZOLE | 480MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2383 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AUGMENTIN | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 100 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X25.0 ML VIAL |
| NDA/MAL/HDP/2384 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CLARIX 500 | CLARITHROMYCIN | 500MG | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2385 | COSMOS LIMITED | ASTRA PHARMA (U) LIMITED | COZEPAM 5MG | DIAZEPAM | 5MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2386 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | NEOGAB | GABAPENTIN | 100MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2387 | DAWA LIMITED | SUPER MEDIC LTD | VERMOUT | MEBENDAZOLE | 100MG/5ML | DAWA LIMITED -BABA DOGO RWARAKA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/2388 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | DAFRACLAV | AMOXYCILLIN + POTASSIUM CLAVULANATE | 400MG + 57MG | BILIM PHARMACEUTICALS--CERKEZKOY PLANT, 59500 CERKEZKOY, TEKIRDAG | TURKEY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/2389 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELOCIN | ERYTHROMYCIN | 250 | ELYS CHEMICAL INDUSTRIES LIMITED-ROAD B?, OFF ENTERPRISE ROAD
PLOT NO. 209/8927 INDUSTRIAL AREA
| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2390 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN | DIHYDROARTEMISININ/ PIPERAQUINE PHOSPHATE | 80MG /640MG | BLISS 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/DROPS | 1.0X80.0 ML BOTTLE |
| NDA/MAL/HDP/2394 | MERCK SHARP & DOHME BV | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | STOCRIN | EFAVIRENZ | 600MG | ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES? REPUBLIC OF CHINA,MERCK SHARP & DOHME B.V-WAARDENWEG 392031 BN, HAARLEM | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2395 | A.MENARINI INDUSTRIE FARMACEUTICHE S.R.I | STAR PHARMACEUTICALS LTD | FASTUM GEL | KETOPROFEN | 2.5%W/W | A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA SETTE SANTI 3, 50131 FIRENZE-ITALY | ITALY | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE |
| NDA/MAL/HDP/2399 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | VOLINI | MULTI INGREDIENT | MULTI INGREDIENT | SUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIA | INDIA | TOPICAL EXTERNAL OTHER GELS/SOLS | 1.0X1.0X30.0 G TUBE |
| NDA/MAL/HDP/2400 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | TOPIDIC 2% | FUSIDIC ACID | 20MG/G | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2401 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | SURGIPHARM (U) LIMITED | ENAT | NATURAL VITAMIN E | 400IU | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2402 | IDA FOUNDATION | KIMSY MEDS LTD | PRAZIQUANTEL | PRAZIQUANTEL | 600MG | CIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/2404 | UNICHEM LABORATORIES LIMITED? | EUROPA HEALTHCARE (U) LTD | LOSAR 50 | LOSARTAN POTASSIUM | 50MG | UNICHEM LABORATORIES LTD---VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2405 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | ERYTHROMYCIN STEARATE | ERYTHROMYCIN STEARATE | 250MG | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2408 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | RENIRON TONIC | MULTI-INGREDIENT | MULTI-INGREDIENT | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/2409 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | DEPLATT | CLOPIDOGREL | 75MG | TORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2410 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | DOXYREN | DOXYCYCLINE | 100MG | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2411 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ | POVIDONE IODINE + METRONIDAZOLE | 5%W/W + 1%W/W | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE |
| NDA/MAL/HDP/2414 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCIL | AMPICILLIN | 125MG/5ML | SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2415 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | SOLINA TABLETS | DIAZEPAM | 5MG | CENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2416 | IDA | KIMSY MEDS LTD | SODIUM STIBOGLUCONATE INJECTION | SODIUM STIBOGLUCONATE | 100MG/ML | ALBERT DAVID LTD .-15-CHITTARANJAN AVE. KOLKATA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X30.0 ML VIAL |
| NDA/MAL/HDP/2420 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | LIDOCAINE INJ.BP | LIDOCAINE | 2% W/V | INDOCO REMEDIES LTD-L-32,33 AND VERNA INDUSTRIAL ESTATE VERNA ? SALCATTE GOA, 403722 INDIA | INDIA | PARENTERAL ORDINARY OTHER VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/2421 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | TAMIGEN EYE/EAR DROPS | GENTAMICIN SULPHATE | 0.3%W/V | INDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722 | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE,1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/2422 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | TAMIGEN-S EYE/EAR DROPS | GENTAMICIN SULPHATE+DEXAMETHASONE | 0.3%W/V+0.1%W/V | INDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722 | INDIA | OTHER SYSTEMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/2423 | MEDLEY PHARMACEUTICALS | MEDVIN PHARMA LIMITED | ATORIN | ATORVASTATIN | 10MG | MEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2426 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | PROBEX SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2427 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | CLONEM | CLOTRIMAZOLE | 1%W/W | NEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2428 | ERIS LTD | BENLE CONSULT LIMITED | CLOTRI-DENK 1% CREAM | CLOTRIMAZOLE | 1%W/W | RUBIEPHARM ARZNEIMITTEL GMHH--BRUDER-GRIMU, STRABE 62, GERMANY
| GERMANY | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2429 | ERIS LTD | BENLE CONSULT LIMITED | CLOTRI-DENK 100 VAGINAL | CLOTRIMAZOLE | 100MG | DENK 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 TABLETS | 1.0X6.0 PESSARY CARTON |
| NDA/MAL/HDP/2431 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | FORMONIDE 200 | BUDESONIDE + FORMOTEROL FUMARATE | 200MCG/ 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 INHALER | 1.0X1.0 CANNISTER CARTON |
| NDA/MAL/HDP/2432 | CADILA HEALTH CARE LTD | ABACUS PHARMA (AFRICA) LIMITED | FORMONIDE 100 | BUDESONIDE + FORMOTEROL FUMARATE | 100MCG+6MCG | CADILA 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 INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/2434 | STRIDES SHASUN LIMITED . | DELMAW ENTERPRISES LIMITED | SOLCER | OMEPRAZOLE | 40MG | STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD
BANGALORE 560076
INDIA
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/2437 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | RISDONE | RISPERIDONE | 1MG/ML | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2438 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | HIFENAC | ACECLOFENAC | 100MG | INTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2440 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMADOL KIDS | PARACETAMOL | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2450 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | TODAY PESSARY | NONOXYNOL-9 | 5%W/V | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | VAGINAL TABLETS | 1.0X5.0 PESSARY BLISTER |
| NDA/MAL/HDP/2451 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | OLFEN 75 SR | DICLOFENAC SODIUM | 75 MG | MEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASEL | SWITZERLAND | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2452 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DELASED CHEST COUGH SYRUP (NON DROWSY) | GUAIFENESIN + MENTHOL | 100MG/5ML + 1.1MG/5ML | REGAL PHARMACEUTICALS-PLOT 7879/18 BABA DOGO ROAD NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2453 | ABBVIE (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | NORVIR | RITONAVIR | 80MG/ML | AESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENT | UNITED KINGDOM | ORAL LIQUID ORDINARY LIQUIDS | 1.0X90.0 ML BOTTLE |
| NDA/MAL/HDP/2455 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | ARTEQUIN 600/750 LACTAB | ARTESUNATE + MEFLOQUINE | 200 MG + 250 MG | MEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASEL | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/2458 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | PRISTINEX 2% CREAM | KETOCONAZOLE | 2%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 2.0X15.0 G TUBE |
| NDA/MAL/HDP/2459 | MYLAN LABORATORIES LIMITED. | NORVIK ENTERPRISES LIMITED | P2 | LEVONORGESTREL | 0.75MG | MYLAN 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, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/2460 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BENZHEXOL TABLETS 2MG | BENZHEXOL HCL | 2MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2461 | UMEDICA LABORATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | UMERAN SR - 100 | DICLOFENAC | 100MG | UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2462 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | HISTALIN SYRUP | CHLORPHENIRAMINE MALEATE/PROMETHAZINE/DIPHENHYDRAMINE/EPHEDRINE/AMMONIUM CHLORIDE/SODIUM CITRATE | 1.0MG+ 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 SYRUPS | 1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN |
| NDA/MAL/HDP/2467 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | NOKLOT | CLOPIDOGREL | 75MG | CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2470 | GLAXOSMITHKLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | EURAX | CROTAMITON | 10%W/W | NOVATIS CONSUMER HEALTH INC -ZYMA SA-CH- 1260 NYON SWITZERLAND | SWITZERLAND | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2471 | GLAXOSMITHKLINE LIMITED- | UNITED HEALTHCARE DISTRIBUTORS LTD | OTRIVIN 0.1% NASAL DROPS | XYLOMETAZOLINE | 0.1%W/V | NOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND | SWITZERLAND | NASAL SYSTEMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/2472 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | TRAN-GEL | DICLOFENAC DIETHYLAMMONIUM | 1%W/W | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE,1.0X20.0 G TUBE |
| NDA/MAL/HDP/2473 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NUGREL | CLOPIDOGREL | 75MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2474 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | TYPHIM VI | POLYSACCHARIDES OF SALMONELLA TYPHI(TY2 STRAIN) | 25MCG | SANOFI 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 SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE) |
| NDA/MAL/HDP/2475 | WIN-MEDICURE LTD | SURGIPHARM (U) LIMITED | URGENDOL INJECTION | TRAMADOL HYDROCHLORIDE | 50MG/ML | WIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2476 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | DERIVA AQUEOUS GEL | ADAPALENE | 0.1%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2477 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | LOGICAN-150 | FLUCONAZOLE | 150MG | WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X1.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2478 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL PLUS | PARACETAMOL+DICLOFENAC | 500MG+50MG | WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH -INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2479 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANCEPH-250 CAP | CEPHALEXIN | 250MG | SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2480 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | ARTESIANE 40 | ARTEMETHER | 40MG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/2481 | GALENTIC PHARMA (PVT)LTD | NORVIK ENTERPRISES LIMITED | NETRACORT | HYDROCORTISONE | 1%W/W | GALENTIC PHARMA PVT LIMITED-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI MUMBAI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X20.0 G TUBE |
| NDA/MAL/HDP/2489 | UMEDICA LABORATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | UMETAC-150 | RANITIDINE | 150MG | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2492 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | PROFIL 25 | PROMETHAZINE HYDROCHLORIDE | 25MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2497 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | NEVIMUNE | NEVIRAPINE | 50MG/5ML | CIPLA 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 SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2500 | MACLEODS PHARMACEUTICALS LTD | ROYAL PHARMA 2011 LIMITED | CHLORAMPHENICOL SODIUM SUCCINATE INJECTION BP | CHLORAMPHENICOL SODIUM SUCCINATE | 1G | MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA. | INDIA | PARENTERAL RETARD DRY AMPOULES | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/2502 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | PROBETA N EYE DROP | BETAMETHASONE + NEOMYCIN | 0.1%W/V+0.5%W/V | ATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | OPHTHALMIC DROPS | 1.0X7.5 ML VIAL |
| NDA/MAL/HDP/2504 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | RESTOCIN | PARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL | 500MG+ 2MG+ 2MG + 30MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/2505 | GLAXO WELLCOME(KENYA),LTD | ERIS LTD | BETNOVATE OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | GLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM | UNITED KINGDOM | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/2506 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | NADOXIN | NADIFLOXACIN | 1%W/W | WOCKHARDT LTD -VILLAGE KUNJHAL P.O BAROTIWALA DIST SOLAN HIMACHAL PRADESH | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/2507 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | EXERMET 1000 | METFORMIN HCL | 1000MG | CIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TAL | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2508 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | HYOSCINE | HYOSCINE | 20MG/ML | NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANG | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/2509 | BETA HEALTHCARE | BETA HEALTHCARE UGANDA LIMITED | OPELE LOTION | BENZYL BENZOATE | 25%W/V | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL LOTIONS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/2510 | PANACEA BIOTEC LTD | ABACUS PHARMA (AFRICA) LIMITED | GIRO | ORDNIDAZOLE | 500MG | PANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH ? 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2511 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | ULTIVA INJECTION 5MG | REMIFENTANIL | 5MG | GLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONA | ITALY | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/2512 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | DICLOFENAC SODIUM INJECTABLE SOLUTION | DICLOFENAC SODIUM | 25MG/ML | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/2513 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIPEN DRY SYRUP | PHENOXYMETHYLPENICILLIN | 125MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2515 | AFRICURE PHARMACEUTICALS (INDIA) LTD | ROYAL PHARMA 2011 LIMITED | SIMFEN 200 TABLETS | IBUPROFEN | 200MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2516 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIAMP DRY SUSPENSION | AMPICILLIN | 125MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2519 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | SURGIPHARM (U) LIMITED | VITA CAP | MULTI-INGREDIENT | MULTI-INGREDIENT | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2521 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | MOTINORM | DOMPERIDONE | 10MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2522 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | PANTAZ TABLETS | PANTOPRAZOLE | 40MG | MEDLEY 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2523 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | SULPHUR OINTMENT | SULPHUR | 10%W/W | NEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/2524 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | PRIMODIL-5 | AMLODIPINE BESYLATE | 5MG | MEDLEY 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2525 | ERIS LTD | BENLE CONSULT LIMITED | DICLO-DENK 100 RETARD | DICLOFENAC SODIUM | 100MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID RETARD TABLETS | 10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2526 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNISTEN COMBI PACK | CLOTRIMAZOLE | 500MG & 1 %W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | VAGINAL COMBINATION PACK TABLETS | 1.0X1.0 PESSARY BLISTER + 1*20G TUBE |
| NDA/MAL/HDP/2527 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ACIVIR CREAM | ACICLOVIR | 5%W/W | CIPLA LTD-VERNA INDUSTRIAL ESTATE, GOA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X5.0 G TUBE |
| NDA/MAL/HDP/2528 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LABESTEN | CLOTRIMAZOLE | 1%W/W | LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE |
| NDA/MAL/HDP/2529 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | G-CEFTRIA | CEFTRIAXONE | 1G | GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 10 ML AMPOULE WFI |
| NDA/MAL/HDP/2545 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | TOBREX | TOBRAMYCIN | 0.3%W/V | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/2549 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | AZY-250 | AZITHROMYCIN | 250MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/2552 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | CAROFIT | VITAMIN C/ VITAMIN A/ ZINC SULPHATE | 150MG/10MG/75MG | AJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2553 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | ESOZ-20 | ESOMEPRAZOLE | 20MG | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2554 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | ESOZ | ESOMEPRAZOLE | 40MG | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2555 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PHENOBARBITONE TABLETS BP 30MG | PHENOBARBITONE | 30MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/2556 | GILEAD SCIENCE INC | MEDICAL ACCESS (UGANDA) LIMITED | TRUVADA | EMTRICITABINE/TENOFOVIR | 200MG/300MG | PATHEON 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 TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/2557 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | EPSITRON 25 TABLETS | CAPTOPRIL | 25MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2558 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | MYCOREN SUSPENSION | NYSTATIN | 100000 I.U/ML | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL TOPICAL SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/2559 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ERYTHROREN | ERYTHROMYCIN STEARATE | 250MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2560 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LANCID-30 | LANSOPRAZOLE | 30MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2561 | PHARMATHEN LTD | GOODMAN INTERNATIONAL LTD | LANOMYCIN | AMIKACIN SULPHATE | 500MG | PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE | GREECE | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2562 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | TRABILIN-100 | TRAMADOL | 100MG/2ML | MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2565 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | TRAMAZAC INJECTION | TRAMADOL HYDROCHLORIDE | 50MG/ML | CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE,1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2566 | MEDREICH PLC | LABOREX UGANDA LIMITED | ZEBEN | ALBENDAZOLE | 400MG | MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/2567 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CIPROBID-500 | CIPROFLOXACIN | 500MG | CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
,S.KANT HEALTHCARE LIMITED--PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2568 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | ZINNAT | CEFUROXIME AXETIL | 500MG | GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON |
| NDA/MAL/HDP/2569 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | NO-SPA | DROTAVERINE HYDROCHLORIDE | 40MG/2ML | CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO. LTD CSANYIKVOLGY SITE-CSANYIKVOLGY, P.O.BOX 565.3510, MISKOLC, HUGARY | HUNGARY | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2570 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | AMOXAPEN 250 CAPSULES | AMOXYCILLIN | 250MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2571 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | CO-METHER | ARTEMETHER + LUMEFANTRINE | 180 MG + 1080 MG | 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 DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/2575 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | MYTEKA | MONTELUKAST SODIUM | 10MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2576 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEQUINE TABLETS | CHLOROQUINE PHOSPHATE | 250MG | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2577 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TOPCEF 200 | CEFIXIME | 200MG | TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2578 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MAGNOMINT TABLETS | MAGNESIUM TRISILICATE+ALUMINIUM HYDROXIDE | 250MG+120MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2579 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | ARTEQUIN 300/375 LACTAB | ARTESUNATE + MEFLOQUINE | 300 MG + 375 MG | MEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASEL | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/2580 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | HEDON TABLETS | PARACETAMOL + ASPIRIN + CAFFEINE | 250 MG+ 300 MG + 30 MG | REGAL 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, 6 | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/2581 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AVAS-10 | ATORVASTATIN | 10MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2582 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROXETIL-250 | CEFUROXIME AXETIL | 250MG | AUROBINDO 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 TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2591 | SWISS PHAMACEAUTICAL PUT LTD | HEALTHCARE LTD. | VITAGLOBIN SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | SWISS PHARMACEUTICALS PVT LTD-A159 SINDH INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/2593 | E DENK OHG | BENLE CONSULT LIMITED | ATENOLOL DENK 50 | ATENOLOL | 50MG | ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2594 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | FEF | FERROUS SULPHATE + FOLIC ACID | 200MG + 0.4MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2595 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | ZEPILEN | CEFAZOLIN | 1000MG | MEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/2596 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | URISEPTIC | NALIDIXIC ACID | 500MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2597 | E DENK OHG | BENLE CONSULT LIMITED | PARA DENK 250 | PARACETAMOL | 250MG | RUBIEPHARM ARZNEIMITTEL GMHH -GERMANY | GERMANY | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/2600 | IND SWIFT LTD | TATA UGANDA LIMITED | CLARIE-OD | CLARITHROMYCIN(EXTENTED RELEASE) | 500MG | IND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2601 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | AXETINE 750MG | CEFUROXIME | 750MG | MEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/2602 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM BID | AMOXICILLIN + CLAVULANIC ACID | 200 MG + 28.5 MG/ 5 ML | ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2603 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | VIRADAY | TENOFOVIR + EMTRICITABINE + EFAVIRENZ | 300 MG + 200 MG + 600 MG | CIPLA 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 TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2604 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GROVIT SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | SAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2606 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | PROTAS 40 | ESOMEPRAZOLE | 40MG | SQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2607 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | FLOTRAL | ALFUZOSIN HCL | 10MG | SUN PHARMACEUTICAL INDUSTRIES LTD-VILLAGE GANGUWALA, PAONTA SAHIB,173 025,DISTRICT SIRMOUR HIMACHAL PRADESH INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2610 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ATROPINE | ATROPINE | 1MG/ML | NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/2612 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | RENIRON | MULTI-INGREDIENT | MULTI-INGREDIENT | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2614 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | DIALIN | LOPERAMIDE HCL | 2MG | REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2615 | ASTRA ZENECA AB | MACNAUGHTON LIMITED | SYMBICORT TURBUHALER | BUDESONIDE+FORMOTEROL | 160MCG+4.5MCG/DOSE | ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM | SWEDEN | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X60.0 DOSE CANNISTER |
| NDA/MAL/HDP/2617 | BLUE CROSS LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | BLUDROX TABLETS DISPERSABLE | CEFADROXIL | 250MG | BLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2628 | MICRO LABS LTD | LABOREX UGANDA LIMITED | AZILIDE-500 | AZITHROMYCIN | 500MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/2640 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | BENZYL BENZOATE APPLICATION | BENZYL BENZOATE | 25%W/W | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | TOPICAL EXTERNAL LOTIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2641 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | AXETINE 250MG | CEFUROXIME AXETIL | 250MG | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2642 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | MEDOXANUM | CEFTRIAXONE | 1G | MEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 10 ML AMPOULE WFI |
| NDA/MAL/HDP/2643 | FREDUN PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | NEOPHIL -100 TABLETS | AMINOPHYLLINE | 100MG | FREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2645 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANZIDIME 1000 | CEFTAZIDIME | 1000MG | SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/2647 | DENK PHARMA | BENLE CONSULT LIMITED | IBUPROFEN DENK 400MG | IBUPROFEN | 400MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2648 | E DENK OHG | BENLE CONSULT LIMITED | PARA DENK 125 | PARACETAMOL | 125MG | RUBIEPHARM ARZNEIMITTEL GMHH -GERMANY | GERMANY | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/2650 | DENK PHARMA | BENLE CONSULT LIMITED | VIT-B-DENK | THIAMINE HCL + PYRIDOXINE HCL | 100MG + 200MG | DENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 M?NCHEN, G?LLSTR. 1, 84529 TITTMONING, GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2651 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | RINAVIT SYRUP | MULTIVITAMIN | MULTI-INGREDIENT | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2652 | AVENTIS PHARMA (PTY) LTD SOUTH AFRICA | LABOREX UGANDA LIMITED | FLAGENTYL TABLETS | SECNIDAZOLE | 500MG | FAMAR LYON-29 AVENUE CHARLES DE GAULLE SAINT | FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/2653 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | SONADERM-GM | CLOBETASOL + MICONAZOLE + GENTAMICIN | 0.05%W/W + 2% W/W+ 0.1%W/W | BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/2654 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | BEBE VIT | VITAMIN A+ VITAMIN D3+VITAMIN E+ VITAMIN C +VITAMIN B1 + VITAMIN B2 | 1500IU+ 400IU+ 5MG+ 40MG+0.5MG+0.6MG | MEDICAL UNION PHARMACEUTICALS -HEAD OFFICE 36 6TH DISTRICT NASR CITY CAIRO EGYPT PLANT ABUSULTAN ISMAILIA | EGYPT | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/2670 | ELDA INTERNATIONAL DMCC | REDDYS PHARMA LIMITED | SENSINIL | LIDOCAINE | 2%W/V | CLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL,1.0X20.0 ML VIAL,1.0X30.0 ML VIAL |
| NDA/MAL/HDP/2671 | CIPLA LTD.. | QUALITY CHEMICALS LTD - HUMAN | DUOLIN RESPULES | IPRATROPIUM BROMIDE & SALBUTAMOL | 500MG + 2.5 MG /2.5ML | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | LUNG ADMINISTRATION LIQUID FOR INHALATION | 4.0X5.0X2.5 ML VIAL |
| NDA/MAL/HDP/2672 | ROTEX MEDICA GBH ARZNEIMITTELI | GITTOES PHARMACEUTICALS LIMITED | LIDOCAINE | LIDOCAINE | 2%W/V | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X25.0X20.0 ML VIAL |
| NDA/MAL/HDP/2673 | PHARMATHEN LTD | GOODMAN INTERNATIONAL LTD | STRADUMEL | ALLOPURINOL | 300MG | PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE | GREECE | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE |
| NDA/MAL/HDP/2675 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | LIBITUS PLUS SYRUP | TERBUTALINE/ BROMHEXINE/ GUAIPHENESIN | 1.25MG/ 4MG/ 50 MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2679 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ALERID SYRUP | CETIRIZINE HYDROCHLORIDE | 5MG/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 SYRUPS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/2680 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMPIREN CAPSULES | AMPICILLIN TRIHYDRATE | 250MG | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/2681 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMOXIREN | AMOXICILLIN TRIHYDRATE | 250MG | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/2683 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | VITAMIN C | ASCORBIC ACID | 100MG | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2685 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEDOL(SUSPENSION) | PARACETAMOL | 120MG/5ML | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2686 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | AMOXYDAR FORTE | AMOXICILLIN TRIHYDRATE | 250MG/5ML | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2687 | M.J BIOPHARM PVT LTD | TATA UGANDA LIMITED | TEICO 1000 | CEFEPIME | 1000MG | M.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL |
| NDA/MAL/HDP/2688 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMOXYN-250 | AMOXICILLIN | 250MG | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2690 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPIMAX-250 | AMPICILLIN | 250MG | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/2691 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | AMPIMAX-500 | AMPICILLIN | 500MG | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X500.0 MG VIAL |
| NDA/MAL/HDP/2692 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | RAMITAS 5 | RAMIPRIL | 5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/2695 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | IDUMSTRA | PARACETAMOL + IBUPROFEN + CAFFEINE | 325MG + 200MG + 40MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2696 | BHARAT SERUMS AND VACCINES LIMITED, | GITTOES PHARMACEUTICALS LIMITED | AMPHOTRET | AMPHOTERICIN B | 50MG | BHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/2697 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | LUCIN OINTMENT | HYDROCORTISONE | 1%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2698 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | AZICIN-500 | AZITHROMYCIN | 500MG | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/2699 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | CARVIL 12.5 | CARVEDILOL | 12.5 MG | CADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2702 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | EUGLIM 2 | GLIMEPIRIDE | 2MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2703 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KOACT 312.50 | CO-AMOXICLAV (AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNATE) | 250+62.50MG/ 5ML | AUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2704 | MACLEODS PHARMACEUTICALS LTD | ROYAL PHARMA 2011 LIMITED | PRIMACORT-100 | HYDROCORTISONE SODIUM SUCCINATE | 100MG | MACLEODS PHARMACEUTICALS LTD-MAHIM ROAD, NEAR KULDEEP NAGAR REGAR(W0 MAHARASHTRA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X100.0 MG VIAL |
| NDA/MAL/HDP/2705 | ASTRAZENECA | MACNAUGHTON LIMITED | PULMICORT NEBULISER | BUDESONIDE | 0.5MG/ML | ASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN | SWEDEN | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X4.0X5.0X2.0 ML VIAL |
| NDA/MAL/HDP/2706 | SOLVAY PHARMACEUTICALS BV | HARLEYS UGANDA LIMITED | DUSPATALIN | MEBEVERINE HCL | 135MG | SOLVAY PHARMACEUTICALS PV-VEERVEG 12 8121 AA 0187
NETHERLAND | NETHERLANDS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/2707 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMCLOXA | CLOXACILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 100.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,10.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/2708 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | HYPER TABLETS | PROPRANOLOL HYDROCHLORIDE | 40MG | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER |
| NDA/MAL/HDP/2710 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AUGMENTIN BD | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/2712 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | ANAWIN | BUPIVACAINE | 0.025%W/V | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/2714 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | ANAFRANIL | CLOMIPRAMINE | 25MG | NOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/2715 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE | LAMIVUDINE | 150MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/2717 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | OCUMYCIN EYE OINTMENT | CHLORAMPHENICOL | 1%W/W | CENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA | INDIA | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE |
| NDA/MAL/HDP/2719 | SEDICO PHARMACEUTICAL CO. | WIDE SPECTRUM ENTERPRISES (U) LIMITED | LORASED | LORATADINE | 10MG | SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2720 | SEDICO PHARMACEUTICAL CO. | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FLUCAMOX 250MG POWDER FOR ORAL SUSPENSION | AMOXICILLIN +FLUCLOXACILLIN | 125MG/5ML+125MG/5ML | SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT | EGYPT | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X80.0 ML BOTTLE |
| NDA/MAL/HDP/2721 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | PRIMAFEN TABLET | IBUPROFEN + PARACETAMOL | 400MG + 325MG | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2722 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | NO SORES | CHOLINE SALICYLATE/LIDOCAINE | 8.7%W/W+2%W/W | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/2724 | UNEED GLOBAL GROUP LIMITED | ASTRA PHARMA (U) LIMITED | CHLORAMPHENICOL 250MG CAPSULES BP | CHLORAMPHENICOL | 250MG | ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2726 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | QUININE INJECTION | QUININE DIHYDROCHLORIDE | 600MG/2ML | ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD-KAIFA ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2730 | MISSION PHARMA A/S INDIA | JOINT MEDICAL STORE (UPMB - UCMB) | TRICLOVERA | MEDROXYPROGESTERONE ACETATE | 150MG/ML | PT TUNGGAI IDAMAN ABDI,-J1.JEND.YANI NO.7 JAKARTA TIMUR | INDONESIA | PARENTERAL ORDINARY I M VIALS | 1.0X20.0X1.0 ML VIAL |
| NDA/MAL/HDP/2734 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | AMLODAR-10 | AMLODIPINE BESILATE | 10MG | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2735 | SQUARE CEPHALOSPORINS LTD | GAMA PHARMACEUTICALS (U) LIMITED | FORCE | CEFPIROME | 1G | SQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL + 1*10 ML AMPOULE WFI |
| NDA/MAL/HDP/2736 | IDA | KIMSY MEDS LTD | FUROSEMIDE | FUROSEMIDE | 20MG/2ML | GLAND PHARMA LTD -GLAND PHARMA LTD D.P PALLY DUNDIGAL HYDERABAD | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0 AMPOULE CARTON |
| NDA/MAL/HDP/2738 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | HEPA-MERZ INFUSION | L-ORNITHINE- L-ASPARTATE | 5MG/ML | WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH | INDIA | PARENTERAL ORDINARY I V VIALS | 1.0X5.0X10.0 ML VIAL |
| NDA/MAL/HDP/2739 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | BISPANOL TABLET | HYOSCINE BUTYLBROMIDE | 10MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2745 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENFORMIN | METFORMIN HYDROCHLORIDE | 500MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2746 | ERIS LTD | BENLE CONSULT LIMITED | ACYCLOVIR DENK 200 | ACYCLOVIR | 200MG | DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X25.0 TABLET BLISTER |
| NDA/MAL/HDP/2749 | CLARIS LIFESCIENCE LTD | REDDYS PHARMA LIMITED | HESTAR-200 PENTASTARCH | HYDROXYETHYLSTARCH | 6%W/V | CLARIS OTSUKA PRIVATE LIMITED-N3 | INDIA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/2751 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | FLUDAC CAPSULES | FLUOXETINE HCL | 20MG | CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X20.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2753 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | PRASIL | METOCLOPRAMIDE HYDROCHLORIDE | 10MG | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2754 | FDC LTD | AIVEEN (U) LIMITED | ZATHRIN 500 | AZITHROMYCIN DIHYDRATE | 500MG | FDC LIMITED -PLOT NO. L121 B VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X3.0 TABLET BLISTER,1.0X50.0X1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/2756 | PFIZER LABORATORIES LTD | LABOREX UGANDA LIMITED | CYTOTEC | MISOPROSTOL | 200MCG | PIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND NE 613YA | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/2760 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DELASED DRY COUGH SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN+SODIUM CITRATE+MENTHOL | 14MG+6.5MG+57MG+2MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2761 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | TRIFLUOPERAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | 5MG | REMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2763 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | CANDISTAT | CLOTRIMAZOLE | 100MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | VAGINAL SUPPOSITORIES | PESSARY STRIP, PESSARY STRIP, KG AMPOULE |
| NDA/MAL/HDP/2765 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | HAEM F | FOLICACID+ VITAMIN B12+IRON AMMONIUM CITRATE | 1MG+5MCG+200MG/15ML | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/2767 | MISSION PHARMA A/S INDIA | JOINT MEDICAL STORE (UPMB - UCMB) | PHENOXYMETHYLPENICILLIN TABLETS BP | PHENOXYMETHYLPENICILLIN | 250MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2768 | ALCON PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ECONOPRED PLUS | PREDNISOLONE ACETATE | 1%W/W | ALCON (PUETRO RICO) LABORATORIES-INC USA | UNITED STATES | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/2770 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | RELISURE | MEFENAMIC ACID | 250MG | WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR
PRADESH - INDIA
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2772 | ASTRAZENECA | MACNAUGHTON LIMITED | TENORMIN | ATENOLOL | 100MG | ASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/2773 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | BISPANOL ELIXIR | HYOSCINE-N-BUTYLBROMIDE | 5MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA, NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2774 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | BACTIFLOX NEO 500 | CIPROFLOXACIN | 500MG | ACINO PHARMA AG.-DORNACHERSTRASSE 114, CH-4147 AESCH, SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2776 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | TENSIMIN-100 | ATENOLOL | 100MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,14.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2777 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CO-DIOVAN 160/12.5MG TABLETS | VALSARTAN + HYDROCHLOROTHIAZIDE | 160MG + 12.5MG | NOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/2779 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | PYODINE SURGICAL SCRUB | POVIDONE IODINE | 7.5%W/V | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X450.0 ML BOTTLE |
| NDA/MAL/HDP/2780 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CO-DIOVAN 160/25MG TABLETS | VALSARTAN + HYDROCHLOROTHIAZIDE | 160 MG + 25MG | NOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND,NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/2781 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | CARVETAS 6.25 | CARVEDILOL | 6.25MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2782 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | KWINIL | QUININE DIHYDROCHLORIDE | 300MG/ML | INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 20.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/2783 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SUPPOSITORIES 25MG | DICLOFENAC SODIUM | 25MG | DELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X10.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/2784 | MISSION PHARMA A/S | JOINT MEDICAL STORE (UPMB - UCMB) | AMOXICILLIN ORAL SUSPENSION | AMOXICILLIN | 125MG/5ML | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2787 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | AMOXICILLIN TABLETS FOR ORAL SUSPENSION | AMOXICILLIN | 125MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2788 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | MULTIVITAMIN TABLETS | MULTIINGREDIENT | N/A | RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2790 | UNICHEM LABORATORIES LIMITED? | EUROPA HEALTHCARE (U) LTD | TG-TOR 20 | ATORVASTATIN | 20MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2792 | UNICHEM LABORATORIES LIMITED? | EUROPA HEALTHCARE (U) LTD | TG-TOR 10 | ATORVASTATIN | 10MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2793 | GILEAD SCIENCE INC | MEDICAL ACCESS (UGANDA) LIMITED | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 300MG | PATHEON 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 TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2796 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | BENZYLPENICILLIN INJECTION | BENZYLPENICILLIN SODIUM | 1,000,000I.U | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/2797 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | LUMAREN | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X8.0 TABLET BLISTER |
| NDA/MAL/HDP/2798 | UMEDICA LABS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | OMEGARD | OMEPRAZOLE | 20MG | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2799 | IVEE AQUA EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYCHLORNICOL EAR DROPS | CHLORAMPHENICOL | 5%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OTIC DROPS | 1.0X5.0 ML BOTTLE,1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/2800 | NOVO NORDISK | STAR PHARMACEUTICALS LTD | ACTRAPID HM PENFILL | HUMAN INSULIN | 100 I.U/ML | NOVO NORDISK PHARMA-NOVO ALLE | DENMARK | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.5 ML PREFILLED PEN,1.0X3.0 ML PREFILLED PEN |
| NDA/MAL/HDP/2802 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | TASOL | CLOBETASOL | 0.05%W/W | CENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2805 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | NIFELAT 20R TABLETS | NIFEDIPINE | 20MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2806 | RENE INDUSTRIES LIMITED | RENE PHARMACY LTD | PHENOBARBITONE TABLETS | PHENOBARBITONE | 30MG | CYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2807 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | ASAQ GPSC | ARTESUNATE + AMODIAQUINE | 100 MG + 270 MG | GUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/2809 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | MAITRI | PEG 150OBP/ PEG 1000BP | 1280MG/ 320MG | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | VAGINAL TABLETS | 1.0X5.0 PESSARY STRIP |
| NDA/MAL/HDP/2811 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | SULPHUR OINTMENT | SULPHUR PRECIPITATED | 10%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/2812 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | CO-ARTESIANE | BETA ARTEMETHER + LUMEFANTRINE | 180 MG/60ML + 1080 MG/60ML | MANUFACTURING PACKAGING FARMACIA APPELHOF OUDEHASK-NETHERLANDS | NETHERLANDS | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2813 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | INTACYCLINE SKIN OINTMENT | TETRACYCLINE HYDROCHLORIDE | 3%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2816 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CATENOL-100 TABLETS | ATENOLOL | 100MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2820 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | VALODIN 500MG CAPSULES | CEPHADRINE | 250MG | HILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN. | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X6.0 CAPSULE STRIP |
| NDA/MAL/HDP/2821 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DIOLIN-M | GLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS | 5MG+500MG | LINCOLN PHARMACEUTICAL LIMITED..-LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2826 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PIRITON SYRUP | CHLORPHENIRAMINE MALEATE | 4MG/10ML | GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X2.0 L BOTTLE |
| NDA/MAL/HDP/2830 | MEDIPHARM SALES (E.A) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | QUINIMIX MIXTURE | QUININE HYDROCHLORIDE | 100MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD (BWEYOGERERE) | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2832 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | OLFEN 100 RECTOCAP | DICLOFENAC | 100MG | R P SCHERER GMBH & CO. EBERBACH BALEN-R P SCHERER GMBH & CO. EBERBACH BALEN | GERMANY | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/2835 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | SOLUDINE-M | POVIDONE IODINE / METRONIDAZOLE | 5%W/W / 1%W/W | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE,1.0X125.0 G TUBE |
| NDA/MAL/HDP/2837 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GRAMOFIL TABLETS | NALIDIXIC ACID | 500MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2838 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | DILCONTIN XL 120 | CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE | 120MG | MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/2848 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIPROGENTA OINTMENT | BETAMETHASONE /GENTAMICIN SULPHATE | 0.5MG/G+1.0MG/G | SCHERING-PLOUGH LABONV-INDUSTRIE PARK 30, B-220 HEIST-OP-DEN-BERG, BELGIUM | CANADA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/2850 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DISPERCAM | PIROXICAM | 20MG | MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT | EGYPT | PARENTERAL ORDINARY AMPOULES | 1.0X3.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/2852 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | LEK-500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | BLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK MAHARASHTRA 422010 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2858 | GLAXOSMITHKLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | VIBROCIL | PHENYLEPHRINE + DIMETHINDENE MALEATE | 0.25% W/V + 0.025% W/V | NOVARTIS CONSUMER INT. INC.-ZYMASA-CH-1260, NYON SWITZERLAND | SWITZERLAND | NASAL TOPICAL DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/2863 | KWALITY AFRO-ASIA LTD | KWALITY AFRO ASIA LIMITED | K-MOL | PARACETAMOL | 120MG/5ML | KWALITY AFROASIA LTD-KAWEMPE | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2867 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII RABIVAX | RABIES VACCINE | 2.5I.U/ML | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/2868 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | LOSACAR 50 | LOSARTAN POTASSIUM | 50MG | CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2869 | GLAXO SMITHKLINE LTD | ERIS LTD | PRIORIX VACCINE | MEASLES + MUMPS + RUBELLA | 103.0CCID50 + 103.7CCID50 + 103.0CCID50 | GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY DRY VIALS | 1.0X0.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/2873 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | HELIGO KIT | TINIDAZOLE/CLARITHROMYCIN/LANSOPRAZOLE | 500MG+ 250MG+30MG | INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X7.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/2875 | GLAXOSMITHKLINE LIMITED- | UNITED HEALTHCARE DISTRIBUTORS LTD | OTRIVIN 0.05% NASAL DROPS | XYLOMETAZOLINE | 0.05%W/V | NOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND | SWITZERLAND | NASAL TOPICAL DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/2878 | PHARCO PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FARCOCIN CREAM | GENTAMYCIN SULPHATE | 0.1%W/W | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/2879 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | OFLIN-200 | OFLOXACIN | 200MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X20.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2880 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CARBIMAZOLE 5 | CARBIMAZOLE | 5MG | REMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2882 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | HYOSCINE BROMIDE | HYOSCINE BROMIDE | 2OMG/ML | GLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/2884 | NOVARTIS PHARMA SERVICES INC | ERIS LTD | HYCAMTIN | TOPOTECAN HYDROCHLORIDE | 4MG | GLAXOSMITHKLINE MANUFACTURING S.P.A-STRADA PROVINCIALE ASOLANA, 9043056 SAN POLO DI TORRILE,PARMA ITALY
| ITALY | PARENTERAL ORDINARY VIALS | 1.0X5.0X17.0 ML VIAL |
| NDA/MAL/HDP/2885 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | FORECOX-TRAC | RIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL | 150MG + 75MG+ 400MG + 275MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/2887 | MISSION PHARMA A/S | JOINT MEDICAL STORE (UPMB - UCMB) | QUININE SULPHATE | QUININE SULPHATE | 300MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2888 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | SUCCICORT | HYDROCORTISONE SODIUM SUCCINATE | 100MG/VIAL | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0 MG VIAL |
| NDA/MAL/HDP/2890 | KPI INDUSTRIES(1996) LTED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | BETASOL N | BETAMETHASONE+NEOMYCIN | 1MG/G+5MG/G | KPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2891 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | TORVAST 20 | ATORVASTATIN | 20MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2892 | UNIQUE PHARMACEUTICAL LABORATORIES | TATA UGANDA LIMITED | NICARDIA-20 TABLETS | NIFEDIPINE | 20MG | UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI ? 394 116, GUJARAT, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2893 | DAWA LIMITED | SUPER MEDIC LTD | STOPACID SUSPENSION | MAGNESIUM TRISILICATE + ALUMINIUM HYDROXIDE | 250MG/5ML + 120MG/5ML | DAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2894 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MUCOGEL SUSPENSION | DRIED ALUMINIUM HYDROXIDE + MAGNESSIUM HYDROXIDE + OXETHAZAINE | 8G/100ML + 2G/100ML + 0.2 G/100ML | EGYPIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO EIPICO-10TH OF RAMADAN CITY-FIRST INDUSTRIAL AREA -EGYPT | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X125.0 ML BOTTLE |
| NDA/MAL/HDP/2896 | KPI INDUSTRIES(1996) LTED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | MCG CREAM | MICONAZOLE NITRATE BP + CLOBETASOL PROPIONATE BP + GENTAMYCIN SULPHATE | 2.0%W/W + 0.05%W/W + 0.1 %W/W | KPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X25.0 G TUBE |
| NDA/MAL/HDP/2897+A823 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | STORILAT | CARBAMAZEPINE | 200MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2898 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | TORVAST 10 | ATORVASTATIN | 10MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2900 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-O-200 | CEFIXIME | 200MG | MICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2902 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | MEGALIS-20 | TADALAFIL | 20MG | MACLEODS PHARMACEUTICALS LIMITED (BLOCK ?N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X15.0X1.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/2903 | STRIDES ARCOLAB LIMITED | DELMAW ENTERPRISES LIMITED | ABACAVIR SULPHATE TABLETS | ABACAVIR SULFATE | 300MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/2904 | PHARMATHEN LTD | GOODMAN INTERNATIONAL LTD | NELTOLON SOLUTION | BIFONAZOLE | 10MG | PHARMATHEN LTD.-6 DERVENAKION STR. 153 51 PALLINI-GREECE | GREECE | TOPICAL EXTERNAL LIQUIDS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/2905 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BRONCHOPHANE SYRUP | GUAIPHENESIN+EPHEDRINE HYDROCHLORIDE+DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN | 50MG+7.5MG+5MG+4.58MG | EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. EIPICO-10TH STREET RAMADAN CITY, FIST INDUSTRIES ARE | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X125.0 ML BOTTLE |
| NDA/MAL/HDP/2906 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | RIFAMPICIN/ISONIAZID/ETHAMBUTOL | RIFAMPICIN+ISONIAZID+ETHAMBUTOL | 150MG+75MG+275MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/2907 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART DS | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | BLISS 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 TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/2908 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | PAINGO MEDICATED CREAM | METHYLSALICYLATE+CAPSICUM OLEORESIN+TURPENTINE OIL | 15%W/W + 1%W/W + 1.47%W/W | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X2.0X15.0 G TUBE |
| NDA/MAL/HDP/2910 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | TENVIR EM | TENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE | 300MG+200MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2911 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL LORATADINE | LORATADINE | 10MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2912 | FDC LTD | AIVEEN (U) LIMITED | MYCODERM | SALICYLIC ACID + BENZOIC ACID | 3%W/W + 6%W/W | FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | TOPICAL EXTERNAL POWDERS | 1.0X100.0 G CONTAINER |
| NDA/MAL/HDP/2914 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | CHLOROCIDE SYRUP | CHLORAMPHENICOL PALMITATE | 125MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2915 | VENUS REMIDIES LTD | HARLEYS UGANDA LIMITED | TREXOL | METHOTREXATE | 50MG | VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X2.0 ML VIAL |
| NDA/MAL/HDP/2917 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | CETAMOL TABLETS | PARACETAMOL | 500MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP,1.0X100.0X10.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2919 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ODIMONT 5 | MONTELUKAST | 5MG | CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210 | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2920 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | TRANSLIPO -C CREAM | CLOTRIMAZOLE | 1%W/W | CENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X20.0 G TUBE,1.0X10.0 G TUBE |
| NDA/MAL/HDP/2923 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | COLD PLUS SYRUP | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE | 125MG + 2.5MG + 2.5MG/ 5ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2926 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | TETRACYCLINE 250MG CAPSULES BP | TETRACYCLINE | 250MG | ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2934 | ASTRA LIFE CARE PVT LTD | ASTRA PHARMA (U) LIMITED | ASTOLON | PREDNISOLONE | 5MG | ASTRA LIFE CARE PVT LTD-57/P RAJODA-382220 BAVIA AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/2936 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | FEMIN-P | NYSTATIN | 100,000IU | ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA | INDIA | VAGINAL TABLETS | 1.0X15.0 PESSARY BLISTER |
| NDA/MAL/HDP/2937 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | PEN-A-CLOX CAPSULES | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2938 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CLOXIL-250 CAPSULES | CLOXACILLIN | 250MG | AUROBINDO PHARMA LIMITED UNIT -SURVEY NO. 314, BACHUPALLY, QUTHUBULLAPUR (MANDAL),
R.R - DISTRICT, HYDERABAD ? 500 072, AP ? INDIA
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2939 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASTODIUM | LOPERAMIDE HYDROCHLORIDE | 2MG | ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2940 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENZOX 5 GEL | BENZOYL PEROXIDE | 5%W/W | CENTAUR PHARMACEUTICALS LTD- PLOT NO. 39 TIVIN IN
| INDIA | TOPICAL EXTERNAL OTHER GELS/SOLS | 1.0X2.0 G TUBE |
| NDA/MAL/HDP/2941 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ATORVA 20 | ATORVASTATIN | 20MG | CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/2942 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | ARGISSEPT CREAM | CHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE | 0.2%W/W / 1%W/W | CENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE,1.0X10.0 G TUBE |
| NDA/MAL/HDP/2943 | SCHERING N.V.SA... | SURGIPHARM (U) LIMITED | SCHERIPROCT OINTMENT | PREDNISOLONE CAPROATE + CINCHOCAINE HYDROCHLORIDE | 1.9MG/G + 5MG/G | BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY | ITALY | RECTAL SYSTEMIC UNIT DOSE OINTMENTS AND PASTES | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/2945 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | ONCET | CETIRIZINE DIHYDROCHLORIDE | 10MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2946 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO ORAL SUSPENSION(THANE) | CO-TRIMOXAZOLE | 240MG/5ML | 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 SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2947 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO TABLETS | CO-TRIMOXAZOLE | 480MG | AGOG 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 TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X250.0 BLISTER CARTON |
| NDA/MAL/HDP/2948 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | METFORMIN DENK 850 | METFORMIN HYDROCHLORIDE | 850MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X15.0 TABLET BLISTER,1.0X8.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/2949 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | FUNGNIL V TABLET | CLOTRIMAZOLE | 100MG | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP |
| NDA/MAL/HDP/2950 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | XALATAN | LATANOPROST | 0.005%W/V | PFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURS | BELGIUM | OPHTHALMIC DROPS | 1.0X2.5 ML BOTTLE |
| NDA/MAL/HDP/2951 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART FORTE TABLETS | ARTEMETHER + LUMEFANTRINE | 40 MG + 240 MG | BLISS 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 TABLETS | 1.0X10.0X2.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/2954 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | VELORIN 100 F.C TABLETS | ATENOLOL | 100MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2955 | SHAIGAN PHARMACEUTICALS (PVT) LTD | HEALTHCARE LTD. | CLOZOX | CLOTRIMAZOLE | 2%W/W | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | VAGINAL CREAMS | 1.0X1.0X35.0 G TUBE + TWO APPLICATORS |
| NDA/MAL/HDP/2956 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | TRANLOK 500MG TABLETS | TRANEXAMIC ACID | 500MG | ARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2957 | MEDIPHARM SALES (E.A) LTD | ABACUS PHARMA (AFRICA) LIMITED | MEDITROL | CALCITRIOL | 0.25MCG | MEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0X5.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2959 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | CETAMOL SYRUP | PARACETAMOL | 120MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/2960 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | CLAVODAR | AMOXICILLIN/CLAVULANIC ACID | 400MG/57MG | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY GRANULES | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/2961 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | OFTALMOLOSA CUSI ERYTHROMYCIN 0.5% | ERYTHROMYCIN | 0.5%W/W | ALCON CUSI SA-CAMIL FABRA 58 08320 EL MASNOUR BARCELONA | SPAIN | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE |
| NDA/MAL/HDP/2962 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASTIDIN | CIMETIDINE | 200MG | ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA
382220 BAVIA
AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2966 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | TENVIR | TENOFOVIR DISOPROXIL FUMARATE | 300MG | CIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/2969 | UNIQUE PHARMACEUTICALS LTD | TATA UGANDA LIMITED | TENSIMIN-50 | ATENOLOL | 50MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,14.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2970 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GLYCOMET 500 | METFORMIN | 500MG | FREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2971 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | LEFRA-20 TABLETS | LEFLUNOMIDE | 20MG | TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2972 | SHAIGAN PHARMACEUTICALS LTD | HEALTHCARE LTD. | ANTIMIN SYRUP | LORATIDINE | 5MG/ML | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2974 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | TRAVATAN | TRAVOPROST | 4?G/ML | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X2.5 ML VIAL |
| NDA/MAL/HDP/2978 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | TETAVAX | TETANUS VACCINE | 40 I.U | SANOFI 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 SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE) |
| NDA/MAL/HDP/2979 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM N CREAM | BETAMETHASONE VALERATE + NEOMYCIN | 0.1%W/W + 0.5%W/W | ATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/2980 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART TABLETS | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | BLISS 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 TABLETS | 1.0X10.0X3.0X8.0 TABLET BLISTER |
| NDA/MAL/HDP/2981 | SHAIGAN PHARMACEUTICALS (PVT) LTD | HEALTHCARE LTD. | STAMIN | CETIRIZINE DIHYDROCHLORIDE | 1MG/ML | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/2982 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | NEURO-FORTE TABLETS | VITAMIN B1 + VITAMIN B6 + VITAMIN B12 | 200MG + 50MG + 1MG | CENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2983 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | FORCAN-200 | FLUCONAZOLE | 200MG | CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X1.0X4.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2985 | SANOFI WINTHROP LTD | LABOREX UGANDA LIMITED | EPILIM CHRONO | SODIUM VALPROATE PH. EUR | 500MG | SANOFI WINTHROP INDUSTRIE-1,RUE DE LA VIERGE ,AMBARES ET LAGRAVE 33565,CARBON BLANC CEDEX FRANCE | FRANCE | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2986 | GLAXO WELLCOME(KENYA) LTD | ERIS LTD | OXYBRAL SR | VINCAMINE | 30MG | GLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO | EGYPT | ORAL SOLID RETARD CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/2987 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | SALDOPA | METHYLDOPA | 250MG | STRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAVADI CROSS ANECAL TULK BANGALORE 562 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2990 | MICRO LABS LTD | LABOREX UGANDA LIMITED | PULMOCEF-500 | CEFUROXIME AXETIL USP | 500MG | MICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/2991 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | LIPOR | ATORVASTATIN | 20MG | ASTRA 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 TABLETS | 1.0X2.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/2992 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | HAVRIX1440 | HEPATITIS A ANTIGEN(HM 175 STRAIN) | NLT 1440 ELISA UNITS OF VIRAL ANTIGENS(HM 175 STRAIN) | SMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUM | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/2993 | SCHERING N.V.SA... | SURGIPHARM (U) LIMITED | TRAVOCORT | DIFLUCORTOLONE VALERATE + ISOCONAZOLE NITRATE | 0.1% + 1% W/W | BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY | ITALY | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/2995 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | GALLOP | LOPERAMIDE HYDROCHLORIDE USP | 2MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/2997 | MEDLEY PHARMACEUTICALS | MEDVIN PHARMA LIMITED | ACENAC TABLETS | ACECLOFENAC | 100 MG | MEDLEY 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2998 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | FITIN-5 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI
CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/2999 | MISSION PHARMA A/S INDIA | JOINT MEDICAL STORE (UPMB - UCMB) | AMOXICILLIN | AMOXICILLIN TRIHYDRATE | 250MG | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO. LTD-NO. 6 HYANXING RD ZNONGHU SHIJIAZHUANG | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3002 | LEBEN LABORATORIES LTD | ANDYCO PHARMACY (UGANDA) LTD | KELVIN | PARACETAMOL | 500MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3003 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOVIR | ACICLOVIR | 200MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3005 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | OLFEN-100 SR DEPOCAPS | DICLOFENAC SODIUM | 100MG | ACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BL | SWITZERLAND | ORAL SOLID RETARD CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3007 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | TORTAS 5 | TORSEMIDE | 5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3008 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | BLEOSOL | BLEOMYCIN | 15 UNITS | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/3009 | VENUS REMEDIES LIMITED | HARLEYS UGANDA LIMITED | SULBACTOMAX 1.5G | CEFTRIAXONE+SULBACTAM | 1000MG+500MG | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/3011 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | GYNEST | CLOTRIMAZOLE | 100MG | ASTRA LIFE CARE (INDIA) PVT-PLOT 57 ROJADA382220, BAVLA AHMEDABAD INDIA | INDIA | VAGINAL TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3012 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL TABLETS | DICLOFENAC SODIUM | 50MG | WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR
PRADESH - INDIA
| INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3013 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOZOLE | ALBENDAZOLE | 400MG | AGOG 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 TABLETS | 1.0X1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/3015 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | PENEGRA-50 TABLETS | SILDENAFIL | 50MG | CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3017 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | LIDOCAINE INJECTION | LIDOCAINE HYDROCHLORIDE | 20MG/ML | ZHEJIANG RUIXIN PHARMACEUTICALS CO LTD-KAIFA ROAD TIANNING IDOUS ZONE LISHUI CITY | CHINA | PARENTERAL ORDINARY VIALS | 1.0X25.0X20.0 ML VIAL |
| NDA/MAL/HDP/3018 | ROYAL PHARMA 2011 LIMITED | SINO AFRICA MEDICINES & HEALTH LTD | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG/3ML | KIVI PHARM CO. LTD-DONGSHAN HIGH TECH INDUSTRIAL DEVELOPMENT ZONE,XUANHUA,ZHANGJIAKOU CITY,HEBEI CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/3019 | MJ BIOPHARM PRT LTD | TATA UGANDA LIMITED | BIOSULIN 30/70 | INSULIN SOLUBLE + INSULIN ISOPHANE | 30 I.U + 70 I.U | MJ BIOPHARM PRT LTD-L-7 MIDC INDUSTRIAL AREA, TALOJA, NARI MUMBAI MAHARASHTRA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3020 | M.J BIOPHARM PVT LTD | TATA UGANDA LIMITED | BIOSULIN N | INSULIN ISOPHANE | 100 I.U/ML | M.J .BIOPHARM-L7, M.I.D.C INDUSTRIAL AREA TALOJA, NAVI MUMBAI MAHARAHTRA | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3021 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | GLIBENCLAMIDE TABLETS | GLIBENCLAMIDE | 5MG | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3022 | M.J BIOPHARM PVT LTD | TATA UGANDA LIMITED | BIOSULIN L | INSULIN ZINC SUSPENSION | 100 I.U/ML | M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3023 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOTRAX | LEVAMISOLE HYDROCHLORIDE | 40MG | AGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP,1.0X10.0X1.0X3.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/3024 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | 150MG + 200MG + 300MG | MYLAN 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 TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/3026 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL DETROMETHORPHAN-15 SYRUP | DEXTROMETHORPHAN HYDROBROMIDE | 15MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3029 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOZOLE SUSPENSION | ALBENDAZOLE USP | 200 MG/ 5 ML | 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 SUSPENSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/3030 | MJ BIOPHARM PVT LTD | TATA UGANDA LIMITED | BIOSULIN R | INSULIN SOLUBLE | 100 IU/ML | M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3031 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOMETHASONE | DEXAMETHASONE | 0.5MG | AGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3032 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | XYLO-ACINO 0.05% | XYLOMETAZOLINE | 0.05%W/V | MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/3033 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | PENAMOX | AMOXICILLIN | 125MG/5ML | MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3035 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOFORTE TONIC | FERRIC AMMONIUM + FOLIC ACID + PYRIDOXINE + THIAMINE | 50 MG + 0.55 MG + 2.4 MG + 1.2 MG | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3036 | BETA HEALTHCARE UGANDA LIMITED | BETA HEALTHCARE UGANDA LIMITED | ASPIRIN TABLETS | ACETYL SALICYLIC ACID | 300MG | BETA HEALTH CARE INTERNATIONAL LTD-INDUSTRIAL AREA BONDO RD PLOT NO.7261/207 NAIROBI KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X200.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3037 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOVIT SYRUP | MULTI-INGREDIENT | N/A | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3040 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGODOX | DOXYCYCLINE | 100MG | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3041 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | LEVOFLOXACIN | LEVOFLOXACIN | 250MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3043 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | FEBREX TABLETS | PARACETAMOL | 500MG | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3044 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | PIRICAM-20 CAPSULES | PIROXICAM | 20MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3045 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | BRAMESTON 2.5 | BROMOCRIPTINE MALEATE | 2.5MG | REMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3046 | GLAXO SMITHLINE LIMITED | ERIS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 400 MG + 57 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/3047 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ABACAVIR SULFATE+LAMIVUDINE+ZIDOVUDINE | ABACAVIR SULFATE + LAMIVUDINE + ZIDOVUDINE | 300 MG + 150 MG + 300 MG | MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13
MIDC, WALUJ INDUSTRIAL AREA,
AURANGABAD. ? 431136,
MAHARASHTRA STATE, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/3048 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | TRIMAGO-DS TABLETS | SULFAMETHOXAZOLE/TRIMETHOPRIM | 800MG/160MG | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3049 | CIPLA LTD.. | QUALITY CHEMICALS LTD - HUMAN | EFAVIRENZ | EFAVIRENZ | 600MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/3051 | BETA HEALTHCARE | BETA HEALTHCARE UGANDA LIMITED | BETROZOLE | DILOXANIDE FUROATE/METRONIDAZOLE | 25MG/ML + 20MG/ML | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3054 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | NOSIC | DOXYLAMINE SUCCINATE + PYRIDOXINE HYDROCHLORIDE | 10MG+10MG | INDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3055 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ABACAVIR SULFATE | ABACAVIR SULPHATE | 300MG | CIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/3056 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASCAF | CHLORAMPHENICOL | 250MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, SARKEJ BAVLA HIGHWAY RAJODA AHMEDABAD 382220, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3057 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | COLD-A-GO CAPSULES | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + DIPHENHYDRAMINE + CAFFEINE | 400MG + 5MG + 12.5MG + 30MG | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3058 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | XATRAL LP 10MG | ALFUZOSIN | 10MG | SANOFI WINTHROP INDUSTRIE,-30-36, AVENUE GUSTAVEEIFFEL BP 27166 - 37071 TOURS CEDEX 2 | FRANCE | ORAL SOLID ORDINARY COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3060 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | KETOS TABLET | KETOCONAZOLE USP | 200 MG | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3062 | CIPLA | QUALITY CHEMICALS LTD - HUMAN | LAMIVUDINE,ZIDOVUDINE, NEVIRAPINE | LAMIVUDINE/ZIDOVUDINE/NEVIRAPINE | 150MG + 300MG + 200MG | CIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE ?II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH,CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/3063 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODIC-50 | DICLOFENAC SODIUM | 50MG | AGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3064 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | TIN-TIN TABLETS | TINIDAZOLE | 500MG | AGOG 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 TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3067 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | PROMAGO SYRUP | PROMETHAZINE | 5MG/5ML | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3068 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | OPTACHLOR EYE DROPS | CHLORAMPHENICOL | 0.5%W/V | REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3069 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOMOVE CAPSULES | PIROXICAM | 20MG | AGOG 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 CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3070 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | AMBRODIL | AMBROXOL HYDROCHLORIDE | 30MG | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3072 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL TABLETS(THANE) | PARACETAMOL | 500 MG | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3073 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CARDINOL TABLET | ATENOLOL | 50MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X14.0 TABLET STRIP |
| NDA/MAL/HDP/3076 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS 40 | TELMISARTAN | 40MG | ARISTO PHAMACUTLAB PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3077 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | UNISTEN HC CREAM | CLOTRIMAZOLE + HYDROCORTISONE | 1%W/W + 1%W/W | REGAL PHERMACUTICALS -PLOT 7879/18 OFF BABA RWARAKA NAIROBI KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/3078 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SINUTAB ALLERGY CONGESTION | PARACETAMOL/ CHLORPHENIRAMINE/ EPHEDRINE | 500MG/ 2MG/ 30MG | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3079 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | CO-AMOX ACINO 457 | CO-AMOXICLAV | 400MG+47MG/ 5ML | LEK D.D PREVALJE SDOVENIA-DORNACHERSTASSE 144 P.O.BOX 445,CH 4147 AESCH (BASEL) SWITZERLAND | SWITZERLAND | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/3080 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | CO-AMOX ACINO 156.25 | CO-AMOXICLAV | 125MG+31.25MG/ 5ML | LEK D.D PREVALJE SDOVENIA-DORNACHERSTASSE 144 P.O.BOX 445,CH 4147 AESCH (BASEL) SWITZERLAND | SWITZERLAND | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3083 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS 80 | TELMISARTAN | 80MG | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3084 | CIPLA LIMITED | QUALITY CHEMICALS LTD - HUMAN | NEVIRAPINE | NEVIRAPINE | 200MG | CIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/3085 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCOLD TABLETS | PARACETAMOL+PHENYLEPHRINE HCL+CAFFEINE+CHLORPHENIRAMINE HYDROCHLORIDE | 500.MG+5.0MG+30.0MG+2.0MG | AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3087 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | SULPHATRIM TABLETS B.P. 480 | CO-TRIMOXAZOLE | 480MG | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3088 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | PILL 72 | LEVONORGESTREL | 0.75MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/3090 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFODOX | CEFPODOXIME PROXETIL | 100MG/5ML | PHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/3091 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | ONDI | ONDANSETRON | 2MG/ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3092 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | EXFORGE HCT 10MG/160MG/12.5MG | AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE | 10MG + 160MG +12.5MG | NOVARTIS 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 TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/3095 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | AMPHEN SUSPENSION | CHLORAMPHENICOL PALMITATE | 125MG/5ML | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3097 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | DEBACRON | GLICLAZIDE | 80MG | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BLISTER |
| NDA/MAL/HDP/3098 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MOSEDIN | LORATADINE | 5MG/5ML | AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT. | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3099 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | ZONA 0.1% CREAM | HYDROCORTISONE 17-BUTYRATE | 0.1%W/W | PHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE |
| NDA/MAL/HDP/3101 | DAWA LIMITED | SUPER MEDIC LTD | DACOLD SYRUP | PARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE | 120MG/5ML+10MG/5ML+2MG/5ML | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3102 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | EPANUTIN READY MIXED | PHENYTOIN SODIUM | 50MG/ML | ACTAVIS ITALY S.P.A-VIALE PASTEUR, 10 20014 NERVIANO(MILAN) - ITALY | ITALY | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/3104 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | NYSTALEB ORAL SUSPENSION | NYSTATIN | 100000IU/ML | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/3105 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | DEPIN-E RETARD | NIFEDIPINE | 20MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3106 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | LABOREX UGANDA LIMITED | PENAMOX | AMOXICILLIN | 250MG/5ML | MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3108 | IPCA LABORATOIES LTD | MEDVIN PHARMA LIMITED | ZERODOL | ACECLOFENAC | 100MG | IPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3110 | VENUS REMEDIES LIMITED | AARON PHARMACEUTICALS LTD | ZYDOTUM | CEFTAZIDIME + SULBACTAM | 1000 MG + 500 MG | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/3111 | GLAXOSMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CALPOL | PARACETAMOL | 120MG/5ML | GLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3112 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | BUPROL 400MG | IBUPROFEN BP | 400 MG | HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3113 | ROTEX MEDICA GBH ARZNEIMITTELI | GITTOES PHARMACEUTICALS LIMITED | PANCURONIUM | PANCURONIUM BROMIDE | 4MG/2ML | ROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAU | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3116 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | KLOXY | CLOXACILLIN | 125MG/5ML | LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3118 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LUMARTEM | ARTEMETHER /LUMEFANTRINE | 20MG /120MG | QUALITY CHEMICAL INDUSTRIES LIMITED. -PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3122 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GROVIT | MULTI-INGREDIENT | MULTI-INGREDIENT | REMIDEX PHARMA PVT LTD- B-249+ 250 II STAGE PEENYA INDUSTRIAL ESTATE BANGLORE 560058. | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3123 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | RECTOL 250 SUPPOSITORY | PARACETAMOL BP | 250 MG | BLISS GVS PHARMA LIMITED-PLOT NO. 10/11 SURVEY NO.39/1 DEWAN UDYOG
NAGAR ALIYALI VILLAGE TAL PALGHAR
DIST. THANE 401404 MAHARASHTRA
INDIA | INDIA | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/3125 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | AMLODAR 5 | AMLODIPINE BESILATE | 5MG | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3127 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | DIDANOSINE DELAYED - RELEAS | DIDANOSINE DELAYED RELEASE | 250MG | AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID RETARD CAPSULES | 1.0X30.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3134 | PANACEA BIOTEC LTD | ABACUS PHARMA (AFRICA) LIMITED | TOFF PLUS | PARACETAMOL+CHLORPHENIRAMINE MALEATE+ DEXTROMETHORPHAN + PHENYLEPHRINE | 500 MG + 2 MG + 15 MG + 10 MG | PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3136 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/3138 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANUSOL SUPPOSITORY | BISMUTH SUBGALLATE + BISMUTH OXIDE + ZINC OXIDE | 59 MG + 24 MG + 296 MG | PERFORMANCE HEALTH LTD-241 NAIN ROAD RETREAT SOUTH AFRICA 7945 | SOUTH AFRICA | TOPICAL EXTERNAL SUPPOSITORIES | 1.0X10.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/3139 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | OMEDAR | OMEPRAZOLE | 20MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/3140 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | ULTIVA INJECTION 1MG | REMIFENTANIL | 1ML | GLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONA | ITALY | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/3141 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | AMLOPRESS-5 | AMLODIPINE BESYLATE | 5MG | CIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3143 | MJ BIOPHARM PVT LTD | TATA UGANDA LIMITED | OMIPIX 20 | OMEPRAZOLE | 20 MG | M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3144 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | ULSEC | OMEPRAZOLE | 20MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/3145 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AMOXICAP | AMOXYCILLIN | 500MG | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3147 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ARISTO TELVAS-H 40/12.5 | TELMISARTAN/HYDROCHLOROTHIAZIDE | 40MG/12.5MG | ARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3148 | BAYER AG | SURGIPHARM (U) LIMITED | ALKA-SELTZER | ACETYL SALICYLIC ACID + SODIUM HYDROGEN CARBONATE + CITRIC ACID | 342 MG + 1625 MG + 965 MG | BAYER BITTERFIELD GMBH- -ORTSEIL GREPPIN SALEGASTER CHAUSSEE 1,06803, BITTERFIELD WOLFEN, GERMANY | GERMANY | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X72.0 TABLET STRIP,1.0X10.0 TABLET STRIP,1.0X20.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/3150 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | MTX-VHB | METHOTREXATE | 50MG/2ML | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X2.0 ML VIAL |
| NDA/MAL/HDP/3151 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | CLOTRINE 100 MG PESSARIES | CLOTRIMAZOLE | 100MG | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP |
| NDA/MAL/HDP/3153 | M.J BIOPHARM PVT LTD | TATA UGANDA LIMITED | CEFUROXIME-MJ | CEFUROXIME | 750MG | M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3155 | MEDREICH PLC | LABOREX UGANDA LIMITED | BIOFERON | FERRIC AMMONIUM CITRATE + CYANOCOBALAMIN + FOLIC ACID | 200MG/5ML + 10MG/5ML + 750MCG/5ML | MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062,TEJKAMAL PHARMACEUTICALSPVT. LTD--SURVEY NO. 6/2, ALADAHALLI VILLAGE, SOMAPURA HOBCI NELAMANGALA TALUKI BANGALORE RURAL | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/3156 | PFIZER LABORATORIES (PTY) | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN FOR COLDS | PSEUDOEPHEDRINE HCL + IBUPROFEN | 30MG + 200MG | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3158 | MJ BIOPHARM PVT LTD | TATA UGANDA LIMITED | GLIBEX-5 | GLIBENCLAMIDE | 5MG | M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3161 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASCILLIN | AMPICILLIN | 250MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3162 | M.J BIOPHARM PST LTD | TATA UGANDA LIMITED | KLAROL | LORATADINE | 10MG | M.J BIOPHARM PVT LTD --L-7 MIDC TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3163 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SUPPOSITORIES 50MG | DICLOFENAC SODIUM | 50MG | DELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X1.0X10.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/3165 | MEDREICH PLC | LABOREX UGANDA LIMITED | MUCODIL EXPECTORANT | TERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE + GUAIFENESIN | 2.5MG + 8MG + 100MG | MEDREICH LTD-4/3 OFF KANAPURA ROAD, AVALAHALLI, A, TEJKAMAL PHARMACEUTICAL PVT, SURVEY NO.6/2 ALADAHALLI,SOMAPURAHOBIL,NELAMANGALA TALUK,BANGALORE RURAL-562111,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3166 | PHARMACARE LTD | BETA HEALTHCARE UGANDA LIMITED | SEPTRIN | TRIMETHOPRIM + SULPHAMETHOXAZOLE | 40MG/5ML + 200MG/5ML | GLAXO WELLCOME EGYPT CO. S.A.E-CAIRO | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3167 | MJ BIOPHARM PVT LTD | TATA UGANDA LIMITED | MONAN-0.5G | MEROPENEM | 0.5G | M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X0.5 G VIAL |
| NDA/MAL/HDP/3173 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOCILLIN 250 | AMPICILLIN | 250MG | MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3175 | M.J.BIOPHARM PVT LTD | TATA UGANDA LIMITED | SPACOVIN | DROTAVERINE | 40MG | M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208
NAVI MUMBAI, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3177 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM CREAM | BETAMETHASONE VALERATE | 0.1%W/W | ATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE |
| NDA/MAL/HDP/3178 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BENDURIC TABLETS | BENDROFLUMETHIAZIDE | 5MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3179 | GOOD DAY PHARMACY LIMITED | GOOD DAY PHARMACY LIMITED | SULPHUR OINTMENT | SULPHUR | 10%W/W | KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506 | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X25.0 G TUBE |
| NDA/MAL/HDP/3180 | MJ BIOPHARM PVT LTD | TATA UGANDA LIMITED | LOFIN 500 | METFORMIN HYDROCHLORIDE | 500MG | M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3182 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | TADACIP 20 | TADALAFIL | 20MG | CIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3184 | M.J BOPHARM PUT LTD | TATA UGANDA LIMITED | MONAN | MEROPENEM | 1G | M.J BIOPHARM PUT LTD -L-7 MIDC INDUSTRIOL DIST GAIDED TOLOJA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/3185 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | AMINOPHYLLINE INJECTION | AMINOPHYLLINE | 25MG/ML | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X10.0X10.0 ML AMPOULE,1.0X10.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/3186 | IDA FOUNDATION | KIMSY MEDS LTD | PARACETAMOL | PARACETAMOL | 500MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3191 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | ERECTO -100 | SILDENAFIL CITRATE | 100 MG | CIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/3192 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ANZAVIR-R | ATAZANAVIR + RITONAVIR | 300 MG + 100 MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/3193 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | ERECTO- 50 | SILDENAFIL CITRATE | 50MG | CIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/3196 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | MOTINORM | DOMPERIDONE | 10MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/3197 | ERIS LTD | BENLE CONSULT LIMITED | TRIAM-DENK 40 INJECTION | TRIAMCINOLONE ACETONIDE | 40 MG/ML | DENK PHARMA, GOLLSTR.,-1-D-845 529 TITTMONING GERMANY
| GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3198 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPEN-125 | PHENOXYMETHYL PENICILLIN SODIUM | 125MG/ML | MILAN 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/DROPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3199 | MERCK SHARP & DOHME BV | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ISENTRESS | RALTEGRAVIR | 400MG | ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD -ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD XUNQIAE LINHAI ZHIJIANG | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/3200 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LETRAX | LEVAMISOLE HYDROCHLORIDE | 40MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X200.0 TABLET CONTAINER,1.0X25.0X3.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/3202 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | PRESARTAN-50 | LOSARTAN | 50MG | IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3203 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | TETANUS ANTITOXIN | TETANUS ANTITOXIN | 1500 I.U | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X50.0X1.0 ML AMPOULE (1 DOSE AMPOULE) |
| NDA/MAL/HDP/3204 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | RELCER GEL | ALUMINIUM HYDROXIDE/MAGNESIUM HYDROXIDE/DIMETHICONE/LIQUORICE | 6G+80MG+100MG+400MG/5ML | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X180.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3205 | EAGLEVET UGANDA LIMITED | MEDVIN PHARMA LIMITED | AZIFAST-250 | AZITHROMYCIN | 250MG | IPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3206 | HEALTHCARE LTD. | HEALTHCARE LTD. | POSTINOR 2 | LEVONORGESTREL | 0.75MG | GEDEON RICHTER PLC-1103 BUDAPEST GYOMROI UT 19-21 | HUNGARY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/3207 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | DILCONTIN XL 90 | CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE | 90MG | MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3208 | NIRMA LIMITED. | SUPER MEDIC LTD | NIRFOL 1% | PROPOFOL | 1%W/V | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0X1.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL |
| NDA/MAL/HDP/3212 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | CLOPIVAS 75MG | CLOPIDOGREL BISULPHATE | 75MG | CIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3214 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | INDICONTIN | INDAPAMIDE | 1.5MG | MODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM ? 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3215 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | SEROFLO-125MG | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG + 125MCG | CIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/3219 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPHENOL ORAL SUSPENSION | CHLORAMPHENICOL | 125MG/5ML | 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 SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3220 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | PYLO KIT | LANSOPRAZOLE+TINIDAZOLE+CLARITHROMYCIN | 30MG+500MG+250 MG | CIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS) |
| NDA/MAL/HDP/3221 | REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN | HEALTHCARE LTD. | OPTADEX-N EYE DROPS | DEXAMETHASONE/NEOMYCIN | 1MG/3MG | REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/3224 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM FLUFED ELIXIR | MULTI-INGREDIENT | MULTI-INGREDIENT | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3225 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DIFLAME | DICLOFENAC DIETHYLAMINE + LINSEED OIL + METHYL SALICYLATE MENTHOL | N/A | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/3226 | SEARLE PAKISTAN LIMITED | HEALTHCARE LTD. | PEDITRAL | ORAL REHYDRATION SALT | N/A | SEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X29.5 G SACHET |
| NDA/MAL/HDP/3228 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | ENTOSEC | SECNIDAZOLE | 1000MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/3229 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | CIFLO | CIPRFLOXACIN | 500MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/3230 | GLAND PHARMA LIMITED | TATA UGANDA LIMITED | METOCLOPRAMIDE INJECTION | METOCLOPRAMIDE HYDROCHLORIDE | 5MG/ML | GLAND PHARMA LTD -DOMMARA POCHAMPALLY SURVEY NO. 5 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3231 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | FLUCOMOL | PARACETAMOL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/CHLORPHENIRAMINE MALEATE | 500MG/10MG/15MG/2MG | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3232 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | L-TRIM | SULFAMETHOXAZOLE + TRIMETHOPRIM | 400MG + 80MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3233 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | WHITFIELD'S OINTMENT BP | BENZOIC ACID + SALICYLIC ACID | 0.06G+0.03G | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/3235 | IDA FOUNDATION | KIMSY MEDS LTD | CHLORPROMAZINE INJECTION | CHLORPROMAZINE HYDROCHLORIDE | 25MG/ML | GLAND PHARMA LIMITED-D. P PALLY NARSAPUR ROAD, HYDERABAD ?
500 043, INDIA
| INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3236 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM COTRI | CO-TRIMOXAZOLE | 480MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3237 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | KONAZOL CREAM | KETOCONAZOLE | 2% W/W | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3239 | GLAND PHARMA LIMITED | TATA UGANDA LIMITED | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG/ML | GLAND PHARMA LTD -DOMMARA POCHAMPALLY SURVEY NO. 5 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3241 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | CLOTRILIN | CLOTRIMAZOLE | 1%W/W | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/3244 | UNI MEDICO LAB | SHREEJI PHARMACEUTICALS LIMITED | UMICILLIN | AMPICILLIN | 250MG | UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3245 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NYSTATIN ORAL DROPS | NYSTATIN | 100,000 I.U/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | ORAL TOPICAL DROPS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/3246 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | COMPOUND MAGNESIUM TRISILICATE | MAGNESIUM TRISILICATE | 370MG | AGOG 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3249 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | LOSACAR-H | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3251 | SCHERING N.V.SA... | SURGIPHARM (U) LIMITED | UROGRAFIN | DIATRIZOIC ACID | 76%W/V | SCHERING N.V, SA-SPAIN | SPAIN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/3252 | GALENTIC PHARMA( INDIA)PVT LTD | NORVIK ENTERPRISES LIMITED | PYLOOCAIN | BETAMETHASONE + PHENYLEPHRINE + LIDOCAINE | O.5 MG/G + 1 MG/G + 25 MG/G | GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X30.0 G TUBE |
| NDA/MAL/HDP/3254 | VENUS REMEDIES LIMITED | AARON PHARMACEUTICALS LTD | ROBOL | DOXORUBICIN HCL | 50MG/25ML | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY I V VIALS | 1.0X30.0 ML VIAL |
| NDA/MAL/HDP/3255 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | SATISFIL-50 | SILDENAFIL CITRATE | 50MG | AGOG 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 TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3258 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | LAMIVUDINE/ ZIDOVUDINE & EFAVIRENZ COMBIPACK | LAMIVUDINE/ ZIDOVUDINE + EFAVIRENZ | 150MG/300MG + 600MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE,1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/3259 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | TIGBODERM | BETAMETHASONE + CHLOROCRESOL + GENTAMICIN + CLIOQUINOL + TOLNAFTATE | 0.05% W/W + 0.1% W/W + 0.1% W/W + 1% W/W + 1% W/W | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X3.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/3261 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | TENOFOVIR DF + EMTRICITABINE + EFAVIRENZ | TENOFOVIR DF + EMTRICITABINE + EFAVIRENZ | 300MG+200MG+600MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
,MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA,MYLAN LABORATORIES LIMITED -PLOT NO. 11,12&13 INDORE SPECIAL ECONO | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/3262 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEGEL | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE | 250MG + 250MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3263 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | TRIMEX MUCOLYTIC SYRUP | SALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN | 2MG/5ML + 4MG/5ML + 100MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3266 | BETA HEALTHCARE | BETA HEALTHCARE UGANDA LIMITED | SALIMIA LINIMENT | METHYL SALICYLATE+TURPENTINE OIL | 5ML+25ML | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/3270 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | FORTIFIED PROCAINE PENICILLIN | FORTIFIED PROCAINE PENICILLIN | 4000000 IU | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/3273 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | BETASOL CREAM | BETAMETHASONE VALERATE | 0.1%W/W | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/3275 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | MEFLIN-500 | MEFENAMIC ACID | 500MG | LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3277 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | TRANSAMIN CAPSULES 500MG | TRANEXAMIC ACID | 500MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3278 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | TOPIDIC 2% OINTMENT | SODIUM FUSIDATE | 20MG/G | PHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3279 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | HAEMOFORTE SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/3280 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | TUSPEL PLUS EXPECTORANT | BROMHEXINE HYDROCLORIDE + TERBUTALINE SULPHATE + AMMONIUM CHLORIDE + MENTHOL | 8 MG + 2.5 MG + 100 MG + 1.5 MG | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3282 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | KOFF-GO | PHENYLEPHRINE HCL + CHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN | 5MG/5ML + 2MG/5ML + 10MG/5ML | TORQUE PHARMACEUTICALS (P) LTD-P.O.DAPPAR VILLISS | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3284 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | CHALEATE | CHLORPHENIRAMINE MALEATE | 4MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3285 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AMOXIL | AMOXYCILLIN | 250MG/5ML | GLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3286 | CIPLA LIMITED | QUALITY CHEMICALS LTD - HUMAN | LOMAC-20 | OMEPRAZOLE | 20 MG | CIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,
SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3288 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DELASED SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3289 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID DUSTING POWDER | CLOTRIMAZOLE | 1%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL DUSTING POWDERS | 1.0X30.0 G BOTTLE,1.0X100.0 G BOTTLE |
| NDA/MAL/HDP/3291 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | FINTOP | BUTENAFINE HCL | 1%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3292 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | DELASED PAEDIATRIC SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL | 7MG+28.5MG+0.55MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3294 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | URGENDOL CAPSULES | TRAMADOL HYDROCHLORIDE | 50 MG | WIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3295 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLEVATE | CLOBETASOL | 0.05%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3296 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LOPINAVIR / RITONAVIR | LOPINAVIR / RITONAVIR | 100MG / 25MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER, 1.0X120.0 TABLET CONTAINER |
| NDA/MAL/HDP/3297 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | NEPIN-SR-20 | NIFEDIPINE | 20MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3299 | SEARLE PAKISTAN LIMITED | HEALTHCARE LTD. | METODINE-DF SUSPENSION | METRONIDAZOLE/DILOXANIDE FUROATE | 200MG/250MG | SEARLE PAKISTAN LIMITED-PLOT 35KM, MULTAN ROAD, LAHORE - PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3300 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | MUCOSOL PEDIATRIC SYRUP | CARBOCISTEINE | 125 MG/5 ML | MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/3301 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | TRANSAMIN CAPSULES 250 | TRANEXAMIC ACID | 250MG | HILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN. | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3302 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | AMOXICILLIN ORAL SUSPENSION | AMOXICILLIN | 125MG/5ML | OKASA PVT LTD-346 KUNDAIM INDUSTRIAL ESTATE GOA, 403115 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3304 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | FELEXIN | CEFALEXIN MONOHYDRATE | 250MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3309 | UMEDICA LABORATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | CLOTRIMAZOLE PESSARIES | CLOTRIMAZOLE | 100MG | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP |
| NDA/MAL/HDP/3310 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | GEMFOS | RISEDRONATE SODIUM | 35MG | ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3312 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TIDOMET FORTE | CO-CARELDOPA | 25MG/250MG | TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3314 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | SILVEREX | SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE | 10MG/G+10MG/G | SUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X250.0 G TUBE,1.0X25.0 G TUBE,1.0X10.0 G TUBE |
| NDA/MAL/HDP/3315 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | ERO-250 TABLETS | ERYTHROMYCIN STEARATE | 250MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3316 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3318 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENETRIM TABLETS | CO-TRIMOXAZOLE | 480MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3319 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | SURGIPHARM (U) LIMITED | FERROTONE CAPSULES | FERROUS FUMERATE+FOLIC ACID+VITAMIN B12 | 162MG +0.75MG +7.5MCG | MEGA LIFESCIENCES LTD.-384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKAN | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3321 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DERMOLIN-GM | CLOBETASOL+GENTAMICIN+MICONAZOLE | 0.05%W/W+0.1%W/W+2%W/W | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3322 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | NEVIRAPINE | NEVIRAPINE | 50MG | AUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/3325 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | RAPIDEX | ACETAMINOPHEN+ASPIRIN+CAFFEINE | 200MG+ 400MG+50MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3326 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | AMICIP | AMIKACIN | 500MG/2ML | CIPLA LTD-M-61, M-62 &M-63 UNIT IX VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE GOA 403 722 | INDIA | PARENTERAL ORDINARY DRY VIALS | 5.0X2.0 ML VIAL |
| NDA/MAL/HDP/3328 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENZYLPENICILLIN INJECTION | BENZYLPENICILLIN | 1 MU | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 MU VIAL,1.0X10.0X1.0 MU VIAL |
| NDA/MAL/HDP/3330 | SWISS PHAMACEAUTICAL PUT LTD | HEALTHCARE LTD. | DEXA-N | DEXAMETHASONE+NEOMYCIN SULPHATE | 1%W/W+0.5%W/W | SWISS PHARMACEUTICALS PVT LTD-A159 SINDH INDUSTRIAL AREA KARACHI | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3331 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | BETOPTIC | BETAXOLOL | O.5%W/V | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/3333 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | NOVACLAV-625 | AMOXICILLIN + CLAVULANATE POTASSIUM | 500 MG + 125 MG | OKASA PVT LTD-346 KUNDAIM INDUSTRIAL ESTATE GOA, 403115 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3334 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MYCLAV 375 | AMOXICILLIN + CLAVULANIC ACID | 250 MG + 125 MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP |
| NDA/MAL/HDP/3340 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | POVED | POVIDONE IODINE | 200MG | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | VAGINAL TABLETS | 1.0X2.0X7.0 PESSARY STRIP |
| NDA/MAL/HDP/3341 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | AZILIN-250 | AZITHROMYCIN | 250MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3342 | SEARLE PAKISTAN LTD | HEALTHCARE LTD. | METODINE DF TABLETS | METRONIDAZOLE+DILOXANIDE | 400MG+500MG | SEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X3.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/3343 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MEDIVEN-CREAM | BETAMETHASONE VALERATE | 0.1%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3345 | ASTRA PHARMACY (U) PVT LTD | ASTRA PHARMA (U) LIMITED | PAINOL-P | PARACETAMOL + CAFFEINE | 650MG + 50MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/3346 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | ZEDEX | BROMHEXINE +AMMONIUM CHLORIDE+ MENTHOL + DEXTROMETHORPHAN | 8MG+100MG+5MG+10MG | WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3347 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIPEN TABLETS | PHENOXYMETHYLPENICILLIN | 250MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3348 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | PIMCEF | CEFEPIME USP | 1G | VENUS REMEDIES LTD.-UNIT 11 HOLL TOP INDUSTRIAL ESTATE JHARMAJRI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/3352 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | OMLINK-20 | OMEPRAZOLE | 20MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3354 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MEDIVEN OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3356 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZYCEL-100 CAPSULES | CELECOXIB | 100MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3357 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | ESOREST 20 | ESOMEPRAZOLE | 20MG | CENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEAR | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3359 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | ARTI | ARTEMETHER | 80MG/ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3360 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CHLORAMPHENICOL EAR DROPS | CHLORAMPHENICAL | 5%W/V | NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN | CHINA | OTIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3361 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AZUCLOX | AMPICILLIN + CLOXACILLIN | 250 MG / 5 ML + 250 MG / 5 ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3364 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | ESOREST 40 | ESOMEPRAZOLE | 40MG | CENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEAR | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3366 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | DIAS | GLIBENCLAMIDE | 5MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3367 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMOL SUSPENSION | PARACETAMOL | 125 MG/5ML | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3368 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | VIAGRA 50MG | SILDENAFIL | 50MG | PFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE | FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X12.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3369 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | AZILIN-500 | AZITHROMYCIN | 500MG | LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR
KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR,
GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/3370 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | DERMOREN 500 | GRISEOFULVIN | 500MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3372 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | MUCOLEX | AMBROXOL HYDROCHLORIDE + SALBUTAMOL SULPHATE + GUAIFENESIN | 30MG +1MG + 30MG /5ML | S KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3373 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MYCLAV 625 | AMOXILLICIN/CLAVULANATE | 500MG/125MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP |
| NDA/MAL/HDP/3374 | COSMOS LIMITED | ASTRA PHARMA (U) LIMITED | ZITHROX 250MG | AZITHROMYCIN | 250MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3376 | ASTRAZENECA | MACNAUGHTON LIMITED | TENORMIN | ATENOLOL | 50MG | ASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/3377 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AMILINE | AMITRIPTYLINE | 25 MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3378 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | CHLOZINE TABLETS | CHLORPROMAZINE | 100MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3379 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIFASI | HUMAN CHORIONIC GONADOTROPIN | 5000I.U | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 AMPOULE CARTON |
| NDA/MAL/HDP/3382 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOFEN SUSPENSION | IBUPROFEN | 100MG/5ML | 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 SUSPENSIONS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3383 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | ZEPIN | CARBAMAZEPINE | 200 MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3384 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | PROXIMEXA 250MG | CEFUROXIME AXETIL | 250MG | GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3385 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | MEFTAL-P-SUSPENSION | MEFENAMIC ACID | 100MG/5ML | BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3386 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | AMBROSE 2 | CHLORAMBUCIL | 2MG | NAPROD LIFE SCIENCES PVT LTD-G17 MDC TARAPUR IND AREA THONE, MUMBAI INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BOTTLE |
| NDA/MAL/HDP/3387 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | PROXIMEXA 500MG | CEFUROXIME AXETIL | 500MG | GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3389 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | CLARINASE REPE TABS | LORATADINE + PSEUDOEPHEDRINE | 5MG + 120MG | SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM | BELGIUM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/3390 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ALUGEL | ALUMINIUM HYDROXIDEL / MAGNESIUM TRISLICATE | 120MG/250MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | ML BOTTLE, L JERRYCAN |
| NDA/MAL/HDP/3391 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | CEZIN TABLET | CETIRIZINE | 10MG | AGOG 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 TABLETS | 1.0X2.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3392 | SWISS PHAMACEAUTICAL PUT LTD | HEALTHCARE LTD. | TRAMACIN POWDER | NEOMYCIN + BACITRACIN | 0.052G + 0.0432G | SWISS PARENTERALS PVT LTD- 809, KERALA INDUSTRIAL ESTATE, G.I.D.C,
BAVIA ROAD, DIST, AHMEDABAD, GUJARAT,
INDIA
| INDIA | TOPICAL EXTERNAL POWDERS | 1.0X10.0 G CONTAINER |
| NDA/MAL/HDP/3393 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AUGMENTIN 375MG | AMOXICILLIN + CLAVULANIC ACID | 250 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3396 | ELDA INTERNATIONAL DMCC | REDDYS PHARMA LIMITED | BUPICAN HEAVY | BUPIVACAINE HYDROCHLORIDE IN DEXTROSE | 0.5%W/V | CLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X25.0X4.0 ML AMPOULE |
| NDA/MAL/HDP/3397 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | AUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/3399 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | LDNIL 10 | ROSUVASTATIN | 10MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3400 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | OLFEN GEL | DICLOFENAC SODIUM | 1%W/W | MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | TOPICAL EXTERNAL GELS AND SOLS | 1.0X50.0 G TUBE,1.0X20.0 G TUBE |
| NDA/MAL/HDP/3401 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASCODYL | BISACODYL | 5MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3404 | GLAXO SMITHLINE LIMITED | ERIS LTD | CLAVULIN | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 100 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X600.0 MG VIAL |
| NDA/MAL/HDP/3405 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL BABY AND INFANT 120MG/5ML | PARACETAMOL | 120MG/5ML | FARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCE | FRANCE | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3409 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | CLARITINE | LORATADINE | 10MG | SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM | BELGIUM | ORAL SOLID ORDINARY TABLETS | 3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3410 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | NAPRODOX-50 | DOXORUBICIN | 50MG | NAPROD LIFE SCIENCES PVT LTD-G17 MDC TARAPUR IND AREA THONE, MUMBAI INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 MG VIAL |
| NDA/MAL/HDP/3411 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABNAL NASAL DROPS | SODIUM CHLORIDE | 0.9%W/V | ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | NASAL SYSTEMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3412 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | TETRACYCLINE | TETRACYCLINE HYDROCHLORIDE | 250 MG | NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN | CHINA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3413 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | COMBANTRIN | PYRANTEL PAMOATE | 125MG | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/3414 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | EXFORGE 10MG/160MG | AMLODIPINE + VALSARTAN | 10 MG + 160 MG | NOVARTIS 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 TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/3415 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID V-1 | CLOTRIMAZOLE | 500MG | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | VAGINAL TABLETS | 1.0X1.0 PESSARY STRIP |
| NDA/MAL/HDP/3419 | MEDIPHARM (EA) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | PIRITEX BABY COUGH LINCTUS | COUGH LINCTUS WITH DILUTE ACETIC ACID | 0.42ML/5ML | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3422 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | GENTAMICIN EYE/ EAR DROPS | GENTAMYCIN | 0.3%W/V | NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3423 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | AMOXICLAV-DENK 1000/125 | AMOXICILLIN TRIHYDTATE + POTASSIUM CLAVULANATE | 1000 MG + 125 MG | PENCEF PHARMA GMBH-BRITENBACHSTR ASSE 13 D-13509 BERLIN | GERMANY | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X12.0X3.0 G SACHET,1.0X8.0X3.0 G SACHET |
| NDA/MAL/HDP/3426 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | RUBEM CREAM | METHYL NICOTINATE + CAPSICUM OLEORESIN+ METHYLSALICYLATE | 1%W/W+0.1%W/W+5%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/3427 | UNIVERSAL CORPORATION LTD | HARLEYS UGANDA LIMITED | SULFRAN | COTRIMOXAZOLE | 480MG | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3428 | MEDI PHARMA IDUSTRIES E.A LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORALYTE CO-PACK | MULTI INGREDIENT | MULTI INGREDIENT | MEDI PHARMA INDUSTRIES E.A LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE | UGANDA | ORAL SOLID ORDINARY OTHER SPECIAL FORMS | 1.0X2.0X20.5 G SACHET + 1*60.0 ML BOTTLE |
| NDA/MAL/HDP/3429 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | EZEDE | LORATADINE | 10MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3431 | UNEED GLOBAL GROUP LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NAZOL-200 | KETOCONAZOLE | 200MG | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3433 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CO-DIOVAN 80/12.5 | VALSARTAN + HYDROCHLOROTHIAZIDE | 80 MG +12.5 MG | NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/3434 | PHARMACARE LIMITED | BETA HEALTHCARE UGANDA LIMITED | SEPTRIN | CO-TRIMOXAZOLE | 480MG | GLAXO WELLCOME EGYPT CO. S.A.E-CAIRO | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET CARTON,1.0X50.0 TABLET CARTON |
| NDA/MAL/HDP/3437 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | REMYCIN 100 CAPSULES | DOXYCYCLINE HYDROCHLORIDE | 100MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3438 | MEDREICH PLC | LABOREX UGANDA LIMITED | PROXACIN | CIPROFLOXACIN | 500MG | MEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3439 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENECHLOR CAPSULE | CHLORAMPHENICOL | 250MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3440 | ELI-LILLY EXPORT SA | LABOREX UGANDA LIMITED | HUMALOG | INSULIN LISPRO | 100IU | LILLY FRANCE SA-FRANCE | FRANCE | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3441 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | LEVOFLOXACIN | LEVOFLOXACIN | 500MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3443 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | BETASOL OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | KAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/3444 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORVADIL 10 | AMLODIPINE BESILATE | 10MG | UNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3446 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | CORDARONE | AMIODARONE HYDROCHLORIDE | 50MG/ML | SANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE
| FRANCE | PARENTERAL ORDINARY AMPOULES | 1.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/3449 | VENUS REMEDIES LIMITED | HARLEYS UGANDA LIMITED | IMMUNOX | CEFTRIAXONE SODIUM | 1000MG | VENUS REMEDIES LTD-VNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL,1.0X10.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3450 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | TRAMADEX 50 | TRAMADOL | 50MG | AEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIA | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3451 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPHENOL CAPSULES (THANE0 | CHLORAMPHENICOL | 250MG | AGOG 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 CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3452 | VENUS REMEDIES LTD | AARON PHARMACEUTICALS LTD | PAXOL | PACLITAXEL USP | 30MG/5ML | VENUS REMEDIES LTD-VNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIA | INDIA | PARENTERAL ORDINARY OTHER VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/3453 | MJ BIOPHARM PVT LTD | TATA UGANDA LIMITED | AMINOPHYLLINE | AMINOPHYLLINE | 25MG/ML | M.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/3455 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LAMIVUDINE + ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 30MG + 60MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/3457 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANUSOL OINTMENT | BISMUTH SUBGALLATE + BISMUTH OXIDE + ZINC OXIDE | 22.5 MG + 8.75 MG + 107.5 MG | PERFORMANCE HEALTH LTD-241 NAIN ROAD RETREAT SOUTH AFRICA 7945 | SOUTH AFRICA | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/3458 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIXIL | AMOXYCILLIN TRIHYDRATE | 250MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3459 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ENEMAX | HYPERTONIC SOLUTION OF SODIUM PHOSPHATES | 6GM AND 16GM/100ML | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT | EGYPT | RECTAL SYSTEMIC ENEMA LIQUIDS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/3460 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | MALANIL ADULT TABLETS | ATOVAQUONE + PROGUANIL HCL | 250MG + 100MG | GLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/3461 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ZIDOVUDINE | ZIDOVUDINE | 300MG | MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13
MIDC, WALUJ INDUSTRIAL AREA,
AURANGABAD. ? 431136,
MAHARASHTRA STATE, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/3462 | VENUS REMIDIES LTD | AARON PHARMACEUTICALS LTD | PLATOL | CISPLATIN | 500MG/100ML | VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3464 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TARTAR CONTROL LISTERINE ANTISEPTIC | ZINC CHLORIDE + DENATURED ALCOHOL MENTHOL 95% + THYMOL | 18MG/ 20ML + 0.9ML/20ML + 12.7MG/20ML | JOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794
| SOUTH AFRICA | ORAL LIQUID ORDINARY OTHER LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/3465 | MONDI-MUNDI PHARMA PVT LIMITED | SURGIPHARM (U) LIMITED | FECONTIN-Z | FERROUS GLYCINE SULPHATE+ZINC SULPHATE+FOLIC ACID | 100MG+61.8MG+0.5MG | MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3466 | DAWA LIMITED | SUPER MEDIC LTD | DAWASEC | SECNIDAZOLE | 1G | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/3467 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | RONEM | MEROPENEM TRIHYDRATE | 1000MG | VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL |
| NDA/MAL/HDP/3471 | VENUS REMEDIES LTD | AARON PHARMACEUTICALS LTD | PAXOL | PACLITAXEL | 100MG/16.7ML | VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/3473 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TRIXONE | CEFTRIAXONE | 1G | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100,SHANDONG P.R & INJECT CARE PARENTERALS PVT LTD-PLOT 130, SILVASSA ROAD,G.I.D.C,VAPI-396195,GUJARAT,INDIA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.0 G VIAL,1.0X10.0X1.0 G VIAL |
| NDA/MAL/HDP/3474 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | AMCLOREN DRY SYRUP | AMPICILLIN + CLOXACILLIN | 125MG+125MG/5ML | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3475 | VENUS REMIDIES LTD | HARLEYS UGANDA LIMITED | RONEM | MEROPENEM | 500MG | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/3476 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | PARAFIL | PARACETAMOL | 500MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3478 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | DICLOREN | DICLOFENAC SODIUM BP | 50MG | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3480 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | HYOSPAN | HYOSCINE BUTYL BROMIDE | 10MG | CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3482 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCLOX-250 | CLOXACILLIN | 250MG | MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3483 | JOHNSON&JOHNSON PTY LTD. 241 | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SINUTAB 3-WAY | IBUPROFEN + PSEUDOEPHEDRINE HCL | 200MG + 30MG | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3485 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | ERGOMETRINE | ERGOMETRINE MALEATE | 0.5MG/ML | CIRON DRUGS AND PHARMACEUTICALS PRIVATE LTD-N-118 MIDC TARAPUM BOISAR DIST THANE 401506 MAHARASHTRA, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3489 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | NEO MEDROL | METHYLPREDNISOLONE ACETATE+ NEOMYCIN SULFATE | 2.5MG+2.5MG | PATHEON YM INC. TORONTO- TORONTO, CANADA | CANADA | TOPICAL EXTERNAL LOTIONS | 1.0X25.0 ML BOTTLE |
| NDA/MAL/HDP/3490 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | LAXOLAC SYRUP | LACTULOSE | 67G/100ML | MEDICAL UNION PHARMACEUTICALS LTD-ABU SULTAN, ISMAILLIA, EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/3491 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | BENDEX-400 | ALBENDAZOLE | 400MG | CIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 10.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/3492 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | OLFEN-50 | DICLOFENAC SODIUM | 50MG | ACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3493 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASVIR | ACICLOVIR | 200MG | ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3494 | LABORATORIOS NOVAG SA | LABOREX UGANDA LIMITED | GAMALATE B6 SOLUTION | MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B6 | 2G + 2G + 1G +1G | FERRER INTERNACIONAL S.A --FOR LABORATORIOS NOVAG S.A GRAN VIA CARLOS III 94 08028 BARCELONA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X80.0 ML BOTTLE |
| NDA/MAL/HDP/3495 | BELL SONS & CO.(DRUGGISTS) LTD | ECHO PHARMACY (U) LIMITED | MENTHODEX COUGH MIXTURE | MULTIINGREDIENT | N/A | BELL SONS & CO (DRUGGISTS) LTD-SLAIDBURN CRES
CHESHIRE HOUSE/GORSEY LA | UNITED KINGDOM | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/3497 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | SURGIPHARM (U) LIMITED | LIVOLIN FORTE | MULTI-INGREDIENT | MULTI-INGREDIENT | MEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3500 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | GIZLAN 300 | IRBESARTAN | 300MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3502 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | HYDROCORTISONE SODIUM SUCCINATE | HYDROCORTISONE SODIUM SUCCINATE | 100MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0 MG VIAL + 1*2ML AMPOULE OF WFI |
| NDA/MAL/HDP/3504 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BIFRIL | ZOFENOPRIL | 30MG | A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILA | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/3505 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASFLIC | FOLIC ACID | 5MG | ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3506 | ABBVIE (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ULTANE | SEVOFLURANE | 100%W/W | AESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENT | UNITED KINGDOM | NASAL SYSTEMIC UNIT DOSE LIQUIDS | 1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/3507 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOX 250 | AMOXICILLIN | 250MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3512 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | LAMISIL 250MG | TERBINAFINE | 250MG | NORVATIS PHARMA PRODUKTIONS GMBH -79644 WEHR/BADEN-GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET CARTON |
| NDA/MAL/HDP/3515 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN 40/240 | ARTEMETHER + LUMEFANTRINE | 40 MG + 40 MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3516 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BENZHEXOL TABLETS BP 5MG | TRIHEXYPHENIDYL HYDROCHLORIDE | 5MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET BLISTER |
| NDA/MAL/HDP/3517 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TOTO ZINC | ZINC SULPHATE | 20MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3518 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASFLOX | CIPROFLOXACIN | 500MG | ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3519 | STRIDES ARCOLAB LIMITED | DELMAW ENTERPRISES LIMITED | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/3520 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ POWDER | POVIDONE IODINE + METRONIDAZOLE | 1%W/W + 5%W/W | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL POWDERS | 1.0X100.0 G BOTTLE,1.0X10.0 G BOTTLE |
| NDA/MAL/HDP/3522 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CLOXACILLIN SODIUM FOR INJECTION | CLOXACILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY VIALS | 1.0X10.0X500.0 MG VIAL |
| NDA/MAL/HDP/3525 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCLLIN | AMPICILLIN TRIHYDRATE | 250MG | MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3526 | CYANO PHARMA(P) | RENE PHARMACY LTD | PROMETHAZINE TABLETS | PROMETHAZINE HYDROCHLORIDE | 25MG | CYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDORE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3527 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LEVOTOP-500 | LEVOFLOXACIN | 500MG | GLENMARK PHARMACEUTICALS LTD (UNIT III)-B-4/5/6 MIDC INDUSTRIAL AREA,CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3528 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART-DISPERSABLE | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | BLISS 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 SOLUBLE TABLETS | 1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3530 | GLAXO SMITH KLINE LTD | ERIS LTD | FLIXOTIDE ACCUHALER | FLUTICASONE PROPIONATE | 100MCG | GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X60.0 ML CANNISTER |
| NDA/MAL/HDP/3532 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | SIMEPAR CAPSULES | MULTINGREDIENT | MULTINGREDIENT | ACINO PHARMA AG-DORNACHERSTRASSE 114 P.O.BOX 445 CH4147 AESCH/BL SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY CAPSULES | 1.0X40.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3533 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | LEVOZIN | LEVOCETIRIZINE | 5MG | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3535 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | ADIFLAM-50 | DICLOFENAC SODIUM TABLETS BP | 50MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3536 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | TETRAXIM | DIPHTHERIA/ TETANUS/ PERTUSSIS (ACELLULAR, COMPONENT) POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED) | 301IU/ 401IU/ 25MCG/ POLIOMYELITIS - 40DU (TYPE 1)/ 8DU TYPE 2/ 32DU TYPE 3 | SANOFI PASTEUR CAMPUS MERIEUX--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 SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/3537 | PHARMATHEN LTD | GOODMAN INTERNATIONAL LTD | NELTOLON GEL | BIFONAZOLE | 1%W/W | PHARMATHEN LTD.-6 DERVENAKION STR. 153 51 PALLINI-GREECE | GREECE | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3540 | EAGLEVET UGANDA LIMITED | MEDVIN PHARMA LIMITED | CLOPACT-75 | CLOPIDOGREL | 75 MG | IPCA LABORATORIESLIMITED-IPCA LABORATORIES LTD P.O SEJANTA DISTRICT RATLAM 457002 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3541 | VENUS REMEDIES LTD | HARLEYS UGANDA LIMITED | CARBOL | CARBOPLATIN | 450MG/45ML | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY VIALS | 1.0X45.0 VIAL CARTON |
| NDA/MAL/HDP/3542 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | MARA MOJA | ASPIRIN + PARACETAMOL + CAFFEINE | 400MG + 200MG + 50MG | BETA 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 TABLETS | 1.0X50.0X2.0 TABLET STRIP,1.0X110.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/3543 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DROX 250 | CEFADROXIL | 250 MG | AUROBINDO PHARMA LTD (UNIT VI) ,-SURVEY NOS. 329/39 & 329/47,CHITKUL VILLAGE,PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3545 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDID MOUTH PAINT | CLOTRIMAZOLE | 1%W/W | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL TOPICAL LIQUIDS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/3546 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENETRIM D.S | SULPHAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | RENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3547 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORBIS-10 | BISOPROLOL | 10 MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3548 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | BECLATE 200 | BECLOMETASONE | 200MCG/DOSE | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/3549 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | TRIMEX PAEDIATRIC COUGH EXPECTORANT | CHLORPHENIRAMINE MALEATE+PSEUDO EPHEDRINE HCL+GUAIPHENISIN+MENTHOL | 1.0MG+15.0MG+50.0MG+0.5MG / 5ML | REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3550 | VENUS REMEDIES LIMITED | AARON PHARMACEUTICALS LTD | DOXOL | DOCETAXEL | 20MG/0.5ML | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY VIALS | 1.0X7.5 ML VIAL |
| NDA/MAL/HDP/3551 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZAHA-500MG | AZITHROMYCIN | 500MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/3552 | VENUS REMIDIES LTD | HARLEYS UGANDA LIMITED | CARBOL | CARBOPLATIN | 150MG/15ML | VENUS REMEDIES LTD-VNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/3553 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | FALCIMON 25/67.5 B/L | ARTESUNATE+AMODIAQUINE | 25MG+67.5MG | CIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/3556 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | GRISACTIN-500 TABLETS | GRISEOFULVIN TABLETS | 500MG | REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3558 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | SEROFLO-250 | SALMETEROL+ FLUTICASONE PROPIONATE | 25MCG + 250MCG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/3560 | ASTRA PHARMA UGANDA LIMITED | ASTRA PHARMA (U) LIMITED | DERMIZOL | KETOCONAZOLE | 200MG | ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3561 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOCILLIN ORAL SUSPENSION | AMPICILLIN TRIHYDRATE | 125MG/5ML | MILAN 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/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3563 | EUROLIFE HEALTHCARE PVT LIMITED | AIVEEN (U) LIMITED | LEVOLIFE | LEVOFLOXACIN | 500MG/100ML | EUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3564 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ATROPINE INJECTION | ATROPINE SULPHATE | 1MG/ML | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3565 | PFIZER LABS LIMITED | LABOREX UGANDA LIMITED | UNASYN | SULTAMICILLIN TOSYLATE DIHYDRATE | 375MG | HAUPT PHARMA LATINA S.R.L -S.S 156 KM BORGO SAN MICHELE LATINA | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3566 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | ARTESUN | ARTESUNATE | 60 MG | GUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5% NAHCO3 + 5 ML NACL INJECTION |
| NDA/MAL/HDP/3568 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | MYCOSPOR CREAM | BIFONAZOLE | 1%W/W | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | TOPICAL EXTERNAL CREAMS | 1.0X50.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/3569 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CARBADAC-200 | CARBAMAZEPINE | 200MG | CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
| INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3570 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASTRIM-960 | TRIMETHOPRIM/SULFAMETHOXAZOLE | 160MG/800MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3571 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | CADIPHEN EXPECTORANT | CHLORPHENIRAMINE/GUAIFENESIN/AMMONIUM CHLORIDE | 2MG//80MG/100MG | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3573 | VENUS REMEDIES LIMITED | AARON PHARMACEUTICALS LTD | PARIN-E | ENOXAPARIN SODIUM | 40MG/0.4ML | VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P) | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/3574 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | METOZ 2.5 TABLET | METOLAZONE TABLETS USP | 2.5MG | CENTAUR PHARMA PVT.LIMITED-PLANT I-PLOT3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3575 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFIX 400 CAPSULES | CEFIXIME | 400MG | PHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X5.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3577 | ASTRA PHARMA (U) LTD | ASTRA PHARMA (U) LIMITED | METOCLOPRAMIDE | METOCLOPRAMIDE | 5MG/ML | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3578 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | CINNARON 25 | CINNARIZINE | 25MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3580 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | FEXOFEN-120 | FEXOFENADINE HYDROCHLORIDE | 120MG | ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3581 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | METOZ 5 | METOLAZONE | 5MG | CENTAUR PHARMA PVT.LTD-PLANT I-PLOT 3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3582 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | SULPHADIMIDINE | SULPHADIMIDINE | 500MG | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3583 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | SIMVA-DENK 40 | SIMVASTATIN | 40MG | DENK PHARMA GMBH & CO-G0 11 STR.1 84529 T,HMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3584 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CHLORAMPHENICOL EYE DROPS | CHLORAMPHENICOL | 0.5%W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/3585 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | AMPILIN | AMPICILLIN | 250MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3586 | VENUS REMEDIES LIMITED | AARON PHARMACEUTICALS LTD | DOXOL | DOCETAXEL | 80MG/2ML | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/3588 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | FEXOFEN-180 | FEXOFENADINE | 180MG | ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3589 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | SIMVA-DENK 20 | SIMVASTATIN | 20MG | DENK PHARMA GMBH & CO-.GK GOII STR.1 84529 TIHMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3590 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ALFOXAN 500 FC TABLETS | MEFENAMIC ACID | 500MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3591 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | ARTESIANE 80MG/ML | ARTEMETHER | 80MG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY I M AMPOULES | 1.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3592 | FOURRTS (INDIA) LABORATORIES PUT LTD | DELMAW ENTERPRISES LIMITED | MEGATRIM DS | CO-TRIMOXAZOLE TABLETS BP | 960MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3593 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DROX 500 | CEFADROXIL | 500MG | AUROBINDO 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 CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3594 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | STERILE QUININE DIHYDROCHLORIDE | QUININE DIHYDROCHLORIDE | 300MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LIMITED-N-118, N119, N113, MIDC TARAPUR BOISAR DIST THANE 401506, INIDA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3595 | UNI MEDICO LAB | SHREEJI PHARMACEUTICALS LIMITED | UMOXIL 125 | AMOXICILLIN TRIHYDRATE | 125MG/5ML | UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3596 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | SYNTOCINON | OXYTOCIN | 10 I.U/ML | NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | SWITZERLAND | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3597 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | ARTESIAN 20MG/ML | ARTEMETHER | 20MG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY I M AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3598 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | MYOSPAZ | PARACETAMOL + CHLORZOXAZONE | 500MG + 250MG | WIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3599 | ASTRA PHARMA LTD | ASTRA PHARMA (U) LIMITED | CHLORPROMAZINE INJECTION | CHLORPROMAZINE | 25MG/ML | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3600 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | P-ALAXIN TABLETS | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 40MG + 320MG | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X9.0 TABLET BLISTER |
| NDA/MAL/HDP/3601 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | HYDROKANT | HYDROCORTISONE ACETATE | 1%W/W | SKANT HEALTH CARE LTD -1802-1805 GIDC PHASE III VAPI GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3603 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | VUMTREX SYRUP | LEVAMISOLE | 40MG/5ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | ML BOTTLE |
| NDA/MAL/HDP/3604 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | AC-FENAC | ACECLOFENAC | 100MG | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3606 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | CELLTRIAXON | CEFTRIAXONE | 1G | SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/3607 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | LINOPRIL | LISINOPRIL DIHYDRATE | 20MG | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X14.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/3608 | SHAIGAN PHARMACEUTICALS (PVT) LTD | HEALTHCARE LTD. | MESAN | NICLOSAMIDE | 500MG | SHAIGAN PHARMACEUTICALS (PVT) LIMITED-14 KM ADYALA RD, RAWALPINDI, PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3609 | AMOUN PHARMACEUTICALS COMPANY | BOOTS PHARMACEUTICALS LIMITED | ANTINAL | NIFUROXAZIDE | 200MG | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X12.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3610 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PROMETHAZINE TABLETS BP 25MG | PROMETHAZINE HYDROCHLORIDE | 25MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/3611 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | COLDRIL SYRUP | PARACETAMOL + CHLORPHENIRAMINE + PSEUDOEPHEDRINE | 120MG+1MG+10MG | SHELYS PHARMACEUTICALS LTD,-NEW BAGAMOYO ROAD, MWENGE, PLOT NO 696,BLOCK NO 32, P.O.BOX 3016, DAR ES SALAAM, BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | TANZANIA/KENYA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3612 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LOSARTAS-HT | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3613 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | ZIDOVUDINE ORAL SOLUTION | ZIDOVUDINE | 50MG/5ML | HETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH , | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X240.0 ML BOTTLE |
| NDA/MAL/HDP/3614 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | ERYTHROREN SUSPENSION | ERYTHROMYCIN STEARATE | 125MG/5ML | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3615 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AMPICLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3616 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | ZAXTER | MEROPENEM | 1G | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/3618 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | CLOXACILLIN SODIUM | CLOXACILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON |
| NDA/MAL/HDP/3619 | ERIS LTD | BENLE CONSULT LIMITED | CAPTOPRIL DENK -25 | CAPTOPRIL | 25MG | DENK PHARMA, GOLLSTR.,-1-D-845 529 TITTMONING GERMANY
| GERMANY | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3620 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | HALOXEN 10 TABLETS | HALOPERIDOL BP | 10MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3621 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | AMPILIN | AMPICILLIN | 125MG/5ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3622 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | PROXIMEXA | CEFUROXIME AXETIL | 125MG/5ML | GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/3624 | AVENTIS INTERCONTINENTAL | LABOREX UGANDA LIMITED | ORELOX | CEFPODOXIME | 40MG/5ML | SANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE
56, RUE DE CHOISY AU BAC
60205 COMPI?GNE
| FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/3626 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ORIPHEX CAPSULES | CEPHALEXIN | 250MG | SAKAR HEALTHCARE LIMITED-BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY,
VILL: CHANGODAR, DIST: AHMEDABAD-382213,
GUJARAT ? INDIA.,SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3628 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CELEMIN 5S | AMINO ACIDS/SORBITOL | 5%W/V+5%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/3630 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | UNICONTIN 600 | THEOPHYLLINE | 600MG | MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3631 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | ENA-DENK 10 | ENALAPRIL MALEATE | 10MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3634 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOPLUS | PARACETAMOL/ DEXTROMETHORPHAN HCL/ CHLORPHENIRAMINE | 500MG/ 15MG/ 2MG /10MG | AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3635 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CIROGAN | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3637 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | TINODERM | MULTI-INGREDIENT | MULTI-INGREDIENT | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X18.0 G TUBE |
| NDA/MAL/HDP/3638 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | PETILIN 200 | SODIUM VALPROATE | 200MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X4.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3639 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PANADOL ADVANCE | PARACETAMOL | 500MG | GLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X11.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3640 | PHARMATHEN LTD | GOODMAN INTERNATIONAL LTD | STABILANOL | FLUCONAZOLE | 100MG | PHARMATHEN S.A--6,DERVENAKION STR .153 51,PALLINI,AHICA GREECE | GREECE | ORAL SOLID ORDINARY CAPSULES | 1.0X7.0 CAPSULE STRIP |
| NDA/MAL/HDP/3641 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | TRD-CONTIN 100 | TRAMADOL HYDROCHLORIDE | 100MG | MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3642 | IND-SWIFT | TATA UGANDA LIMITED | CLARIE 250 | CLARITHROMYCIN | 250MG | IND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/3643 | GLAXOSMITHKLINE LIMITED | UNITED HEALTHCARE DISTRIBUTORS LTD | LAMISIL CREAM | TERBINAFINE | 1%W/W | NOVARTIS CONSUMER HEALTH-SWITZERLAND | SWITZERLAND | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3645 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | NEUROBEX | THIAMINE + RIBOFLAVIN + PYRIDOXINE + CYANOCOBALAMIN+ FOLIC ACID | 250MG + 15MG + 200MG + 250MG + 500MCG | TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3647 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | NYSTAGO ORAL SUSPENSION | NYSTATIN | 100000 IU | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL TOPICAL SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/3648 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | UNICONTIN 400 | THEOPHYLLINE | 400MG | MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3649 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | LAMISIL | TERBINAFINE | 125MG | NOVARTIS BARBERA -SPAIN | SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/3650 | AMOUN PHARMACEUTICALS COMPANY | BOOTS PHARMACEUTICALS LIMITED | ANTINAL | NIFUROXAZIDE | 220MG/5ML | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3651 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ORIPHEX SYRUP | CEPHALEXIN | 125MG/5ML | SAKAR HEALTHCARE LIMITED-BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY,
VILL: CHANGODAR, DIST: AHMEDABAD-382213,
GUJARAT ? INDIA.,SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3652 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | BENDAS-400 | ALBENDAZOLE | 400MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/3653 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN | ARTEMETHER + LUMEFANTRINE | 80 MG + 480 MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO),30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO) |
| NDA/MAL/HDP/3654 | IVEE AQUA EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYNOZVIN A NASAL DROPS | XYLOMETAZOLINE HYDROCHLORIDE | 1MG/ML | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | NASAL TOPICAL DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/3655 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | QUADRAJEL GEL | CHLORHEXIDINE+METRONIDAZOLE+LIDOCAINE | 5%W/W+1.61%W/W+2.13%W/W | FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
| INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3656 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | LARITEM | ARTEMETHER / LUMEFANTRINE | 80MG/480MG | IPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3657 | DAWA LIMITED | SUPER MEDIC LTD | DAWASTIN | NYSTATIN | 100000IU/ML | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/3660 | ASTRA PHARMA (U) PVT LTD | ASTRA PHARMA (U) LIMITED | ASTAGRA | SILDENAFIL CITRATE | 100MG | ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3663 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | AMLODAC 10 | AMLODIPINE BESYLATE | 10MG | CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3664 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | AZZY | AZITHROMYCIN | 500MG | TORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/3666 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | STROM 50 | TRAMADOL HYDROCHLORIDE | 50MG | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3668 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AUGMENTIN BD | AMOXICILLIN + CLAVULANIC ACID | 200 MG/ 5 ML + 28.5 MG/ 5 ML | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE,1.0X140.0 ML BOTTLE |
| NDA/MAL/HDP/3669 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | CO-TRIMOXAZOLE | SULFAMETHOXAZOLE/TRIMETHOPRIM | 200MG/40MG | MEDICAMEN BIOTECH LTD - -SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3670 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | TETRAREN CAPSULES | TETRACYCLINE HYDROCHLORIDE | 250MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3671 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | CLAVULIN TABLETS | AMOXICILLIN + CLAVULANIC ACID | 500 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET STRIP,10.0X10.0 TABLET STRIP,1.0X20.0 TABLET STRIP |
| NDA/MAL/HDP/3672 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | NITROCONTIN 6.4 | NITROGLYCERIN | 6.4MG | MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE | INDIA | ORAL SOLID ORDINARY SUBLINGUAL TABLETS | 1.0X25.0 TABLET CONTAINER |
| NDA/MAL/HDP/3673 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | PROMETHAZINE | PROMETHAZINE HCL | 25MG/ML | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3674 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | INTAMINE SYRUP | PROMETHAZINE HYDROCHLORIDE | 5MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN |
| NDA/MAL/HDP/3675 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASCOPAN - SC | HYOSCINE BUTYLBROMIDE | 10MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3676 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | COTRIMOXAZOLE | CO-TRIMOXAZOLE | 480MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3677 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | IBUREN | IBUPROFEN | 200MG | RENE INDUSTRIES LTD-680,KAMULI,KIREKA
KAMPALA,UGANDA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3678 | FOURRTS LABORATORIES LTD | DELMAW ENTERPRISES LIMITED | REDINPLUS | IRON PENTACARBONYL + ZINC SULPHATE MONOHYDRATE + FOLIC ACID + SODIUM SELENITE + LYSINE HYDROCHLORIDE + HISTIDINE HYDROCHLORIDE + CHOLINE BITARTRATE | 100MG + 30MG + 7.5MG + 0.11MG + 26MG + 4.4MG + 52MG | FOURRTS (INDIA) LABS PVT LTD .-VANDALUR ROAD. KELAMBAKK AM-603103 TAMIL, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X30.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3681 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEDOL | PARACETAMOL | 500MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3682 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | EXFORGE 10MG/320MG | AMLODIPINE + VALSARTAN | 1OMG + 320MG | NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/3683 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | COLD TABS FORTINSA | PARACETAMOL + PHENYLEPHRINE +CHLORPHENIRAMINE + CAFFEINE | 500MG + 5MG + 2MG + 30MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER |
| NDA/MAL/HDP/3684 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | I-PILL | LEVONORGESTREL | 1.5MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/3685 | GALPHAR LABORATORIES LTD | AIVEEN (U) LIMITED | ODICEF | CEFTRIAXONE | 1G | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/3686 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | NEURORUBINE | MULTIVITAMIN | MULTINGREDIENT | ACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BL | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3687 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-PROM | PROMETHAZINE HCL | 5MG/5ML | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3688 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | NEUTRAFLUX MINT FLAVOUR | ALGNIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE | 200MG +250MG + 250MG + 250MG + 125MG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE,1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/3690 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | INTUSSED SYRUP | DEXTROMETHORPHAN HBR BP+EPHEDRINE HCL BP+ PROMETHAZINE HCL BP | 8MG+8MG+4MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3692 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | COTRIM 120 | CO-TRIMOXAZOLE | 120MG | MACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3693 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | IMODIUM | LOPERAMIDE HCL | 2MG | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3694 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | LORIDIN RAPITAB | LORATADINE | 10MG | CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3698 | CADILA HEALTHCARE PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | HIPHEN SYRUP | AMOXICILLIN | 125MG/5ML | SPARSH BIO-TECH LTD -PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR ? 361006 GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3699 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SINOPRIL 5MG TABLETS | LISINOPRIL | 5MG | GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3702 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ATORFIT-20 | ATORVASTATIN | 20MG | AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3703 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | SONATEC | CETYLPYRIDINIUM CHLORIDE | 0.05%W/V | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL TOPICAL LIQUIDS | 1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/3704 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | PENEGRA 100 | SILDENAFIL | 100MG | CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3705 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SORAL 20MG CAPSULES | TENOXICAM | 20MG | GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3707 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | OBETAS-120 | ORLISTAT | 120MG | INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3708 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | AMARYL M | GLIMEPIRIDE+METFORMIN HYDROCHLORIDE | 2MG+500MG | HANDOK INC-78, DAEPUNGSANDAN-RO, DAESO-MYEON, EUMSEONG-GUN, CHUNGCHEONGBUK-DO, KOREA | NORTH KOREA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3709 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | NIGHT & DAY -N | PARACETAMOL/ DIPHENHYDRAMINE CHLORIDE + PARACETAMOL/ PSEUDOEPHEDRINE | 500MG/ 25MG +600MG/ 90MG | MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3710 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LACILLIN | AMPICILLIN | 250MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3711 | BHARAT SERUMS AND VACCINES LIMITED, | GITTOES PHARMACEUTICALS LIMITED | POLY-MXB | POLYMYXIN B | 500,000 UNITS | BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/3712 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMLOZAAR | LOSARTAN POTASSIUM / AMLODIPINE | 50MG + 5MG | MICRO LABS LTD-92,SIPCOT INDUSTRIAL COMPLEX,HOSUR-635-126(T.N)INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3714 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | ADALAT LA | NIFEDIPINE | 30MG | BAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANY | GERMANY | ORAL SOLID RETARD FILM-COATED TABLETS | 2.0X14.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3716 | I CARE PHARMA LIMITED | VITACARE LTD | CLOXACILLIN SODIUM FOR INJECTION | CLOXACILLIN SODIUM FOR INJECTION | 500MG | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/3717 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CEFTRIAXONE SODIUM | CEFTRIAXONE SODIUM | 1G | CSPC ZHONGNUO PHARMACEUTICALS LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/3718 | ALCON PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ISOPTO ATROPINE 1% | ATROPINE SULPHATE | 1%W/V | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/3719 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | PARACETAMOL TABLETS | PARACETAMOL | 500MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | TABLET BLISTER, AMPOULE AMPOULE, TABLET CONTAINER |
| NDA/MAL/HDP/3720 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | HALDOL DECANOAS | HALOPERIDOL DECANOATE | 50MG/ML | JANSSEN PHARMACEUTICAL NV-TURNHOUTSEWEG 30
B-2340 BEERSE
BELGIUM
| BELGIUM | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3723 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LACILLIN | AMPICILLIN | 125MG/5ML | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3724 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | EPIGAB | PREGABALIN | 150MG | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X14.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3725 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | NEW TUXIRIL | DEXTROMETHORPHAN HBR + PHENYLEPHRINE HCL + MENTHOL | 10MG/ML + 5MG/10ML + 5MG/10ML | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3728 | ERIS LTD | BENLE CONSULT LIMITED | DICLO-DENK 50 | DICLOFENAC SODIUM | 50MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER + 1 * 10 SAMPLE |
| NDA/MAL/HDP/3729 | MEDLEY PHARMACEUTICALS | MEDVIN PHARMA LIMITED | DECIFEN-SR | DICLOFENAC SODIUM | 100MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID RETARD ENTERIC-COATED TABLETS | 1.0X10.0X20.0 TABLET STRIP |
| NDA/MAL/HDP/3730 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 400MG | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 2.0X5.0 TABLET BLISTER,1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/3731 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ 50MG | EFAVIRENZ | 50MG | AUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3732 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | ALBASOL TABLETS 200MG | ALBENDAZOLE | 200MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/3733 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | DOMADOL | TRAMADOL HCL | 100MG/2ML | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0X2.0 ML AMPOULE,1.0X5.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3734 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | ZARICORT CREAM | MICONAZOLE + HYDROCORTISONE | 2%W/W + 1%W/W | XEPA SAUL PATTINSON MALAYSIA-1-5 INDUSTRIAL ESTATE 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3735 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMSPRO | ACETYL SALICYLIC ACID | 300MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,100.0 TABLET CONTAINER |
| NDA/MAL/HDP/3736 | PHARMAVET LTD | DELMAW ENTERPRISES LIMITED | RECTOL 125 SUPPOSITORY | PARACETAMOL | 125MG | BLISS GVS PHARMA LIMITED-PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/3737 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | ECOFLOX 500 TABLETS | CIPROFLOXACIN HYDROCHLORIDE | 500MG | MEDLEY PHARMACEUTICALS LTD..-PLOT NO. 18 & 19, SURVEY NO.378/7&8, 379/2&3,ZARI CAUSEWAY ROAD, KACHIGAM,DAMAN (U.T) 396210-INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3738 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | AMPICILLIN SODIUM | AMPICILLIN SODIUM | 500MG | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL,1.0X50.0X500.0 MG VIAL |
| NDA/MAL/HDP/3739 | CADILA HEALTH CARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ALDREN | ALENDRONATE | 70MG | CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3741 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | ACTIZINE | CETIRIZINE HYDROCHLORIDE | 10MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X15.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3743 | CADILA HEALTH CARE LTD | ABACUS PHARMA (AFRICA) LIMITED | CARVIL 3.125 | CARVEDILOL | 3.125 MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3745 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | WINDERM CREAM | BECLOMETHASONE+MICONAZOLE+NEOMYCIN | 0.025%W/W + 2%W/W + 0.5%W/W | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE |
| NDA/MAL/HDP/3746 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENDRO | BENDROFLUMETHIAZIDE | 5MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3747 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | ALZOL TABLETS | ALBENDAZOLE | 200MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 30.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/3748 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOSPIRIN | ACETYL SALICYLIC ACID | 100MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3752 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | PAINOTAB 200 | PARACETAMOL/CAFFEINE | 500MG+65MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3753 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | MYFORTIC 180 | MYCOPHENOLATE SODIUM | 180MG | NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND,NORVATIS PHARMA PRODUCTIONS GMBH, WEHR-OEFLINGER STR. 4479664 WEHR GERMANY | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X12.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3754 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | SINAREST PD NASAL DROPS | OXYMETAZOLINE HYDROCHLORIDE | 0.025%W/V | CENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | NASAL TOPICAL DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/3757 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNITRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3760 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | COMPOUND MAGNESIUM TRISILICATE | MAGNESIUM TRISILICATE | 370MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
| INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3761 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | RIFAMPICIN CAPSULES B.P 300MG | RIFAMPICIN | 300 MG | COSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3762 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | LAMICTAL 2MG | LAMOTRIGINE | 2MG | GLAXO WELLCOME INC-ZI DE LA PEYENNIERE, 53100, MAYENNE | UNITED STATES | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/3765 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ALPRIM | CO-TRIMOXAZOLE | 480MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/3766 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | BUKOL TABLETS | HYOSCINE N-BUTYLBROMIDE | 10MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY OTHER COATED TABLETS | TABLET BLISTER, AMPOULE AMPOULE, TABLET CONTAINER |
| NDA/MAL/HDP/3767 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | AMPOXIN 500 | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3768 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NIMOTOP 30MG | NIMODIPINE | 30MG | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3770 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XITHRONE | AZITHROMYCIN | 500 MG | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT | EGYPT | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/3771 | FAES FARMA S.A | LABOREX UGANDA LIMITED | BRONQUIDIAZINA C.R | TRIMETHOPRIM/SULFAMETHOXAZOLE/BROMHEXINE/SODIUM BENZOATE/TOLU BALSAM | 80MG/400MG/4MG/250MG/325MG | FAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA | SPAIN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X150.0 ML BOTTLE |
| NDA/MAL/HDP/3772 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | HUMULIN N NPH | HUMAN INSULIN ISOPHANE | 100IU | LILLY EGYPT S.A.E. & ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,-INDIANA 46285 USA | EGYPT | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/3773 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOBUTOL-4 | SALBUTAMOL SULPHATE | 4 MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3777 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | AMPOXIN 500 | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/3778 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | XITHRONE | AZITHROMYCIN | 200MG/5ML | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/3779 | CADILA PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | LOSIUM 50 | LOSARTAN POTASSIUM | 50MG | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/3781 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ALZENTEL | ALBENDAZOLE | 20MG/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X20.0 ML BOTTLE |
| NDA/MAL/HDP/3782 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LAE-PEN V | PHENOXYMETHYLPENICILLIN | 250MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3784 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | CIPIUM | CHLORPHENIRAMINE | 2MG/5ML | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3787 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPENIV | PHENOXYMETHYLPENICILLIN | 125MG/5ML | SPARSH BIO-TECH PVT. LTD .-PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR ? 361006 GUJARAT INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3789 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | LEVITRA | VARDENAFIL HCL | 5MG | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3790 | AGOG PHARMA | GITTOES PHARMACEUTICALS LIMITED | AGOFLOX-P | PEFLOXACIN | 400MG | AGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3792 | MEDREICH PLC | LABOREX UGANDA LIMITED | FLEMING 228.5 | AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE | 200MG+28.5MG | MEDREICH LIMITED UNIT 1-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR, BANGOLORE-560049 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/3794 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOMET-200 (THANE) | METRONIDAZOLE | 200MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3797 | ELDA INTERNATIONAL DMCC | REDDYS PHARMA LIMITED | PROVIVE 1% | PROPOFOL | 10MG/ML | CLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL |
| NDA/MAL/HDP/3798 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | NEUROTON TABLET | MULTI-INGREDIENT | N/A | AMOUN PHARMACETICAL COMPANY-1ST INDUSTRIAL ZONE, EL OBOUR CITY, CAIRO, EGYPT | EGYPT | ORAL SOLID ORDINARY COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3800 | CENTAUR PHARMACEUTICALS PRIVATE LIMITED | GITTOES PHARMACEUTICALS LIMITED | COLDAREST | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE + CAFFEINE | 500MG+5MG+2MG+30MG | CENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X50.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/3801 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | FUNGISTIN ORAL SUSPENSION | NYSTATIN | 100000 IU/ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/3802 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | LEVITRA 10MG | VARDENAFIL MONOHYDROCHLORIDE TRIHYDRATE | 10 MG | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3803 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | DICLODYNE SUPPOSITORY | DICLOFENAC SODIUM | 100MG | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/3804 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | NEURORUBINE | VITAMIN B1+VITAMIN B6+VITAMIN B12 | 100MG+100MG+1MG | ACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY I M AMPOULES | 1.0X1.0 ML AMPOULE,1.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/3806 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | NOCID GEL | ALUMINIUM HYDROXIDE + SIMETHICONE + MAGNESIUM | 400MG/5ML + 25MG/5ML + 100MG/5ML | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/3807 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | ARTEMETHER INJECTION | ARTEMETHER | 80MG/ML | NINGBO DAHONGYING PHARMACEUTICALS-N0.396 MINZHU RD NINGBO CITY ZHEJIANG, CHINA | CHINA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3808 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN SUPPOSITORIES 12.5MG | DICLOFENAC SODIUM | 12.5MG | DELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE | FRANCE | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X1.0X10.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/3809 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | COLDRID DAY & NIGHT | PARACETAMOL+CHLORPHENIRAMINE MALEATE+PHENYLEPRINE HYDROCHLORIDE + CAFFEINE | 500MG+2MG+5MG+15MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3810 | GALENTIC PHARMA (PVT)LTD | NORVIK ENTERPRISES LIMITED | TRIOSPORINE OINTMENT | NEOMYCIN+ POLYMYXIN B +BACITRACIN | 3.4%W/W + 5%W/W + 0.4%W/W | GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE |
| NDA/MAL/HDP/3812 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | B-TONE | PHENOBARBITONE | 30MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3813 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | ACTIPAR | PIPERAZINE CITRATE | 500MG/5ML | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/3814 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | PETHIDINE INJECTION | PETHIDINE | 50MG/1ML | MARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3815 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | QURE 500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/3816 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | RAPICLAV-375 | AMOXYCILLIN + CLAVULANIC ACID | 250 MG + 125 MG | IPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X7.0X3.0 TABLET STRIP,1.0X5.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/3817 | ROYAL PHARMA | ROYAL PHARMA 2011 LIMITED | BENZYLPENICILLIN INJECTION | BENZYLPENICILLIN SODIUM | 1000000 I.U | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 MU VIAL |
| NDA/MAL/HDP/3818 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | REPOITIN | RECOMBINANT HUMAN ERYTHROPOIETIN | 2000 I.U/0.5ML | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/3819 | PHARMATHEN LTD | GOODMAN INTERNATIONAL LTD | STRADUMEL | ALLOPURINOL | 100MG | PHARMATHEN S.A--6,DERVENAKION STR .153 51,PALLINI,AHICA GREECE | GREECE | ORAL SOLID ORDINARY TABLETS | 1.0X25.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/3823 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | D-WORM ORAL SUSPENSION | ALBENDAZOLE | 200MG/5ML | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/3824 | STRIDES ARCOLAB LIMITED | ROYAL PHARMA 2011 LIMITED | ASPIRIN | ACETYL SALICYLIC ACID | 300MG | STRIDES ARCO LAB LTD-K.R.S GARDENS SURAGAJAKKANAHALLI,INDLAWADI CROSS ANEKAL TALUK,BANGALORE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | TABLET BLISTER, AMPOULE AMPOULE, TABLET CONTAINER |
| NDA/MAL/HDP/3825 | UNI MEDICO LAB | SHREEJI PHARMACEUTICALS LIMITED | UMOXIL 250 | AMOXICILLIN | 250MG | UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3826 | MACLEODS PHARMACEUTICAL LTD | NORVIK ENTERPRISES LIMITED | KETOMAC | KETOCONAZOLE | 200 MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3827 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ATORFIT-10 | ATORVASTATIN | 10MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3828 | MEDREICH PLC | LABOREX UGANDA LIMITED | PARAFLAM | IBUPROFEN + PARACETAMOL | 400MG + 325MG | MEDREICH STERILAB LTD-UNIT VI 54/2 BOODHIHALLI VI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3829 | BETA HEALTHCARE | BETA HEALTHCARE UGANDA LIMITED | BETACOOL | DRIED ALUMINUM HYDROXIDE/MAGNESIUM HYDROXIDE /MAGNESIUM ALUMINUM SILICATE/SIMETHICANE | 300MG / 25MG / 50MG / 25MG | BETA 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 TABLETS | 1.0X2.0X50.0 TABLET STRIP |
| NDA/MAL/HDP/3831 | ABBVIE (PTY) LTD | MEDICAL ACCESS (UGANDA) LIMITED | ALUVIA | LOPINAVIR+RITONAVIR | 200MG+50MG | ABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY. | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X120.0 TABLET CONTAINER |
| NDA/MAL/HDP/3833 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LABSTATIN VAGINAL TABLETS | NYSTATIN | 100.000 I.U | LABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBI | KENYA | VAGINAL TABLETS | 1.0X15.0 PESSARY STRIP |
| NDA/MAL/HDP/3835 | GLAXOSMITHKLINE LTD | BETA HEALTHCARE UGANDA LIMITED | HEDEX CAPLETS | PARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS | 200MG+400MG+50MG | SMITHKLINE BEECHAM (NAIROBI)-NAIROBI, KENYA,BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET PACK,1.0X110.0 TABLET PACK,1.0X100.0 TABLET PACK |
| NDA/MAL/HDP/3837 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | NITROFURANTOIN | NITROFURANTOIN | 100MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3839 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLURID | ACETAMINOPHEN + PHENIRAMINE MALEATE | 500 MG + 10.5 MG | KAMPALA PHARMACEUTICALS INDUSTIES-PLOT M 444B STRETCHER NTINDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3840 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | TORACTIN TABLETS | CYPROHEPTADINE | 4MG | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 2.0X50.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3841 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | MEGATRIM TABLETS | CO-TRIMOXAZOLE | 480MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3843 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | AZIWOK | AZITHROMYCIN | 250MG | WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3844 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | VOLTAREN RETARD | DICLOFENAC SODIUM | 100MG | NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NORVATIS FARMA SPA--VIA PROVINCIALE SCHITO, 131 1-80052, TORRE ANNUNCIATA (NA) ITALY | SWITZERLAND | ORAL SOLID RETARD TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/3845 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CARDIPAC | AMLODIPINE | 5MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3846 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | LEVITRA | VARDENAFIL HCL | 20 MG | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3847 | ROYAL PHARMA | ROYAL PHARMA 2011 LIMITED | FORTIFIED PROCAINE PENICILLIN | FORTIFIED PROCAINE PENICILLIN | 4 MEGA UNIT | SHIJIAZHUANG PHARMA GROUP-ZHOUGNUO, PHARMACEUTICAL | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON,1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/3848 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | AZIWOK | AZITHROMYCIN | 200MG/5ML | WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/3850 | MICRO LABS LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ANGIZAAR-H | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3852 | GLAXOSMITHKLINE LIMITED | UNITED HEALTHCARE DISTRIBUTORS LTD | PROCTO GLYVENOL | TRIBENOSIDE + LIDOCAINE HCL | 5%W/W + 2%W/W | NOVARTIS CONSUMER INT. INC.-ZYMASA-CH-1260, NYON SWITZERLAND | SWITZERLAND | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/3853 | MISSION PHARMA A/S | JOINT MEDICAL STORE (UPMB - UCMB) | ZINC SULPHATE TABLET USP | ZINC SULPHATE | 20MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3854 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LOSARTAS 50 TABLETS | LOSARTAN POTASSIUM | 50MG | INTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUN | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/3856 | KWALITY AFRO ASIA LIMITED | KWALITY AFRO ASIA LIMITED | QUININE-K | QUININE HYDROCHLORIDE | 100MG/5ML | KWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROAD | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3859 | UNIQUE PHARMACEUTICAL LABORATORIES | TATA UGANDA LIMITED | IFIMOL | PARACETAMOL | 10MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES--PLOT NO. 4 PASE IV, GIDC PANOLI -394 116
GUJARAT INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3860 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOLAC | LACTULOSE | 3.35MG/5ML | 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 SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/3862 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | LAMITOR 100 | LAMOTRIGINE | 100MG | TORRENT PHAMACEUTICALS LTD-TORRENT PHAMACEUTICALS LTD INDRAD 382721 DIST MEHSANA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3865 | SIRMAXO CHEMICALS PVT LTD | SUPER MEDIC LTD | SANIQUAD GHS | CETRIMIDE + CHLORHEXIDINE GLUCONATE | 15%W/V + 1.5%W/V | SIRMAXO CHEMICALS PVT LTD-PLOT NO. E-35. TARAPRU MIDC BOISAR, THANE, MUMBAI, INDIA | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE,1.0X5000.0 ML JERRYCAN |
| NDA/MAL/HDP/3866 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | RL | COMPOUND SODIUM LACTATE INFUSION BP | 0.6/ 0.25 /0.04 / 0.027 % W/V | ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/3867 | ROYAL GROUP | ABACUS PHARMA (AFRICA) LIMITED | BETADERM OINTMENT | BETAMETHASONE VALERATE | 0.1%W/W | ATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X5.0 G TUBE |
| NDA/MAL/HDP/3869 | UNIQUE PHARMACEUTICAL LABORATORIES | TATA UGANDA LIMITED | RANTAB INJECTION | RANITIDINE | 25MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3871 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | DOVERIN 40 | DROTAVERINE HYDROCHLORIDE | 40MG | INTAS PHARMACEUTICALS LIMITED-PLOT NO. 457 / 458
SARKHEJ-BAVLA HIGHWAY, MATODA - 382 210, TALUKA - SANAND,
DISTRICT - AHMEDABAD, STATE - | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3872 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | ZYNCET SYRUP | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | UNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA,THE MADRAS PHARMACEUTICALS-137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3873 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CHLORPROMAZINE INJECTION B.P | CHLORPROMAZINE | 25MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3874 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | RIDMAL 40/320 | DIHYDROARTEMISININ + PIPERAQUINE | 40MG + 320MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X8.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3875 | PHAMA INTERNATIONAL CO | OMAB UGANDA LIMITED | OPTIMAL(0.05% GEL | TRETINOIN USP | 0.25MG/1G | PHARMA INTERNATIONAL COMPANY .-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN | JORDAN | TOPICAL EXTERNAL GELS AND SOLS | 1.0X1.0X30.0 G TUBE |
| NDA/MAL/HDP/3878 | ASTRA PHARMA (U) LTD | ASTRA PHARMA (U) LIMITED | ASTIDIN 400 | CIMETIDINE TABLETS | 400 MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3879 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | METRIM SUSPENSION | CO-TRIMOXAZOLE | 240MG/5ML | MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3881 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | MOXACIL | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3882 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | PEDIVIT FORTE CAPSULES | MULTIINGREDIENT | N/A | J.B. CHEMICALS AND PHARMACEUTICALS LTD-J.B. CHEMICALS & PHARMACEUTICALS LTD, 215/216, GIDC, PANOLI, GUJARAT | INDIA | ORAL SOLID ORDINARY CAPSULES | 3.0X7.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3883 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | MYFORTIC 360 | MYCOPHENOLATE SODIUM | 360MG | NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS PHARMA PRODUKTIONS GMBH-OEFLINGER STR.4479664 WEHR GERMANY | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X12.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3885 | GLAXO WELLCOME(KENYA) LTD | ERIS LTD | ZANTAC | RANITIDINE | 150MG | GLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3886 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | DELOR | CLOBETASOL PROPIONATE | 0.5 MG/G | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/3887 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | LYRICA 150MG | PREGABALIN | 150 MG | PFIZER GMBH ARZEIMITELWORK -MOSWALDA 1144 79090 FREUBURG | GERMANY | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3888 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | PYRIREN | PYRIDOXINE HYDROCHLORIDE | 25MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3889 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | LYRICA 75MG | PREGABALIN | 75 MG | PFIZER GMBH ARZEIMITELWORK -MOSWALDA 1144 79090 FREUBURG | GERMANY | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3890 | UNIMED INDIA | METAPLUS (U) LIMITED | PARACETAMOL SYRUP | PARACETAMOL | 120MG/5ML | UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD
ANDHERE(E)MUMBAI 400059 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3891 | PHARMATHEN S.A | GOODMAN INTERNATIONAL LTD | LADININ | CIPROFLOXACIN | 500MG | PHARMATHEN S.A--6,DERVENAKION STR .153 51,PALLINI,AHICA GREECE | GREECE | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3892 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | TETRAX | LEVAMISOLE HYDROCHLORIDE | 40MG/5ML | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/3893 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | EPINEPHRINE INJECTION USP | EPINEPHRINE HCL | 1MG/ML | NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3895 | ASTRA PHARMA UGANDA LIMITED | ASTRA PHARMA (U) LIMITED | ASNOR | NORFLOXACIN | 400MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3896 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | VALCONTIN 500 | SODIUM VALPROATE (CONTROLLED RELEASE) | 500MG | MODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM ? 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3897 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | CLAVODAR | AMOXICILLIN/CLAVULANIC ACID | 875MG/125MG | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/3899 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | FEDATE SYRUP | SODIUM FEREDETATE + PYRIDOXINE + CYANOCOBALAMIN + FOLIC ACID | 216.87MG + 1.5MG + 7.5MCG + 1.5MG | AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/3900 | ASTRA PHARMA UGANDA LTD | ASTRA PHARMA (U) LIMITED | ASTIBA-500 | TINIDAZOLE | 500MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/3901 | BAYER SCHERING PHARMA FRANCE | SURGIPHARM (U) LIMITED | MICROGYNON ED FE | LEVONORGESTREL + ETHINYLESTRADIOL | 0.15MG + 0.03MG | BAYER WEIMER GMBH- DOBEREINERSTRASSE 20, D-99427 WEIMER 2.BAYER PHARMA AG 13342, BERLIN,BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/3902 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | NODON | NEBIVOLOL | 5MG | CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3903 | PFIZER LABS LTD | ERIS LTD | CELSENTRI 300MG | MARAVIROC | 300MG | GODECKE GMBH -MOOSWALDALLEE 179090, FREIBERG GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3904 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | NYCOSTAT PESSARIES | NYSTATIN | 100,000 I.U | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | VAGINAL TABLETS | 1.0X50.0X14.0 PESSARY STRIP,1.0X14.0 PESSARY STRIP |
| NDA/MAL/HDP/3906 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | LEROLE | PANTOPRAZOLE | 40MG | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL 1*10ML 0.9%NACL AMPOULE |
| NDA/MAL/HDP/3907 | GLAXOSMITHKLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ANDREWS LIVER SALT REGULAR | MAGNESIUM SULPHATE +SODIUM HYDROGEN CARBONATE +CITRIC ACID | 17.4 %W/W+22.6 % W/W+19.5 % W/W | SMITHLINE BEECHAM (NAIROBI)-NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X8.0X5.0 G SACHET,1.0X48.0X5.0 G SACHET |
| NDA/MAL/HDP/3908 | AUROBINDO PHARMA | GITTOES PHARMACEUTICALS LIMITED | ZIDOVUDINE | ZIDOVUDINE | 100MG | AUROBINDO PHARMA LTD --UNIT VII PLOT NO. S1 GREEN INDUSTRIAL PARK POLLEPALLY VILLAGE ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X100.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3911 | ASTRA PHARMA UGANDA LTD | ASTRA PHARMA (U) LIMITED | ASID | OMEPRAZOLE | 20 MG | ASTRA LIFECARE PVT LTD-57/P RAJODA 382220 BAVLA AHMEDABAD | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3912 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LAMIVUDINE/ZIDOVUDINE/NEVIRAPINE | LAMIVUDINE+ZIDOVUDINE+NEVIRAPINE | 150MG+300MG+200MG | AUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/3913 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | VALCONTIN | SODIUM VALPROATE | 200 MG | MODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM ? 250110 UTTAR PRADESH | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3914 | GLAXOSMITHKLINE LTD | ERIS LTD | AUGMENTIN | AMOXICILLIN + CLAVULANATE POTASSIUM | 875 MG + 125 MG | SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/3920 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | PHOTERICIN B | AMPHOTERICIN B | 50MG | CIPLA LTD-M-61, M-62 & M-63, VERNA INDUSTRIAL ESTATE VERNA GOA,INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 MG VIAL |
| NDA/MAL/HDP/3921 | ASTRA PHARMA (U) PVT LTD | ASTRA PHARMA (U) LIMITED | AS-B | PYRIDINE-3-CARBOXAMIDE/ RIBOFLAVIN/ THIAMINE NITRATE | 17.25MG/ 1.3MG/ 1.3MG | ASTRA LIFECARE (INDIA) PVT. LTD. -PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/3922 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | DIAZI | DIAZEPAM | 5MG/ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3923 | ASTRA PHARMA UGANDA LIMITED | ASTRA PHARMA (U) LIMITED | AXASONE | DEXAMETHASONE | 0.5MG | ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3924 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLUFED | PARACETAMOL+PSEUDOEPHEDRINE HYDROCHLORIDE+TRIPOLIDINE HYDROCHLORIDE | 300MG+36MG+1.5MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3925 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CALCIUM GLUCONATE INJECTION | CALCIUM GLUCONATE | 10 %W/V | NINGBO DAHONGYING PHARMACEUTICALS-N0.396 MINZHU RD NINGBO CITY ZHEJIANG, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X50.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/3926 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | MIFUPEN TABLETS | ASPIRIN + CAFFEINE | 350 MG + 50 MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET STRIP |
| NDA/MAL/HDP/3927 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL CEPHALEXIN 125 | CEPHALEXIN MONOHYDRATE | 125MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3928 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | MALAREN | SULPHADOXINE + PYRIMETHAMINE | 500MG/25MG | RENE INDUSTRIES LTD .-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/3931 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | COARTEM 80/480 | ARTEMETHER + LUMEFANTRINE | 80MG +480MG | NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3932 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIRAX TABLETS | CLIDINIUM BROMIDE + CHLORDIAZEPOXIDE | 2.5MG + 5MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/3933 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TOZAAR-50 | LOSARTAN POTASSIUM | 50MG | TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY TABLETS | 5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3938 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | ADRENALINE INJECTION | ADRENALINE | 1MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3941 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROZIL 500 | CEFPROZIL | 500MG | AUROBINDO PHARMA LTD-UNIT VI SY.NO.329/39 & 329/47 CHITKUL VILLAG,PATARICHEM,MANDAT MEDAK DISTRICT,ANDRA PRADESH,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3942 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AUROZIL 250 | CEFPROZIL | 250 MG | AUROBINDO PHARMA LTD-UNIT VI SY.NO.329/39 & 329/47 CHITKUL VILLAG,PATARICHEM,MANDAT MEDAK DISTRICT,ANDRA PRADESH,INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3943 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | SYNTOCINON | OXYTOCIN | 5 I.U | NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | SWITZERLAND | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3945 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | CEFONE | CEFTRIAXONE | 1G | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/3947 | INTAS PHARMACUITICALS LTD | NORVIK ENTERPRISES LIMITED | RABTAS-20 | RABEPRAZOLE SODIUM | 20 MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA,INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3948 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | TAXIM-O | CEFIXIME | 50MG/5ML | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3949 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MAGNOMINT SUSPENSION | MAGNESIUM TRISILICATE+ALUMINIUM HYDROXIDE | 500MG/5ML+250MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3950 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | STROM | TRAMADOL HYDROCHLORIDE | 50MG/ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/3951 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMCLOX | AMPICILLIN + CLOXACILLIN | 125MG/5ML + 125MG/5ML | SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3954 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | POWERCEF 1GM INJECTION | CEFTRIAXONE SODIUM | 1GM | ZEISS PHARMACEUTICALS PVT. LIMITED-PLOT NO. 72, EPIP I, JHARMAJIRI, BADDI (HP), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/3955 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | NEVIRAPINE | NEVIRAPINE | 200 MG | STRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAVADI CROSS ANECAL TULK BANGALORE 562 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/3960 | UNEED GLOBAL GROUP LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IBUPAR | PARACETAMOL/IBUPROFEN | 325/400MG | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3961 | MEDREICH PLC | LABOREX UGANDA LIMITED | BIOFERON | MULTI INGREDIENT | N/A | MEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3963 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | COARTEM DISPERSIBLE TABLETS | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY | TURKEY | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,2.0X1.0X24.0 TABLET BLISTER,2.0X1.0X18.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/3965 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | OROFER SYRUP | IRON(II) HYDROXIDE POLYMALTOSE COMPLEX | 50MG/5ML | EMCURE PHARMACEUTICALS LTD -LANE NO.3 PHASE II,SIDCO INDUSTRIAL COMPLEX,BARI-BRAHMANA JAMMU 181 133, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE |
| NDA/MAL/HDP/3966 | DAWA LIMITED | SUPER MEDIC LTD | ASCORBIC ACID TABLETS | ASCORBIC ACID | 100 MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3967 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCLOX-125 | CLOXACILLIN | 125MG/5ML | MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL
ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).
| INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3968 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | NORLUT-N | NORETHISTERONE ACETATE | 5MG | CIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3969 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FAWAR FRUIT EFFERVESCENT GRANULES | SODIUM CARBONATE + TARTARIC ACID + CITRIC ACID | 2.8G + 1.33G + 0.82G | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES | 1.0X6.5 G SACHET |
| NDA/MAL/HDP/3970 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | LECOTRIM | CO-TRIMOXAZOLE | 480MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3971 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | VIRIAXONE-SL | CEFTRIAXONE + SULBACTAM | 1G+500MG | VIRCHOW HEALTHCARE PVT LTD,-PLOT NO.130, SILVASSA ROAD, GGID VAPI-396 195, GUJURAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 10 ML AMPOULE WFI |
| NDA/MAL/HDP/3972 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | FERTOMID-50 | CLOMIPHENE | 50MG | CIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3973 | IPCA LABORATORIES LIMITED | MEDVIN PHARMA LIMITED | LARITHER | ARTEMETHER | 80MG/ML | IPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067 | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE,1.0X8.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/3974 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMCLOXA | CLOXACILLIN | 125MG/5ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 100.0 ML BOTTLE |
| NDA/MAL/HDP/3977 | CHINOIN PHARMACEUTICALS AND CHEMICAL WORKS, CO. LTD | LABOREX UGANDA LIMITED | NO-SPA 40MG | DROTAVERINE HYDROCHLORIDE | 40MG | CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO.LTD-H-2112, VERESEGYHAZ, LEVAI U.5.HUNGARY | HUNGARY | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3980 | UNEED GLOBAL GROUP LIMITED | ABACUS PHARMA (AFRICA) LIMITED | AB-TONE TONIC | VITAMIN B1 + VITAMIN B2 + VITMAIN B6 + VITAMIN B12 + FOLIC ACID + VITAMIN B5 + CALCIUM GLUCONATE + VITAMIN B3 + IRON + ZINC SULPHATE + COPPER SULPHATE + MANGANESE CHLORIDE + LYSINE HCL + HONEY + MALT | MG PER 5ML: 5 + 1 + 1 + 5 + 50 + 2 + 20 + 10 + 10 + 3 + 0.2 + 0.25 + 20 + 100 + 100 | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X200.0 ML BOTTLE,1.0X90.0 ML BOTTLE |
| NDA/MAL/HDP/3981 | GLAXO SMITH KLINE LTD | ERIS LTD | PENAMOX | AMOXYCILLIN | 500MG | MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 25.0X20.0 CAPSULE BLISTER,10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/3982 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | LONART SUPPOSITORY | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X6.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/3983 | UNEED GLOBAL GROUP LIMITED | ABACUS PHARMA (AFRICA) LIMITED | EXTRADOL | PARACETAMOL/CAFFEINE TABLETS | 500MG/65MG | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/3985 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOMYCIN SUSPENSION | ERYTHROMYCIN ESTOLATE | 125MG/5ML | AGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3987 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | ROHISOL SYRUP | LEVAMISOLE HYDROCHLORIDE | 40MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X500.0 ML BOTTLE,1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/3989 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CELIB 200MG | CELECOXIB | 200MG | UNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/3990 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIXIL SYRUP | AMOXYCILLIN TRIHYDRATE | 125MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/3991 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOFULVIN | GRISEOFULVIN TABLETS | 500MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3993 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | NEM SCAB | MULTI-INGREDIENT | MULTI-INGREDIENT | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/3995 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | LAMIVUDINE | LAMIVUDINE | 150 MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/3996 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOTOIN TABLETS | NITROFURANTOIN BP | 100MG | AGOG 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 TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/3998 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOKOFF SYRUP | TERBUTALINE SULPHATE +GUAIFENESIN+BROMHEXINE HYDROCHLORIDE +LEVOMENTHOL | 1.25MG/5ML+50MG//5ML+4MG/5ML+2.5MG/5ML | 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 SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/3999 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | PANSEC DR | PANTOPRAZOLE SODIUM | 40MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X4.0X7.0 TABLET STRIP |
| NDA/MAL/HDP/4000 | AMOUN PHARMACEUTICAL COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | APIDONE SYRUP | CHLORPHENARIMINE MALEATE/DEXAMETHASONE | 2MG/5ML + 0.5MG/5ML | AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE,EL OBOUR CITY, CAIRO, EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X125.0 ML BOTTLE |
| NDA/MAL/HDP/4001 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCOLD PLUS SYRUP | PARACETAMOL+PHENYLEPHRINE+CHLORPHENIRAMINE+SODIUM CITRATE | 125MG/5ML+2.5MG/5ML+1MG/5ML+60MG /5ML | 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 SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4002 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCID | ALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE | 250MG/5ML+ 250MG/5ML | 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 SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X170.0 ML BOTTLE |
| NDA/MAL/HDP/4003 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | OXYTOCIN INJ | OXYTOCIN | 10IU/ML | GLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0 ML AMPOULE |
| NDA/MAL/HDP/4004 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | ANTHEL | ALBENDAZOLE | 400MG | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/4006 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | RHINATHIOL 5% FOR ADULTS SUGARFREE | CARBOCISTEINE | 5G/100ML | NATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANY | GERMANY | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/4007 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | SHANCHOL CHOLERA VACCINE | V.CHOLERA STRAINS- 01 INABA FORMALDEHYDE KILLED +01 OGAWA HEAT KILLED + 01 OGAWA FORMALDEHYDE KILLED + 01 INABA HEAT KILLED + 0139 FORMALDEHYDE KILLED | 600 + 300 +300 +300 + 600 ELISA UNITS(EU) OF LIPOPOLYSACCHARIDE (LPS) | SHANTHA BIOTECHNICS LTD -SURVEY NO. 274, ATHVELLI VILLAGE, MEDCHAL MANDAL ? 501401, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA | INDIA | PARENTERAL ORDINARY I M VIALS | 1.0X10.0X1.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/4010 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | PYRI | PYRIDOXINE HYDROCHLORIDE | 25MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4012 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | MESPORIN 2000 | CEFTRIAXONE | 2000MG | LABESFAL LABORATORIOS ALMIRO, S.A ,.-ZONA INDUSTRIAL DO LABENGO, 3465-157 SANTIAGO DE BESTEIROS | PORTUGAL | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X50.0 ML VIAL |
| NDA/MAL/HDP/4014 | GENO PHARMACEUTICALS PVT LTD | HARLEYS UGANDA LIMITED | FUSIGEN | SODIUM FUSIDATE | 20MG/G | GENO PHARMACEUTICALS LIMITED-KARASWADA,MAPUSA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/4015 | CADILA PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | TAMBAC 50 | CEFPODOXIME PROXETIL | 50MG/5ML | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4016 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | COMPOUND SODIUM LACATE INTRAVENOUS INFUSION | MULTI-INGREDIENT | MULTI-INGREDIENT | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/4017 | THE ARAB P'CAL MANUFACTIRING CO. | GOODMAN INTERNATIONAL LTD | ZOCIN CAPSULES | AZITHROMYCIN | 250MG | ARAB PHARMACEUTICAL MANUFACTURING INDUSTRIES --KING ABDULAH 2ND STREET / INDUSTRIAL AREA BUILDING NO. 1 AL-BUHAIRAH / SULT-JORDAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4018 | MEDREICH PLC | LABOREX UGANDA LIMITED | ZEBEN | ALBENDAZOLE | 100MG/5ML | MEDREICH LTD-4/3 OFF KANAPURA ROAD, AVALAHALLI, A, TEJKAMAL PHARMACEUTICAL PVT, SURVEY NO.6/2 ALADAHALLI,SOMAPURAHOBIL,NELAMANGALA TALUK,BANGALORE RURAL-562111,INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X20.0 ML BOTTLE |
| NDA/MAL/HDP/4019 | SEDICO PHARMACEUTICAL CO. | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FLUCAMOX 1G | AMOXICILLIN + FLUCLOXACILLIN | 500 MG + 500 MG | SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/4021 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | AZY-500 | AZITHROMYCIN | 500MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/4022 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASPI-M | CHLORPHENIRAMINE | 4MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4023 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | SINAREST LINCTUS | CHLORPHENIRAMINE+DEXTROMETHORPHAN+METHANOL | 2MG+10MG+1.5MG | CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4024 | SEDICO PHARMACEUTICAL CO. | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SEDALAC SYRUP | LACTULOSE | 3.350G/5ML | SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/4030 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | XBETA- N | BETAMETHASONE + NEOMYCIN | 0.1%W/V +0.5%W/V | ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/4031 | SEDICO PHARMACEUTICAL CO | WIDE SPECTRUM ENTERPRISES (U) LIMITED | SALBUTAMOL SYRUP | SALBUTAMOL | 2MG/5ML | SIDECO PHARMACEUTICAL CO LTD- EGYPT-1ST INDUSTRIAL ZONE, 6 OCTOBER CITY- EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/4033 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN PAEDIATRIC SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE | 7MG/5ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4035 | BAYER SCHERING PHARMA | SURGIPHARM (U) LIMITED | YASMIN | DROSPIRENONE + ETHINYLESTRADIOL | 3MG+0.3MG | BAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X21.0 TABLET BLISTER |
| NDA/MAL/HDP/4038 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | PREDSONE-5 | PREDNISOLONE | 5MG | NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4039 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ | EFAVIRENZ | 50MG | AUROBINDO PHARMA LTD UNIT VII---UNIT VII PLOT NO. S1 GREEN INDUSTRIAL PARK POLLEPALLY VILLAGE ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/4042 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | S-CHLOR | CHLORAMPHENICOL | 1G | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/4043 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM AMPI | AMPICILLIN | 125MG/ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4047 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | NEOGAB | GABAPENTIN | 300MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4049 | CADILA HEALTH CARE LTD | ABACUS PHARMA (AFRICA) LIMITED | LEVODAY 500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER,1.0X6.0X2.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/4050 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CHLORAMPHENICOL EYE DROPS | CHLORAMPHENICOL | 0.5%W/V | NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN | CHINA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/4052 | HETERO DRUGS LTD | ABACUS PHARMA (AFRICA) LIMITED | EFAVIRENZ | EFAVIRENZ | 600MG | HETERO DRUGS LTD-UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055,HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/4055 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | BAYER ASPIRIN CARDIO | ACETYLSALICYLIC ACID | 100MG | BAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANY | GERMANY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/4056 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | FASIGYN | TINIDAZOLE | 500MG | PFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE | FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER |
| NDA/MAL/HDP/4057 | LEBEN LABORATORIES PVT. LTD | ANDYCO PHARMACY (UGANDA) LTD | LAMPY | AMPICILLIN | 250MG | LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA? 444 104 (MS).
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4060 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | TOBRADEX | TOBRAMYCIN/DEXAMETHASONE | 0.3%W/V+ 0.1%W/V | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/4062 | GLAXO SMITH KLEINE LIMITED | ERIS LTD | KIVEXA | ABACAVIR SULFATE + LAMIVUDINE | 600 MG + 300 MG | GLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3
09400 ARANDA DE DUERO
BURGOS
SPAIN
| SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4064 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | TERAFINE | TERBINAFINE | 250MG | AGOG 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 TABLETS | 1.0X1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4066 | UNIVERSAL CORPORATION LTD | DELMAW ENTERPRISES LIMITED | UNIBROL | AMINOSIDINE | 125MG/ML | UNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4067 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CATENOL-50 TABLETS | ATENOLOL | 50MG | CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4068 | AUROBINDO PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | LAMIVUDINE/ZIDOVUDINE/EFAVIRENZ | LAMIVUDINE+ZIDOVUDINE + EFAVIRENZ | 150MG + 300MG + 600MG | AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/4072 | SIRMAXO CHEMICALS PVT LTD | SUPER MEDIC LTD | SANIQUAD M 20 | CHLORHEXIDINE | 4%W/V | SIRMAXO CHEMICALS-PLOT NO E 35, TARAPUR, BOISAR DIST, MUMBAI | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X500.0 ML BOTTLE,1.0X5.0 L JERRYCAN |
| NDA/MAL/HDP/4074 | UMEDICA LABORATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | UMICORT-100 | HYDROCORTISONE SODIUM SUCCINATE | 100MG | UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0 MG VIAL |
| NDA/MAL/HDP/4075 | RANBAXY LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | CHERICOF COUGH FORMULAR | CHLORPHENIRAMINE + DEXTROMETHORPHAN HBR + PHENYLEPHRINE HCL | 2MG + 10MG + 5MG | RANBAXY LABORATORIES LTD AT: THE MADRAS PHARMACEUTICALS-137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4078 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | EPIGAB | PREGABALIN | 75MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X14.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4079 | PHARMA INTL CO.. | OMAB UGANDA LIMITED | NERVAMINE | MECOBALAMIN | 500MCG | PHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/4082 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | NO-SPA FORTE | DROTAVERINE HCL | 80MG | CHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY. | HUNGARY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4084 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | WATER FOR INJECTION | STERILIZED WATER FOR INJECTION | N/A | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL |
| NDA/MAL/HDP/4085 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | ZINACEF | CEFUROXIME SODIUM | 750MG | GLAXO WELLCOME -VERONA ITALY | ITALY | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL |
| NDA/MAL/HDP/4086 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | KELVIN SUSPENSION | PARACETAMOL | 120MG/5ML | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4089 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | CONAZOL | KETOCONAZOLE | 200MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4091 | HILTON PHARMA PVT LTD | HEALTHCARE LTD. | MYTEKA TABLETS | MONTELUKAST SODIUM | 5MG | HILTON PHARMA PVT,LTD-13 SECTOR 15,KORANG,IND.AREA,8TH FLOOR PROGRESSIVE PLAZA,BEAMONT RD,KARACHI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/4092 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FLORANORM | SACCHAROMYCES BOULARDII | 250MG | BHARAT BIOTECH INTERNATIONAL LTD-TURKPALLY
SHAMEX
500 078
MYDERAHAD
INDIA | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X2.0X250.0 MG SACHET,1.0X10.0X250.0 MG SACHET |
| NDA/MAL/HDP/4093 | LEBEN LABORATORIES LTD | ANDYCO PHARMACY (UGANDA) LTD | BECLOMIN OINTMENT | BECLOMETHASONE+MICONAZOLE+NEOMYCIN | 0.025%W/W + 2%W/W + 0.5%W/W | LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4094 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | EFAVIRENZ | EFAVIRENZ | 200MG | STRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAVADI CROSS ANECAL TULK BANGALORE 562 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X90.0 TABLET CONTAINER |
| NDA/MAL/HDP/4095 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | IBUT-200 | IBUPROFEN | 200MG | LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4097 | GLAXOSMITHKLINE LTD UK | ERIS LTD | DERMOVATE | CLOBETASOL PROPIONATE | 0.05%W/W | GLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM | UNITED KINGDOM | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/4098 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | EFAVIRENZ TABLETS | EFAVIRENZ | 600MG | STRIDES ARCOLAB LTD-36/7 SURAGAJAKKANAHALI INDLAVADI CROSS ANECAL TULK BANGALORE 562 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/4099 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | GLEVO I.V | LEVOFLOXAXIN | 500MG/100ML | AMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4100 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | NORETHISTERONE | NORETHISTERONE | 5MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4101 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | AMLOTRUST 5 | AMLODIPINE | 5MG | CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4102 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | AZULIX-2 | GLIMEPIRIDE | 2MG | TORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4103 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | POLIO SABIN - ONE AND THREE [ORAL] | LIVE ATTENUATED POLIOMYELITIS VIRUS VACCINE OF THE SABIN STRAINS TYPE 1 +TYPE 2 | 10?CCID??+10?.?CCID?? | GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY I M VIALS | 1.0X100.0X2.0 ML VIAL (20 DOSES) |
| NDA/MAL/HDP/4104 | DAWA LIMITED | SUPER MEDIC LTD | DAWA-PROM | PROMETHAZINE HCL | 25MG | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4107 | ABBOTT HEALTHCARE , SAS | HARLEYS UGANDA LIMITED | DUSPATALIN 200 MG | MEBEVERINE | 200MG | SOLVY PHARMACEUTICALS LTD-VEERWEG 12 NL 8121 NETHERLANDS | NETHERLANDS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4112 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | ERYTHRONE TABLETS 250MG | ERYTHROMYCIN | 250MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4113 | MICRO LABS LTD | LABOREX UGANDA LIMITED | EROSTIN 10 | EBASTINE | 10 MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4114 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | RINALIN SYRUP | CHLORPHENIRAMINE MALEATE | 2MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4115 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | PREDILONE | PREDNISOLONE | 5.0 MG | REGAL PHARMACEUICALS LTD-PLOT NO 7879 OFF BABA DOGO ROAD KUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4118 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | OCUREST-AH | PHENYLEPHRINE HYDROCHLORIDE+NAPHAZOLINE HYDROCHLORIDE+CHLORPHRENIRAMINE MALEATE+MENTHOL+CAMPHOR | 0.12%+0.05%+0.1%+0.005%+0.01% | CENTAUR PHARMACEUTICALS PRIVATE LIMITED-PLOT NO.3,TIVIM INDUSTRIAL ESTATE KARASWADA MUPUSA-GOA 403 526 INDIA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/4121 | AVENTIS PHARMA (PTY) LTD SOUTH AFRICA | LABOREX UGANDA LIMITED | RIFINAH 300 | RIFAMPICIN + ISONIAZID | 300MG + 150MG | AVENTIS PHARMA-AVENTIS PHARMA, 315 WALTLOO ROAD, SILVERTON 0127 PRETORIA | SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/4123 | HETERO LABS LTD UNIT VI | ABACUS PHARMA (AFRICA) LIMITED | NEVIRAPINE | NEVIRAPINE | 200MG | HETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABAD,HETERO LABS LIMITED .-UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/4125 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | PARACETAMOL SUSPENSION | PARACETAMOL | 120MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4126 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CELIB 100MG | CELECOXIB | 100MG | UNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4127 | SANOFI AVENTS FRANCE | LABOREX UGANDA LIMITED | EPILIM | SODIUM VALPROATE | 200MG/5ML | UNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770 | FRANCE | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X300.0 ML BOTTLE |
| NDA/MAL/HDP/4128 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | VITAREN SYRUP | VITAMIN A + VITAMIN B2 + VITAMIN B1 + VITAMIN B6 + VITAMIN C + VITAMIN E + VITAMIN B3 | 1500IU/5ML + 1MG/5ML + 1MG/5ML + 0.5MG/5ML + 20MG/5ML + 100 IU/5ML + 10MG/5ML | RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4129 | IDA FOUNDATION | KIMSY MEDS LTD | PRAZIQUANTEL | PRAZIQUANTEL | 600MG | MICRO LABS LTD --PLOT NO. S-155 TO S-159 VERNA INDUSTRIAL ESTATE III VERNA GOA 403722 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/4131 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | NEVIRAPINE | NEVIRAPINE | 200MG | MYLAN 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 TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/4132 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | ZYCEL 200 | CELECOXIB | 200MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4133 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYCETIN | CHLORAMPHENICOL | 125MG/ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE, 1.0X5.0 L JERRYCAN |
| NDA/MAL/HDP/4134 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | CITAL | DISODIUM HYDROGEN CITRATE | 1.37G/5ML | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4138 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYCLOX CAPSULES | AMPICILLIN + CLOXACILLIN | 250MG + 250MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER, 1.0X500.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/4140 | ROTEX MEDICA GBH ARZNEIMITTELI | GITTOES PHARMACEUTICALS LIMITED | DIAZEPAM INJECTION | DIAZEPAM INJECTION | 10MG/2ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4141 | SANOFI WINTHROP A.M.O | LABOREX UGANDA LIMITED | EPILIM 200 | SODIUM VALPROATE | 200MG | FISONS LTD (ALSO KNOWN AS SANOFI-AVENTIS)-RIELL, SPAIN | SPAIN | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4142 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | CO-ARTESAINE | ARTEMETHER + LUMEFANTRINE | 360MG + 2160MG | MPF BV-APPLEHOF 13; NI 8465 RX OUDEHASKE
NETHERLANDS | NETHERLANDS | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/4143 | MODI NUNDIPHARMA PVT LTD | SURGIPHARM (U) LIMITED | TAM CONTIN 0.4 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | MODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM ? 250110 UTTAR PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/4144 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | NYCOSTAT OINTMENT | NYSTATIN | 100.000 I.U | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/4146 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOMPICLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4147 | ERIS LTD | BENLE CONSULT LIMITED | NIFEDI-DENK 20 RETARD | NIFEDIPINE | 20MG | DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 | GERMANY | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/4148 | COSMOS LIMITED | ASTRA PHARMA (U) LIMITED | AMITRIPTYLINE TABLETS | AMITRIPTYLINE | 25MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4149 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | TRACRIUM INJECTION | ATRACURIUM BESYLATE | 10MG/ML | GLAXO SMITHKLINE MANUFACTURING S.P.A .-STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA),GLAXOSMITHKLINE SPA FLEMING -2, 37135 PARMA | ITALY | PARENTERAL ORDINARY AMPOULES | 1.0X2.5 ML AMPOULE,1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/4150 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | ANGIOPRIL-25 | CAPTOPRIL | 25MG | TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4151 | IDA | KIMSY MEDS LTD | AMITRIPTYLINE | AMITRIPYTLINE | 25MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4153 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | DIAZEPAM INJECTION | DIAZEPAM | 5MG/ML | GLAND PHARMA LTD.-GLAND PHARMA LTD, D.P. PALLY, SURVEY NO. 143,150 & | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4165 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ZEFONE INJECTION | CEFTRIAXONE SODIUM | 1G | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA,REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100,INJECTCARE PARENTERALS | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/4169 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCOZYD-200 | FLUCONAZOLE | 200MG | CADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X7.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4170 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | TRAMAZAC | TRAMADOL HYDROCHLORIDE | 50MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4171 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | TOREX | MULTIINGREDIENT | N/A | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4172 | RENE INDUSTRIES | RENE INDUSTRIES LIMITED | KOF OFF EXPECTORANT | MULTI-INGREDIENT | MULTI-INGREDIENT | RENE INDUSTRIES-PLOT 680 KAMULI KIREKA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X110.0 ML BOTTLE |
| NDA/MAL/HDP/4173 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NASONEX | MOMETASONE FUROATE MONOHYDRATE | 0.05%W/V | MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685,SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM | BELGIUM | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/4175 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KOACT 156.25 | AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNALATE | 156.25MG/5ML | AUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4180 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | OSMOWIN | LACTULOSE | 10G/15ML | G.S PHAMBUTOR PVT LTD-G.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/4181 | UMEDICA LABS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | USTREP | STREPTOMYCIN SULPHATE | 1G | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/4182 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | SINAREST- FORTE | MULTI INGREDIENT | MULTI INGREDIENT | CENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/4183 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | CHLORPROMAZINE | CHLORPROMAZINE | 25MG/ML | NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4187 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NORIGYNON | ESTRADIOL VALERATE +NORETHINDRONE ENANTHATE | 5 MG+50 MG / ML | BAYER PHARMA A.G-MULLERSTRASSE 178, 13353 BERLIN, GERMANY | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/4188 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOPRAZ | PRAZIQUANTEL | 600MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X4.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/4190 | ASTRAZENECA | MACNAUGHTON LIMITED | NOLVADEX | TAMOXIFEN | 10MG | ASTRAZENECA UK LIMITED -ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4241 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AMPICILLIN SODIUM FOR INJECTION BP | AMPICILLIN SODIUM | 500MG | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL |
| NDA/MAL/HDP/4273 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | SOLUDINE 10% | POVIDINE IODINE | 10 %W/V | LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
| INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0 L BOTTLE |
| NDA/MAL/HDP/4275 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | AVASTIN 100MG/4ML | BEVACIZUMAB | 100 MG/ 4ML | F.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL,ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANY | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X4.0 ML VIAL |
| NDA/MAL/HDP/4276 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | FALCI CARE | ARTESUNATE | 60MG | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 5 ML NACL + 1 ML SODIUM BICARBONATE |
| NDA/MAL/HDP/4277 | NABIQASIM INDUSTRIES (PVT) LIMITED | JEET PHARMACEUTICALS LIMITED | VIVIRON PLUS SYRUP | FERRIC AMMONIUM CITRATE +FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE | 50MG + 0.5MG + 2.2MG + 1.3MG +11MG | NABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN. | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/4279 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROTIM | TIMOLOL MALEATE | 0.5% W/V | AUROLAB-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/4280 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ABACAVIR SULFATE+LAMIVUDINE | ABACAVIR SULFATE + LAMIVUDINE | 600 MG + 300 MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/4284 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | AVASTIN 400MG/4ML | BEVACIZUMAB | 400MG/4ML | F.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL,ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANY | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X16.0 ML VIAL |
| NDA/MAL/HDP/4286 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEEGRA-50 | SILDENAFIL CITRATE | 50MG | THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/4287 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANAXONE 1000 | CEFTRIAXONE | 1000MG | SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL,1.0X50.0X10.0 ML VIAL |
| NDA/MAL/HDP/4288 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | COLESTOP | ATORVASTATIN | 10MG | LEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIA | SLOVENIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4289 | GLAXOSMITHKLINE LTD | ERIS LTD | TWINRIX ADULT | INACTIVATED HEPATITIS A ANTIGEN + HEPATITIS B SURFACE ANTIGEN | 720 ELISA UNITS + 20MCG | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/4291 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | VITAMIN B COMPLEX INJECTION | VITAMIN B COMPLEX | 10MG/2ML | NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4294 | GLAXO SMITHLINE LIMITED | ERIS LTD | FLIXOTIDE ACCUHALER 250 | FLUTICASONE PROPIONATE | 250MCG | GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X60.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/4295 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASTRAFLAM TABLETS | PARACETAMOL + IBUPROFEN | 500MG + 400MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4297 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | CLOBEN-G | CLOTRIMAZOLE/BECLOMETHASONE/GENTAMYCIN | 1%W/W+0.025%W/W+0.1%W/W | INDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4298 | SANDOZ GMBH, KENYA C/O NORVATIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | COLESTOP | ATORVASTATIN | 40MG | LEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIA | SLOVENIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4302 | GLAXO SMITH KLINE LTD | ERIS LTD | FLIXOTIDE ACCUHALER 500 | FLUTICASONE PROPIONATE | 500MCG | GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X60.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/4303 | PFIZER LABORATORIES (PTY) | LABOREX UGANDA LIMITED | SAYANA PRESS | MEDROXYPROGESTERONE ACETATE | 104MG/0.65ML | PFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURS | BELGIUM | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X200.0X0.65 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/4309 | HETERO DRUGS LTD | ABACUS PHARMA (AFRICA) LIMITED | LAMIVUDINE + ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 150MG + 300MG | HETERO 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 FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/4310 | GLAXOSMITHLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ACTIFED SYRUP | TRIPLORIDINE HCL/PSEUDOEPHEDRINE | 1.25MG/30MG | GLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN |
| NDA/MAL/HDP/4312 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GONAL-F | FOLLITROPIN ALFA | 75IU/IE | MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY,MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1 PRE FILLED SYRINGE OF WFI |
| NDA/MAL/HDP/4315 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | DESLORA-DENK 5 | DESLORATIDINE | 5MG | DENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4317 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | COLOSAR-DENK 50/12.5 | LOSARTAN + HYDROCHLOROTHIAZIDE | 50MG + 12.5MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4318 | UNOSOURCE PHARMA LTD. | ESCORTS PHARMACEUTICALS LIMITED | AKUGABALIN | PREGABALIN | 75 MG | AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4320 | STRIDES ARCOLAB LIMITED | ROYAL PHARMA 2011 LIMITED | HYOSCINE BUTYL BROMIDE | HYOSCINE BUTYL BROMIDE | 10MG | STRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4321 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | CUSIMOLOL 0.5% | TIMOLOL MALEATE | 0.5% W/V | ALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAIN | SPAIN | OPHTHALMIC DROPS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/4322 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | VALSAR-DENK 160 | VALSARTAN | 160MG | DENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/4323 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | ANDARAN | IRBESARTAN | 300 MG | LEK PHARMACEUTICALS LTD-LEK PHARMACEUTICALS VEROVSKOVA 57 SI 1526 LJUBLJANA SLOVENIA | SLOVENIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4324 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | PRASUSAFE 5 | PRASUGREL | 5MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4325 | AJANTA PHARMA LTD 31-0 | ABACUS PHARMA (AFRICA) LIMITED | ACTINAC 100 | ACECLOFENAC | 100MG | GLENMARK PHARMACEUTICALS LTD (UNIT III)-B-4/5/6 MIDC INDUSTRIAL AREA,CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4326 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | CUSICROM 4% EYE DROPS | SODIUM CROMOGLYCATE | 4 %W/V | ALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAIN | SPAIN | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/4329 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-CPM | CHLORPHENIRAMINE MALEATE | 2MG/5ML | 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 SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4330 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCLOXACILLIN CAPSULES | FLUCLOXACILLIN | 250MG | SPARSH BIO-TECH PVT. LTD.--PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR ? 361006 GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/4331 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | STEDNAC | ACECLOFENAC | 100MG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4332 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | VALSAR-DENK 320 | VALSARTAN | 320MG | DENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/4333 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | CARVIBERG | CARVEDILOL USP | 6.25MG | THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4334 | DENK PHARM GMBH&CO.KG | BENLE CONSULT LIMITED | LOSAR-DENK 50 | LOSARTAN | 50MG | DENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 M?NCHEN, G?LLSTR. 1, 84529 TITTMONING, GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4335 | DAWA LIMITED | SUPER MEDIC LTD | CURAMOL SUSPENSION | PARACETAMOL | 120MG/5ML | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4336 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | NEOGAB | GABAPENTIN | 400MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4337 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | VALSAR-DENK 80 | VALSARTAN | 80MG | DENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4338 | MISSION PHARMA | JOINT MEDICAL STORE (UPMB - UCMB) | ALBENDAZOLE | ALBENDAZOLE | 400MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/4339 | GLAXOSMITHKLINE LIMITED | ERIS LTD | SERETIDE 125 EVOHALER | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG/125MCG | GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2
23 RUE LAVOISER 27000 EVREUX | FRANCE | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/4340 | ASTRA PHARMA (U) LTD | ASTRA PHARMA (U) LIMITED | VITAMIN B COMPLEX | VITAMIN B1 + VITAMIN B2 + SODIUM NICOTINAMIDE + VITAMIN B6 + D-PANTHENOL SODIUM | 10MG + 1.37MG + 15MG + 1MG + 0.5MG | ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4343 | PASTEUR MERIEUX CONNANGHT | LABOREX UGANDA LIMITED | EUVAX B (PAEDIATRIC) | HEPATITIS B VACCINE, RECOMBINANT | 20MCG/ML | LG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JE | SOUTH KOREA | PARENTERAL ORDINARY I M VIALS | 1.0X0.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/4347 | GENO PHARMACEUTICALS PVT LTD | HARLEYS UGANDA LIMITED | VERTIGON | CINNARIZINE | 25MG | GENO PHARMACEUTICALS LTD. -TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA, GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4348 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MEDICLOAMP SYRUP | CLOXACILLIN+AMPICILLIN | 250MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4350 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | OLFEN-75 | DICLOFENAC SODIUM | 75MG/2ML | MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4351 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | ABACAVIR SULFATE | ABACAVIR SULPHATE | 60MG | CIPLA LTD-PATALGANGA UNIT II PLOT MO A-33 A42 MIDC RAIGAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/4352 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REQUIN SYRUP | QUININE HYDROCHLORIDE | 100MG/5ML | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4354 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RUXID 300 | ROXITHROMYCIN | 300MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/4355 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | ANDARAN | IRBESARTAN | 150MG | LEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIA | SLOVENIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4356 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | FRESHEN | BISACODYL | 5 MG | ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/4358 | A.MENARINI INDUSTRIE FARMACEUTICHE S.R.I | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LIOTON | HEPARIN SODIUM | 1000I.U/G | A. MENARINI MANUFACTURING LOGICTICS AND SERVICES-VIA 3 SETTE SANTI FLORENCE 50131 ITALY | ITALY | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/4360 | ASTRAZENECA | MACNAUGHTON LIMITED | ZESTRIL | LISINOPRIL | 5MG | ASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-UNITED KINGDOM | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4361 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | TAXIM-O | CEFIXIME | 200MG | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4362 | MACLEODS PHARMACEUTICAL LTD | NORVIK ENTERPRISES LIMITED | LEVOMAC 750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA
TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101
INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4363 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEPTRIN | CO-TRIMOXAZOLE | 480MG | THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4364 | CADILA HEALTHCARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | VOMIZ OD 8 | ONDANSETRON HYDROCHLORIDE DIHYDRATE | 8MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4365 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ACTINAC PLUS | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | AJANTA PHARMA LIMITED-B-4/5/6,MIDC AREA, PAITHAN,431 148 INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4366 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CLOXISPA | CLOXACILLIN | 250MG | SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4367 | ASTRA ZENECA | MACNAUGHTON LIMITED | ATACAND 8MG | CANDESARTAN | 8MG | ASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4369 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLUCAP | CHLORPHENAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE+PARACETAMOL | 1.25MG+10MG+120MG | TIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4371 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | NEVIHOPE 200 | NEVIRAPINE | 200MG | MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/4373 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | AZIBERG | AZITHROMYCIN DIHYDRATE | 500MG | THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/4375 | PFIZER LAB LTD | LABOREX UGANDA LIMITED | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 200MG/5ML | HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | ITALY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/4376 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | EFAVIRENZ+LAMIVUDINE & TENOFOVIR TABLETS | EFAVIRENZ + LAMIVUDINE + TENOFOVIR | 600MG +300MG + 300MG | CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/4377 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORALYTE | ANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE DIHYDRATE + POTASSIUM CHLORIDE | 13.5MG + 2.6MG + 2.9MG + 1.5MG | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X20.5 G SACHET,1.0X10.25 G SACHET |
| NDA/MAL/HDP/4379 | LEBEN LABORATORIES PVT.LTD | ANDYCO PHARMACY (UGANDA) LTD | SINURHON | MULTI-INGREDIENT | N/A | LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA? 444 104 (MS).
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X12.0X40.0 TABLET BLISTER,1.0X1.0X6.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/4380 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | ZINNAT SUSPENSION | CEFUROXIME AXETIL- | 125MG/5ML | GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED | UNITED KINGDOM | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/4381 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
| INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4383 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEEMYCIN - 150 | CLINDAMYCIN HYDROCHLORIDE BP | 150MG | THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4388 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | TAZOBAK | PIPERACILLIN SODIUM + TAZOBACTAM SODIUM | 4.0G + 0.5G | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X4.5 G VIAL |
| NDA/MAL/HDP/4389 | PHARMACARE LTD | MEDICAL ACCESS (UGANDA) LIMITED | PREZISTA | DARUNAVIR | 600MG | JANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778 | UNITED STATES | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/4390 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROCOL | CHLORAMPHENICOL | 0.5%W/V | AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI ? 625 020 TAMIL NADU, INDIA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/4391 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | MOBYLE-A | ACECLOFENAC + PARACETAMOL | 100 MG + 325 MG | LINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AT & POST KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4392 | IND SWIFT LTD | TATA UGANDA LIMITED | CAPLOR | CLOPIDOGREL | 75MG | IND SWIFT LTD-GBU JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4394 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | NS | SODIUM CHLORIDE | 0.9% W/V | ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/4396 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ABACAVIR SULPHATE | ABACAVIR SULFATE | 300MG | MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/4397 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BISODAC-HF 2.5 | BISOPROLOL FUMARATE | 2.5MG | AUROBINDO PHARMA LTD UNIT III.-SURVEY NO.313 BACHUPALL VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4398 | NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARE | SUPER MEDIC LTD | SODIUM CHLORIDE | SODIUM CHLORIDE | 0.9 % W/V | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/4399 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GEFIL | COMPOUND MAGNESIUM TRISILICATE | ALUMINIUM HYDROXIDE & MAGNESIUM TRISILICATE 132 & | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4400 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ORAL REHYDRATION SALT (DTS) | ORAL REHYDRATION SALT | N/A | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X100.0X20.6 G SACHET,1.0X100.0X10.3 G SACHET |
| NDA/MAL/HDP/4401 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPICEPHIN | CEFTRIAXONE DISODIUM | 2G | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 G VIAL + 2*5 ML OF WFI GLASS AMPOULES |
| NDA/MAL/HDP/4402 | VIRBAC RSA (PTY) LTD | METRO PHARMACEUTICALS LIMITED | CLOTRILIN | CLOTRIMAZOLE | 100MG | LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA
| INDIA | VAGINAL TABLETS | 1.0X6.0 TABLET STRIP |
| NDA/MAL/HDP/4404 | BHARAT SERUMS AND VACCINES LIMITED, | GITTOES PHARMACEUTICALS LIMITED | FOLIGRAF | RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE | 75I.U/ VIAL | BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
| INDIA | PARENTERAL RETARD OTHER VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/4406 | AGOG PHARMA | GITTOES PHARMACEUTICALS LIMITED | SATISFIL -100 | SILDENAFIL | 100MG | AGOG 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 TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/4407 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | SUXAMETHONIUM CHLORIDE- FRESENIUS | SUXAMETHONIUM CHLORIDE | 100MG/2ML | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD ?-6 GIBAUD?ROAD KORSTEN, PORT ELIZABETH, SOUTH AFRICA. | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4408 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNISTEN CREAM | CLOTRIMAZOLE | 1%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/4409 | SANDOZ GBH LTD | SURGIPHARM (U) LIMITED | ROBESTAR 10MG | ROSUVASTATIN CALCIUM | 10MG | LEK PHARMACEUTICALS .D.D -VEROVSKOVA 57, 1526 LJUBLJANA
SLOVENIA
| SLOVENIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4410 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | M-KAST 4 | MONTELUKAST CHEWABLE TABLETS 4 MG | 4MG | AUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4411 | ASTRA ZENECA | MACNAUGHTON LIMITED | ATACAND PLUS | CANDESARTAN + HYDROCHLOROTHIAZIDE | 16 MG + 12.5 MG | ASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4412 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | M-KAST 5 | MONTELUKAST SODIUM | 5MG | AUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4413 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPICEPHIN | CEFTRIAXONE | 1G | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 2 PLASTIC AMPOULES OF WFI |
| NDA/MAL/HDP/4414 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | ROBESTAR 20MG | ROSUVASTATIN CALCIUM | 20MG | LEK PHARMACEUTICALS LTD-LEK PHARMACEUTICALS VEROVSKOVA 57 SI 1526 LJUBLJANA SLOVENIA | SLOVENIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4415 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CATAFLAM 5OMG TABLETS | DICLOFENAC POTASSIUM | 50MG | NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS--URUNLERI INSTABUL TURKEY | ITALY | ORAL SOLID ORDINARY COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4417 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPICEPHIN | CEFTRIAXONE SODIUM | 500MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | PARENTERAL ORDINARY DRY VIALS | 1.0X0.5 G VIAL + 1*5 ML OF WFI GLASS AMPOULES |
| NDA/MAL/HDP/4418 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | VALORAN | CEFOTAXIME | 1000MG | MEDOCHEMIC LTD-1-10 ASTRONAFTON & CONSTANTINOPOLEOS 3505 LIMASSOL | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/4419 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIGONAL 75 | HUMAN MENOPAUSAL GONADOTROPHIN | 75IU/5ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL + 1 ML AMPOULE 0.9%W/V NACL |
| NDA/MAL/HDP/4425 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REQUIN FC | QUININE | 300MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4446 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | HI-ALFA 2.5 | ALFUZOSIN HYDROCHLORIDE | 2.5MG | AUROBINDO PHARMA LTD UNIT III.-SURVEY NO.313 BACHUPALL VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4468 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TOPRAZ 40 | PANTOPRAZOLE SODIUM SESQUIHYDRATE | 40MG | AUROBINDOPHARMA LIMITED,-UNIT VII, SEZ APIIC, PLOT NO.SI SURVEY NO?S 425, 434,435 & 458 GREEN INDUSTRIAL PARK, POLEPALLY VILLAGEJEDCHERTA MANDAL, MAHABOOBNAGAR DISTTRICT, ANDRA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4480 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | KIPEL 5 | MONTELUKAST | 5MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4519 | ARISTO PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | S-AMLOSAFE 5 | AMLODIPINE BESILATE | 5MG | ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4522 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | S-AMLOSAFE 2.5 | AMLODIPINE BESILATE | 2.5 MG | ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4523 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | BIGOMET SR 500 | METFORMIN HYDROCHLORIDE | 500MG | ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4524 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCOZAL 150 | FLUCONAZOLE | 150MG | AEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4526 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AZ-500 | AZITHROMYCIN | 500MG | AGOG 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 TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/4528 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | PIOSAFE MF 15/500 | PIOGLITAZONE + METFORMIN | 15 MG + 500 MG | ARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4530 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | TREDOL 100 | ATENOLOL | 100MG | AEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4531 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | TREDOL 50 | ATENOLOL | 50MG | AEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4532 | DELOBORIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | VIRUCID 400 | ACICLOVIR | 400 MG | AEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUS | CYPRUS | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4534 | DELOBORIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | LORYTEC 10 | LORATADINE | 10MG | DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4535 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | CLERON 250 | CLARITHROMYCIN | 250MG | AEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUS | CYPRUS | ORAL SOLID ORDINARY COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/4536 | SEDICO PHARMACEUTICAL CO. | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FLUCAMOX | FLUCLOXACILLIN + AMOXICILLIN | 250MG+250MG | SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X4.0 CAPSULE STRIP |
| NDA/MAL/HDP/4539 | VENUS REMEDIES LTD | AARON PHARMACEUTICALS LTD | CRISTOL | VINCRISTINE SULPHATE | 1MG | VENUS REMIDIES LTD-UNIT-11 HILL TOP INDUSTRIAL ESTATE JHARMATI | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML VIAL |
| NDA/MAL/HDP/4540 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | VIPROLOX500 | CIPROFLOXACIN | 500MG | AEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4541 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AMOXIL | AMOXYCILLIN | 500MG | GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE | FRANCE | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4542 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | CLERON 500 | CLARITHROMYCIN | 500MG | AEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4543 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | RHINATHIOL 5% | CARBOCISTEINE | 5%W/V | NATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANY | GERMANY | ORAL LIQUID ORDINARY SYRUPS | 1.0X125.0 ML BOTTLE |
| NDA/MAL/HDP/4544 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | SALBUT TABLET 4MG | SALBUTAMOL | 4MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/4545 | CACHET PHAMACUITICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACH-ART 20/120 | ARTEMETHER + LUMEFANTRINE | 20 MG + 120 MG | CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X8.0 TABLET BLISTER |
| NDA/MAL/HDP/4546 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | CHLORAMPHENICOL INJECTION IG | CHLORAMPHENICOL SODIUM SUCCINATE | 1G | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0X1.0 G VIAL,1.0X50.0X1.0 G VIAL |
| NDA/MAL/HDP/4549 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | UNIXIL 500MG | AMOXYCILLIN TRIHYDRATE | 500MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/4550 | SANOFI AVENTS FRANCE | LABOREX UGANDA LIMITED | RHINATHIOL 2% | CARBOCISTEINE | 20MG/ML | UNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770,A. NATTERMANN & CIE GMBH.-NATTERMANNALLEE 1 ,50829 COLOGNE, GERMANY | FRANCE | ORAL LIQUID ORDINARY SYRUPS | 1.0X125.0 ML BOTTLE |
| NDA/MAL/HDP/4553 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | ARTESUN | ARTESUNATE | 30MG | GUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 MG VIAL + 1*0.5 ML SODIUM BICARBONATE |
| NDA/MAL/HDP/4556 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 375 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 250MG + 125MG | ALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/4557 | HETERO DRUGS LTD | ABACUS PHARMA (AFRICA) LIMITED | LAMIVUDINE | LAMIVUDINE | 150MG | HETERO LABS LTD-HETERO LABS LTD, UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055,HETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/4558 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | IFICIPRO 500 | CIPROFLOXACIN | 500MG | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4559 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | PREGASAFE 75 | PREGABALIN | 75MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4561 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | LORVAS SR | INDAPAMIDE | 1.5MG | TORRENT PHARMACEUTICALS LTD-VILLAGE. BHUD-MAKHNU MAJRA, TEHSIL: BADDI 173205 DIST SOLAN (H.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET CONTAINER |
| NDA/MAL/HDP/4562 | F. HOFFMANN- LA ROCHE LTD | LABOREX UGANDA LIMITED | PEGASYS | PEGINTERFERON ALPHA 2A | 180MCG/2ML | F.HOFFMANN- LA ROCHE LTD-CH-4070 BASEL SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X2.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/4563 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | QUININE DIHYDROCHLORIDE INJECTION | QUININE DIHYDROCHLORIDE | 300MG/ML | GLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150& | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4566 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | FUROSEMIDE INJECTION BP | FUROSEMIDE | 10MG/ML | GLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150& | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4568 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 625 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 500MG + 125MG | ALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/4569 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMADOL SYRUP | PARACETAMOL | 120MG/5ML | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4570 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | NEVIRAPINE | NEVIRAPINE | 200MG | AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/4571 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASPICLOX | AMPICILLIN + CLOXACILLIN | 250 MG + 250 MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE STRIP,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/4573 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM DT 228.5MG | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 200MG + 28.5MG | ALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/4575 | FDC LTD | AIVEEN (U) LIMITED | PYRICORT EYE/EAR DROPS | DEXAMETHASONE+GENTAMICIN | 0.1%+0.3%W/V | FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/4577 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MAGTAM | CEFOPERAZONE + SULBACTAM | 500 MG + 500 MG | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/4579 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | MESPORIN 500 IV VIALS | CEFTRIAXONE | 500MG | LABESFAL LABORATORIOS ALMIRO, S.A ,.-ZONA INDUSTRIAL DO LABENGO, 3465-157 SANTIAGO DE BESTEIROS | PORTUGAL | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL + 1*5 ML WFI AMPOULE |
| NDA/MAL/HDP/4581 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CLAVAM 1000 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 875MG + 125MG | ALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/4587 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CIRATRO | ATROPINE | 1MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/4588 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | FLUCAN 200 | FLUCONAZOLE | 200MG | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/4589 | FEROZSONS LABORATORIES LTD | TOP UNIVERSAL MEDICARE LIMITED | LEFOXCIN-500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | FEROZSONS LABORATORIES LTD-AMANGARH-NOWSHERA, (KHYBER
PAKHTOONKHWA), PAKISTAN
| PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4591 | S KAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | SILVER KANT | SILVER SULPHADIAZINE USP | 1%W/W | S.KANT HEALTHCARE LTD-1802-18-5 GIDC PHASE III, VAPI-396195,GUJARAT INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4592 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | PENTALINK 40 | PANTOPRAZOLE | 40MG | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4594 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | TINIBA-500 TABLETS | TINIDAZOLE | 500MG | CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0X4.0 TABLET BLISTER,1.0X25.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/4595 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | VAST-20 | ATORVASTATIN | 20MG | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4596 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | TRIZ TABLETS | CETIRIZINE | 10MG | INDOCO REMEDIES LTD, B-20,-B-20 MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X5.0X10.0 BLISTER BLISTER,1.0X5.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4598 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AZ-250 | AZITHROMYCIN | 250MG | AGOG 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 TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/4601 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | PENTAXIM VACCINE | MULTI-INGREDIENT | MULTI-INGREDIENT | SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) | FRANCE | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE,1.0X0.5 ML VIAL |
| NDA/MAL/HDP/4602 | ELI-LILLY (SUISSE) SA | LABOREX UGANDA LIMITED | HUMALOG MIX 50 | INSULIN LISPRO | 100 .IU(50 I.U+50 I.U) | LILLY FRANCE SA-FRANCE | FRANCE | PARENTERAL ORDINARY S C VIALS | 1.0X3.0 ML VIAL,1.0X5.0 ML VIAL |
| NDA/MAL/HDP/4603 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | HALOXEN - 5 | HALOPERIDOL | 5MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4605 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGODRYL SYRUP | BROMHEXINE HCL+DEXTROMETHORPHAN HBR+AMMONIUM CHLORIDE+MENTHOL | 4MG/5ML+5MG/5ML+50MG/5ML+2.5MG/5ML | 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 SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4606 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | ROVAS 10 | ROSUVASTATIN | 10MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4609 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYCORT | HYDROCORTISONE | 1%W/W | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4611 | DAFRA PHARMA LTD | LABOREX UGANDA LIMITED | DAFRACLAV | AMOXYCILLIN + POTASSIUM CLAVULANATE | 200MG + 28MG | BILIM PHARMACEUTICALS-ISLETMESI 59501 CERKEZKOY TEKIRDAG | TURKEY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/4614 | GALENTIC PHARMA LTD | NORVIK ENTERPRISES LIMITED | COMPOUND BENZOIC ACID OINTMENT | BENZOIC ACID + SALICYLIC ACID | 6 %W/W + 3 %W/W | GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X25.0 G TUBE,1.0X500.0 G TUBE |
| NDA/MAL/HDP/4615 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | TASIGNA 150 | NILOTONIB HYDROCHLORIDE MONOHYDRATE | 150MG | NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND. | SWITZERLAND | ORAL SOLID ORDINARY CAPSULES | 1.0X7.0X4.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4617 | ASTRA ZENECA | MACNAUGHTON LIMITED | CRESTOR | ROSUVASTATIN | 10MG | IPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4620 | GLAXO SMITH KLINE LTD | ERIS LTD | MALANIL PAEDIATRIC TABLET | ATOVAQUONE + PROGUANIL | 62.5 MG + 25.0 MG | GLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/4621 | CADILA HEALTH CARE LIMITED | ABACUS PHARMA (AFRICA) LIMITED | CARVIL 6.25 | CARVEDILOL | 6.25MG | CADILA HEALTHCARE LTD--PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA 403401 | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4622 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | CLOXAREN | CLOXACILLIN | 250MG | RENE INDUSTRIES-PLOT 680 KAMULI KIREKA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4623 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | LOPERAREN | LOPERAMIDE HYDROCHLORIDE | 2MG | RENE INDUSTRIAL LTD-RENE INDUSTRIES LTD, PLOT 680, KAMULI-KIREKA KAMPALA UGANDA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4626 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | GASEC-20 | OMEPRAZOLE | 20MG | ACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X14.0 CAPSULE BOTTLE |
| NDA/MAL/HDP/4627 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | HYCORUM CREAM | HYDROCORTISONE | 1%W/W | LABORATORY AND ALLIED LTD-PLOT 209/10349-MOMBASA ROAD NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4629 | DAWA LIMITED | SUPER MEDIC LTD | ORACEF | CEFALEXIN MONOHYDRATE | 125MG/5ML | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4634 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | LOSAR-DENK 100 | LOSARTAN | 100MG | DENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 M?NCHEN, G?LLSTR. 1, 84529 TITTMONING, GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4635 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | RHINATHIOL 5% | CARBOCISTEINE | 5%W/V | UNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770 | FRANCE | ORAL LIQUID ORDINARY SYRUPS | 1.0X125.0 ML BOTTLE |
| NDA/MAL/HDP/4636 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | ZOLARAM 0.5 | ALPRAZOLAM | 0.5MG | AEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4637 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | PARACETAMOL | PARACETAMOL | 500MG | HEBEI (JIHENG GRP) PHARMACEUTICALS CO.LTD-368 JIANSHE ST HENGSHUI CITY HEBEI 053000 | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4640 | GLAXOSMITHLINE LTD | ERIS LTD | REQUIP PD 24 HOUR 8 MG | ROPINIROLE | 8MG | GLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 3
09400 ARANDA DE DUERO
BURGOS
SPAIN
| SPAIN | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/4641 | YURIA PHARM EAST AFRICA LIMITED | YURIA PHARM EAST AFRICA LIMITED | RHEOSORBILACT | SORBITOL + SODIUM LACTATE + NACL + CALCIUM CHLORIDE + MAGNESIUM CHLORIDE | 6G +1.9G +0.6G + 0.01G +0.03G +0.02 | YURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE. | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X200.0 ML BOTTLE,1.0X400.0 ML BOTTLE |
| NDA/MAL/HDP/4645 | ASTRA ZENECA | MACNAUGHTON LIMITED | CRESTOR | ROSUVASTATIN CALCIUM | 20MG | IPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO | PUERTO RICO | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/4646 | YURIA PHARM EAST AFRICA LIMITED | YURIA PHARM EAST AFRICA LIMITED | LEFLOCIN | LEVOFLOXACIN | 5MG/ML | YURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE. | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X150.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4647 | CIPLA LTD.. | QUALITY CHEMICALS LTD - HUMAN | LEVOLIN | LEVOSALBUTAMOL | 50MCG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/4650 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | DUOTRAV | TRAVOPROST + TIMOLOL MALEATE | 40MG/ML + 5MG/ML | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X1.0X2.5 ML VIAL |
| NDA/MAL/HDP/4652 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | SII TETANUS TOXOID VACCINE | TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE | ? 5 LF (? 40 IU) ON ? 1.25 MG OF ALUMINIUM PHOSPHATE | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE (1 DOSE AMPOULE),1.0X10.0 ML VIAL (20 DOSE VIAL) |
| NDA/MAL/HDP/4655 | YURIA PHARM EAST AFRICA LIMITED | YURIA PHARM EAST AFRICA LIMITED | DECASAN | DECAMETHOXIN | 0.2MG/1ML | YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE | UKRAINE | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X400.0 ML BOTTLE,1.0X1000.0 ML CONTAINER,1.0X2.0 ML CONTAINER |
| NDA/MAL/HDP/4656 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASCET | CETIRIZINE | 10MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4657 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | VOLAR 300MG | GABAPENTIN | 300MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4658 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | MEROSAN 0.5 | MEROPENEM | 0.5G | PT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X0.5 G VIAL |
| NDA/MAL/HDP/4660 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | RISDONE 2MG | RISPERIDONE | 2MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4661 | YURIA PHARM EAST AFRICA LIMITED | YURIA PHARM EAST AFRICA LIMITED | FLUCONAZOLE-UF | FLUCONAZOLE | 2MG/ML | YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4662 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASDOL | TRAMADOL | 50MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4663 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | LORATAN | LORATIDINE | 5MG/5ML | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4665 | YURIA PHARM LTD | YURIA PHARM EAST AFRICA LIMITED | ORNIGIL | ORNIDAZOLE | 5MG/ML | YURIA-PHARM, LTD. -18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.. | UKRAINE | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4666 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | ANTIPLEX | CLOPIDOGREL BISULFATE | 30MG | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4669 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | DICLOGESIC 100MG SUPPOSITORIES | DICLOFENAC SODIUM. | 100MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | TOPICAL EXTERNAL ADULT SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/4670 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOX 500 | AMOXICILLIN | 500MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4675 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | DICLOGESIC RETARD 100 | DICLOFENAC SODIUM | 100MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4677 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF | CEFUROXIME | 125MG/5ML | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X30.0 ML BOTTLE,1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/4678 | : ALKEM LABORATORIES LIMITED? | ABACUS PHARMA (AFRICA) LIMITED | ZOCEF-500 | CEFUROXIME AXETIL | 500MG | ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4680 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANCEPH DS | CEPHALEXIN | 125MG/5ML | SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
| INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4681 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | INSUMAN COMB 30 | DISSOLVED INSULIN+CRYSTALLINE PROTAMINE INSULIN | 30%+70% | SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING
H650 65926 FRANKFURT AM MAIN, GERMANY
| GERMANY | PARENTERAL ORDINARY VIALS | 1.0X5.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/4682 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LAMIVUDINE | LAMIVUDINE | 10MG/ML | AUROBINDO PHARMA LIMITED-UNIT ? III-SURVEY NO.:313 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA. | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X240.0 ML BOTTLE |
| NDA/MAL/HDP/4686 | AUROBINDOM PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | ZIDOVUDINE ORAL SOLUTION USP | ZIDOVUDINE | 50MG/5ML | AUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHU | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X240.0 ML BOTTLE |
| NDA/MAL/HDP/4690 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYPEN | PHENOXYMETHYL PENICILLIN | 250MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4693 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYVATE | BETAMETHASONE VALERATE | 1%W/W | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4694 | MERCK SHARP & DOHME INTAPHARMA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ROTATEQ | ROTAVIRUS LIVE REASSORTANT VIRUS G1+G2+G3+G4 &P1 | 2.2M IU+2.8M IU+2.2M IU+2.0M IU | MERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA | UNITED STATES | ORAL LIQUID ORDINARY EMULSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/4697 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | SANBE CLANEKSI | AMOXICILLIN + CLAVULANIC ACID | 1000 MG + 200 MG | PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA | INDONESIA | PARENTERAL ORDINARY VIALS | 1.0X6.0 VIAL CARTON |
| NDA/MAL/HDP/4700 | MEDIPHARM SALES (E.A) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | MEDIZOLE | METRONIDAZOLE | 125MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4701 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | MEBRONE 100 TABLETS | MEBENDAZOLE | 100MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
| INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4702 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABTOL 20%W/V | MANNITOL | 200MG/ML | ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4703 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABGYL | METRONIDAZOLE | 500MG | ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4704 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | DICLOGESIC 12.5 | DICLOFENAC SODIUM | 12.5MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/4705 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | DICLOGESIC-50 | DICLOFENAC | 50MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/4706 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL GEL | DICLOFENAC DIETHYLAMINE | 1.16%W/W | G,S PHARMBUTOR PVT LTD -B-172 INDUSTRIAL AREA BEHROR 301701 RAJASTHAN | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G CONTAINER |
| NDA/MAL/HDP/4707 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL INJECTION | DICLOFENAC SODIUM | 25MG/ML | WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR
PRADESH - INDIA
| INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/4708 | MEDIPHARM SALES (E.A) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | MEDIFEN | IBUPROFEN | 100MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4710 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | MEDOPRESS TABLETS 250MG | METHYLDOPA | 250MG | COSMOS LIMITED..-RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4712 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MEFINAL-500 | MEFENAMIC ACID | 500MG | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4713 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MEFLAM | MEFENAMIC ACID | 50MG/5ML | AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4714 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CEPHOXIN 250MG/5ML | CEPHALEXIN | 250MG/5ML | PHARCO 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/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4715 | BLUE CROSS LABARATORIES LIMITED | STAR PHARMACEUTICALS LTD | MEFTAL FORTE | MEFENAMIC ACID + PARACETAMOL | 500MG + 450MG | BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4717 | BLUE CROSS LABARATORIES LIMITED | STAR PHARMACEUTICALS LTD | MEFTAL-SPAS | MEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE | 250MG + 10MG | BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/4718 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | SURGIPHARM (U) LIMITED | ACNOTIN 20 | ISOTRETINOIN | 20MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4719 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | SURGIPHARM (U) LIMITED | ACNOTIN 10 | ISOTRETINOIN | 10MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4720 | SQUARE CEPHALOSPORINS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CEFTRON | CEFTRIAXONE | 1G | SQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*10 ML AMPOULE WATER FOR INJECTION |
| NDA/MAL/HDP/4721 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | MEGABAL | MECOBALAMIN | 5000MCG | PT SANBE FARMA,UNIT 1-JI INDUSTRI NO.9 LEUWIGAJAH CIMINDI CIMAHI WEST JAVA,INDONESIA | INDONESIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/4722 | GLAXO SMITHKLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ACTIFED COLD TABLETS | TRIPROLIDINE HYDROCHLORIDE+PSEUDOPHEDRINE HYDROCHLORIDE | 2.5MG+60MG | GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE | FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X96.0 TABLET BLISTER,1.0X480.0 TABLET BLISTER |
| NDA/MAL/HDP/4723 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | MEGYL SUSPENSION | METRONIDAZOLE BENZOATE | 200MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4724 | GLAXOSMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ACTIFED DRY COUGH & COLD | TRIPROLIDINE HYDROCHLORIDE+PSEUDOEPHEDRINE HYDROCHLORIDE+DEXTROMETHORPHAN | 1.25MG+30MG+10MG | GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE | FRANCE | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X2.0 L BOTTLE |
| NDA/MAL/HDP/4725 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MEGYL TABLET | METRONIDAZOLE | 200MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4726 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | ADB MIN MULTIPOWER | MULTI-INGREDIENT | MULTI-INGREDIENT | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X300.0 ML BOTTLE |
| NDA/MAL/HDP/4727 | STRIDES SHASUN LIMITED . | DELMAW ENTERPRISES LIMITED | MELONAX | MELOXICAM | 15MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4728 | M.J.BIOPHARM PVT LTD | TATA UGANDA LIMITED | ADRENALINE | ADRENALINE | IMG/ML | M.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/4729 | STRIDES SHASUN LIMITED . | DELMAW ENTERPRISES LIMITED | MELONAX | MELOXICAM | 7.5MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4730 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | MENACTRA | MENINGOCOCCAL GROUPS (A + C +Y + W-135) + POLYSACCHARIDE DIPTHERIA TOXOID CONJUGATE VACCINE | 4MCG + 4MCG + 4MCG + 4MCG + 48MCG | SANOFI PASTEUR-INC DISCOVERY DRIVE SWIFTWATER PENNSYLVANIA 183370-0187 | UNITED STATES | PARENTERAL ORDINARY I M VIALS | 1.0X5.0 ML VIAL (10 DOSE VIAL) |
| NDA/MAL/HDP/4731 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | MENAFRIVAC | MENINGOCOCCAL A CONJUGATE VACCINE | 10MCG/ 0.5ML + 10-33MCG/0.5ML | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X10.0 DOSE VIAL + 1*5ML AMPOULE OF DILUENT |
| NDA/MAL/HDP/4734 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | MENINGOCOCCAL VACCINE A+C | MENINGOCOCCAL A+C VACCINE | 50MCG/0.5ML + 50MCG/0.5ML | SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE,SANOFI PASTEUR S.A-2,AVENUE PONT PASTEUR 69007 LYON-FRANCE(BUSINESS ADDRESS) | FRANCE | PARENTERAL ORDINARY I M VIALS | 1.0X10.0 DOSE VIAL |
| NDA/MAL/HDP/4735 | MENTHOLATUM | HARLEYS UGANDA LIMITED | MENTHOLATUM BALM | MULTI-INGREDIENT | MULTI-INGREDIENT | THE MENTHOLATUM COMPANY LTD- TWYFORD, BENKSHIRE, E | UNITED KINGDOM | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X4.0 G TUBE |
| NDA/MAL/HDP/4736 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | MEPHAQUIN LACTAB | MEFLOQUINE | 250MG | ACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BL | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/4737 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CICOL DROPS | DICYCLOMINE HYDROCHLORIDE + SIMETICONE | 10MG + 40MG/ 5ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/4738 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | CILOXAN | CIPROFLOXACIN | 0.3%W/V | ALCON -ALCON COUVREUR NV B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/4739 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | MERO | MEROPENEM | 1G | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/4740 | ASTRA ZENECA | MACNAUGHTON LIMITED | MERONEM | MEROPENEM | 500MG | SUMITOMO PHARMACEUTICALS CO. LTD-JAPAN,ACS-DOBFAR ITALIA | JAPAN | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/4742 | ASTRA ZENECA | MACNAUGHTON LIMITED | MERONEM | MEROPENEM | 1G | SUMITOMO PHARMACEUTICALS CO. LTD-JAPAN,ACS-DOBFAR ITALIA | JAPAN | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/4743 | DAFRA PHARMA N.V/S.A | LABOREX UGANDA LIMITED | MERONIA 1000 | MEROPENEM | 1000MG | PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE | GREECE | PARENTERAL ORDINARY VIALS | 1.0X1000.0 MG VIAL |
| NDA/MAL/HDP/4744 | DAFRA PHARMA N.V/S.A | LABOREX UGANDA LIMITED | MERONIA 500 | MEROPENEM | 500MG | PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE | GREECE | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/4745 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PIPZO | PIPERACILLIN + TAZOBACTAM | 4.5G | ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X4.5 G VIAL |
| NDA/MAL/HDP/4746 | MIRACALUS PHARMA PVT.LTD | AIVEEN (U) LIMITED | ABINGEM-200 | GEMCITABINE | 200MG | NAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAI | INDIA | PARENTERAL ORDINARY VIALS | 1.0X200.0 MG VIAL |
| NDA/MAL/HDP/4747 | RIVA PHARMA FREE ZONE | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ZITHRORIV | AZITHROMYCIN | 200MG/5ML | RIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT | EGYPT | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X22.5 ML BOTTLE |
| NDA/MAL/HDP/4748 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | ACICONE-S CHEWABLE TABLET | MAGALDRATE+SIMETHICONE | 720MG+25MG | MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X5.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/4749 | PT SANBE FARMA | MEDVIN PHARMA LIMITED | MEROSAN | MEROPENEM | 1G | PT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/4750 | BAYER AG | SURGIPHARM (U) LIMITED | CIPROBAY I.V | CIPROFLOXACIN | 2MG/ML | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4751 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | FEROL | FERROUS SULPHATE | 200MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4752 | PFIZER LABORATORIES LTD | LABOREX UGANDA LIMITED | ADRIBLASTINA RD | DOXORUBICIN HYDROCHLORIDE | 10MG | PHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALY | ITALY | PARENTERAL ORDINARY OTHER VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/4753 | BAYER AG | SURGIPHARM (U) LIMITED | CIPROBAY 750 | CIPROFLOXACIN | 750MG | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4754 | BAYER PHARMA | SURGIPHARM (U) LIMITED | CIPROBAY XR | CIPROFLOXACIN | 500MG | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | ORAL SOLID RETARD TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/4755 | BAYER SCHERING AG | SURGIPHARM (U) LIMITED | ADVANTAN CREAM | METHYL PREDNISOLONE ACEPONATE | 0.1%W/W | BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY | ITALY | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4757 | ERIS LTD | BENLE CONSULT LIMITED | METFORMIN-DENK 500 | METFORMIN | 500MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4758 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | METFORMIN DENK 1000 | METFORMIN | 1000MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/4759 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | CIPRODAR | CIPROFLOXACIN | 500MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4760 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | FEROSOFT | IRON (III) HYDROXIDE POLYMALTOSE COMPLEX | 50MG/5ML | HILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN. | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/4763 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | FEROSOFT | IRON(III) HYDROXIDE POLYMALTOSE COMPLEX | 100MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4765 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | FEROSOFT-FA | IRON(III)HYDROXIDE POLYMALTOSE COMPLEX/FOLIC ACID | 100MG/0.35MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4766 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOBEN SUSPENSION | MEBENDAZOLE | 100MG/5ML | 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 SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/4768 | REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD | HEALTHCARE LTD. | METHACHLOR EYE DROPS | DEXAMETHASONE/CHLORAMPHENICOL | 1MG/2MG | REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM | PAKISTAN | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/4769 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOBEX | MEBENDAZOLE | 100MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4771 | ROTEX MEDICA GBH ARZNEIMITTELI | GITTOES PHARMACEUTICALS LIMITED | METHYLERGOMETRINE | METHYLERGOMETRINE MALEATE | 20MCG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/4773 | IDA FOUNDATION | KIMSY MEDS LTD | METHYLERGOMETRINE | METHYLERGOMETRINE | 0.2MG/ML | GLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/4774 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FERROFOL VIT-Z | FERROUS SULPHATE+FOLIC ACID+ASCORBIC ACID+THIAMINE MONONITRATE+RIBOTLAVINE+PYRIDOXINE HCL+NICOTINAMIDE+ZINC | 150MG+0.5MG+50MG+2MG+2MG+1MG+10MG+25MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0X6.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4777 | MERCK SHARP & DOHME BV | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CRIXIVAN | INDINAVIR SULPHATE | 400MG | MERCK SHARP & DOHME B.V-WAARDENWEG 392031 BN, HAARLEM | NETHERLANDS | ORAL SOLID ORDINARY CAPSULES | 1.0X180.0 CAPSULE BOTTLE |
| NDA/MAL/HDP/4778 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CURISAFE | CEFADROXIL MONOHYDRATE | 125MG/5ML | PHARCO 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/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4779 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | CUTIVATE | FLUTICASONE PROPIONATE | 0.05%W/W | GLAXO WELLCOME (UK)-UK | UNITED KINGDOM | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/4780 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | CUTIVATE | FLUTICASONE PROPIONATE | 0.005%W/W | GLAXO WELLCOME (UK)-UK | UNITED KINGDOM | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/4781 | CYANO PHARMA(P) | RENE PHARMACY LTD | CYANO IRON TABLETS | FERROUS SULPHATE | 200MG | CYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDORE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4782 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | CYBIN PF | CYTARABINE | 100MG/ML | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4783 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CYPOTIN | CYPROHEPTADINE HYDROCHLORIDE | 2MG/5ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4784 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | D50 | GLUCOSE INTRAVENOUS INFUSION | 50%W/V | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4785 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | DAKTACORT | MICONAZOLE NITRATE+HYDROCORTISONE | 2%W/W+1%W/W | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4786 | MISSION PHARMA A/S | JOINT MEDICAL STORE (UPMB - UCMB) | COTRIMOXAZOLE 960MG | SULPHAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4787 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | DAKTARIN | MICONAZOLE NITRATE | 20MG/G | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/4788 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | DAKTARIN ORAL GEL | MICONAZOLE NITRATE | 20MG/G | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | ORAL TOPICAL GELS AND SOLS | 1.0X40.0 G TUBE |
| NDA/MAL/HDP/4789 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | DALACIN C | CLINDAMYCIN HYDROCHLORIDE | 300MG | FAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCE | FRANCE | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CARTON,1.0X2.0X8.0 CAPSULE STRIP |
| NDA/MAL/HDP/4790 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | DALACIN C | CLINDAMYCIN HYDROCHLORIDE | 150MG | FAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCE | BELGIUM | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X8.0 CAPSULE STRIP,1.0X100.0 CAPSULE CARTON |
| NDA/MAL/HDP/4791 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | DALACIN C | CLINDAMYCIN PALMITATE | 75MG/5ML | PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS | BELGIUM | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X80.0 ML BOTTLE |
| NDA/MAL/HDP/4792 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | DALACIN C | CLINDAMYCIN PHOSPHATE | 150MG/ML | PFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X4.0 ML VIAL,1.0X2.0 ML VIAL |
| NDA/MAL/HDP/4793 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | DALACIN T | CLINDAMYCIN PHOSPHATE | 1%W/V | PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS | BELGIUM | TOPICAL EXTERNAL LIQUIDS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/4794 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | DALADOL | DICLOFENAC SODIUM + PARACETAMOL | 50MG+500MG | NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4795 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | DAROXIME | CEFUROXIME | 500MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BOTTLE |
| NDA/MAL/HDP/4796 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | DARROWS SOLUTION (HALF STRENGTH) | POTASSIUM CHLORIDE+SODIUM CHLORIDE+SODIUM LACTATE | 0.13%+0.20%+0.30% | ABACUS PARENTERAL DRUGS LTD-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/4798 | VENUS REMIDIES LTD | AARON PHARMACEUTICALS LTD | CITABOL | GEMCITABINE | 2MG/ML | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL |
| NDA/MAL/HDP/4799 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CITROLIN SOLUTION | CETRIMIDE+LIDOCAINE | 25MG+3MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL TOPICAL LIQUIDS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/4800 | DAWA LIMITED | SUPER MEDIC LTD | DAWAVITE SYRUP | MULTI-INGREDIENT | MULTI-INGREDIENT | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4801 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | DAZEL KIT | FLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE | 150MG + 1G + 1G | AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/4804 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | CLAVODAR | AMOXICILLIN + CLAVULANIC | 200MG + 28MG /5ML | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/4805 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOFEN | IBUPROFEN | 200MG | AGOG 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 TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4806 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOFER | FERROUS SULPHATE+FOLIC ACID | 200MG + 0.25MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4807 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOFORMIN | METFORMIN | 500MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4809 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOCORT | HYDROCORTISONE | 0.1%W/W | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4810 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | METHYLERGONOVINE | METHYLERGONOVINE MALEATE | 0.2MG/ML | GLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/4811 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOGYL | METRONIDAZOLE | 200MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4812 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOMETROL SUSPENSION | METRONIDAZOLE BENZOATE | 125MG/5ML | 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 SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4813 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOMETROL TABLETS (THANE) | METRONIDAZOLE | 200MG | AGOG 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 TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4814 | EUROLIFE HEALTHCARE PVT LIMITED | AIVEEN (U) LIMITED | METLIFE | METRONIDAZOLE | 500MG/100ML | EUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4815 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | FERROLIC-LF | FERROUS SULPHATE +FOLIC ACID | 200MG+0.4MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4817 | CYANO PHARMA(P) | RENE PHARMACY LTD | METOCLOPRAMIDE TABLETS | METOCLOPRAMIDE | 10MG | CYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDORE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4818 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | FERROUS SULPHATE | FERROUS SULPHATE | 200MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4819 | FDC LTD | AIVEEN (U) LIMITED | ORAL REHYDRATION SALT | ORAL REHYDRATION SALT | 27.9GM | FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X27.9 G SACHET |
| NDA/MAL/HDP/4820 | IDA | KIMSY MEDS LTD | FERROUS SULPHATE+FOLIC ACID | FERROUS SULPHATE+FOLIC ACID | 200MG+0.4MG | BIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLI | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4821 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | METPURE-XL 50 | METOPROLOL | 50MG | EMCURE PHARMACEUTICALS LIMITED -LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4823 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | METRIS INFUSION | METRONIDAZOLE | 5MG/ML | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4824 | MISSION PHARMA A/S | JOINT MEDICAL STORE (UPMB - UCMB) | FERROUS SULPHATE+FOLIC ACID | FERROUS SULPHATE+FOLIC ACID | 200MG+0.25MG | BIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLI | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4825 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | ALOHA LIQUID | MULTI-INGREDIENT | N/A | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/4826 | UNIQUE PHARMACEUTICALS LTD | TATA UGANDA LIMITED | METROGYL DENTA GEL | METRONIDAZOLE + CHLORHEXIDINE | 1%W/W + 0.25%W/W | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/4828 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | METROGYL GEL | METRONIDAZOLE | 1%W/W | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | TOPICAL EXTERNAL EMULSION GELS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/4830 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | METROGYL INJECTION | METRONIDAZOLE | 5MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116,UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--304-308 GIDC INDUSTRIAL A | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4832 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | METROGYL SUSPENSION | METRONIDAZOLE | 200MG/5ML | UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI ? 394 116, GUJARAT, INDIA.
,J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4836 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | METRON | METRONIDAZOLE | 200MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4839 | PHARMAVET LTD | DELMAW ENTERPRISES LIMITED | ANOMEX | ZINC OXIDE+LIDOCAINE+HYDROCORTISONE+ALLANTOIN | 5%W/W+3%W/W+0.25%W/W+0.5%W/W | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER,1.0X2.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/4845 | TORRENT PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | ANTIDEP | IMIPRAMINE | 25MG | TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.) | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4849 | UNI-MED INDIA | METAPLUS (U) LIMITED | METRONIDAZOLE ORAL SUSPENSION | METRONIDAZOLE BENZOATE | 125MG/5ML | UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD
ANDHERE(E)MUMBAI 400059 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4854 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | METROREN FC | METRONIDAZOLE | 200MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4855 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ASCORIL EXPECTORANT | BROMHEXINE+MENTHOL+TERBUTALINE+GUAIFENESIN | 2MG+0.5MG+1.25MG+50MG | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4856 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | METROREN | METRONIDAZOLE | 200MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4858 | RENE INDUSTRIES | RENE INDUSTRIES LIMITED | METROREN SUSPENSION | METRONIDAZOLE BENZOATE | 200MG/5ML | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4859 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | FLOXAPEN | FLUCLOXACILLIN | 250MG | SMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEX | UNITED KINGDOM | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CARTON |
| NDA/MAL/HDP/4860 | KWALITY AFRO ASIA LIMITED | KWALITY AFRO ASIA LIMITED | K-FEN SUSPENSION | IBUPROFEN | 100MG/5ML | KWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROAD | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/4862 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | FLOXAPEN SYRUP | FLUCLOXACILLIN | 125MG/5ML | MEDREICH LIMITED-12TH MIL,OLD MADRAS ROAD,VIRGONAGAR,BANGALORE-560 049,INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4863 | MEDICAL UNION PHARMACUITICALS | KARURI PHARMACEUTICALS LTD. | MICONAZ ORAL GEL | MICONAZOLE | 2%W/W | MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | ORAL TOPICAL GELS AND SOLS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/4865 | MEDICAL UNION PHARMACUITICALS | KARURI PHARMACEUTICALS LTD. | MICONAZ CREAM | MICONAZOLE NITRATE | 2%W/W | MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT | EGYPT | VAGINAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/4866 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | FLUCAN | FLUCONAZOLE | 150MG | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/4867 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | MICONA ORAL GEL | MICONAZOLE | 20MG | CENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X40.0 G TUBE,1.0X20.0 G TUBE |
| NDA/MAL/HDP/4868 | NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARE | SUPER MEDIC LTD | FLUCANIR | FLUCONAZOLE | 2MG/ML | NIRMA LIMITED (HEALTHCARE DIVISION)-VILLAGE-SACHANA, TALUKA-VIRAMGAM
DISTRICT- AHMEDABAD 382 150, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4869 | CIPLA LIMITED. | QUALITY CHEMICALS LTD - HUMAN | MICOGEL CREAM | MICONAZOLE NITRATE | 2%W/W | CIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4870 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | FLUCAS | FLUCONAZOLE | 150MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4871 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | MICOBACT POWDER | MICONAZOLE + CHLOROHEXIDINE | 2%W/W + 0.05%W/W | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL POWDERS | 1.0X30.0 G CONTAINER,1.0X50.0 G CONTAINER,1.0X75.0 G CONTAINER,1.0X100.0 G CONTAINER |
| NDA/MAL/HDP/4872 | DAWA LIMITED | SUPER MEDIC LTD | MICLOCIN CREAM | MICONAZOLE NITRATE + CLOBETASOL PROPRIONATE + GENTAMICN | 2%W/W+0.5%W/W+0.1W/W | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4873 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | FLUCAS | FLUCONAZOLE | 200MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4874 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | CLEXANE | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEX | FRANCE | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.6 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/4875 | PHARM ACCESS AFRICA LTD | MARIE STOPES UGANDA LIMITED | MISOCLEAR | MISOPROSTOL | 200MCG | ACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4876 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | CLEXANE | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEX | FRANCE | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.8 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/4877 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | CLEXANE | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEX | FRANCE | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.4 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/4878 | EUROLIFE HEALTHCARE PVT LIMITED | AIVEEN (U) LIMITED | FLUCOLIFE | FLUCONAZOLE | 200MG/100ML | EUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4879 | SANOFI-AVENTIS | LABOREX UGANDA LIMITED | CLEXANE | ENOXAPARIN SODIUM | 100MG/ML | SANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEX | FRANCE | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.2 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/4880 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | MISOPROST 200 | MISOPROSTOL | 200MCG | CIPLA LTD .-CIPLA GOA UNIT 8 L-147 TO L-147/1 L-147-3 TO L-138 VERNA INDUSTRIAL ESTATE VERNA GOA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X4.0 TABLET BLISTER,1.0X7.0X4.0 TABLET BLISTER,1.0X15.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/4881 | ASTRA LIFE CARE (INDIA) PVT LTD | ASTRA PHARMA (U) LIMITED | ASDOXIN | DOXYCYCLINE | 100MG | ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4883 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASFEN-FC | IBUPROFEN | 200MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4884 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASFULVIN-500 | GRISEOFULVIN | 500MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4887 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCOZAL | FLUCONAZOLE | 200MG | AEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4888 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASOMYCIN | ERYTHROMYCIN | 250MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4889 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCOZAL | FLUCONAZOLE | 50MG | AEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X14.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4890 | DELORBIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCOZAL | FLUCONAZOLE | 100MG | AEGIS LTD-17 ATHINON STREET, ERGATON INDUSTRIAL AREA, NICOSIA CYPRUS | CYPRUS | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4891 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | ASPEC TABLET | ASPIRIN+PARACETAMOL+CAFFEINE ANHYDROUS | 150MG+250MG+300MG | REGAL PHARMACEUTICALS LTD-OFF BABA DOGO RD, RUARAKA, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/4892 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | FLUFED COUGH FORMULA | MULTI-INGREDIENT | MULTI-INGREDIENT | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4895 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | CLOMIFERT | CLOMIPHENE | 50MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4899 | CIPLA LIMITED | QUALITY CHEMICALS LTD - HUMAN | CLOSERINE | CYCLOSERINE | 250MG | CIPLA LTD -CIPLA LTD VERNA IND BT GOA 403722 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X40.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/4901 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | AVELOX IV | MOXIFLOXACIN HCL | 400MG/250ML | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/4903 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | CMT-TABLETS | MAGNESIUM TRISILICATE+DRIED ALUMINIUM HYDROXIDE+PEPPERMINT OIL | 250MG+120MG+0.003ML | AGOG 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 TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4904 | NOVO NORDISK | STAR PHARMACEUTICALS LTD | MIXTARD 30 | INSULIN HUMAN | 100 I.U/ML | NOVO NORDISK PHARMA-NOVO ALLE | DENMARK | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/4905 | XEPA-SOUL PATTINSON | DELMAW ENTERPRISES LIMITED | AVORAX CREAM | ACYCLOVIR | 5%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE |
| NDA/MAL/HDP/4906 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | AVORAX TABLETS | ACYCLOVIR | 200MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X5.0 TABLET STRIP |
| NDA/MAL/HDP/4908 | NOVO NORDISK | STAR PHARMACEUTICALS LTD | MIXTARD 30 PENFILL | BIPHASIC ISOPHANE INSULIN (HUMAN) | 100 I.U/ML | NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD | DENMARK | PARENTERAL ORDINARY CARTRIDGES | 1.0X3.0 ML CARTRIDGE,1.0X1.5 ML CARTRIDGE |
| NDA/MAL/HDP/4909 | AXA PARENTERALS LTD | GITTOES PHARMACEUTICALS LIMITED | AXAGYL | METRONIDAZOLE | 0.5%W/V | AXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA. | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4910 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | FLUZOL | FLUCONAZOLE | 200MG | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4911 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | MOFILET-500 | MYCOPHENOLATE MOFETIL | 500MG | EMCURE PHARMACEUTICALS LIMITED -LANE NO.3 PHASE II SIDCO INDUSTRIAL COMPLEX BARI-BRAHMANA JAMMU ,181133 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4915 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FOGYL-S TABLETS | METRONIDAZOLE | 200MG | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4917 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL EVILINE FORTE SUSPENSION | MAGNESSIUM HYDROXIDE +ALUMINIUM HYDROXIDE+SIMETHICONE | 400MG/5ML+400MG/5ML+40MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/4918 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FOGYL SUSPENSION | METRONIDAZOLE BENZOATE | 200MG/5ML | FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4919 | KOTRA PHARMA (M) SDN BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL FUSIDIC ACID- B CREAM | FUSIDIC ACID+BETAMETHASONE 17 VALERATE | 2%,W/W,+0.1% W/W | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/4920 | LEBEN LABORATORIES LTD | ANDYCO PHARMACY (UGANDA) LTD | FOLIBEN | FOLIC ACID | 5MG | LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X20.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4922 | KOPRAN LIMITED | TATA UGANDA LIMITED | CIPROQUIN-500 | CIPROFLOXACIN | 500MG | KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4924 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | MULTIVIT TABLET | MULTIVITAMIN | MULTI-INGREDIENT | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4926 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | FOLIC ACID | FOLIC ACID | 5MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4927 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | AZOPT | BRINZOLAMIDE | 10MG/ML | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/4928 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | FOLIC ACID TABLETS | FOLIC ACID | 5MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4929 | MARTINDALE AND AURUM PHARMACEUTICAL | LABOREX UGANDA LIMITED | MORPHINE INJECTION | MORPHINE | 15MG/ML | MARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/4931 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | FOLIC ACID TABLET | FOLIC ACID | 5MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4932 | MARTINDALE AND AURUM PHARMACEUTICAL | LABOREX UGANDA LIMITED | MORPHINE INJECTION | MORPHINE | 10MG/ML | MARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/4933 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | AZUDOX | DOXYCYCLINE HYDROCHLORIDE | 100MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X100.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/4935 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | BACTROBAN OINTMENT | MUPIROCIN | 2%W/W | GLAXO OPERATIONS UK LTD -PRIORY STREET, WARE
HERTFORDSHIRE SG12 0DJ, UK
| UNITED KINGDOM | TOPICAL EXTERNAL OINTMENTS | 1.0X3.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/4936 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | COMBIFEN | IBUPROFEN + PARACETAMOL | 400MG + 500MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4937 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | MOTILIUM | DOMPERIDONE | 10MG | JANSSEN-CILAG-27 100 VAL DE REUIL, FRANCE | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0 TABLET CARTON,1.0X30.0 TABLET CARTON |
| NDA/MAL/HDP/4938 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | BACTROBAN CREAM | MUPIROCIN | 2%W/W | GLAXO OPERATIONS UK LTD -PRIORY STREET, WARE
HERTFORDSHIRE SG12 0DJ, UK
| UNITED KINGDOM | TOPICAL EXTERNAL CREAMS | 1.0X1.0X15.0 G TUBE |
| NDA/MAL/HDP/4939 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | FOLIREN | FOLIC ACID | 5MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4940 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | FOLON | FOLIC ACID | 5MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4941 | GLAXO SMITH KLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | BEECHAMS POWDERS HOT LEMON | PARACETAMOL+PHENYLEPHEDRINE | 600MG+10MG | SMITHLINE BEECHAM (NAIROBI)-NAIROBI, KENYA | KENYA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X48.0X5.6 G SACHET,1.0X5.0X5.6 G SACHET |
| NDA/MAL/HDP/4943 | ASTRAZENECA | MACNAUGHTON LIMITED | NOLVADEX | TAMOXIFEN | 20MG | ASTRAZENECA UK LIMITED -ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA, | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4944 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | BENA EXPECTORANT | DIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + SODIUM CITRATE | 14MG + 135MG + 57.5MG | XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250
MALEKA, MALAYSIA | MALAYSIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/4945 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | FORMIT | METFORMIN | 850MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4946 | ESAPHARMA S.R.L.. | BYAMAKA PHARMACEUTICAL COMPANY LTD | MOVATE | CLOBETASOL | 0.05%W/W | ESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY
| ITALY | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/4948 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | FORMIT 1000 | METFORMIN HYDROCHLORIDE | 1000MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4949 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN DRY COUGH DM | DEXTROMETHORPHAN HYDROBROMIDE | 15MG/ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4950 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | FORMIT 500 | METFORMIN | 500MG | DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4951 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN ORIGINAL | DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE | 12.5 MG/5ML + 125 MG/5ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X2.5 L BOTTLE |
| NDA/MAL/HDP/4952 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN WITH CODEINE | DIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + CODEINE PHOSPHATE | 12.5MG/5ML +125MG/5ML +10MG/5ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/4953 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | SURGIPHARM (U) LIMITED | NAT-B | MULTI-INGREDIENT | MULTI-INGREDIENT | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280 | THAILAND | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/4955 | NIRMA LIMITED. | SUPER MEDIC LTD | COMPOUND SODIUM LACTATE INFU. | COMPOUND SODIUM LACTATE | MULTI INGREDIENT | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/4956 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | CONTRAPAQUE 30 | IOHEXOL | 350MG | UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL |
| NDA/MAL/HDP/4957 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | MUMFER | IRON (111) POLYMALTOSE COMPLEX + FOLIC ACID | 100MG + 500MCG | GLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY CHEWABLE COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4958 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | BENZOSED | MIDAZOLAM | 1MG/ML | TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL |
| NDA/MAL/HDP/4959 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS PAEDIATRIC LINCTUS | CHLORPHENIRAMINE / PHENYLEPHRINE / DEXTROMETHORPHAN | 1MG/ 5MG/ 10MG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/4962 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | BETAD | BETAMETHASONE DIPROPRIONATE | 0.05%W/W | S.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X1.0X30.0 G TUBE,1.0X1.0X15.0 G TUBE |
| NDA/MAL/HDP/4964 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS PLUS PAEDIATRIC SUSPENSION | CHLORPHENAMINE+PHENYLEPHRINE+PARACETAMOL | IMG+5MG+160MG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/4965 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | BETAFEN SYRUP | IBUPROFEN | 100MG/5ML | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4966 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | CONTUS-650 | CHLORPHENIRAMINE + PHENYLEPHRINE + PARACETAMOL | 2MG + 5MG + 650MG | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/4967 | MEDIPHARM SALES (E.A) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | PIRITEX JUNIOR | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4968 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FRUSEMIDE INJECTION | FUROSEMIDE | 10MG/ML | NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4969 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | BENZATHINE PENICILLIN | BENZATHINE PENICILLIN | 2.4 M.U | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X2.4 MU VIAL |
| NDA/MAL/HDP/4970 | MEDIPHARM SALES (E.A) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | PIRITEX DRY COUGH SYRUP | DIPHENHYDRAMINE HCL/ DEXTROMETHORPHAN HBR/ PSEUDOEPHEDRINE HCL | 14MG+15MG+30MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/4971 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | FRUSEMIDE TABLETS | FUROSEMIDE | 40MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4972 | JOHNSON &JOHNSON (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | COOLMINT LISTERINE | MENTHOL + ALCOHOL 95% | 0.02% + 4.58ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER |
| NDA/MAL/HDP/4973 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | PERGOVERIS | FOLLITROPIN ALFA/LUTROPIN ALFA | 150 I.U/75 I.U | MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 ML VIAL + 1*1ML VIAL OF WFI |
| NDA/MAL/HDP/4974 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | FRUSEMIDE TABLETS BP 40MG | FUROSEMIDE | 40MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4975 | FREDUN PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | FRUSINA TABLETS | FUROSEMIDE | 40MG | FREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4976 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | PERGLIM 2 | GLIMEPIRIDE | 2MG | INVENTIA HEALTHCARE PVT. LTD .-FI ? FI /1 ADDITIONAL AMBERNATH(EAST) ? 421 506,MAHARASHTRA DIST. THANE, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4978 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | PERAZONE | DEXAMETHASONE | 0.5MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/4979 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | FUROSEMIDE | FUROSEMIDE | 10MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/4982 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSMAG TABLETS | MAGNESIUM TRISILICATE | 370MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/4983 | PT SAMBE FARMA | MEDVIN PHARMA LIMITED | PELASTIN | IMIPENEM + CILASTATIN | 500MG + 500MG | PT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA | INDONESIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/4986 | IDA FOUNDATION | KIMSY MEDS LTD | CO-TRIMOXAZOLE | CO-TRIMOXAZOLE | 960MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/4987 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | PYRAZINAMIDE | PYRAZINAMIDE | 400 MG | CADILA PHARMACEUTICALS LIMITED-1389,TRASAD ROAD, DHOLKA-382 225, AHMEDABAD GUJARAT STATE,INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X24.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/4990 | IDA FOUNDATION | KIMSY MEDS LTD | COTRIMOXAZOLE | SULFAMETHOXAZOLE + TRIMETHOPRIM | 800MG +160MG | MEDOPHARM -34B INDUSTRIAL AREA MALUR 563130 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/4995 | ROYAL GROUP | HARLEYS UGANDA LIMITED | GENTABACT EYE/EAR DROPS | GENTAMYCIN SULPHATE | 0.3%W/V | AHLCON PARENTERALS (I) LIMITED-SP-918,INDUSTRIAL AREA,PHASE III BHIWADI DIST, ALWAR (RAJASTHAN) INDIA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/4998 | MYLAN LABORATORIES LIMITED. | NORVIK ENTERPRISES LIMITED | HYAN | LEVONORGESTREL | 0.03MG | MYLAN 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, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/4999 | UNIQUE PHARMACEUTICAL LABORATORIES | TATA UGANDA LIMITED | PAMIDOL*370 | IOPAMIDOL | 755.3MG/ML | UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL |
| NDA/MAL/HDP/5001 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | GENTAMICIN INJECTION | GENTAMYCIN | 80MG/2ML | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/5002 | ELI-LILLY EXPORT SA | LABOREX UGANDA LIMITED | HUMALOG MIX 25 | INSULIN LISPRO + INSULIN LISPRO PROTAMINE | 25I.U+75I.U | LILLY FRANCE SA-FRANCE | FRANCE | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/5004 | GLAXOSMITHKLINE LIMITED LIKONI | BETA HEALTHCARE UGANDA LIMITED | COFTA TABLETS | MULTI-INGREDIENT | N/A | GLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA,BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY LOZENGES | 1.0X100.0 TABLET CARTON,1.0X50.0 TABLET CARTON,1.0X150.0 TABLET CARTON |
| NDA/MAL/HDP/5005 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | COLD GO | PARACETAMOL+PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE MALEATE+CAFFEINE | 325MG+10MG+2MG+30MG | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/5007 | DELOBORIS PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | VIRUCID | ACYCLOVIR | 200MG | AEGIS LIMITED -17, ATHINON STREET, ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081, LEFKOSIA | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X25.0 TABLET CONTAINER |
| NDA/MAL/HDP/5008 | UNIMED | METAPLUS (U) LIMITED | COLDAFEX | MULTI-INGREDIENT | MULTI-INGREDIENT | UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD
ANDHERE(E)MUMBAI 400059 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5010 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | ZARIN CREAM | CLOTRIMAZOLE | 2%W/W | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/5011 | UNIMED | METAPLUS (U) LIMITED | COLDAFEX TABLETS | MULTI-INGREDIENT | MULTI-INGREDIENT | UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD
ANDHERE(E)MUMBAI 400059 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X4.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5012 | ROYAL GROUP | HARLEYS UGANDA LIMITED | GENTAMICIN INJECTION | GENTAMYCIN SULPHATE | 40MG/ML | GRAND PHARMACEUTICAL (CHINA) CO. LTD--LAKE ROAD NELL JINYINHU ECOLOGICAL PARKDONG XI HU DISTRICT, WUHAN, HEBEI PROVINCE. | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/5013 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | GENTAMYCIN EYE/EAR DROPS | GENTAMYCIN | 0.3%W/V | CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5014 | UNIQUE PHARMACEUTICAL LABORATORIES | TATA UGANDA LIMITED | VERMOREX SUSPENSION | MEBENDAZOLE | 100MG/5ML | J.B CHEMICALS & PHARMACEUTICALS LTD-128/1 GIDC ANKLESHWAR 393 022 GUJARAT INDIA,UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/5015 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | COLDCAP CAPSULES | PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE | 5MG+4MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X8.0X12.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5016 | IDA FOUNDATION | KIMSY MEDS LTD | GENTAMYCIN INJECTION | GENTAMYCIN SULPHATE | 40MG/ML | GLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/5017 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | COLDCAP SYRUP | PARACETAMOL+PROMETHAZINE HYDROCHLORIDE+CODEINE PHOSPATE+PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG+6.5MG+5MG+25MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5018 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | VENTOLIN | SALBUTAMOL | 100MCG | GLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE NO.2 23, RUE LAVOISIER 27000 EVREUX,FRANCE. | FRANCE | RECTAL SYSTEMIC METERED-DOSE PRESSURISED AEROSOLS | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/5019 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | COLOSPASMIN FORTE | MEBEVERINE | 135MG | EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)-EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O) | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/5020 | GLAXO WELLCOME (KENYA) LTD | ERIS LTD | VENTOLIN | SALBUTAMOL | 2MG/ML | GLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5021 | BAYER SCHERING PHARMA FRANCE | SURGIPHARM (U) LIMITED | COMBINATION 3 | ETHINYL ESTRADIOL+ LEVONORGESTREL+FERROUS FUMARATE | 0.03MG+0.15MG+75MG | DELPHARMA SAS ZONE INDUSTRIELLE -DELPHARMA SAS ZONE INDUSTRIELLE DE ROUBAIX EST RUE DE TOUFFLERS BP 50070 59452 LYS LEZLANNOY CEDEX / BAYER PHARMA AG BERLIN,BAYER PHARMA AG -13353 BERLIN GERMANY,BAYER WEIMAR GMBH UND CO. KG,-WEIMAR DEBEREINERSTRASSE 20, 9 | FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X100.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/5023 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | COTREICH | CO-TRIMOXAZOLE | 240MG/5ML | MEDRIECH STERILAB LTD.--ANALGHALLI, BANGLORE - 560062 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/5025 | THE MENTHOLATUM COMPANY LTD | HARLEYS UGANDA LIMITED | DEEP FREEZE COLD GEL | MENTHOL | 2%W/W | THE MENTHOLATUM COMPANY LTD, TWYFORD,-TWYFORD, BENKSHIRE, E | UNITED KINGDOM | TOPICAL EXTERNAL GELS AND SOLS | 1.0X35.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE |
| NDA/MAL/HDP/5027 | PFIZER LAB LTD | LABOREX UGANDA LIMITED | TERRA-CORTRIL | MULTI-INGREDIENT | MULTI-INGREDIENT | PFIZER PGM ORLEANS FRANCE-AVENUE DE CONCYR, F-450 | FRANCE | OPHTHALMIC LIQUIDS | 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE,1.0X4.0 ML BOTTLE |
| NDA/MAL/HDP/5028 | THE MENTHOLATUM COMPANY LTD TWY | HARLEYS UGANDA LIMITED | DEEP HEAT SPRAY | MULTI-INGREDIENT | MULTI-INGREDIENT | THE MENTHOLATUM COMPANY LTD, TWYFORD,-1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLAND | UNITED KINGDOM | TOPICAL EXTERNAL PRESSURISED AEROSOLS | 1.0X150.0 ML CANNISTER |
| NDA/MAL/HDP/5030 | PFIZER LAB LTD | LABOREX UGANDA LIMITED | SOLU-MEDROL | METHYLPREDNISOLONE HEMISUCCINATE | 125MG/2ML | PFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 ML VIAL,1.0X8.0 ML VIAL |
| NDA/MAL/HDP/5031 | THE MENTHOLATUM COMPANY LTD | HARLEYS UGANDA LIMITED | DEEP HEAT RUB | MULTI-INGREDIENT | MULTI-INGREDIENT | THE MENTHOLATUM COMPANY LTD, TWYFORD,-1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLAND | UNITED KINGDOM | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X35.0 G TUBE,1.0X67.0 G TUBE,1.0X100.0 G TUBE |
| NDA/MAL/HDP/5032 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | DELASED DRY COUGH SYRUP (NON DROWSY) | DEXTROMETHORPHAN | 7.5MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5033 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | MEBFIL TABLETS | MEBENDAZOLE | 100MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
| INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5034 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | MEBENDAZOLE TABLET | MEBENDAZOLE | 100MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5035 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | MEBENDAZOLE | MEBENDAZOLE | 100MG/5ML | MEDICAMEN BIOTECH LTD - -SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/5038 | UNICHEM LABORATORIES LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | M-CAM TABLETS | MELOXICAM | 15MG | UNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5039 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | SURGIPHARM (U) LIMITED | GILOBA | GINKO BILOBA EXTRACT | 40MG | MEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND | THAILAND | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5040 | PFIZER LABORATORIES (PTY) LTD BELGIUM | LABOREX UGANDA LIMITED | DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | 40MG/ML | PFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL,1.0X2.0 ML VIAL,1.0X5.0 ML VIAL |
| NDA/MAL/HDP/5041 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | MAXITROL | DEXAMETHASONE/NEOMYCIN/POLYMYXIN B | 0.1%W/W +0.1%W/W+6000 I.U | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC OINTMENTS | 1.0X3.5 G TUBE |
| NDA/MAL/HDP/5042 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSATRIM DS TABLETS | CO-TRIMOXAZOLE | 960MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/5043 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | MAXITROL | DEXAMETHASONE/NEOMYCIN/POLYMYXIN B | 0.1%W/W+3500I.U/ML+6000I.U/ML | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/5044 | PFIZER LABORATORIES (PTY) LTD BELGIUM | LABOREX UGANDA LIMITED | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 150MG/ML | PFIZER GLOBAL MANUFACTURING BELGIUM NV-RIJKSWEG 12, 2870 PUURS - BELGIUM | BELGIUM | PARENTERAL ORDINARY I M VIALS | 1.0X3.5 ML VIAL,1.0X1.0 ML VIAL |
| NDA/MAL/HDP/5045 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | MAXIT TABLETS | DICLOFENAC | 50MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5046 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | GIZLAN PLUS 150/12.5 | IRBESARTAN+HYDROCHLOROTHIAZIDE | 150MG+12.5MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/5047 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | MAXINEM 500MG | MEROPENEM | 500MG | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/5048 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | MAXINEM 1G | MEROPENEM | 1G | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/5049 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | GIZLAN PLUS 300/12.5 | IRBESARTAN/HYDROCHLOROTHIAZIDE | 300MG/12.5MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/5050 | NORVATIS PHARMA AG- SWITZERLAND | LABOREX UGANDA LIMITED | MAXIDEX | DEXAMETHASONE | 0.1%W/V | ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM | BELGIUM | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/5051 | CADILA HEALTHCARE LIMITED SARKHEJ | ABACUS PHARMA (AFRICA) LIMITED | DERIHALER | SALBUTAMOL | 100CMG/DOSE | CADILA 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 INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/5052 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | GLAMIDE TABLETS | GLIBENCLAMIDE | 5 MG | LA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 2.0X50.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5054 | SANOFI AVENTIS KENYA LTD | LABOREX UGANDA LIMITED | MAALOX | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE | 200MG + 200MG | WINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5055 | GLAXOSMITHKLINE LTD UK | ERIS LTD | DERMOVATE | CLOBETASOL PROPIONATE | 0.05%W/W | GLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM | UNITED KINGDOM | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE,1.0X25.0 G TUBE |
| NDA/MAL/HDP/5056 | AVENTIS PHARMA (PTY) LTD SOUTH AFRICA | LABOREX UGANDA LIMITED | MAALOX SUSPENSION | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE | 665MG/5ML + 200MG/5ML | WINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X350.0 ML BOTTLE,1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/5057 | SANOFI AVENTIS KENYA LTD | LABOREX UGANDA LIMITED | MAALOX PLUS | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE | 200MG + 200MG + 25MG | WINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X4.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5059 | AVENTIS PHARMA (PTY) LTD SOUTH AFRICA | LABOREX UGANDA LIMITED | MAALOX PLUS SUSPENSION | MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE | 665MG/5ML + 200MG/5ML | WINTHROP PHARMACEUTICALS (PTY) LTD.-PLOT NO.315 WALTLOO ROAD,PRETORIA,0186PRETORIA-PRIVATE BAG X516,SILVERTON,0127,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X350.0 ML BOTTLE,1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/5061 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | MAGNESIUM SULPHATE | MAGNESIUM SULPHATE | 50MG/ML | GLAND PHARMA LIMITTED 143-148-SURVEY NOS. 143-148, 150&151, NEAR GANDIMAISAMMA CROSS ROADS. RANGA REDDY DISTRICT HYDERABAD 500043 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/5062 | EUROLIFE HEALTHCARE PVT LIMITED | AIVEEN (U) LIMITED | MANNILIFE | MANNITOL | 20MG/100ML | EUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5066 | M.J.BIOPHARM PVT LTD | TATA UGANDA LIMITED | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | 4MG/ML | M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208
NAVI MUMBAI, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/5067 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | LUFENAC | DICLOFENAC | 25MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/5068 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | 8MG/2ML | NINGBO DAHONGYING PHARMACEUTICAL CO LTD.-NO. 3986, HI-TECH PARK MINZHU ROAD, NINGBO CITY, ZHEJIANG | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/5070 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | LOMOH-60 | ENOXAPARIN SODIUM | 60MG/0.6ML | EMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/5071 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | LOMOH-40 | ENOXAPARIN SODIUM | 40MG/0.4ML | EMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/5072 | CYANO PHARMA(P) | RENE PHARMACY LTD | DEXAMETHASONE TABLETS | DEXAMETHASONE | 0.5MG | CYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDORE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5073 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | DEXONA EYE/EAR DROP | DEXAMATHASONE SODIUM PHOSPHATE+NEOMYCIN SULPHATE | 0.35%W/V+0.1%W/V | AHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE,1.0X2.5 ML BOTTLE |
| NDA/MAL/HDP/5074 | CADILA HEALTH CARE LTD | ABACUS PHARMA (AFRICA) LIMITED | DEXONA INJECTION | DEXAMETHASONE DISODIUM PHOSPHATE | 4MG/ML | CADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X2.0 ML VIAL |
| NDA/MAL/HDP/5075 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | DEXONA TABLETS | DEXAMETHASONE | 0.5MG | CADILA HEALTHCARE LIMITED SARKHEJ-SARKHEJ-BAVLA N.H NO.8A, N.H NO.8A, | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/5076 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | DEXTRACIN EYE DROPS | DEXAMETHASONE + NEOMYCIN | 0.1MG + 0.5MG | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/5078 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | GLANDIN E2 VAGINAL | DINOPROSTONE | 3MG | NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | VAGINAL TABLETS | 1.0X1.0 TABLET STRIP |
| NDA/MAL/HDP/5079 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | GLEMONT CT 5 | MONTELUKAST | 5MG | GLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5080 | GENO PHARMACEUTICALS PVT LTD | HARLEYS UGANDA LIMITED | LOBAK | DICLOFENAC + PARACETAMOL + CHLORZOXAZONE | 50MG + 325MG + 250MG | GENO PHARMACEUTICALS LTD--PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5086 | FOURRTS (INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | GLIFIL M FORT | GLIBENCLAMIDE + METFORMIN HYDROCHLORIDE | 5MG+500MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5087 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DIABEN TABLETS | GLIBENCLAMIDE | 5MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5092 | MICRO LABS LTD 92 SIPCOT | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIAPRIDE | GLIMEPIRIDE | 2MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5093 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | LIPODAR 10 | ATORVASTATIN | 10MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5095 | MICRO LABS LTD | LABOREX UGANDA LIMITED | DIAPRIDE PLUS | GLIMEPIRIDE + METFORMIN | 1MG + 500MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5097 | EUROLIFE HEALTHCARE PVT LIMITED | AIVEEN (U) LIMITED | GLUCOLIFE | GLUCOSE | 5%W/V | EUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5098 | RIVA PHARMA FREE ZONE | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DIARIV | DI-IODO HYDROXYQUINOLINE + PHTHALYL SULPHATHIAZOLE + HOMATROPINE + STREPTOMYCIN | 125MG + 150MG + 1MG + 100MG | RIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT | EGYPT | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/5099 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | GLUCOMET | METFORMIN | 500MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5100 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | L-GENTA | GENTAMICIN | 0.3%W/V | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5101 | F. HOFFMANN- LA ROCHE LTD | LABOREX UGANDA LIMITED | LEXOTANIL | BROMAZEPAM | 1.5MG | F. HOFFMANNLA ROCHE LTD BASEL, SWITZERLAND-GRENZACHERSTRASSE 124 4070, BASEL | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5102 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE 500MG | METFORMIN | 500MG | MERCK SANT?-2, RUE DU PRESSOIR VERT F 45400, SEMOY,NKUNZI PHARMACEUTICALS (PTY) LTD.-259 DAVIDSON ROAD CNR PEDDIE STREET, WADEVILLE EST. 1 GERMISTON 1422 | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X500.0 TABLET CONTAINER,1.0X6.0X15.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER |
| NDA/MAL/HDP/5103 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE 1000MG | METFORMIN | 1000MG | NKUNZI PHARMACEUTICALS (PTY) LTD --259 DAVIDSON ROAD, WADEVILLE, EXT 1, GERMINSTON, SOUTH AFRICA | FRANCE | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/5104 | NOVO NORDISK PHARMA GULF FZ-LC | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | LEVEMIR FLEXPEN | INSULIN DETEMIR | 100 I.U/ML | NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD | DENMARK | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN |
| NDA/MAL/HDP/5106 | ESAPHARMA S.R.L.. | BYAMAKA PHARMACEUTICAL COMPANY LTD | LEMONVATE CREAM | CLOBETASOL PROPIONATE | 0.05%W/W | ESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY
| ITALY | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/5107 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | INDOREN CAPSULES | INDOMETHACIN | 25MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/5109 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | LEBASMA ORAL SOLUTION | SALBUTAMOL | 2MG/5ML | LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5110 | NIRMA LIMITED. | SUPER MEDIC LTD | GLUCOSE INFUSION BP | DEXTROSE | 5%W/V | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/5112 | WIN-MEDICARE PVT LTD | SURGIPHARM (U) LIMITED | DICLOMOL SR TABLETS | DICLOFENAC SODIUM | 100MG | WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM ? 250110, UTTAR PRADESH -INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5114 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | LATONE MULTIVITAMIN | MULTIVITAMIN | MULTI-INGREDIENT | NEM LABORATORIES PVT LTD-NEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5115 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | INDOS-25(THANE) | INDOMETHACIN | 25MG | AGOG 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 CAPSULES | 1000.0 CAPSULE CONTAINER,20.0X5.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5117 | VENUS REMEDIES LIMITED | HARLEYS UGANDA LIMITED | LASTINEM | IMIPENEM + CILASTATIN | 500MG + 500MG | VENUS REMMEDIES-UNIT II HILLTOP INDUSTRIAL ESTATES JHARMAJRI EPIP PHASE 1 BHOTOLI KALA BADDI INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5119 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | KONTRAC 200 | MISOPROSTOL | 200MCG | FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X2.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5120 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | GLYFORMIN 500 TABLETS | METFORMIN | 500MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/5121 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | DICLORAN GEL | DICLOFENAC DIETHYLAMMONIUM | 1%W/W | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116 | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X50.0 G TUBE,1.0X20.0 G TUBE |
| NDA/MAL/HDP/5122 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | KOFAREST SYRUP | SALBUTAMOL SULPHATE/AMBROXOL SULPHATE/GUAFENESIN/MENTHOL | 2MG+30MG+100MG+5MG/10ML | CENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/5123 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | GLYFORMIN 850 TABLETS | METFORMIN | 850MG | REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5124 | GLAXOSMITHKLINE LTD BELGIUM | ERIS LTD | INFANRIX-HEXA | DIPHTHERIA + PERTUSSIS + BORDETELLA/PERTUSSIS + PERTUSSIS + HAEMAGGLUTININ + PERTACTIN + (HEPATITIS B/POLIOVIRUS TYPE 1 +2 +3) | NLT 30 IU + NLT 40IU + 25MCG + 25MCG + 8MCG + 10MCG + (TYPE I 40D +TYPE 2 + TYPE 3) | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY COMBINATION PACK VIALS | 1.0X0.5 ML VIAL (1 DOSE) |
| NDA/MAL/HDP/5125 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | GLYGESIC FORTE RHUMETIC CREAM | MULTI INGREDIENT | N/A | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/5126 | UNIVERSAL CORPORATION LTD | DELMAW ENTERPRISES LIMITED | KNAC-75 | DICLOFENAC | 75MG | UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5127 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | DICLORAN INJECTION | DICLOFENAC SODIUM | 25MG/ML | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X100.0X3.0 ML AMPOULE,1.0X5.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/5128 | MEDIPHARM SALES LTD | ABACUS PHARMA (AFRICA) LIMITED | GOFEN 400 CLEARCAP | IBUPROFEN | 400MG | MEGA LIFESCIENCES LTD.-384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKAN | THAILAND | ORAL SOLID ORDINARY CAPSULES | 6.0X1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5129 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | KLEEN ENEMA | DISODIUM BISPHOSPHATE/ SODIUM PHOSPHATE | 19.2G+7.2G/ 120ML | NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | RECTAL SYSTEMIC ENEMA LIQUIDS | 1.0X135.0 ML BOTTLE |
| NDA/MAL/HDP/5130 | UNIQUE PHARMACEUTICALS LTD | TATA UGANDA LIMITED | DICLORAN MS GEL | DICLOFENAC+METHYL SALICYLATE+MENTHOL | 1%W/W+10%W/W+5%W/W | UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116 | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/5131 | NOVO NORDISK | STAR PHARMACEUTICALS LTD | INSULATARD HM | ISOPHANE INSULIN (HUMAN) | 100 I.U/ML | NOVO NORDISK PHARMA-NOVO ALLE | DENMARK | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5132 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | KETROZOL 200 TABLETS | KETOCONAZOLE | 200MG | REMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5133 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GONAL-F PEN 900IU/1.5ML(66MCG/1.5ML) | FOLLITROPIN ALFA | 66MCG/1.5ML | MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D?AUBONNE ZONE INDUSTRIELLE DE L?OURIETTAZ, SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.0 CARTRIDGE PREFILLED PEN + 20 NEEDLES FOR INJECTION,1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR INJECTION. |
| NDA/MAL/HDP/5134 | BETA HEALTHCARE | BETA HEALTHCARE UGANDA LIMITED | GOODMORNING COUGH TABLETS | MULTIINGREDIENT | N/A | BETA 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 TABLETS | 1.0X100.0 TABLET CARTON |
| NDA/MAL/HDP/5135 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | KETOZ | KETOCONAZOLE | 2%W/W | SK ANT HEALTHCARE LTD-1802-1805 GIDC PHASE III, VAPI-396195 GUJARAT, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/5136 | BETA HEALTHCARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | GOODMORNING LUNG TONIC | MULTIINGREDIENT | N/A | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/5137 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | KETOREN | KETOCONAZOLE | 200MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5139 | NOVO NORDISK | STAR PHARMACEUTICALS LTD | INSULATARD HM PENFILL | ISOPHANE INSULIN (HUMAN) | 100I.U/ML | NOVO NORDISK PHARMA-NOVO ALLE | DENMARK | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X1.5 ML CARTRIDGE,1.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/5140 | PFIZER LABORATORIES PTY LTD | LABOREX UGANDA LIMITED | DIFLUCAN | FLUCONAZOLE | 200MG | FAREVA AMBOISE - -ZONE INDUSTRIELLE, 29 ROUTE DES INDUSTRIES, 37530 POCE SUR CISSE, FRANCE | FRANCE | ORAL SOLID ORDINARY CAPSULES | 1.0X7.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5141 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | KETOMAC SHAMPOO | KETOCONAZOLE | 2%W/V | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X75.0 ML BOTTLE |
| NDA/MAL/HDP/5142 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | INTAMINE CREAM | MEPYRAMINE MALEATE | 2%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X25.0 G TUBE,1.0X400.0 G TUBE |
| NDA/MAL/HDP/5143 | ASTRA ZENECA | MACNAUGHTON LIMITED | BETALOC ZOK - 25MG | METOPROLOL | 25MG | ASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDEN | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/5144 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | KETOCONAZOLE 200MG | KETOCONAZOLE | 200MG | HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5146 | ASTRA ZENECA | MACNAUGHTON LIMITED | BETALOC ZOK - 100MG | METOPROLOL | 100MG | ASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5147 | ASTRA ZENECA | MACNAUGHTON LIMITED | BETALOC ZOK - 50MG | METOPROLOL | 50MG | ASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDEN | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5148 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | BETANASE TABLETS | GLIBENCLAMIDE | 5MG | CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER |
| NDA/MAL/HDP/5149 | SEARLE PAKISTAN LIMITED | HEALTHCARE LTD. | GRAVINATE SYRUP | DIMENHYDRINATE | 12.5MG/4ML | SEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/5150 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | KETO PLUS SHAMPOO | KETOCONAZOLE/ZINC PYRITHIONE | 1%W/V+2%W/V | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/5151 | SOLVAY PHARMACEUTICALS BV | HARLEYS UGANDA LIMITED | BETASERC | BETAHISTINE | 8MG | SOLVAY PHARMACEUTICALS -VEERWENG 12,8121AA,DIST. THE NETHERLANDS | NETHERLANDS | ORAL SOLID ORDINARY TABLETS | 4.0X25.0 TABLET BLISTER |
| NDA/MAL/HDP/5153 | SEARLE PAKISTAN LIMITED | HEALTHCARE LTD. | GRAVINATE TABLETS | DIMENHYDRINATE | 50MG | SEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5154 | BETA HEALTH CARE INTERNATIONAL LTD | BETA HEALTHCARE UGANDA LIMITED | BETASIL PAEDIATRIC SYRUP | IPECACUANHA TINCTURE | 0.5ML | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/5155 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | BETAVEL | MULTI-INGREDIENT | N/A | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/5156 | PHARMATHEN LTD | GOODMAN INTERNATIONAL LTD | IRIFONE GEL | ETOFENAMATE | 5%W/W | PHARMATHEN LTD.-6 DERVENAKION STR. 153 51 PALLINI-GREECE | GREECE | TOPICAL EXTERNAL OTHER GELS/SOLS | 1.0X50.0 G CONTAINER,1.0X100.0 G CONTAINER |
| NDA/MAL/HDP/5157 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | BETAVEL N | BETAMETHASONE+NEOMYCIN SULPHATE | 1MG+5MG | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X3.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/5158 | NIRMA LIMITED. | SUPER MEDIC LTD | KETANIR | KETAMINE | 50MG/ML | NIRMA LIMITED (HEALTHCARE DIVISION)-VILLAGE-SACHANA, TALUKA-VIRAMGAM
DISTRICT- AHMEDABAD 382 150, GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5161 | STRIDES ARCOLAB LIMITED | ROYAL PHARMA 2011 LIMITED | GRISEOSIM-500 | GRISEOFULVIN | 500MG | STRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5162 | VENUS REMIDIES LTD | AARON PHARMACEUTICALS LTD | IRINOL | IRINOTECAN HYDROCHLORIDE TRIHYDRATE | 20MG/ML | VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP | INDIA | PARENTERAL ORDINARY I V VIALS | 1.0X2.0 ML VIAL |
| NDA/MAL/HDP/5163 | ROTEX MEDICA GBH ARZNEIMITTELI | GITTOES PHARMACEUTICALS LIMITED | KETAMINE HYDROCHLORIDE INJECTION | KETAMINE HYDROCHLORIDE | 50MG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY VIALS | 10.0 ML VIAL |
| NDA/MAL/HDP/5164 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | BROMSAL EXPECTORANT | SALBUTAMOL SULPHATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL | 1MG+2MG+50MG+0.5MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5165 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | GRISEOFULVIN 500 TABLETS | GRISEOFULVIN | 500MG | REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/5166 | UMEDICA LABORATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | KETAMINE HYDROCHLORIDE | KETAMINE HYDROCHLORIDE | 50MG/ML | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5167 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | BRUSTAN TABLETS | IBUPROFEN + PARACETAMOL | 400MG + 300MG | SUN PHARMACEUTICALS IND. LTD-B-2,MADAKAI INDUSTRIAL ESTATE, PONDA,GOA-403404, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5169 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GVGYL SUPPOSITORY | METRONIDAZOLE BP | 500MG | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/5170 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | CANDITRAL CAPSULE | ITRACONAZOLE | 100MG | GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE STRIP |
| NDA/MAL/HDP/5171 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | KETAMAX-50 | KETAMINE | 50MG/ML | TROIKAA PHARMACUETICALS LIMITED-C-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5174 | BAYER AG | SURGIPHARM (U) LIMITED | CANESTEN CREAM | CLOTRIMAZOLE | 1%W/V | BAYER AG-D-51368 LEVERKUSEN GERMANY | GERMANY | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/5175 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | GYNO-DAKTARIN | MICONAZOLE NITRATE | 20MG/G | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | VAGINAL CREAMS | 1.0X40.0 G TUBE |
| NDA/MAL/HDP/5176 | BAYER AG | SURGIPHARM (U) LIMITED | CANESTEN | CLOTRIMAZOLE | 100MG | BAYER AG -D-51368 LEVERKUSEN GERMANY | GERMANY | VAGINAL TABLETS | 1.0X6.0 TABLET STRIP |
| NDA/MAL/HDP/5177 | YURIA PHARM LTD | YURIA PHARM EAST AFRICA LIMITED | ISONIAZID | ISONIAZID | 100MG/5ML | YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE | UKRAINE | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/5178 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | CARBOTEEN | CARBOPLATIN | 450 MG / 45 ML | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL |
| NDA/MAL/HDP/5179 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFIX 200MG CAPSULES | CEFIXIME TRIHYDRATE | 200MG | PHARMA INTERNATIONAL CO.,-AL-QASTAL AREA, AIRPORT ROAD, 11941, AMMAN | JORDAN | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X8.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5180 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | ISORYN DROPS ( PAEDRIATRIC) | EPHEDRINE HYDROCHLORIDE | 5MG/ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | NASAL TOPICAL DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/5181 | JASSEN-CILAG (PTY) LTD | LABOREX UGANDA LIMITED | GYNO-DAKTARIN OVULES | MICONAZOLE NITRATE | 400MG | JANSSEN PHARMACEUTICAL PTY LTD-15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | VAGINAL SUPPOSITORIES | 1.0X3.0 OVULE BLISTER |
| NDA/MAL/HDP/5182 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | ISORYN DROPS (ADULT) | EPHEDRINE HYDROCHLORIDE | 10MG/ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | NASAL TOPICAL DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/5183 | PHARCO B PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GYNOZOL VAGINAL CAPSULES | MICONAZOLE NITRATE | 400MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | VAGINAL SUPPOSITORIES | 1.0X3.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5184 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | GYNOZOL VAGINAL CREAM | MICONAZOLE NITRATE | 2%W/W | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | VAGINAL CREAMS | 1.0X40.0 G TUBE |
| NDA/MAL/HDP/5185 | CENTAUR PHARMACEUTICALS LTD | GITTOES PHARMACEUTICALS LIMITED | HB FORTE | MULTI INGREDIENT | N/A | CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/5186 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | ISOTROY 250 | ISOFLURANE | 250ML | TROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA | INDIA | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/5188 | AGOG PHARMA LTD. | GITTOES PHARMACEUTICALS LIMITED | ITRAZ CAPSULES | ITRACONAZOLE | 100MG | AGOG 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 CAPSULES | 1.0X3.0X5.0 CAPSULE BLISTER,1.0X6.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5189 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | HEMOZEBEX | FERROUS SULPHATE+FOLIC ACID+PYRIDOXINE HCL+CYANOCOBALAMIN+ZINC SULPHATE | 300MG+1000MCG+1.5MG+7.5MG+61.8MG | TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5190 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | HICLOR | CEFACLOR | 250MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X12.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5191 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYBETASONE EYE DROPS | BETAMETHASONE | 1MG/ML | IVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE,
LR NO.18474/84,
ATHI RIVER,KENYA
| KENYA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/5192 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYDEXGENT EYE/EAR DROPS | DEXAMETHASONE/GENTAMICIN | 0.1% & 0.3%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/5193 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYDEXNEOCIN EYE DROPS | DEXAMETHASONE/NEOMYCIN | 0.1% & 0.35%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/5194 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYDEXONE EYE DROPS | DEXAMETHASONE | 0.1%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC DROPS | 5.0 ML BOTTLE |
| NDA/MAL/HDP/5195 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYFRIN P NASAL DROPS | EPHEDRINE HYDROCHLORIDE | 0.5%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | NASAL TOPICAL DROPS | 1.0X15.0 ML BOTTLE,1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/5196 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYFRIN NASAL DROPS | EPHEDRINE HYDROCHLORIDE | 1%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | NASAL TOPICAL DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/5197 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYGENTACIN EYE/EAR DROP | GENTAMICIN SULPHATE | 0.3%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC DROPS | 5.0 ML BOTTLE,10.0 ML BOTTLE,7.5 ML BOTTLE |
| NDA/MAL/HDP/5198 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | HICLOR | CEFACLOR | 500MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X12.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5199 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | HYCORUM OINTMENT | HYDROCORTISONE | 1%W/W | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/5200 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | HYDRALAZINE TABLETS B.P 25MG. | HYDRALAZINE HYDROCHLORIDE | 25MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5201 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM BENDAZOLE | MEBENDAZOLE | 100MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5202 | CIPLA LIMITED | QUALITY CHEMICALS LTD - HUMAN | HYDROCORT INJECTION | HYDROCORTISONE SODIUM SUCCINATE | 100MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0 MG VIAL |
| NDA/MAL/HDP/5203 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM METRO | METRONIDAZOLE | 200MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/5204 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM METRO | METRONIDAZOLE BENZOATE | 200MG/5ML | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5205 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM-VENT | SALBUTAMOL | 4MG | KAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET JAR,1.0X500.0 TABLET JAR,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5206 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | DIGOXIN INJECTION BP | DIGOXIN | 0.25MG/ML | GLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150& | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/5207 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | DIGOXIN TABLETS | DIGOXIN | 0.25MG | NEM LABORATORIES PVT. LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),
THANE ? 401 210, MAHARASHTRA - INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5211 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | DINAC GEL | DICLOFENAC | 1%W/W | S KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/5214 | NIRMA LIMITED. | SUPER MEDIC LTD | NIRMET | METRONIDAZOLE | 500MG/100ML | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5215 | J.B CHEMICALS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | METROGYL TABLETS | METRONIDAZOLE | 200MG | J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5217 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELYDAC | MULTI-VITAMIN | MULTI-INGREDIENT | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE, 1.0X5.0 L JERRYCAN |
| NDA/MAL/HDP/5221 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG/3ML | NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/5222 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | EMTRICITABINE+TENOFOVIR DF | EMTRICITABINE + TENOFOVIR | 200MG + 300MG | MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13
MIDC, WALUJ INDUSTRIAL AREA,
AURANGABAD. ? 431136,
MAHARASHTRA STATE, INDIA.
,MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5224 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE | EMTRICITABINE + TENOFOVIR DISOPROXIL FUMERATE | 200MG + 300MG | AUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5226 | HETERO DRUGS LTD | ABACUS PHARMA (AFRICA) LIMITED | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE | EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE | 200MG + 300MG | HETERO DRUGS LTD-UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055,HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5228 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | DICLOGENTA | DICLOFENAC SODIUM+GENTAMICIN SULPHATE | 1MG/ML+3MG/ML | CENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/5231 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ENAPRIL 10 | ENALAPRIL MALEATE | 10MG | INTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY
MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA
,INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5232 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ENAPRIL-5 | ENALAPRIL MALEATE | 5MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5233 | CADILA PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | ENVAS 10 MG TABLETS | ENALAPRIL | 10MG | CADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA ? 387 810, AHMEDABAD, GUJARAT STATE
INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5234 | CADILA PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | ENVAS 5MG TABLETS | ENALAPRIL MALEATE | 5MG | CADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA ? 387 810, AHMEDABAD, GUJARAT STATE
INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5235 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | DICLORAN DELAYED-RELEASE TABLETS | DICLOFENAC SODIUM | 50MG | UNIQUE PHARMACEUTICALS LABORATORIES--SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ?PLOT NO. 215-219, 396 210 INDIA | INDIA | ORAL SOLID RETARD ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5236 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ETHIONAMIDE TABLETS USP | ETHIONAMIDE | 250MG | CIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/5237 | EUROLIFE HEALTHCARE PVT LIMITED | AIVEEN (U) LIMITED | EUROCIP | CIPROFLOXACIN | 200MG/100ML | EUROLIFE HEALTHCARE PVT LTD-BHAGWANPUR ROAD, UTTARAKHAND | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5242 | SHAIGAN PHARMACEUTICALS LTD | HEALTHCARE LTD. | ERGOMIN | METHYLERGOMETRINE MALEATE | 0.125MG | SHAIGAN PHARMACEUTICALS (PVT) LTD-14TH KM, ADYALA ROAD, RAWALPINDI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X150.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/5243 | IND SWIFT LTD | TATA UGANDA LIMITED | EZO 20 | ESOMEPRAZOLE MAGNESIUM | 20MG | IND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI | INDIA | ORAL SOLID RETARD TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5245 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | FABUTAS-40 | FEBUXOSTAT | 40MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5248 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM-AMPI | AMPICILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1000.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/5249 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | ENCIFER | IRON SUCROSE | 100MG/5ML | EMCURE PHARMACEUTICALS LTD -PLOT NO. P-1 ITBT PARK PHASE II MIDC HINJWADI PUNE 411057 | INDIA | PARENTERAL ORDINARY INFUSION AMPOULES | 1.0X5.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/5250 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FARCOLIN SYRUP | SALBUTAMOL + AMMONIUM CHLORIDE | 2MG/5ML +100MG/5ML | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/5251 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | DIFLUCAN | FLUCONAZOLE | 150MG | PFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE | FRANCE | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5252 | CIPLA LIMITED. | QUALITY CHEMICALS LTD - HUMAN | ENCLEX-40 | ENOXAPARIN SODIUM | 40MG/0.4ML | CIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X2.0X0.4 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/5253 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FARCOZOL SUSPENSION | BENZOYL METRONIDAZOLE | 200MG/5ML | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/5254 | PFIZER LABORATORIES LTD | LABOREX UGANDA LIMITED | FARMORUBICIN RD | EPIRUBICIN HYDROCHLORIDE | 10MG | PHARMACIA AND UPJOHN S.P.A.-EUROPE | EUROPE | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5255 | GLAXOSMITHKLINE LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | ENO LEMONFRUIT SALT | MULTI-INGREDIENT | MULTI-INGREDIENT | GLAXO SMITH KLINE LTD-LIKONI RD, INDUSTRIAL AREA,NAIROBI KENYA,GLAXOSMITHLINE-CAPE TOWN, S.A | SOUTH AFRICA | ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES | 1.0X8.0X4.5 G SACHET,1.0X10.0X4.5 G SACHET,1.0X48.0X4.5 G SACHET |
| NDA/MAL/HDP/5256 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIPROFOS INJECTION | BETAMETHASONE DISODIUM PHOSPHATE + BETAMETHASONE DIPROPIONATE | 2MG + 5MG/ML | MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA,SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG | BELGIUM | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/5258 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ERYMED ORAL SUSPENSION | ERYTHROMYCIN | 125 MG/5ML | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD (BWEYOGERERE) | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5259 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CARDINOL TABLET | ATENOLOL | 100MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X14.0 TABLET STRIP |
| NDA/MAL/HDP/5260 | KAMPALA PHARMACEUTICAL INDUSTRIES LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | ERYMYCIN | ERYTHROMYCIN ESTOLATE | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5263 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIPROSALIC OINTMENT | BETAMETHASONE + SALICYLIC ACID | 0.5 %W/W + 0.3 %W/W | SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG | BELGIUM | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 MG TUBE |
| NDA/MAL/HDP/5265 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIPROSONE OINTMENT | BETAMETHASONE DIPROPIONATE | 0.5%W/W | SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAM | BELGIUM | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G CONTAINER,1.0X10.0 G CONTAINER |
| NDA/MAL/HDP/5267 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | ERYTHROMYCIN STEARATE | ERYTHROMYCIN STEARATE | 250MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5268 | MISSION PHARMA A/S INDIA | JOINT MEDICAL STORE (UPMB - UCMB) | ERYTHROMYCIN STEARATE TABLETS | ERYTHROMYCIN | 100MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5269 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | DIVAA OD 500 | DIVALPROEX | 500MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5271 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | ERYTHYL SYRUP | ERYTHROMYCIN ETHYL SUCCINATE | 125MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5272 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | DIX | DIGOXIN | 0.25MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5274 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | ECOZOLE | ECONAZOLE | 150MG | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | VAGINAL TABLETS | 1.0X3.0 PESSARY STRIP |
| NDA/MAL/HDP/5275 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ | EFAVIRENZ | 200MG | AUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X90.0 CAPSULE CONTAINER,1.0X30.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/5276 | F.HOFFMANN-LA ROCHE LTD | LABOREX UGANDA LIMITED | DORMICUM INJECTION | MIDAZOLAM | 5MG/5ML | F. HOFFMAN LA ROCHE LTD-CH-4070 BASEL
GRENZACHERSTRASSE 124, 4058 BASEL | SWITZERLAND | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/5277 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | EFAVIRENZ | EFAVIRENZ | 600MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5278 | ROCHE | LABOREX UGANDA LIMITED | DORMICUM | MIDAZOLAM | 7.5MG | F. HOFFMAN LA ROCHE LTD-CH-4070 BASEL
GRENZACHERSTRASSE 124, 4058 BASEL | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5279 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DOSIN | DOXAZOCIN | 2MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5281 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXIL | EFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | 600MG +200MG + 300MG | AUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5282 | TRIVENI FORMULATIONS LIMITED | AIVEEN (U) LIMITED | DORFEN | ACECLOFENAC | 100MG | TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5283 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | IBUMEX GEL | IBUPROFEN | 5%W/W | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | TOPICAL EXTERNAL EMULSION GELS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/5284 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | EFAVIRENZ+EMTRICITABINE+TENOFOVIR | EFAVIRENZ + EMTRICITABINE + TENOFOVIR | 600MG + 200MG + 300MG | HETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5287 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE | 600MG + 300MG + 300MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5288 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | IBUMEX SUSPENSION | IBUPROFEN | 100MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 100.0 ML BOTTLE,60.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5290 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ELOCOM CREAM | MOMETASONE FUROATE | 0.1%W/W | SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30,B-2220 HEIST-OP-DEN-BERG,BELGIUM | BELGIUM | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/5291 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | IBUMEX TABLET | IBUPROFEN | 200MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/5292 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | DOMI 10 | DOMPERIDONE | 10MG | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5293 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ELOCOM LOTION | MOMETASONE FUROATE | 0.1%W/V | MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA | SOUTH AFRICA | TOPICAL EXTERNAL LOTIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/5294 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ELOCOM OINTMENT | MOMETASONE FUROATE | 0.1%W/W | SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30,B-2220 HEIST-OP-DEN-BERG,BELGIUM | BELGIUM | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/5295 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | DOXY | DOXYCYCLINE | 100MG | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X280.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5296 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | DOMAXIN-RD | DOXORUBICIN | 50MG | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 MG VIAL |
| NDA/MAL/HDP/5297 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELOGYL | METRONIDAZOLE | 200MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5298 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | ELOGYL | METRONIDAZOLE | 200MG/5ML | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5300 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DOLAC | KETOROLAC TROMETHAMINE | 30MG | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/5301 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | DULTAVAX | DIPHTERIA/ TETANUS/ AND (INACTIVATED) POLIOMYELITIS VACCINE (ADSORBED) | 2 IU/ 20IU/ POLIOMYELITIS (40DU/ 8DU/ 32DU) | SANOFI PASTEUR CAMPUS MERIEUX--1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE | FRANCE | PARENTERAL ORDINARY I V PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/5302 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | IBUGO-COMBI | IBUPROFEN + PARACETAMOL + CAFFEINE | 200MG + 325MG + 30MG | AGOG 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 CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5305 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | IBUGO | IBUPROFEN | 200MG | AGOG 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 TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5307 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | DUOTROL | GLIBENCLAMIDE + METFORMIN HYDROCHLORIDE | 5MG + 500MG | FREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5309 | MISSION PHARMA A/S INDIA | JOINT MEDICAL STORE (UPMB - UCMB) | DOXYCYCLINE CAPSULES BP | DOXYCYCLINE | 100MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/5311 | ABBOTT HEALTHCARE PRODUCTS B.V. | HARLEYS UGANDA LIMITED | DUPHASTON TABLETS | DYDROGESTERONE | 10MG | ABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLST | NETHERLANDS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/5312 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | DOXYCYCLINE | DOXYCYCLINE | 100MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER, 1.0X1000.0 CAPSULE CONTAINE |
| NDA/MAL/HDP/5316 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | DYNAPAR | DICLOFENAC SODIUM + PARACETAMOL | 50MG + 500MG | TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5317 | MACK BROWN | SHURIK LTD | DR MAC'S COUGH FROMULA | GUAIFENESIN+BROMHEXINE | 100MG + 8MG/5ML | TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5318 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | DYNAPAR AQ (1ML) | DICLOFENAC SODIUM | 75MG/ML | TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/5320 | LEBEN LABORATORIES PVT.LTD | ANDYCO PHARMACY (UGANDA) LTD | INDOL | INDOMETHACIN | 25MG | LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5321 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | IBUGESIC COLD & SINUS | IBUPROFEN/PSEUDOEPHEDRINE | 200MG/30MG | DAR AL DAWA-NA'UR PLANT AMMAN | JORDAN | ORAL SOLID ORDINARY GELATIN-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5323 | STEDMAN PHARMACEUTICALS LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ | IODINATED POVIDONE + METRONIDAZOLE | 1.0% W/V + 5.0% W/V | STEDMAN PHARMACEUTICALS PVT LTD...-C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML CONTAINER,1.0X30.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X500.0 ML CONTAINER |
| NDA/MAL/HDP/5324 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | IBUFIL 400 | IBUPROFEN | 400MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5326 | UNIQUE PHARMACEUTICAL LABORATORIES | TATA UGANDA LIMITED | ECODAX G CREAM | ECONAZOLE NITRATE + GENTAMYCIN + BECLAMETASONE | 1%+0.1%+0.025% | UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI ? 394 116, GUJARAT, INDIA.
| INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE,1.0X100.0 G TUBE |
| NDA/MAL/HDP/5327 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | IBUFIL 200 | IBUPROFEN | 200MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5328 | ASTRA PHARMA (UK) LTD | ASTRA PHARMA (U) LIMITED | INDOMETACIN 25MG CAPSULES BP | INDOMETHACIN | 25MG | ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5329 | ELYS CHEMICAL INDUSTRIES LTD | VELVET PHARMA LIMITED | IBUFEN TABLETS | IBUPROFEN | 200MG | ELYS CHEMICAL INDUSTRIES LTD-ROAD 'B' OFF ENTERPRISE ROAD, INDUSTRIAL AREA NAIROBI | KENYA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5330 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ-V | MICONAZOLE + METRONIDAZOLE | 2.0%W/W + 1.0%W/W | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/5333 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | IBUFEN | IBUPROFEN | 200MG | KPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0X10.0 TABLET BLISTER,500.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,250.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5334 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ETHAM-400 | ETHAMBUTOL | 400MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5336 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | AVAXIM 160U | INACTIVATED HEPATITIS A VACCINE ADSORBED | 160 ANTIGEN UNITS | SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE | FRANCE | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/5337 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | AVAXIM 80IU PAEDIATRIC | INACTIVATED HEPATITIS A VACCINE ADSORBED | 80 ANTIGEN UNITS | SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE | FRANCE | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/5338 | XEPA SOUL PATTISON (M) SDN BHD | DELMAW ENTERPRISES LIMITED | HYDROSIL TABLETS | ALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE+SIMETHICONE | 200MG+200MG+20MG | XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/5340 | SEARLE PAKISTAN LIMITED | HEALTHCARE LTD. | HYDRYLLIN SYRUP | DIPHENHYDRAMINE HCL + DEXTROMETHORPHAN HBR | 5MG + 6.25MG | SEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/5341 | LABORATORY&ALLIED LTD | HARLEYS UGANDA LIMITED | HYODOPA | METHYLDOPA | 250MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5342 | BELL SONS & CO.(DRUGGISTS) LTD | ECHO PHARMACY (U) LIMITED | BELL'S MUSCLE RUB | MULTI-INGREDIENT | N/A | BELL SONS & CO (DRUGGISTS) LTD-SLAIDBURN CRES
CHESHIRE HOUSE/GORSEY LA | UNITED KINGDOM | TOPICAL EXTERNAL OINTMENTS | 1.0X40.0 G TUBE |
| NDA/MAL/HDP/5343 | PHARCO PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CEFORAN 1GM | CEFOTAXIME SODIUM | 1GM | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/5344 | IDA FOUNDATION | KIMSY MEDS LTD | CEFTRIAXONE | CEFTRIAXONE | 1G | OKASA PHARMA PVT LTD-L-2, ADDITIONAL M.I.D.C. AREA, SATARA SATARA-415004, MAHARASHTRA, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0X1.0 G VIAL |
| NDA/MAL/HDP/5345 | VHB MEDI SCIENCES LTD | LLOYDS PHARMACY UGANDA LTD. | CEFTRIMAX | CEFTRIAXONE SODIUM + SULBACTAM | 1G + 0.5G | VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/5346 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFUTIL 500 | CEFUROXIME AXETIL | 500MG | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET CONTAINER |
| NDA/MAL/HDP/5347 | PHARMA INTERNATIONAL COMPANY | OMAB UGANDA LIMITED | CEFUTIL 250 | CEFUROXIME AXETIL | 250MG | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5348 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CELEPID 20 | INTRAVENOUS FAT EMULSION | 20%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/5349 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | CELESTAMINE TABLETS | BETAMETHASONE + DEXCHLORPHENIRAMINE | 0.25MG + 2MG | SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAM, MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA | BELGIUM | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/5350 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | CEPHADAR FORTE | CEPHALEXIN | 250MG/5ML | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5351 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | CEPHADAR | CEPHALEXIN MONOHYDRATE | 125MG/5ML | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5352 | GLENMARK PHARMACUTICALS LTD | STAR PHARMACEUTICALS LTD | MUMFER | IRON(111) POLYMALTOSE COMPLEX | 50MG/5ML | GLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE |
| NDA/MAL/HDP/5355 | H.HOFFMAN ROCHE | LABOREX UGANDA LIMITED | BONVIVA | IBANDRONIC ACID | 150MG | H. HOFFMAN ROCHE-GRENZACHERSTRASE 124, EXT 4070, BASEL SWITZERLAND & CH-4303 KAISERANGST SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/5356 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | BURNNEM | MULTI-INGREDIENT | N/A | NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/5357 | GLAXOSMITHKLINE LIMITED- | UNITED HEALTHCARE DISTRIBUTORS LTD | CA-C 1000 | CALCIUM CARBONATE+ASCORBIC ACID | 327MG+1000MG | NOVARTIS CONSUMER HEALTH-SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X10.0 TABLET CONTAINER |
| NDA/MAL/HDP/5358 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | CADISTIN EXPECTORANT | GUAIFENESIN+AMMONIUM CHLORIDE+CHLORPHENIRAMINE+SODIUM CITRATE | 80MG+100MG+2MG+44MG | SAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/5360 | CIPLA LIMITED | QUALITY CHEMICALS LTD - HUMAN | MOXICIP 400 | MOXIFLOXACIN | 400MG | CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/5361 | MACK BROWN PHARMECEUTICALS PVT LTD | SHURIK LTD | CALFIC | MULTI-INGREDIENT | N/A | TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5362 | ASTRA ZENECA | MACNAUGHTON LIMITED | CASODEX 150MG | BICALUTAMIDE | 150MG | ASTRAZENECA MACCLESFIELD-CHESHIRE | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 2.0X14.0 TABLET STRIP |
| NDA/MAL/HDP/5363 | ASTRA ZENECA | MACNAUGHTON LIMITED | CASODEX 50MG | BICALUTAMIDE | 50MG | ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,,BULK CORDEN PHARMA GMBH-OTT HAHN STRASSE ,68723
GERMANY | UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/5364 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | CATAFLAM 25MG TABLETS | DICLOFENAC POTASSIUM | 25MG | NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS--URUNLERI INSTABUL TURKEY | ITALY | ORAL SOLID ORDINARY COATED TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X20.0 TABLET CONTAINER |
| NDA/MAL/HDP/5365 | NORVATIS PHARMA AG | SURGIPHARM (U) LIMITED | CATAFLAM ORAL DROPS | DICLOFENAC POTASSIUM | 15MG/ML | NOVARTIS PHARMA SPA-RUE DE LA CHAPELLE, HUNIGUE | FRANCE | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/5366 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | CEFIM | CEFIXIME | 400MG | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0 CAPSULE STRIP |
| NDA/MAL/HDP/5367 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | CEFIM | CEFIXIME | 100MG/5ML | HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI | PAKISTAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/5368 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFIX 100MG/5ML DRY SUSPENSION | CEFIXIME | 100MG/5ML | PHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/5369 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LAMIVUDINE | LAMIVUDINE | 150MG | AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/5370 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | HYOSCINE BUTYLBROMIDE | HYOSCINE N-BUTYLBROMIDE | 10 MG | COSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET BLISTER |
| NDA/MAL/HDP/5371 | CIPLA LIMITED. | QUALITY CHEMICALS LTD - HUMAN | LAMIVUDINE | LAMIVUDINE | 10MG/ML | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5372 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | DUOMUNE | LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 300MG+300MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA,CIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TAL | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/5374 | CIPLA LIMITED. | QUALITY CHEMICALS LTD - HUMAN | LAMIVIR ORAL SOLUTION | LAMIVUDINE | 50MG/5ML | CIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE ?II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH,CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X240.0 ML BOTTLE |
| NDA/MAL/HDP/5376 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LAMIVUDINE & ZIDOVUDINE | LAMIVUDINE + ZIDOVUDINE | 150MG+300MG | AUROBINDOPHARMA LIMITED,-SURVEY NO. 313 & 314, BACHUPALLY VILLAGE,
QUTHUBULLAPUR MANDAL, HYDERABAD,
RANGA REDDY (DT),
ANDHRA PRADESH - 500090
INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/5377 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | BENYLIN FOUR FLU LIQUID | DIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE | 25MG/20ML + 1G/20ML + 45MG/20ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/5378 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | X-VITA | MULTIINGREDIENT | N/A | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X15.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5379 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ZOLANAS-30 | LANSOPRAZOLE | 30MG | AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5380 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CIROZEP | DIAZEPAM | 5MG/ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/5381 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | ADIFLAM GEL | DICLOFENAC DIETHYLAMINE | 1.16%W/W | LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA? 444 104 (MS).
| INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/5385 | NAPROD LIFE SCIENCES PVT LTD | AIVEEN (U) LIMITED | VINROS A-1 | VINCRISTINE SULPHATE | 1MG | NAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5386 | WIN-MEDICARE LTD | SURGIPHARM (U) LIMITED | UDIHEP TABLETS | URSODEOXYCHOLIC ACID | 150MG | WIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5387 | HILTON PHARMA (PVT) LTD | HEALTHCARE LTD. | TRANSAMIN INJECTION 250MG | TRANEXAMIC ACID | 250MG/5ML | HILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN. | PAKISTAN | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/5388 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | LARINATE | ARTESUNATE | 60MG | IPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5 ML SODIUM CHLORIDE INJECTION + 1*1 ML AMPOULE OF SODIUM BICARBONATE INJECTION |
| NDA/MAL/HDP/5389 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | LUMARTEM | ARTEMETHER + LUMEFANTRINE | 20MG + 120 MG | CIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER |
| NDA/MAL/HDP/5391 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | NITROFURANTOIN | NITROFURANTOIN | 100MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5392 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | AMLO-DENK 10 | AMLODIPINE MESILATE MONOHYDRATE | 10MG | DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5393 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | AMLO-DENK 5 | AMLODIPINE MESILATE MONOHYDRATE | 5MG | DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5394 | FOURTS(INDIA) LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | FINAZOL | ALBENDAZOLE | 400MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X500.0 TABLET CONTAINER, 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5395 | MICRO LABS LTD | LABOREX UGANDA LIMITED | OFLOX | OFLOXACIN | 200MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5397 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | IBICAR-100 | BECLOMETHASONE | 100MCG PER ACTUATION | GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
| INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/5400 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | ALBEN SUSPENSION | ALBENDAZOLE | 400MG/10ML | PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/5401 | PIRAMAL HEALTHCARE LTD | TATA UGANDA LIMITED | HALOTHANE | HALOTHANE | 250ML | PIRAMAL ENTERPRISES LTD --DIGWAL VILLAGE KOHIR MENDAL MEDAK DISTRICT,ANDHRA PRADESH | INDIA | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/5404 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | HIFENAC P | ACECLOFENAC + PARACETAMOL | 100 MG + 500 MG | INTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5405 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | OLANDUS 10 | OLANZAPINE | 10MG | CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA.
.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5406 | INTAS, PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | HIFENAC SR | ACECLOFENAC | 200 MG | INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5409 | LINCON PHARMCUETICALS LIMITED | METRO PHARMACEUTICALS LIMITED | MINTO GEL | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 150 MG + 150 MG + 25 MG | SAKAR 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 SUSPENSIONS | 1.0X180.0 ML BOTTLE |
| NDA/MAL/HDP/5410 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | UNICTAM 1500 | AMPICILLIN + SULBACTAM | 1000 MG + 500 MG | MEDICAL UNION PHARMACEUTICALS LTD - -ABU SULTAN, CR 13363 ISMAILLIA, EGYPT | EGYPT | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/5412 | UNIQUE PHARMACEUTICAL LABORATORIES | TATA UGANDA LIMITED | IFICIPRO 250 | CIPROFLOXACIN | 250MG | JB CHEMICALS AND PHARMACEUTICALS-128/1,CIIDC ANKLESHWER 393 002GUAZARAT INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5413 | PASTEUR MERIEUX CONNANGHT | LABOREX UGANDA LIMITED | EUVAX B (ADULT) | HEPATITIS B VACCINE | 1ML | PASTEUR MERIEUX CONNANGHT-SOUTH KOREA,LG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JE | SOUTH KOREA | PARENTERAL ORDINARY I M VIALS | 1.0X10.0 ML VIAL,1.0X1.0 ML VIAL |
| NDA/MAL/HDP/5414 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | XYLO-ACINO 0.1% | XYLOMETAZOLINE | 0.1 % W/V | MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN | GERMANY | NASAL TOPICAL DROPS | 1.0X1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/5415 | CENTAUR PHARMACEUTICALS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | SINAREST | OXYMETAZOLINE | 0.05%W/V | CENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA | INDIA | NASAL TOPICAL DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5416 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | CIPROX | CIPROFLOXACIN | 0.2%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5417 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CIPROPHARM | CIPROFLOXACIN | 500MG | PHARMA INTERNATIONAL COMPANY-MAIN STREET, AL QASTAL INDUSTRIAL AREA AMMAN- JORDAN JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5418 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | PAEDIATRIC CO-TRIMOXAZOLE | CO-TRIMOXAZOLE | 240MG/5ML | MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5419 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGO-CPM | CHLORPHENIRAMINE | 4MG | AGOG 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5422 | KOTRAPHARMA (M) SDN.BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | VAXCEL CEFUROXIME-750 | CEFUROXIME | 750MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/5423 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | EFAVIRENZ+LAMIVUDINE+TENOFOVIR | EFAVIRENZ+LAMIVUDINE+TENOFOVIR | 600MG + 300MG + 300MG | HETERO DRUGS LTD-UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055,HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/5425 | ROYAL GROUP | HARLEYS UGANDA LIMITED | PARACETAMOL | PARACETAMOL | 500MG | HEBEI (JIHENG GRP) PHARMACEUTICALS CO.LTD-INDIA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5426 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | CEPROLEN | CIPROFLOXACIN | 0.3%W/V | INDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722 | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/5427 | NIRMA LIMITED. | SUPER MEDIC LTD | NIRCIP | CIPROFLOXACIN | 200MG/100MG | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5428 | FOURRTS(INDIA) LABORATORIES PVT.LIMITED | DELMAW ENTERPRISES LIMITED | CIPFIL 500 | CIPROFLOXACIN | 500MG | FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,
TAMIL NADU,INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5429 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | CIPRO-500 | CIPROFLOXACIN | 500MG | AGOG 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 TABLETS | 1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON |
| NDA/MAL/HDP/5431 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | ZIDOVUDINE | ZIDOVUDINE | 300MG | AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/5432 | HETERO DRUGS LTD | ABACUS PHARMA (AFRICA) LIMITED | ZIDOVUDINE | ZIDOVUDINE | 300MG | HETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH , | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/5433 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA (U) LTD | COLDCAP NIGHT TIME | PARACETAMOL+CHLORPHENIRAMINE | 500MG+2MG | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X12.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5434 | MEDIPHARM (EA) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORALYTE CO-PACK | DT ZINC-20 + ORAL REHYDRATION SALTS (ORS) | 20G | MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA,AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | ORAL SOLID ORDINARY OTHER SPECIAL FORMS | 1.0X2.0X20.5 G SACHET + 1.0*10.0 TABLET BLISTER |
| NDA/MAL/HDP/5435 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | PIC | PARACETAMOL+IBUPROFEN+CAFFEINE | 500MG+200MG+30MG | AGOG 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 TABLETS | 1.0X25.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/5436 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | CEFICAD 1000 | CEFEPIME HCL | 1000MG | LA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1000.0 MG VIAL |
| NDA/MAL/HDP/5437 | MEDIPHARM (EA) LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORALYTE ORANGE | GLUCOSE + NACL + TRISODIUM CITRATE + KCL | 13.5G + 2.6G + 2.9G + 1.5G | MEDIPHARM INDUSTRIES (E.A) LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE | UGANDA | ORAL SOLID ORDINARY POWDERS | 1.0X20.8 G SACHET,1.0X10.4 G SACHET |
| NDA/MAL/HDP/5438 | ELDA INTERNATIONAL DMCC | REDDYS PHARMA LIMITED | TAMIN | PARACETAMOL | 10MG/ML | CLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE,1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML VIAL |
| NDA/MAL/HDP/5439 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENIRON SYRUP | VITAMIN B6 + FERROUS GLUCONATE + VITAMIN B1 + VITAMIN C + VITAMIN B2 | 2MG/5ML + 200MG/5ML + 2MG/5ML + 20MG/5ML + 2MG/5ML | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5441 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL NASATAB TABLETS | PARACETAMOL+CHLORPHENIRAMINE+PSEUDOEPHEDRINE | 500MG+4MG+60MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5442 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | CHLORAMPHENICOL OPHTHALMIC OINTMENT USP 1% | CHLORAMPHENICOL | 1%W/W | NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | OPHTHALMIC OINTMENTS | 1.0X20.0X3.5 G TUBE |
| NDA/MAL/HDP/5444 | MSD (PTY) LIMITED SA | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AERIUS TABLETS | DESLORATIDINE | 5MG | MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA,SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG | BELGIUM/SOUTH AFRICA | ORAL SOLID ORDINARY TABLETS | 5.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/5445 | ESKAYEF BANGLADESH LTD | MEDVIN PHARMA LIMITED | AZITHRAX 500 | AZITHROMYCIN DIHYDRATE | 500 MG | ESKAYEF BANGLADESH LTD--400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH
| BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X6.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/5448 | GENO PHARMACEUTICALS PVT LTD | HARLEYS UGANDA LIMITED | FLUNER-5 | FLUNARIZINE | 5MG | GENO PHARMACEUTICALS LTD--PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5449 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | CLOFENAC 50 | DICLOFENAC SODIUM | 50MG | HOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5453 | PHARCO PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FARCONCIL 250MG/5ML | AMOXICILLIN | 250MG/5ML | PHARCO 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/DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/5454 | LEBEN LABORATORIES PVT.LTD | ANDYCO PHARMACY (UGANDA) LTD | MOXILEB | AMOXICILLIN | 125MG/5ML | LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA? 444 104 (MS).
| INDIA | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5456 | PHARCO PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | FARCONCIL 125MG/5ML | AMOXICILLIN | 125MG/5ML | PHARCO 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/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/5457 | CIPLA LIMITED | QUALITY CHEMICALS LTD - HUMAN | FALCIMON 100/270 B/L | ARTESUNATE+AMODIAQUINE | 100MG+270MG | CIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/5458 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | FALCIMON 50/135 B/L | ARTESUNATE+AMODIAQUINE | 50MG+135MG | CIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/5460 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | ASAQ GPSC | ARTESUNATE+AMODIAQUINE | 50MG+135MG | GUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/5461 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | ARTESUNATE AMODIAQUINE | ARTESUNATE+AMODIAQUINE | 25MG+67.5MG | MAPHAR S.A. GROUP OF SANOFI,-KM 10, ROUTE COTIERE 111 QUARTIER, INDUSTRIEL ZENATA AIRI SEBAA, 00212522678099 - MOROCCO | MOROCCO | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X25.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/5462 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | ARTESUNATE AMODIAQUINE WINTHROP | ARTESUNATE+AMODIAQUINE | 50MG+135MG | MAPHAR S.A. GROUP OF SANOFI,-KM 10, ROUTE COTIERE 111 QUARTIER, INDUSTRIEL ZENATA AIRI SEBAA, 00212522678099 - MOROCCO | MOROCCO | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/5463 | SANOFI AVENTIS | LABOREX UGANDA LIMITED | ARTESUNATE AMODIAQUINE WINTHROP | ARTESUNATE+AMODIAQUINE | 100MG+270MG | MAPHAR S.A. GROUP OF SANOFI,-KM 10, ROUTE COTIERE 111 QUARTIER, INDUSTRIEL ZENATA AIRI SEBAA, 00212522678099 - MOROCCO | MOROCCO | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/5464 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | CO-METHER | ARTEMETHER + LUMEFANTRINE | 20MG + 120MG | AGOG 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 TABLETS | 1.0X3.0X4.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,2.0X6.0 TABLET BLISTER,4.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER |
| NDA/MAL/HDP/5467 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAMSIDAR | SULFADOXINE/PYRIMETHAMINE | 525MG | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5468 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIVAL TABLETS | SODIUM VALPROATE | 200MG | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X50.0 TABLET BOTTLE |
| NDA/MAL/HDP/5469 | BAYER PHARMA AG | SURGIPHARM (U) LIMITED | NIMOTOP | NIMODIPINE | 0.2MG/ML | BAYER PHARMA AG -51368 LEVERKUSEN GERMANY | GERMANY | PARENTERAL ORDINARY I V VIALS | 1.0X50.0 ML VIAL |
| NDA/MAL/HDP/5470 | ANKUR DRUGS AND PHARMA LTD | JOINT MEDICAL STORE (UPMB - UCMB) | VERIUN CP-325 | CEFIXIME + CLAVULANATE POTASSIUM | 200 MG + 125 MG | ANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) ? 174 101(INDIA)
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5471 | MICRO LABS LTD | LABOREX UGANDA LIMITED | AVAS 40 | ATORVASTATIN | 40MG | MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5472 | OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED | REDDYS PHARMA LIMITED | NS | SODIUM CHLORIDE | 0.9%W/V | OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE ? VASANA ? CHACHARWADIP, TAL: SANAND, AHMADABAD | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/5473 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | TROYPOFOL | PROPOFOL | 1%W/V | TROIKAA PHARMACEUTICALS LTD .-C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0 ML VIAL,1.0X20.0 ML VIAL |
| NDA/MAL/HDP/5474 | PHARMA INTERNATIONAL CO | OMAB UGANDA LIMITED | CEFODOX | CEFPODOXIME | 200MG | PHARMA INTERNATIONAL CO.-AMMAN JORDAN PLANT
AL-QARTAL MARKETING DEPARTMENT
ALBUJAH COMPLEX, ALJUBAIHA | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5475 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | VAXCEL CEFTAZIDIME | CEFTAZIDIME | 1G | KOTRA PHARMA (M) SDN.BHD,-1,2 & 3 JALAN TTC 12 CHENG INDUSTRIAL ESTATE 75250 MELAKA | MALAYSIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/5476 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | MESPORIN 1000MG I.V | CEFTRIAXONE | 1000MG | LABESFAL LABORATORIES-ALMIRO S.A ZONA INDUSTRIAL DO LAGEDO, 3465-157, SANTIAGO DE BESTERIROS PORTUGAL | PORTUGAL | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL + 10 ML WFI |
| NDA/MAL/HDP/5478 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | BECLATE-50 | BECLOMETHASONE DIPROPIONATE | 50MCG/ACTUATION | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/5479 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | RANFERON 12 CAPSULES | MULTI-INGREDIENT | MULTI-INGREDIENT | SUN PHARMACEUTICAL INDUSTRIES LIMITED,-INDUSTRIAL AREA NO.3, A.B.ROAD DEWAS,455001 MADHYA PRADESH INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE BLISTER |
| NDA/MAL/HDP/5480 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | BECLATE NASAL SPRAY | BECLOMETHASONE DIPROPIONATE | 50MCG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | NASAL TOPICAL METERED DOSE AEROSOLS | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/5482 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOLIN | SALBUTAMOL | 2MG/5ML | 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 SYRUPS | 1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/5483 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | ASAQ GPSC | ARTESUNATE + AMODIAQUINE | 25 MG + 67.5 MG | GUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/5485 | BEXIMCO PHARMACEUTICALS LIMITED | KIMSY MEDS LTD | AZMASOL HFA | SALBUTAMOL | 100MCG/ACTUATION | BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH | BANGLADESH | TOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/5486 | EMCURE PHARMACEUTICALS LTD | HARLEYS UGANDA LIMITED | FOSEAL 400 | SEVELAMER HCL | 400MG | EMCURE PHARMACEUTICALS LTD .-C-10(12) MIDC BHOSAN PUNE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5487 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | IBICAR-S | SALBUTAMOL + BECLOMETASONE | 100MCG/ACTUATION + 50MCG/ACTUATION | GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA
| INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/5489 | UNICHEM LABORATORIES LTD | EUROPA HEALTHCARE (U) LTD | CORBIS-5 | BISOPROLOL | 5MG | UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/5492 | STRIDES ARCOLAB LTD | DELMAW ENTERPRISES LIMITED | RIFAMPICIN + ISONIAZID | RIFAMPICIN + ISONIAZID | 150MG + 75MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/5494 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | ASMOX | AMOXYCILLIN | 250MG | ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/5495 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOCAL TABLETS | CALCIUM LACTATE | 300MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5496 | ASTRA ZENECA | MACNAUGHTON LIMITED | ATACAND 16MG | CANDESARTAN CILEXETIL | 16MG | ASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN) | SWEDEN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/5497 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | EXPEN | BENZYLPENICILLIN | 1MU | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X1.0 MU VIAL |
| NDA/MAL/HDP/5507 | GALENTIC PHARMA LTD | NORVIK ENTERPRISES LIMITED | CALADIN LOTION | CALAMINE | 15 %W/W | GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | TOPICAL EXTERNAL LOTIONS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/5525 | UMEDICA LABS PVT LTD | GITTOES PHARMACEUTICALS LIMITED | RILIF-SR | ACECLOFENAC | 200 MG | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5566 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | HYCORT OINTMENT | HYDROCORTISONE | 1%W/W | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X30.0 G TUBE |
| NDA/MAL/HDP/5575 | SK AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | HYOSCINE BUTYL BROMIDE | HYOSCINE BUTYL BROMIDE | 10MG | S.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5591 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | SWISSCILLIN | AMPICILLIN | 500MG | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/5596 | KWALITY AFRO ASIA LIMITED | KWALITY AFRO ASIA LIMITED | GERMILON | CHLORHEXIDINE GLUCONATE + CETRIMIDE | 0.3%W/V + 3%W/V | KWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROAD | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X1.0 L BOTTLE,1.0X5.0 L BOTTLE |
| NDA/MAL/HDP/5619 | CADILA PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | RABELOC 20 | RABEPRAZOLE SODIUM | 20MG | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/5634 | BAYER AG | SURGIPHARM (U) LIMITED | CIPROBAY | CIPROFLOXACIN | 500MG | BAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/5639 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | FEROMAX | IRON SUCROSE | 20MG/ML | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA, P.O.BOX:
997,
RAS AL KHAIMAH,
U.A.E.
| UNITED ARAB EMIRATES | PARENTERAL ORDINARY INFUSION AMPOULES | 1.0X5.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/5644 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | FORTIFIED PROCAINE PENICILLIN | FORTIFIED PROCAINE PENICILLIN | 4 MEGA UNITS | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA. | CHINA | PARENTERAL ORDINARY VIALS | 1.0X4.0 MU VIAL |
| NDA/MAL/HDP/5648 | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD | TATA UGANDA LIMITED | CLOXACILLIN SODIUM | CLOXACILLIN SODIUM | 500MG | KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL |
| NDA/MAL/HDP/5685 | JOHNSON&JOHNSON PTY LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VERMOX | MEBENDAZOLE | 20MG/5ML | SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE | SOUTH AFRICA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/6031 | NORVATIS PHARMA SERVICES INC. | SURGIPHARM (U) LIMITED | EXFORGE HCT 10MG + 160MG +25MG | GLIBENCLAMIDE,AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE | 5MG,10MG + 160MG +25MG | NORVATIS PHARMA STEIN-SCHAFFHAUSERSTRASSE 4332 STEIN | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6034 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LTD - WILLIAM STREET | AGOXIN -250 DT | AMOXICILLIN TRIHYDRATE | 250 MG | MILAN LABS PVT LTD-63-67 JAWAHAR CO.OP. INDUSTRIAL ESTATE KAMOTHE,NAVI MUMBAI | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6037 | GITTOES PHARMACEUTICALS LIMITED | GITTOES PHARMACEUTICALS LIMITED | AVIT | VITAMIN A | 200,000 IU | OLIVE HEALTHCARE-197/2, ATHIYAWAD DABHEL VILLAGE DAMAN 396210 (U.T) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X30.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 TABLET JAR |
| NDA/MAL/HDP/6038 | UMEDICA LABORATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | FIXDEP-180 | FEXOFENADINE HYDROCHLORIDE | 180MG | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6039 | GLENMARK PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | COMBIWAVE SF 250 | SALMETEROL XINAFOATE/FLUTICASONE PROPIONATE | 25MCG+250MCG/ACTUATION | GLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIA | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/6040 | BHARAT SERUMS AND VACCINES LIMITED, | GITTOES PHARMACEUTICALS LIMITED | U-TRYP | ULINASTATIN | 100,000 I.U | BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/6041 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | CANDIZOL | CLOTRIMAZOLE | 100MG | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | VAGINAL TABLETS | 1.0X6.0 PESSARY STRIP |
| NDA/MAL/HDP/6042 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | COMBIWAVE SF 125 | SALMETEROL XINAFOATE/ FLUTICASONE PROPIONATE | 25MCG+125MCG/ACTUATION | GLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIA | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/6043 | BHARAT SERUMS AND VACCINES LIMITED, | GITTOES PHARMACEUTICALS LIMITED | ZEMILAST | IMIPENEM + CILASTATIN | 500MG+500MG | ZEISS PHARMACEUTICALS PVT. LIMITED-PLOT NO. 72, EPIP I, JHARMAJIRI, BADDI (HP), INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/6044 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | COMBIWAVE SF 50 | SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE | 25MCG+50MCG/ACTUATION | GLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIA | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/6046 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ACYCLOVIR | ACYCLOVIR | 200MG | MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13
MIDC, WALUJ INDUSTRIAL AREA,
AURANGABAD. ? 431136,
MAHARASHTRA STATE, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6047 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | HERTRAZ 150 | TRASTUZUMAB (R-DNA ORIGIN) | 150MG | BIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD
BANGALORE-560 099
| INDIA | PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES | 1.0X150.0 MG VIAL ,1X10ML VIAL OF WFI |
| NDA/MAL/HDP/6048 | GLENMARK PHARMACEUTICAL LTD. | STAR PHARMACEUTICALS LTD | MOMATE AZ | MOMETASONE FUROATE / AZELASTINE HYDROCHLORIDE | 50MCG/140MCG | GLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA | INDIA | NASAL TOPICAL METERED DOSE AEROSOLS | 1.0X150.0 METERED DOSE BOTTLE |
| NDA/MAL/HDP/6050 | MICRO LABS LTD | LABOREX UGANDA LIMITED | ITACARE | ITRACONAZOLE | 100MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6051 | NOVARTIS PHARMA SERVICES | SURGIPHARM (U) LIMITED | EXFORGE HCT 10MG + 320MG + 25MG | AMLODIPINE BESYLATE + VALSARTAN + HYDROCHLOROTHIAZIDE | 10MG + 320MG + 25MG | NORVATIS PHARMA STEIN-SCHAFFHAUSERSTRASSE 4332 STEIN | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6052 | MICRO LABS LTD | LABOREX UGANDA LIMITED | MICROPIME | CEFEPIME HYDROCHLORIDE | 1G | MICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*10ML (WFI) LDPE VIAL |
| NDA/MAL/HDP/6053 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | GLIMEPIRIDE | GLIMEPIRIDE | 4MG | LEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATES | POLAND | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6054 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | GLIMEPIRIDE | GLIMEPIRIDE | 1MG | LEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATES | POLAND | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6055 | SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A | LABOREX UGANDA LIMITED | EURARTESIM | PIPERAQUINE TETRAPHOSPHATE + DIHYDROARTEMISININ | 160MG + 20MG | SIGMA- TAU I.F.R . S.P.A-VIA PONTINA KM 30,400 POMEZIA ROME | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/6056 | SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES. | SURGIPHARM (U) LIMITED | TELMISARTAN | TELMISARTAN | 20MG | SANDOZ GRUP SAGLIK URUNLERI .-ILACLARI SANAYI VE A.S GEBZE 2, GOSB IHSAN DEDE CAD. 900 SOK 41480 GEBZE KOCAELI | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/6057 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | CORAM 5MG | AMLODIPINE BESYLATE | 5MG | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6058 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | FENTANYL FRESENIUS | FENTANYL | 100MCG/2ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6059 | RESONANT PHARMACEUTICALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | NEUROZONE | MECOBALAMIN + PREGABALIN | 750MCG + 75MG | ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6060 | NOVARTIS ACCESS | SURGIPHARM (U) LIMITED | SALBUTAMOL | SALBUTAMOL | 100MCG | AEROPHARM GMBH...-RUDOLSTADT ALLEMAGNE | GERMANY | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X200.0 METERED DOSE CONTAINER |
| NDA/MAL/HDP/6061 | CIPLA LTD.. | QUALITY CHEMICALS LTD - HUMAN | NASEHALER | MOMETASONE FUROATE | 50MCG /SPRAY | CIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775 | INDIA | NASAL TOPICAL SPRAYS WITHOUT GAS | 1.0X140.0 METERED DOSE BOTTLE |
| NDA/MAL/HDP/6062 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | OFPRED | OFLOXACIN + PREDNISOLONE SODIUM PHOSPHATE | 0.3W/V + 0.5%W/V | AUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6063 | CLARIS LIFESCIENCE LTD | REDDYS PHARMA LIMITED | ANSED | FLUMAZENIL | 0.1MG/ML | CLARIS LIFE SCIENCES LTD-CHACHARWADI-VASANA,SANAND, AHMEDABAD GUJARAT-382213 INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X5.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/6064 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | JOCET 10 | CETIRIZINE DIHYDROCHLORIDE | 10MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6065 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | PROXYREN | PIROXICAM | 20MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6066 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | DREZ | IODINATED- POVIDONE | 10%W/V | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6067 | RENE PHARMACY(R) LTD.. | RENE PHARMACY LTD | DIAZEPAM | DIAZEPAM | 5MG | NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6068 | EXIR PHARMACEUTICAL COMPANY | UNEED GLOBAL GROUP LIMITED | ZIMEXIR 250 | AZITHROMYCIN DIHYDRATE | 250MG | EXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRAN | IRAN | ORAL SOLID ORDINARY CAPSULES | 1.0X5.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6069 | EXIR PHARMACEUTICAL COMPANY | UNEED GLOBAL GROUP LIMITED | ZIMEXIR 200MG | AZITHROMYCIN DIHYDRATE | 200MG/5ML | EXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRAN | IRAN | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/6070 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | VAZKOR | AMLODIPINE BESILATE | 10MG | DEVA-CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH ATATURK CAD.,NO.: 32 KAPAKLI | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6071 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | VAZKOR | AMLODIPINE BESILATE | 5MG | DEVA-CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH ATATURK CAD.,NO.: 32 KAPAKLI | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6072 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6073 | EVA PHARMA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MILGA | BENFOTIAMINE + PYRIDOXINE + CYANOCOBALAMIN | 40MG + 60MG + 20MCG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6074 | MARCYRL PHARMACEUTICAL INDUSTRIES | SHREEJI PHARMACEUTICALS LIMITED | CARDILOL CS | CARVEDILOL | 25MG | MARCYRL PHARMACEUTICAL INDUSTRIES -WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITY | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6075 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OLOHISTINE | OLOPATADINE HYDROCHLORIDE | 1MG/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6076 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | FALCI CARE | ARTESUNATE | 30MG | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X30.0 MG VIAL + 1*5 ML OF 0.9%W/V NACL AMPOULE + 1*1 ML OF 5%W/V NAHCO3 AMPOULE |
| NDA/MAL/HDP/6078 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TIMOLOL MALEATE | TIMOLOL MALEATE | 5MG/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6079 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | ALLERGEX | CHLORPHENIRAMINE MALEATE | 4MG | ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6080 | EXPHAR SA | SURGIPHARM (U) LIMITED | FEBRILEX JUNIOR | PARACETAMOL+CHLORPHENIRAMINE MALEATE | 125MG+1MG/5ML | GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE |
| NDA/MAL/HDP/6081 | EXPHAR SA | SURGIPHARM (U) LIMITED | ANTALGEX T | PARACETAMOL + TRAMADOL HYDROCHLORIDE | 325MG + 37.5MG | GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6082 | EXPHAR SA | SURGIPHARM (U) LIMITED | CROMSOL | SODIUM CROMOGLYCATE | 2%W/V | AHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)
TEL: +91-1493-305300 (30 LINES)
FAX: +91-1493-221045, 305345
| INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6086 | UNOSOURCE PHARMA LTD | ESCORTS PHARMACEUTICALS LIMITED | ACEWEL-P | ACECLOFENAC+PARACETAMOL | 100MG+500MG | AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6090 | UNOSOURCE PHARMA LTD | ESCORTS PHARMACEUTICALS LIMITED | PROSTAR 200 | PROGESTERONE | 100MG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6092 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV 1000 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 875 MG + 125 MG | SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6093 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV 625 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 500 MG + 125 MG | SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6094 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPOTCLAV 375 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 250 MG + 125 MG | SPARSH BIO-TECH PVT. LTD-PLOT NO. 1; SURVEY NO. 242/243/244,
LAKHABAVAD, JAMNAGAR-361 006, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6095 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | DIPGEN | BETAMETHASONE DIPROPIONATE + GENTAMICIN SULFATE | 0.64 MG/G + 1 MG/G | S KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/6099 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | HARIPIL-60 | ARTESUNATE | 60MG | PSYCHOTROPICS INDIA LTD -PLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5 ML OF 0.9% W/V NACL GLASS AMPOULE + 1*1 ML OF 5%W/V NAHCO3 GLASS AMPOULE |
| NDA/MAL/HDP/6102 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS 80 | TELMISARTAN | 80MG | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6103 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | OZACE MD 5 | OLANZAPINE | 5MG | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6104 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | FUROSEMIDE | FUROSEMIDE | 10MG/ML | PSYCHOTROPICS INDIA LTD -PLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA | INDIA | PARENTERAL ORDINARY I V AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6105 | PSYCHTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | AZOPIL 200 | AZITHROMYCIN | 200MG/5ML | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/6106 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | TREVOX 500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | SQUARE PHARMACEUTICALS LTD-KALIAKOIR | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6107 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | SULPREX | IPRATROPIUM BROMIDE+SALBUTAMOL SULPHATE | 500MCG/2.5ML+2.5MG/2.5ML | SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X10.0 AMPOULE CARTON |
| NDA/MAL/HDP/6108 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | TREVOX 750 | LEVOFLOXACIN HEMIHYDRATE | 750MG | SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6109 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | MEXLO | LOMEFLOXACIN HYDROCHLORIDE | 0.3%W/V | SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6110 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | AMBROX | AMBROXOL HYDROCHLORIDE | 15MG/5ML | SQUARE PHARMACEUTICAL LIMITED (PABNA UNIT)-SQUARE ROAD, SALGARIA PABNA-6600 BANGLADESH | BANGLADESH | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6111 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | MOTIFAST | DOMPERIDONE | 10MG | SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6112 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | SULTOLIN | SALBUTAMOL SULPHATE | 2.5MG/2.5ML | SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | LUNG ADMINISTRATION LIQUID FOR INHALATION | 1.0X10.0X2.5 ML AMPOULE |
| NDA/MAL/HDP/6114 | FDC LTD | AIVEEN (U) LIMITED | ZOXAN | CIPROFLOXACIN | 0.3% W/V | FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6116 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | ZOLEDRO-DENK 4MG/5ML | ZOLEDRONIC ACID | 4MG/5ML | HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELN | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/6117 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | GRAN-DENK | GRANISETRON HYDROCHLORIDE | 1MG/ML | HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELN | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/6118 | LEBEN LABORATORIES PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | L-TRIM DS | SULPHAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA? 444 104 (MS).
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6119 | NATIONAL HEALTHCARE | ANDYCO PHARMACY (UGANDA) LTD | SUPER CV | AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE | 1 G + 0.2 G | NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA | NEPAL | PARENTERAL ORDINARY VIALS | 1.0X10.0X1.2 G VIAL |
| NDA/MAL/HDP/6120 | NATIONAL HEALTHCARE PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | KMINE | KETAMINE HYDROCHLORIDE | 50MG/ML | NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA NEPAL | NEPAL | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/6121 | ?LKO ?LA? SANAYI VE TICARET A. ?. | CORE ACCESS LTD | DEXIREN | DEXKETOPROFEN TROMETAMOL | 25MG | ?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1
SEL?UKLU / KONYA | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6122 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ROCUTROY | ROCURONIUM BROMIDE | 10MG | TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/6123 | OCTOBER PHARMA | ABACUS PHARMA (AFRICA) LIMITED | MONOMAK | ISOSORBIDE NITRATE | 20MG | OCTOBER PHARMA-1ST INDUSTRIAL ZONE STREET 25 PLOT 190 6TH OCTOBER CITY CAIRO | EGYPT | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6124 | CLARIS LIFE SCIENCES LTD | REDDYS PHARMA LIMITED | SPIVA | PROPOFOL | 1%W/V | CLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/6126 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | DERMOTRACIN | NEOMYCIN SULPHATE + BACITRACIN | 165,000 IU + 12,500 IU | MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT | EGYPT | TOPICAL EXTERNAL PRESSURISED AEROSOLS | 1.0X150.0 ML CANNISTER |
| NDA/MAL/HDP/6127 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | INTELENCE | ETRAVIRINE | 25MG | JANSSEN-CILAG S.P.A.-VIA C. JANSSEN BORGO S. MICHELE 04100 LATINA | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET BOTTLE |
| NDA/MAL/HDP/6128 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYFLUR | FLURBIPROFEN SODIUM | 0.03%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6129 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | TRIUMEQ | DOLUTEGRAVIR + ABACAVIR + LAMIVUDINE | 50MG + 600MG + 300MG | GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)-PRIORY STREET, WARE
HERTFORDSHIRE SG12 0DJ, UK
| UNITED KINGDOM | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/6130 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | IVYSINE EYE DROPS | TETRAHYDROZOLINE HYDROCHLORIDE | 0.05%W/V | IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA | KENYA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/6131 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | FERRACIN | IRON (III) HYDROXIDE SUCROSE COMPLEX | 20MG/ML | RAFARM S.A-AGIO LOUKA STR PEANIA ATTIKI | GREECE | PARENTERAL ORDINARY I V AMPOULES | 1.0X5.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/6132 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | KETOVID | KETOCONAZOLE | 2%W/W | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/6133 | UMEDICA LABORATORIES PVT LTD | GITTOES PHARMACEUTICALS LIMITED | RILIF-100 | ACECLOFENAC | 100MG | UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6134 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ZAMADOL P | TRAMADOL HYDROCHLORIDE+ACETAMINOPHEN | 37.5MG+325MG | MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA
TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101
INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6135 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TRIXONE-S | CEFTRIAXONE SODIUM+SULBACTAM | 1000MG+500MG | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X20.0 ML VIAL |
| NDA/MAL/HDP/6137 | BHARAT SERUMS AND VACCINES LTD | GITTOES PHARMACEUTICALS LIMITED | LUPRODEX | LEUPROLIDE ACETATE | 3.75MG | BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (EAST), INDIA
| INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X1.0 ML VIAL + 1*2ML GLASS AMPOULE OF DILUENT (EACH ML CONTAINS 50MG OF D-MANNITOL AND WFI TO Q.S) + 1 DISPOSABLE SYRINGE, 2 NEEDLES AND 2 ALCOHOL SWABS |
| NDA/MAL/HDP/6139 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | SERVIN CAPSULE | FERROUS SULPHATE+FOLIC ACID+THIAMINE MONONITRATE+RIBOFLAVIN+PYRIDOXINE HYDROCHLORIDE+NICOTINAMIDE+ASCORBIC ACID | 150MG+0.5MG+2MG+2MG+1MG+10MG+50MG | SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6140 | CLARIS OTSUKA LIMITED | REDDYS PHARMA LIMITED | KIDROLYTE | SODIUM ACETATE + DIBASIC POTASSIUM PHOSPHATE + MAGNESSIUM CHLORIDE + DEXTROSE MONONOHYDRATE + POTASSIUM CHLORIDE | (0.32G + 0.026G + 0.031G + 5.50G + 0.13G)/100ML | CLARIS OTSUKA LIMITED .-VILLAGE VASANA CHACHARWADI TAL:SANAD DIST -AHMEDABAD 382 213 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/6141 | UNOSOURCE PHARMA LTD | ESCORTS PHARMACEUTICALS LIMITED | ACEWEL | ACECLOFENAC | 100MG | AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6142 | AGOG PHARMA LIMITED | GITTOES PHARMACEUTICALS LIMITED | AGOCARB | ACTIVATED CHARCOAL | 0.25MG | AGOG 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 TABLETS | 1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6143 | MARCYRL PHARMACEUTICAL INDUSTRIES | SHREEJI PHARMACEUTICALS LIMITED | CONTRACTUBEX | EXTRACT CEPAE FLUID +HEPARIN SODIUM+ALLANTOIN | 10G+5000 I.U+1G/100G | MARCYRL PHARMACEUTICAL INDUSTRIES.-EL OBOUR CITY CAIRO | EGYPT | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/6144 | NATIONAL HEALTHCARE | ANDYCO PHARMACY (UGANDA) LTD | NIKO | PARACETAMOL | 500MG | NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA | NEPAL | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6145 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | ENDULIN SELECT | INSULIN GLARGINE(R-DNA ORGIN) | 100I.U/ML | BIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA
| INDIA | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X3.0 ML PREFILLED PEN |
| NDA/MAL/HDP/6147 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | ENDULIN VAIL | INSULIN GLARGINE (R-DNA ORIGIN) | 100I.U/ML | BIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA
| INDIA | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/6150 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | SERVIFLOX 500MG | CIPROFLOXACIN | 500MG | SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6151 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | NITCAINE | LIDOCAINE | 2%W/V | NITIN LIFESCIENCES LTD..-RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0X30.0 ML VIAL |
| NDA/MAL/HDP/6152 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | CARVEDILOL SANDOZ 12.5MG | CARVEDILOL | 12.5MG | SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6153 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | CARVEDILOL SANDOZ 25MG | CARVEDILOL | 25MG | SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6154 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | EXFORGE 5MG/320MG | AMLODIPINE + VALSARTAN | 5 MG + 320 MG | NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6158 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | DESEFIN | CEFTRIAXONE SODIUM | 1G | DEVA LIAC SAN. VE TIC. A.S. -ORGANISE SANAYI BOLGESI ATATURK MAH. ATATURK CAD. NO: 32 KARAAGAC CERKEZKOY | TURKEY | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/6159 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | AMLODIPINE | AMLODIPINE | 10MG | LEK PHARMACEUTICALS .D.D -VEROVSKOVA 57, 1526 LJUBLJANA
SLOVENIA
| SLOVENIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6164 | SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES. | SURGIPHARM (U) LIMITED | NEXMEZOLE | ESOMEPRAZOLE | 40MG | SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BOTTLE |
| NDA/MAL/HDP/6165 | UNOSOURCE PHARMA LTD. | ESCORTS PHARMACEUTICALS LIMITED | CEFTRISONE - 1000 | CEFTRIAXONE SODIUM | 1G/VIAL | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/6166 | NATIONAL HEALTHCARE | ANDYCO PHARMACY (UGANDA) LTD | GMICIN | GENTAMICIN SULPHATE | 0.3%W/V | NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA | NEPAL | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/6167 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | AKUROSE | IRON SUCROSE | 20MG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
| INDIA | PARENTERAL ORDINARY INFUSION AMPOULES | 1.0X5.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/6168 | KWALITY AFRO ASIA LIMITED | KWALITY AFRO ASIA LIMITED | K-HEM | FERROUS GLUCONATE + THIAMINE MONONITRATE + RIBOFLAVIN + PYRIDOXINE HCL + NIACINAMIDE + VITAMIN B12 | 300MG + 5MG + 5MG + 1.5MG +45MG + 15MCG | KWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROAD | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/6169 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | INTELENCE | ETRAVIRINE | 100MG | JANSSEN-CILAG S.P.A.-VIA C. JANSSEN BORGO S. MICHELE 04100 LATINA | ITALY | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET BOTTLE |
| NDA/MAL/HDP/6170 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ALACOT 0.1% EYE DROPS | OLOPATADINE HYDROCHLORIDE | 0.1%W/V | SQUARE PHARMACEUTICALS LTD-KALIAKOIR | BANGLADESH | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6171 | ROTEXMEDICA GMBH ARZNEIMITTELWERK | GITTOES PHARMACEUTICALS LIMITED | SUXAMETHONIUM CHLORIDE | SUXAMETHONIUM CHLORIDE | 50MG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY DRY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6172 | ROTEXMEDICA GMBH ARZNEIMITTELWERK | GITTOES PHARMACEUTICALS LIMITED | PHYTOMENADIONE | PHYTOMENADIONE | 10MG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6173 | CIPLA LTD.. | QUALITY CHEMICALS LTD - HUMAN | MONTAIR 5 | MONTELUKAST SODIUM | 5MG | CIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722 | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6174 | ROTEXMEDICA GMBH ARZNEIMITTELWERK | GITTOES PHARMACEUTICALS LIMITED | FLUPHENAZINE DECANOATE INJECTION USP 25MG/ML | FLUPHENAZINE DECANOATE | 25MG/ML | ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU | GERMANY | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6175 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | SERVIFLOX 250 | CIPROFLOXACIN | 250MG | SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6176 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | G-GLUTAMIN PLUS | VITAMIN B1 +B6+B12 WITH L-GLUTAMIC ACID | 100MG+50MG+100MCG+50MG | BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6179 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | ON.SETRON-DENK 4MG ODT | ONDANSENTRON | 4MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/6181 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | AZINOWEL-500 | AZITHROMYCIN | 500MG | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/6182 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | ALARID | KETOTIFEN FUMARATE | 0.025%W/V | SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6183 | CIPLA LTD.. | QUALITY CHEMICALS LTD - HUMAN | PRAZIQUANTEL TABLETS | PRAZIQUANTEL | 600MG | CIPLA LTD .-352 KUNDAIM INDL. ESTATE KUNDAIM GOA 403 115 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X100.0 TABLET BOTTLE,1.0X500.0 TABLET BOTTLE |
| NDA/MAL/HDP/6184 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ATOXIA 60MG | ETORICOXIB | 60MG | UNITED 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 TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6185 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | DOLOFORTE DENK | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6186 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ATOXIA 90MG F.C. TABLETS | ETORICOXIB | 90MG | UNITED 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 TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6188 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD | KIMSY MEDS LTD | GIZLAN 150 | IRBESARTAN | 150MG | DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6189 | UNEED GLOBAL GROUP LIMITED | ABACUS PHARMA (AFRICA) LIMITED | WORMEE-4 | ALBENDAZOLE | 400MG | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/6190 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | D-LYTE | ANHYDROUS GLUCOSE,SODIUM CHLORIDE,TRISODIUM CITRATE DIHYDRATE,POTASSIUM CHLORIDE | 2.7G + 0.52G + 0.58G + 0.30G/ 200ML | 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 POWDERS | 1.0X500.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X200.0 ML SACHET |
| NDA/MAL/HDP/6191 | AMOUN PHARMACEUTICALS COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | KAPRON AMPOULE | TRANEXAMIC ACID | 500MG/5ML | AMOUN 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 | PARENTERAL ORDINARY AMPOULES | 1.0X6.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/6192 | GLAXOSMITHKLINE LIMITED | UNITED HEALTHCARE DISTRIBUTORS LTD | ENO FRUIT SALT ORANGE | SODIUM BICARBONATE + CITRIC ACID | 55.80%W/W + 43.20 %W/W | GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBI | KENYA | ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES | 1.0X10.0X5.0 G SACHET,1.0X48.0X5.0 G SACHET |
| NDA/MAL/HDP/6193 | SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES. | SURGIPHARM (U) LIMITED | CEFTRIAXONE SANDOZ | CEFTRIAXONE SODIUM | 1G | SANDOZ GMBH-BIOCHEMIESTRA?E 10 A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/6194 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | FENTANYL FRESENIUS | FENTANYL CITRATE | 500MCG/10ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/6195 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | MORPHINE SULPHATE FRESENIUS | MORPHINE SULPHATE | 10MG/ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6196 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | MORPHINE SULPHATE FRESENIUS | MORPHINE SULPHATE | 15MG/ML | FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6197 | UNEED GLOBAL GROUP LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NYSTATIN | NYSTATIN | 100,000 IU | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | VAGINAL TABLETS | 1.0X14.0 PESSARY STRIP |
| NDA/MAL/HDP/6201 | SPARSH BIO-TECH PVT. LTD | ABACUS PHARMA (AFRICA) LIMITED | AMOXICILLIN AND FLUCLOXACILLIN CAPSULES 500MG | AMOXICILLIN TRIHYDRATE + FLUCLOXACILLIN SODIUM | 250MG + 250MG | SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/6202 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | SALPRAZ 20 | PANTOPRAZOLE SODIUM | 20MG | AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6203 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DEROX-5 | AMLODIPINE BESILATE | 5MG | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6205 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ACICLOVIR | ACICLOVIR | 400MG | MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13
MIDC, WALUJ INDUSTRIAL AREA,
AURANGABAD. ? 431136,
MAHARASHTRA STATE, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6207 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | GO!GEL | DICLOFENAC DIETHYLAMINE+METHYL SALICYLATE | 1.16%W/W + 10%W/W | S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/6208 | WOCKHARDT LTD | STAR PHARMACEUTICALS LTD | WOCKLAV | AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE | 200MG/5ML+28.5MG/5ML | MEDOPHARM PVT LTD-50, KAYARAMBEDU VILLAGE, GUDUVANANCHERRY - 603202,
TAMIL NADU,
| INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6209 | UNOSOURCE PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | RESPIWEL 4 | RISPERIDONE | 4MG | AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6211 | EXPHAR SA | SURGIPHARM (U) LIMITED | CLOFAINS | PARACETAMOL/DICLOFENAC SODIUM | 500MG/50MG | MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6213 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOXIN 250 DT | AMOXICILLIN TRIHYDRATE | 250MG | AGOG 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 SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6214 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | VIXIB | DEXTROMETHORPHAN HYDROBROMIDE | 33.33%W/W | UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210 | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X12.0 LOZENGE BLISTER |
| NDA/MAL/HDP/6215 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | NEORAL 25 | CYCLOSPORIN | 25MG | R P SCHERER GMBH & CO. EBERBACH BALEN-R P SCHERER GMBH & CO. EBERBACH BALEN | GERMANY | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6216 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | NEORAL 100 | CYCLOSPORIN | 100MG | R P SCHERER GMBH & CO. EBERBACH BALEN-R P SCHERER GMBH & CO. EBERBACH BALEN | GERMANY | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X5.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6218 | ASTRA ZENECA | MACNAUGHTON LIMITED | FORXIGA | DAPAGLIFLOZIN | 10MG | BRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620
USA | UNITED STATES | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/6220 | NEM LABORATORIES PRIVATE LIMITED | RENE PHARMACY LTD | METHYLDOPA | METHYLDOPA | 250MG | NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6222 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | METOCLOPRAMIDE HYDROCLORIDE | METOCLOPRAMIDE HYDROCLORIDE | 5MG/ML | NITIN LIFESCIENCES LTD..-RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6223 | AUROLAB | SWASTIK PHARMACEUTICAL LTD | AUROPROST- RT | LATANOPROST | 0.005%W/V | AUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA | INDIA | OPHTHALMIC DROPS | 1.0X2.5 ML BOTTLE |
| NDA/MAL/HDP/6224 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | NICLOFEN | DICLOFENAC SODIUM | 75MG/3ML | NITIN LIFESCIENCES LTD--RAMPUR ROAD PAONTA SAHIB DIST. SIRMOUR (H.P) 173 025 | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X10.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6226 | IDA FOUNDATION | KIMSY MEDS LTD | AMOXICILLIN 500+ CLAVULANIC ACID 125MG BP | AMOXICILLIN + CLAVULANIC ACID | 500MG+125MG | MICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6227 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ISONIAZID | ISONIAZID | 300MG | MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13
MIDC, WALUJ INDUSTRIAL AREA,
AURANGABAD. ? 431136,
MAHARASHTRA STATE, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/6228 | CACHET PHAMACUITICALS PVT LTD | ASTRA PHARMA (U) LIMITED | ACINET | AMOXICILLIN + POTASSIUM CLAVULANATE | 500 MG + 125 MG | ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6229 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | CO-FLUAMPICIL CAPSULES BP 500MG | FLUCLOXACILLIN SODIUM + AMPICILLIN TRIHYDRATE | 250MG +250MG | SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/6230 | CACHET PHAMACUITICALS PVT LTD | ASTRA PHARMA (U) LIMITED | EMITINO | ONDANSENTRON | 4MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6231 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | D-ARTEPP DISPERSIBLE | DIHYDROARTEMISININ/PIPERAQUINE | 20MG/160MG | GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/6233 | NORVATIS PHARMA SERVICES INC. | SURGIPHARM (U) LIMITED | CURAM 250MG/5ML | AMOXICILLIN + CLAVULANATE | 250MG + 62.5MG /5ML | SANDOZ GMBH-BIOCHEMIESTRA?E 10 A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA | ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES | 1.0X60.0 ML VIA |
| NDA/MAL/HDP/6234 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | D-ARTEPP | DIHYDROARTEMESININE/ PIPERAQUINE PHOSPHATE | 40MG/320MG | GUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI | CHINA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X2.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/6235 | UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED | UNITED HEALTHCARE DISTRIBUTORS LTD | ANGINET 160MG | VALSARTAN | 160MG | UNITED 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 TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6236 | MOONLINK PHARMACEUTICALS LTD | PLANET PHARMACEUTICALS UGANDA LTD | FREMOL ADVANCE | PARACETAMOL + IBUPROFEN + CAFFEINE | 325 MG + 400 MG + 40 MG | FREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X40.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6237 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | LOPINAVIR/RITONAVIR | LOPINAVIR/ RITONAVIR | 100MG/25MG | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X120.0 TABLET BOTTLE |
| NDA/MAL/HDP/6238 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG -AM | NEBIVOLOL HYDROCHLORIDE + AMLODIPINE BESILATE | 5MG + 5MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6239 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GSUNATE | ARTESUNATE | 60MG | BLISS GVS PHARMA LTD- PLOT 73 -76 SILVER INDUSTRIAL ESTATE BHIMPORE DAMAN 396 210 (UT) | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*5 ML AMPOULE OF 0.9%W/V NACL + 1*1 ML OF 5%W/V SODIUM BICARBONATE |
| NDA/MAL/HDP/6242 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | D-ARTEPP | DIHYDROARTEMESININ/PIPERAQUINE PHOSPHATE | 80MG/640MG | GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/6243 | ABBVIE (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | SURVANTA | BERACTANT | 100MG/4ML | ABBVIE NORTH CHICAGO FACILITY-1401 SHERDAN ROAD NORTH CHICAGO FACILITY ILLINOIS 60064 -4000 | UNITED STATES | TOPICAL EXTERNAL INSTILLATION VIALS | 1.0X4.0 ML VIAL,1.0X8.0 ML VIAL |
| NDA/MAL/HDP/6244 | CACHET PHAMACUITICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CABALIN | PREGABALIN | 75MG | CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X12.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6245 | BIOLOGICAL E. LTD | ABACUS PHARMA (AFRICA) LIMITED | COSCOPIN LINCTUS | NOSCAPINE + CHLORPHENIRAMINE MALEATE + SODIUM CITRATE + AMMONIUM CHLORIDE | 7MG+2 MG+ 3.25 MG+28 MG/5 ML. | BIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6246 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | LUTHER | ARTEMETHER | 80MG/ML | CIRON DRUGS AND PHARMACEUTICALS PVT. LTD-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIA | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X6.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6247 | MILAN LABORATORIES LTD (INDIA) PVT LTD | GITTOES PHARMACEUTICALS LIMITED | MILOXY 250-DT | AMOXICILLIN TRIHYDRATE | 250MG | MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6248 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | ARTEMETHER | ARTEMETHER | 80MG/ML | NITIN LIFESCIENCES LTD..-RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H. | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X6.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6249 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL METRONIDAZOLE -200 TABLETS | METRONIDAZOLE | 200MG | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6250 | REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD | HEALTHCARE LTD. | ROCIP EYE DROPS | CIPROFLOXACIN HYDROCHLORIDE | 3MG/ML | REMINGTON PHARMACEUTICAL INDUSTRIES (PVT) LTD-18 KM MULTAN ROAD LAHORE 53800 PAKISTAN | PAKISTAN | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6251 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TORGABALIN 75 | PREGABALIN | 75MG | TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6252 | TORRENT PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TORGABALIN 150 | PREGABALIN | 150MG | TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6256 | HOVID BHD (IPOH SITE) | UNITED HEALTHCARE DISTRIBUTORS LTD | AZIMAX- 250 | AZITHROMYCIN DIHYDRATE | 250MG | HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6257 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | EDURANT | RILPIVIRINE | 25MG | JANSSEN CILAG S.P.A-VIA C.JANSSEN, BORGO | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/6264 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | PARACONICA 1000 MG IV | PARACETAMOL | 10MG/ML | S.M FARMACEUTICI SRL-ZONA INDUSTRIALE,
85050 TITO-POTENZA
(PZ) ITALY
| ITALY | PARENTERAL ORDINARY I V VIALS | 1.0X100.0 ML VIAL |
| NDA/MAL/HDP/6267 | DENK PHARMA GMBH & CO KG | BENLE CONSULT LIMITED | TRAMADOL DENK 50 | TRAMADOL HYDROCHLORIDE | 50MG | LOSAN PHARMA GMBH- OTTO-HAHN-STR 13 79395 NEUENBURG | GERMANY | ORAL SOLID ORDINARY EFFERVESCENT TABLETS | 1.0X10.0 TABLET BOTTLE |
| NDA/MAL/HDP/6270 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | FEBUMAC 80 | FEBUXOSTAT | 80MG | MACLEODS PHARMACEUTICALS LTD - - VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA 174101
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6295 | RANBAXY LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | LIRAPYN 75MG | PREGABALIN | 75MG | RANBAXY LABORATORIES LTD-PAONTA SAHIB, DISTRICT ? SIRMOUR, HIRMACHAL | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0X7.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6299 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLANGEM 5 | OLANZAPINE | 5MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6300 | GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AMOXICILLIN | AMOXICILLIN | 250MG | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6301 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLANGEM 10 | OLANZAPINE | 10MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6305 | YELURI FORMULATIONS PVT LTD | ESCORTS PHARMACEUTICALS LIMITED | ELMOX-CV 375 | AMOXICILLIN TRIHYDRATE +CLAVULANATE POTASSIUM | 250MG+125MG | YELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6
IDA BOLLARAM,MEDAK DIST.502325,
TELANGANA,INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/6310 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LTD | ZIMCOX 100 | CELECOXIB | 100MG | ZIM LABORATORIES LTD.
B-21/22, M.I.D.C. AREA,
KALMESHWAR ? 441 501,
DIST. NAGPUR,
MAHARASHTRA,
INDIA | INDIA | ORAL SOLID ORDINARY CAPSULE | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6314 | YELURI FORMULATIONS PVT LTD | ESCORTS PHARMACEUTICALS LIMITED | ELMOX-CV 625 | AMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM | 500MG+125MG | YELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6
IDA BOLLARAM,MEDAK DIST.502325,
TELANGANA,INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/6315 | SQUARE PHARMACEUTICALS LTD.PABNA UNIT | GAMA PHARMACEUTICALS (U) LIMITED | ACE SYRUP, 100ML | PARACETAMOL | 120MG/5ML | SQUARE PHARMACEUTICAL LIMITED (PABNA UNIT)-SQUARE ROAD, SALGARIA PABNA-6600 BANGLADESH | BANGLADESH | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6316 | SQUARE PHARMACEUTICALS LTD.PABNA UNIT | GAMA PHARMACEUTICALS (U) LIMITED | OSMOLAX | LACTULOSE | 3.40G/5ML | SQUARE PHARMACEUTICAL LIMITED (PABNA UNIT)-SQUARE ROAD, SALGARIA PABNA-6600 BANGLADESH | BANGLADESH | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6317 | YELURI FORMULATIONS PVT LTD | ESCORTS PHARMACEUTICALS LIMITED | ELMOX-CV L000 | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 875MG + 125MG | YELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6
IDA BOLLARAM,MEDAK DIST.502325,
TELANGANA,INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X5.0 TABLET BLISTER,1.0X3.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/6322 | CACHET PHARMACEUTICALS PVT LIMITED | ASTRA PHARMA (U) LIMITED | CLAVACE 1000 MG | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 875MG + 125MG | ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6325 | LEBEN LABORATORIES PVT. LTD. | ANDYCO PHARMACY (UGANDA) LTD | PZQ TABLET | PRAZIQUANTEL | 600MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/6337 | LIFEPHARM FZE | AIVEEN (U) LTD - WILSON ROAD | GASTREX | SIMETHICONE | 42MG | LIFEPHARMA FZE - -JEBEL ALI FREE ZONE, PLOT NO. MO 0502,
P.O. BOX 17404, DUBAI, UAE | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6339 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OXY-POL | OXYTETRACYCLINE HCL + POLYMYXIN B SULPHATE | 5MG+10000IU/G | EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY ? INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPT | EGYPT | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE |
| NDA/MAL/HDP/6340 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | AXYLIN CAPSULES | AMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM | 250MG +250 MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6341 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | ROSUMAC 20 | ROSUVASTATIN CALCIUM | 20MG | MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6342 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIFENAC EYE DROPS | DICLOFENAC SODIUM SALT | 1MG/ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B
EGYPT
| EGYPT | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6344 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | LACTEASE | LACTULOSE | 3.35G/5ML | S KANT HEALTHCARE LIMITED. PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT, INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100 ML BOTTLE |
| NDA/MAL/HDP/6345 | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO) | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MAGNABIOTIC 600MG VAIL | AMOXYCILLIN SODIUM/ CLAVULANATE POTASSIUM | 500MG/100MG | SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT | EGYPT | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/6348 | ABARIS HEALTHCARE PVT. LTD | ROYAL PHARMA 2011 LIMITED | COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP | SODIUM LACTATE SOLUTION +SODIUM CHLORIDE + CALCIUM CHLORIDE + POTASSIUM CHLORIDE | 0.533 GM +0.600 GM + 0.027G+ 0.040 GM/100ML | ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/6349 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | GSUNATE-120 | ARTESUNATE | 120MG | BLISS INDASI LIFE SCIENCE PVT.LTD. PLOT NO. 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN (UT), 396210 - INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1X10ML 0.9%W/W SODIUM CHLORIDE SOLUTION AMPOULE + 1X2ML 5.0%W/W SODIUM BICARBONATE SOLUTION AMPOULE |
| NDA/MAL/HDP/6354 | EXPHAR SA. | SURGIPHARM (U) LIMITED | TIMOSOL ? | TIMOLOL MALEATE | O.5%W/V | AHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)
TEL: +91-1493-305300 (30 LINES)
FAX: +91-1493-221045, 305345
| INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6360 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | ETOCOXX 90MG | ETORICOXIB | 90MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN
EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6361 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | NYSTATIN | NYSTATIN | 1,00,000 I.U/ML | S.KANT HEALTHCARE LTD-PLOT 1802, 1805, GIDC PHASE III VAPI 39179, GUJARAT | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/6363 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MF-DAY 850 | METFORMIN HYDROCHLORIDE | 850MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/6366 | BEXIMCO PHARMACEUTICALS LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | ODYCIN EYE DROPS | MOXIFLOXACIN HYDROCHLORIDE | 5MG/ML | "BEXIMCO PHARMACEUTICALS LTD-126 KATHALDIA, AUCHPARA, TONGI-1711,
GAZIPUR."
| BANGLADESH | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL |
| NDA/MAL/HDP/6367 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | FINAGEN1 | FINASTERIDE | 1 MG | AUROBINDO PHARMA LIMITED, UNIT ? III-SURVEY NO.:113 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6368 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | STAR PHARMACEUTICALS LTD | ETOCOXX 120MG | ETORICOXIB | 120MG | SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN
EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6370 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYCROM EYE DROPS | SODIUM CROMOGLYCATE | 2%W/V | IVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE,
LR NO.18474/84,
ATHI RIVER,KENYA
| KENYA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/6372 | ASTRA PHARMA (U) LTD | ASTRA PHARMA (U) LIMITED | IVYTIMOL EYE DROPS | TIMOLOL MALEATE | 0.25%W/V | IVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE,
LR NO.18474/84,
ATHI RIVER,KENYA
| KENYA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6374 | LEBEN LABORATORIES PVT. LTD., INDIA | ANDYCO PHARMACY (UGANDA) LTD | PREDLEB-5 DT | PREDNISOLONE | 5MG | LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA? 444 104 (MS).
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/6377 | REGAL PHARMACEUTICALS LTD | REGAL PHARMA U LIMITED | EPHICOL CAPSULES | CHLORPHENIRAMINE MALEATE+ PARACETAMOL+ CAFFEINE ANHYDROUS+ PHENYLEPHRINE HCL | 2MG+500 MG+30 MG+5MG | REGAL PHARMACEUTICALS LTD..-PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKA | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X12.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6380 | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO) | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MAGNABIOTIC 1200MG VIAL | AMOXICILLIN + CLAVULANIC ACID | 1000MG+120MG | SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT | EGYPT | PARENTERAL ORDINARY DRY VIALS | 1.0X1.2 G VIAL |
| NDA/MAL/HDP/6382 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MF-DAY 500 | METFORMIN TABLETS BP | 500MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/6383 | EXPHAR SA. | SURGIPHARM (U) LIMITED | EXXIB | CELECOXIB | 200MG | GRACURE PHARMACEUTICALS LIMITED -E- 1105, RIICO INDUSTRIAL AREA, PHASE-III BHIWADI, PIN-301019 DIST. ALWAR, RAJASTHAN, INDI | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6385 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KPI HEALTHCARE LIMITED | AMOXIKID-250 | AMOXICILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/6386 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | JUSDEE 60K GRANULES | COLECALCIFEROL | 60000 IU | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X8.0X1.0 G SACHET |
| NDA/MAL/HDP/6388 | IPCA LABORATORIES LTD | SURGIPHARM (U) LIMITED | RAPICLAV 250 DT | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 250MG + 62.5MG | IPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X5.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/6389 | ABARIS HEALTHCARE PVT. LTD | ROYAL PHARMA 2011 LIMITED | METRONIDAZOLE BP | METRONIDAZOLE | 0.5%W/V | ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6392 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | MET XL 50 | METOPROLOL SUCCINATE | 50 MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6396 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | LETROZOLE 2.5 | LETROZOLE | 2.5MG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6397 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | INDOSUPP 100 | INDOMETHACIN | 100 MG | MERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/6399 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | BISUPP 10 | BISACODYL | 10 MG | MERIDIAN ENTERPRISES PVT. LTD PLOT 418, G.I.D.C. KABILPORE, NAVSARI ? 396 424 - GUJARAT - INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0SUPPOSITORY STRIP |
| NDA/MAL/HDP/6400 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | FENSUPP-100 | DICLOFENAC SODIUM | 100MG | MERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/6401 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | SUPPOL 250 SUPPOSITORIES | ACETAMINOPHEN | 250MG | MERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE,NAVSARI 396424 GUJARAT,INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/6404 | STEDMAN PHARMACEUTICALS PVT. LTD | VEERAM HEALTHCARE (U) LIMITED | STEDNAC GEL | ACECLOFENAC + LINSEED OIL + METHYL SALICYLATE | 1.5%W/W + 3.0W/W +10.0%W/W | STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/6405 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | CLOPRAZ | CLOPIDOGREL BISULFATE | 75MG | ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR ? 441501,
DIST. NAGPUR,
MAHARASHTRA,
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6407 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | ZIMCOX 200 | CELECOXIB | 200 MG | ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR ? 441501,
DIST. NAGPUR,
MAHARASHTRA,
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6411 | BLISS GVS PHARMA LTD | DELMAW ENTERPRISES LTD | ABTHER-150 INJECTION | ALPHA BETA ARTEMETHER | 120MG/2ML | BLISS INDASI LIFE SCIENCE PVT.LTD.
PLOT NO. 73-76, SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN (UT), 396210 - INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X3.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6412 | PHARCO PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BUCCAZOLE ORAL GEL | MICONAZOLE | 2%W/W | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL TOPICAL GELS AND SOLS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/6418 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KPI HEALTHCARE LIMITED | AZOX 250 | AZITHROMYCIN DIHYDRATE | 250MG | THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY.-UM-AL-AMAD/PLANT ( RAZI ).P.O.BOX 151 UM-AL-AMAD 16197 JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/6419 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT. LTD | METRO PHARMACEUTICALS LTD | CLINICEF CV | CEFIXIME + POTASSIUM CLAVULANATE | 200MG + 125MG | TWENTY FIRST CENTURY PHARMACEUTICALS PVT LIMITED
UNIT ? II, KHASRA NO.282, NALHERI DEHVIRAN, PUHANA ? IQBALPUR ROAD,
ROORKEE ? 247 668. HARIDWAR DIST. (UTTARAKHAND)
INDIA | INDIA | ORAL SOLID ORDINARY FILM COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6421 | ALEMBIC PHARMACEUTICALS LIMITED. | GITTOES PHARMACEUTICALS LTD | TELLY-H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6422 | INTERNATIONAL ORGANIZATION FOR MIGRATION | AIVEEN (U) LIMITED | EMADON | ONDANSETRON | 4MG | CORONA REMEDIES PVT LTD--VILLAGE JATOLI,POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. OLAN HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6426 | ABARIS HEALTHCARE PVT. LTD | ROYAL PHARMA 2011 LIMITED | SODIUM CHLORIDE INTRAVENOUS INFUSION BP | SODIUM CHLORIDE | 0.9%W/V | ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/6431 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | BRUMOX 125 | AMOXICILLIN TRIHYDRATE | 125MG/5ML | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6433 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | FICYC CREAM | ACICLOVIR | 5%W/W | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/6435 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | FIMABUTE 200 | CEFIXIME TRIHYDRATE | 200MG | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6436 | GUILIN PHARMACEUTICALS CO.LTD | STAR PHARMACEUTICALS LTD | MOXAF | MOXIFLOXACIN HYDROCHLORIDE | 400 MG | GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/6437 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | PILORECT | HYDROCORTISONE ACETATE +LIDOCAINE +ZINC OXIDE +ALLANTOIN | 0.25%W/W+3%W/W+5%W/W+0.5%W/W | MERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,
KABILPORE, NAVSARI
GUJARAT,INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X6.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/6439 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | LIZOMAC 600 | LINEZOLID | 600MG | MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA
TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101
INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/6440 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CEFIWEL 400 | CEFIXIME TRIHYDRATE | 400MG | AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6441 | ABARIS HEALTHCARE PVT. LTD | ROYAL PHARMA 2011 LIMITED | OFLOXACIN INTRAVENOUS INFUSION | OFLOXACIN | 0.2%W/V | ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6442 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | AZITO SUSPENSION | AZITHROMYCIN DIHYDRATE | 200 MG/5ML | ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR ? 441501,
DIST. NAGPUR,
MAHARASHTRA,
| INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/6444 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | CEFRAZ 100 | CEFIXIME TRIHYDRATE | 100MG | ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR ? 441501,
DIST. NAGPUR,
MAHARASHTRA,
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6447 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | AZIBRU 500 | AZITHROMYCIN DIHYDRATE | 500MG | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/6448 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIZOLONE-DEPOT 40 MG/ 1 ML VIAL | METHYLPREDNISOLONE ACETATE | 40 MG/ ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPT | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X1.0X1.0 ML VIAL |
| NDA/MAL/HDP/6449 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | GAMA PHARMACEUTICALS (U) LIMITED | DESLORAT SYRUP | DESLORATIDINE | 0.5MG/ML | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6455 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | FICYC TABLETS | ACYCLOVIR | 200MG | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6456 | ABARIS HEALTHCARE PVT. LTD | ROYAL PHARMA 2011 LIMITED | GLUCOSE INTRAVENOUS INFUSION BP (5% W/V) | GLUCOSE ANHYDROUS | 5%W/V | ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/6457 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MOXIWAR 400 | MOXIFLOXACIN HYDROCHLORIDE | 400MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/6462 | ABACUS PHARMA (A) LTD | ABACUS PHARMA (AFRICA) LIMITED | AMOXYN-500 | AMOXICILLIN TRIHYDRATE | 500MG | REYOUNG PHARMACEUTICAL CO., LTD.
NO.6 ERLANGSHAN ROAD,YIYUAN COUNTY, SHANDONG PROVINCE, P.R. CHINA | CHINA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6465 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | NEUROGAB 75 | PREGABALIN | 75MG | MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA
TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101
INDIA
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6466 | S KAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | NYSTATIN ORAL TABLETS USP 500,000 I.U. | NYSTATIN | 500,000IU | S KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6467 | GULF PHARMACEUTICAL INDUSTRIES "JULPHAR" | GOODMAN INTERNATIONAL LTD | CLOFEN | DICLOFENAC SODIUM | 12.5MG | GULF PHARMACEUTICAL INDUSTRIES "JULPHAR"
P.O. BOX 997 AIRPORT ROAD, DIGDAGA STREET
RAS AL KHAIMAH, U.A.E | UNITED ARAB EMIRATES | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/6468 | CIRON DRUGS & PHARMACEUTICAL PVT LTD | ROYAL PHARMA 2011 LIMITED | CIROLAZINE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | CIRON DRUGS & PHARMACEUTICAL PVT LTD -1, PRABHAT NAGAR, GROUND FLOOR,
JOGESHWARI (W), MUMBAI -400 102. INDIA
| INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6469 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | JUSPRIN 81 E/C TABLETS | ASPIRIN | 81MG | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/6470 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MF-DAY 1000 | METFORMIN HYDROCHLORIDE | 1000MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6471 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | CEFUZIME 500 | CEFUROXIME AXETIL | 500MG | GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6475 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | MOXAL SUSPENSION | ALUMINIUM HYDROXIDE +MAGNESIUM HYDROXIDE | 405 MG+100 MG/ 5ML | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/6476 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPIZOLONE-DEPOT | METHYLPREDNISOLONE | 80MG/2ML | EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY ? INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPT | EGYPT | PARENTERAL RETARD VIALS | 1.0X1.0X2.0 ML VIAL |
| NDA/MAL/HDP/6478 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | RANTAG INJECTION | RANITIDINE HYDROCHLORIDE | 50MG/2ML | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6479 | SWISS PARENTERALS PVT. LTD. | ROYAL PHARMA 2011 LIMITED | TRAMADOL HYDROCHLORIDE INJECTION 100MG/2ML | TRAMADOL HYDROCHLORIDE | 100MG/2ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6481 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | MOXAL PLUS CHEWABLE TABLETS | DRIED ALUMINIUM HYDROXIDE GEL+MAGNESIUM HYDROXIDE+SIMETHICONE | 200MG+200MG+25MG | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6483 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | MOXAL II SUSPENSION | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE | 215MG+80MG/5ML | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6485 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | CEFUZIME 750 | CEFUROXIME SODIUM | 750MG | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA, P.O.BOX:
997,
RAS AL KHAIMAH,
U.A.E.
| UNITED ARAB EMIRATES | PARENTERAL ORDINARY DRY VIALS | 1.0X750.0 MG VIAL |
| NDA/MAL/HDP/6488 | GUILIN PHARMACEUTICAL CO.LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | PARACETAMOL INJECTION | PARACETAMOL | 300MG/2ML | GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6489 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | ASCORIL-SF | SALBUTAMOL+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN | 2MG+4MG+100MG/10ML | GLENMARK PHARMACEUTICALS LTD-VILLAGE, KISHANPURA, BADDI, NALAGARH ROAD, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6490 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | SORVATE OINTMENT | CALCITRIOL | 0.0003% W/W | GLENMARK PHARMACEUTICALS LIMITED, AT: (UNIT II)-VILLAGE BHATTANWALA, P.O. RAJPURA,
NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH, 174 101, INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/6491 | INTAS PHARMACEUTICALS LIMITED | NORVIK ENTERPRISES LIMITED | PREGATAS ME 75 | PREGABALIN +MECOBALAMIN | 75MG+750MCG | INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6492 | UMEDICA LABORATORIES PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | LIDOCAINE INJECTION BP 2%W/V | LIDOCAINE HYDROCHLORIDE | 2%W/V | UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0X2.0 ML VIAL |
| NDA/MAL/HDP/6495 | DAFRA PHARMA GMBH | LABOREX UGANDA LIMITED | MACROLYN? 500 MG FILM COATED TABLETS | AZITHROMYCIN DIHYDRATE | 500MG | DEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/6496 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NEUROKEM 150 | PREGABALIN | 150MG | ALKEM LABORATORIES LTD--167/2, MAHATMA GANDHI UDYOG NAGAR DABHEL, AMALIYA, DAMAN(UT) 396 210 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6498 | MICRO LABS LIMITED | LABOREX UGANDA LIMITED | AMOXICILLIN DISPERSIBLE TABLETS 250 MG | AMOXICILLIN TRIHYDRATE | 250MG | MICRO LABS LIMITED PLOT -NO. 16, VEERASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE ? 560 100. KARNATAKA, INDIA | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/6501 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARTROGYL 200 TABLET | METRONIDAZOLE | 200MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6505 | ASTRA LIFECARE (INDIA) PVT. LTD | ASTRA PHARMA (U) LIMITED | CO-ARLUMETHER FORTE | ARTEMETHER + LUMEFANTRINE | 80MG + 480MG | ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/6507 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | ZITRAM P | ACETAMINOPHEN + TRAMADOL HYDROCHLORIDE | 325MG + 37.5MG | IPCA LABORATORIES LTD-PLOT NO. 255/1,
VILLAGE ATHAL,
SILVASSA-396230,
DADRA AND NAGAR HAVELI, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6509 | ASTRA LIFECARE (INDIA) PVT. LTD | ASTRA PHARMA (U) LIMITED | ASPYROX | PIROXICAM | 20MG | ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABAD | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6512 | AXA PARENTERALS LTD | GITTOES PHARMACEUTICALS LIMITED | AXACIP | CIPROFLOXACIN | 200MG/100ML | AXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA. | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6520 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND-MD 8 | ONDASENTRON | 8MG | MANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6523 | EXPHAR SA. | SURGIPHARM (U) LIMITED | FLEXDOL | IBUPROFEN+METHOCARBAMOL | 200MG+500MG | GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6529 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | PRAZIQUANTEL TABLETS 600 MG | PRAZIQUANTEL | 600MG | MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA
TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101
INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6532 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | BUNASE 200 | BUDESONIDE | 200MCG / ACTUATION | OXALIS LABS--VILLAGE THEDA,P.O.LODHIMAJRA ,TEHSIL BADDI,DIST .SOLAN (HIMACHAL PRADESH) - 174101
INDIA | INDIA | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X1.0 CANNISTER CARTON |
| NDA/MAL/HDP/6534 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | REXIDIN | CHLORHEXIDINE GLUCONATE | 0.2%W/V | INDOCO REMEDIES LTD, B-20,-B-20 MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL TOPICAL LIQUIDS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6537 | EXPHAR SA | SURGIPHARM (U) LIMITED | CARBOSOL | CARMELLOSE SODIUM | 0.5%W/V | AHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)
TEL: +91-1493-305300 (30 LINES)
FAX: +91-1493-221045, 305345
| INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/6540 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | VANCOLON | VANCOMYCIN HYDROCHLORIDE | 1G | GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E | UNITED ARAB EMIRATES | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/6541 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | DIALON 1000 MG | METFORMIN HYDROCHLORIDE | 1000MG | GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6544 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | ORAMAX 150MG | FLUCONAZOLE | 150MG | GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY CAPSULES | 1.0X1.0X1.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6547 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GOODMAN INTERNATIONAL LTD | AMYDRAMINE PAEDIATRIC SYRUP | DIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL | 7MG+28.5MG+0.55 MG/5 ML | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/6548 | CIRON DRUGS & PHARMACEUTICAL PVT LTD | ROYAL PHARMA 2011 LIMITED | CIROPAIN GEL | DICLOFENAC DIETHYLAMINE BP | 1%W/W | CIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/6560 | GULF PHARMACEUTICAL INDUSTRIES "JULPHAR" | GOODMAN INTERNATIONAL LTD | CEFUZIME 250MG | CEFUROXIME AXETIL | 250MG | GULF PHARMACEUTICAL INDUSTRIES "JULPHAR"
P.O. BOX 997 AIRPORT ROAD, DIGDAGA STREET
RAS AL KHAIMAH, U.A.E | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY FILM COATED TABLETS | 1.0X2.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/6561 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | RISEK | OMEPRAZOLE | 20MG | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY CAPSULES | 1.0X14.0 CAPSULE BOTTLE |
| NDA/MAL/HDP/6568 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PINNADIP 50 TABLET | DICLOFENAC | 50MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6573 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | EFAVIRENZ TABLETS USP 400MG | EFAVIRENZ | 400MG | MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA
TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101
INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/6574 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | ARCHIFAR | MEROPENEM | 1G | MEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.0 G VIAL |
| NDA/MAL/HDP/6595 | RAVIAN LIFE SCIENCE PVT. LTD | ROYAL PHARMA 2011 LIMITED | MOLURAV | LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM | 5MG + 10MG | RAVIAN LIFE SCIENCE PVT LTD-PLOT NO.34,SECTOR-8A,IIE,HARIDWAR-249403, UTTARKHAND | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6610 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND | ONDANSENTRON HYDROCHLORIDE | 2MG/ML | MANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X4.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6612 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APRAZOLE PLUS-20 | OMEPRAZOLE + SODIUM BICARBONATE | 20MG/6G + 1680MG/6G | AJANTA PHARMA LTD.-B-4-5-6, MIDC PAITHAN, AURANGABAD | INDIA | ORAL SOLID ORDINARY POWDERS | 1.0X20.0X6.0 G SACHET |
| NDA/MAL/HDP/6613 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | OLMAT-40 | OLMESARTAN MEDOXOMIL | 40MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6614 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | AXETINE | CEFUROXIME SODIUM | 1.5MG | MEDOCHEMIC LTD-1-10 ASTRONAFTON & CONSTANTINOPOLEOS 3505 LIMASSOL | CYPRUS | PARENTERAL ORDINARY VIALS | 1.0X10.0 VIAL CARTON |
| NDA/MAL/HDP/6615 | UNEED GLOBAL GROUP LIMITED | ABACUS PHARMA (AFRICA) LIMITED | PINPAC 50 | DICLOFENAC SODIUM | 50MG | MAXHEAL PHARMACEUTICALS INDIA LTD-J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6616 | SHIN POONG PHARMACEUTICALS CO.LTD | BOOTS PHARMACEUTICALS LIMITED | PYRAMAX | PYRONARIDINE TETRAPHOSPHATE + ARTESUNATE | 180MG + 60MG | SHIN POONG PHARMA.CO.LTD-434-4 MOKNAE-DONG ANSAN-SI,KYUGGI DO KOREA | SOUTH KOREA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X9.0 TABLET BLISTER |
| NDA/MAL/HDP/6617 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APFLU | CHLOROPHENERAMINE + PARACETAMOL + VITAMIN C | 0.5MG + 120MG + 50MG | AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6619 | ESAPHARMA S.R.L.. | BYAMAKA PHARMACEUTICAL COMPANY LTD | ORANVATE | CLOBETASOL PROPIONATE | 0.05G/100G | ESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY
| ITALY | TOPICAL EXTERNAL GELS AND SOLS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/6620 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILET 5MG | NEBIVOLOL HYDROCHLORIDE | 5MG | BERLIN-CHEMIE AG-BERLIN-CHEMIE AG GLIENICKER WEG 125 D-12489 BERLIN | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/6621 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | BAROLE 20 | RABEPRAZOLE | 20MG | INVENTIA HEALTHCARE PVT. LTD .-FI ? FI /1 ADDITIONAL AMBERNATH(EAST) ? 421 506,MAHARASHTRA DIST. THANE, INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6622 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CEFIWEL-100 DT | CEFIXIME TRIHYDRATE | 100MG | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY OTHER TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6623 | SQUARE PHARMACEUTICALS LTD.PABNA UNIT | GAMA PHARMACEUTICALS (U) LIMITED | REFINAC SR | DICLOFENAC SODIUM | 100MG | SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | ORAL SOLID RETARD ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6624 | SQUARE PHARMACEUTICALS LTD.PABNA UNIT | GAMA PHARMACEUTICALS (U) LIMITED | CIPROKEN | CIPROFLOXACIN HYDROCHLORIDE | 0.3%W/V | SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR | BANGLADESH | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6625 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILET PLUS 5/12.5 | NEBIVOLOL HYDROCHLORIDE + HYDROCHLOROTHIAZIDE | 5MG + 12.5MG | BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, -) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, BATCH CONTROL)
TEMPELHOFER WEG 83
D-12347 BERLIN
GERMANY
| GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/6627 | RECKITT BENCKISER HEALTHCARE INTERNATIONAL | GITTOES PHARMACEUTICALS LIMITED | STREPSILS HONEY & LEMON | MULTI-INGREDIENT | MULTI-INGREDIENT | RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED-65 MOO 12,LARD KRABANG-BANGPLEE ROAD, BANGPLEE SAMUTPRAKARAN 10 540, THALAND | THAILAND | ORAL SOLID ORDINARY LOZENGES | 1.0X24.0 LOZENGE PACK,1.0X70.0 LOZENGE PACK |
| NDA/MAL/HDP/6628 | RECKITT BENCKISER HEALTHCARE INTERNATIONAL | GITTOES PHARMACEUTICALS LIMITED | STREPSILS REGULAR | MULTI-INGREDIENT | MULTI-INGREDIENT | RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED-RECKITT BENCKISER HEALTHCARE INTERNATIONAL-65 MOO 12,LARD KRABANG-BANGPLEE ROAD, BANGPLEE SAMUTPRAKARAN 10 540, THALAND | THAILAND | ORAL SOLID ORDINARY LOZENGES | 1.0X24.0 LOZENGE PACK,1.0X70.0 LOZENGE PACK |
| NDA/MAL/HDP/6629 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILET PLUS 5/25 | NEBIVOLOL+HYDROCHLOROTHIAZIDE | 5MG+25MG | ) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION-TEMPELHOFER WEG 83
D-12347 BERLIN
GERMANY
| GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/6630 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TOPRAZ 20 | PANTOPRAZOLE | 20MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6631 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOBURN | SILVER SULFADIAZINE | 1%W/W | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/6632 | UMEDICA LABORATORIES PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | CIPROFLOXACIN | CIPROFLOXACIN | 500MG | UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6633 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | COLDRIL | PARACETAMOL + CHLORPHENIRAMINE MALEATE + PSEUDOEPHEDRINE HCL | 500MG + 30MG + 2MG | SHELYS PHARMACEUTICALS LIMITED-PLOT NO. 696, BLOCK NO. 32,
MIKOCHENI INDUSTRIAL AREA,
NEW BAGAMOYO ROAD, MEWENGE,
DAR ES SALAAM, TANZANIA
,BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 425 | TANZANIA/KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0X1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6634 | UMEDICA LABORATORIES PVT. LTD | GITTOES PHARMACEUTICALS LIMITED | FIXDEP -120 | FEXOFENADINE HYDROCHLORIDE | 120MG | UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6636 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | COSAMIDE 100 | LACOSAMIDE | 100MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6637 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | COSAMIDE 200 | LACOSAMIDE | 200MG | MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6638 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | COSAMIDE 50 | LACOSAMIDE | 50MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6640 | MSN LABORATORIES PVT LTD | GOOD DAY PHARMACY LIMITED | SAFETELMI H ( 40/ 12.5) | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6641 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CEFTISONE- S | CEFTRIAXONE SODIUM + SULBACTAM SODIUM | 1.0G + 0.5G | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.5 G VIAL + 10ML WFI AMPOULE |
| NDA/MAL/HDP/6642 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | DIBETIN | METFORMIN HYDROCHLORIDE | 500MG | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6645 | MSN LABORATORIES PVT LTD | GOOD DAY PHARMACY LIMITED | SAFETELMI H ( 80/ 12.5) | TELMISARTAN + HYDROCHLOROTHIAZIDE | 80MG + 12.5MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6647 | UNOSOURCE PHARMA LTD. | ESCORTS PHARMACEUTICALS LIMITED | JOYCLAV -625 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500MG + 125MG | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6650 | INDUS LIFE SCIENCES PVT LIMITED | PNR PHARMACEUTICALS LIMITED | INTRIAX-S-1 | CEFTRIAXONE SODIUM+SULBACTAM SODIUM | 1G+0.5G | SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/6651 | GOOD DAY PHARMACY LIMITED | GOOD DAY PHARMACY LIMITED | CYCLOVEER | ACICLOVIR | 5%W/W | KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/6652 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | LAMIVUDINE +TENOFOVIR DISOPROXIL FUMARATE | LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE | 300MG+300MG | CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/6653 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | METSAFE 500 ER | METFORMIN HYDROCHLORIDE | 500MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6654 | PANACEA BIOTEC LTD | ABACUS PHARMA (AFRICA) LIMITED | LIVOLUK FIBRE | LACTULOSE + ISPAGHULA HUSK | 10G + 3.5G/ 15G | PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205 | INDIA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X90.0 G CONTAINER |
| NDA/MAL/HDP/6655 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ATORLIP-20 | ATORVASTATIN CALCIUM | 20MG | CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6656 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | PLENMOXI | MOXIFLOXACIN HYDROCHLORIDE | 400MG | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6657 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | METFORMIN | METFORMIN HYDROCHLORIDE | 500MG | CIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6658 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | NEBIEM 10 | NEBIVOLOL | 10MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6660 | ELDA INTERNATIONAL DMCC | REDDYS PHARMA LIMITED | KETAJEX | KETAMINE | 50MG/ML | CLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/6662 | SAKAR HEALTHCARE LIMITED | ROYAL PHARMA 2011 LIMITED | DIAPAM | DIAZEPAM | 5MG/ML | SAKAR HEALTHCARE PVT LTD --406, SILVER OAKS COMMERCIAL COMPLEX, | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6663 | PANACEA BIOTEC LTD | ABACUS PHARMA (AFRICA) LIMITED | SITCOM | EUPHORBIA PROSTATA DRY EXTRACT | 10MG/G | PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) ? 173 205 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/6664 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX 125 KID | AMOXICILLIN TRIHYDRATE | 125MG | SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6665 | REGAL PHARMACEUICALS LTD | REGAL PHARMA (U) LTD | SALBUMOL SYRUP | SALBUTAMOL | 2MG/5ML | REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6666 | MSN LABORATORIES LTD | GOOD DAY PHARMACY LIMITED | NEBIEM 5 | NEBIVOLOL HYDROCHLORIDE | 5MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6667 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | SPAMOX 250 DT | AMOXICILLIN TRIHYDRATE | 250MG | SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/6668 | STRIDES ARCOLAB LTD | ROYAL PHARMA 2011 LIMITED | AMPIRONE-250 CAPSULES | AMPICILLIN | 250MG | SIMRONE PHARMACEUTICAL INDUSTRIES LTD-DEWAN AND SONS INDUSTRIAL AREA, VECOR PALGHAR INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/6669 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | SUPER WELGRA -100 | SILDENAFIL CITRATE + DAPOXETINE HYDROCHLORIDE | 100MG + 60MG | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/6670 | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED | ROYAL PHARMA 2011 LIMITED | METROSIM-200 | METRONIDAZOLE | 200MG | AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/6671 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | NOPEN | ASPRIRIN+CAFFEINE | 350MG+30MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6672 | STRIDES ARCOLAB LTD | ROYAL PHARMA 2011 LIMITED | MOXIRONE 250 CAPSULES | AMOXYCILLIN | | UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/6673 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | TRIXONE-TZ | CEFTRIAXONE SODIUM + TAZOBACTAM | 1000MG + 125MG | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/6676 | YSP INDUSTRIES(M) SDN BHD | ROYAL PHARMA 2011 LIMITED | CASPRIN | ACETYLSALICYLIC ACID | 100MG | YSP INDUSTRIES SND.BHD-LOT 3,5&7 JOLAN P/7 SEC 13,KAWASAN PERINDUSTRIAN | MALAYSIA | ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES | 1.0X1.0X30.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6678 | BLUE CROSS LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | TUSQ-DX | CHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN HBR + PHENYLEPHRINE | 2MG/5ML + 15MG/5ML + 5MG/5ML | BLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6679 | BLUE CROSS LABORATORIES LIMITED | STAR PHARMACEUTICALS LTD | WOMIBAN TABLETS | ALBENDAZOLE | 400MG | BLUE CROSS LABORATORIES LTD-A-12, M.I.D.C AMBAD NASHIK-422010,BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0 TABLET STRIP |
| NDA/MAL/HDP/6680 | PHARMEDIC LABORATORIES(PVT) LIMITED | HEALTHCARE LTD. | ATELOR TABLET | ATENOLOL | 100MG | PHARMEDIC LABORATORIES (PVT) LIMITED-16KM MULTAN ROAD,LAHORE-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X20.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6681 | UNOSOURCE PHARMA LTD. | ESCORTS PHARMACEUTICALS LIMITED | WELQUINE | LEVOFLOXACIN | 0.5%W/V | AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III, PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL, RANIPUR,
HARIDWAR, UTTARAKHAND
| INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6682 | BEIJING HOLLEY COTEC PHARMA CHINA | SUPER PHARMACEUTICALS LIMITED | PROCILIN | FORTIFIED PROCAINE BENZYLPENICILLIN | 4MU | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON |
| NDA/MAL/HDP/6685 | NEON LABARATORIES LTD | AIVEEN (U) LIMITED | EVACEF | CEFOTAXIME | 1 G | NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/6686 | DAWA LIMITED | SUPER MEDIC LTD | DAWASOLONE | PREDNISOLONE | 5MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6688 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | CAREOCEF | CEFTRIAXONE SODIUM | 1G | NITIN LIFESCIENCES LTD..-RAMPUR GHAT ROAD, PAOMTA SAHIB DIST. SIRMOUR H. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0X1.0 G VIAL |
| NDA/MAL/HDP/6690 | SCHERING N.V.SA... | SURGIPHARM (U) LIMITED | ADVANTAN OINTMENT | METHYLPREDNISOLONE ACEPONATE | 0.1%W/W | BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY | ITALY | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/6691 | SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | AZITHROMYCIN SANDOZ | AZITHROMYCIN MONOHYDRATE | 200MG/5ML | SANDOZ SRL LTD-LIVEZENI STREET 7A540472 TARGU MURES ROMANIA | ROMANIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/6692 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | ASUNRA 100 | DEFERASIROX | 100MG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X5.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/6693 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | CERTICAN1 | EVEROLIMUS | 1MG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0*6.0*10.0 TABLET BLISTER |
| NDA/MAL/HDP/6694 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | CERTICAN 0.5 | EVEROLIMUS | 0.5MG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0*6.0*10.0 TABLET BLISTER |
| NDA/MAL/HDP/6698 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ALBUZOL 400MG TABLETS | ALBENDAZOLE | 400MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/6700 | CACHET PHAMACUITICALS PVT LTD | ASTRA PHARMA (U) LIMITED | ARTIMED | DICLOFENAC SODIUM | 50MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6701 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACH-ART DS | ARTEMETHER / LUMEFANTRINE | 80MG/ 480MG | CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/6703 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACHCOLD PLUS | PARACETAMOL/ CAFFEINE/ PHENYLEPHRINE/ CHLORPHENIRAMINE | 500MG/ 30MG/ 5MG/ 2MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/6704 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACHET | CETIRIZINE HCL | 10MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X5.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6705 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACHEWORM | MEBENDAZOLE | 100MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/6706 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACH-E-WORM | MEBENDAZOLE | 100MG/5ML | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/6707 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACHFER | IRON + FOLIC ACID + VITAMIN B12 | 32MG/15ML + 0.5MG/15ML + 7.5MCG/15ML | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/6708 | PHARMEDIC LABORATORIES(PVT) LIMITED | HEALTHCARE LTD. | CLOMINOL TABLETS | CLOMIPHENE | 50MG | PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6709 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACHPAR | PARACETAMOL | 500MG | CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/6710 | PHARMEDIC LABORATORIES(PVT) LIMITED | HEALTHCARE LTD. | DIABIN TABLETS | METFORMIN | 500MG | PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6711 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACHPAR | PARACETAMOL | 125MG/5ML | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6712 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CACID-O | OMEPRAZOLE | 20MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/6713 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CAMET | METOCLOPRAMIDE HYDROCHLORIDE | 10MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6714 | SEARLE PAKISTAN LIMITED | HEALTHCARE LTD. | HYDRYLLIN SYRUP | AMINOPHYLLINE+ AMMONIUM HCL+ DIPHENHYDRAMINE HCL | 32MG +300MG+8MG | SEARLE PAKISTAN LTD-PLOT F-319, SITE KARACH, 75700 PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/6715 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CAZITHRO | AZITHROMYCIN | 200MG/5ML | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/6716 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | CATAFLAM 50 | DICLOFENAC POTASSIUM | 50MG | CATALENT GERMANY EBERBACH GMBH..-GAMMELS BACHERSTRASSE2
| GERMANY | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0 CAPSULE BLISTER,1.0X20.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6717 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CAZITHRO | AZITHROMYCIN | 500MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/6718 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | CETPRO | CYPROHEPTADINE HYDROCHLORIDE | 2MG/5ML | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6719 | PHARMEDIC LABORATORIES(PVT) LIMITED | HEALTHCARE LTD. | NAPROX-500 | NAPROXEN SODIUM | 500MG | PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6720 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | COLESTOP | ATORVASTATIN | 20MG | LEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIA | SLOVENIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6722 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | CILZEC 40 | TELMISARTAN | 40MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6724 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | CILZEC 80 | TELMISARTAN | 80MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6727 | PHARMEDIC LABORATORIES(PVT) LIMITED | HEALTHCARE LTD. | ZYNOL-300MG TABLET | ALLOPURINOL | 300MG | PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6728 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | CIPROCOS-500 TABLETS | CIPROFLOXACIN | 500MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6729 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSCOF 'C' LINCTUS | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/6730 | PHARMEDIC LABORATORIES(PVT) LIMITED | HEALTHCARE LTD. | CEFOTRIM-1000 | CEFTRIAXONE | 1000MG | PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN | PAKISTAN | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL + 5 ML AMPOULE OF WATER FOR INJECTION |
| NDA/MAL/HDP/6731 | SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | PIPTAZO 4.5G | PIPERACILLIN SODIUM+TAZOBACTAM SODIUM | 4G+0.5G | SANDOZ GMBH-BIOCHEMIESTRA?E 10 A6250 KUNDL, TYROL, AUSTRIA | AUSTRIA | PARENTERAL ORDINARY DRY VIALS | 1.0X4.5 ML VIAL |
| NDA/MAL/HDP/6732 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSCOF EXPECTORANT ORIGINAL | MULTI-INGREDIENT | MULTI-INGREDIENT | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6733 | PACIFIC PHARMACEUTICALS LTD | HEALTHCARE LTD. | LOMEXIN | FENTICONAZOLE | 2%W/W | PACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X40.0 G TUBE |
| NDA/MAL/HDP/6734 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | EASCOF | BROMHEXIDINE HCL + SALBUTAMOL SULPHATE + GUAIPHENESIN | 24MG/100ML + 42MG/100ML + 1G/ML | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6735 | PACIFIC PHARMACEUTICALS LTD | HEALTHCARE LTD. | NAPREBEN | NAPROXEN BETAINE SODIUM | 10%W/W | PACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTAN | PAKISTAN | TOPICAL EXTERNAL GELS AND SOLS | 1.0X25.0 G TUBE |
| NDA/MAL/HDP/6736 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | SANDOSTATIN | OCTREOTIDE ACETATE | 0.05MG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6737 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | ESENVIT | GLYCERIN/ ZINC SULPHATE/ SODIUM MOLYBDATE/ MANGANESE CHLORIDE/ LYSINE HCL | 5.0G/ 263.83MG/ 0.4035MG/ 57.66MG/ 612MG | CACHET PHARMACEUTICALSPVT.LTD.--415,SHAH NAHAR,WORLI
MUMBAI | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6738 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | SEEBRI BREEZHALER | GLYCOPYRRONIUM BROMIDE | 50MCG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | LUNG ADMINISTRATION INHALER CAPSULES | 1.0X1.0 CANNISTER CARTON + 30 CAPSULE BLISTER |
| NDA/MAL/HDP/6739 | PACIFIC PHARMACEUTICALS LTD | HEALTHCARE LTD. | PACIFIC'S JACK & JILL CHILDREN'S FORMULA | DEXTROMETHORPHAN + CHLORPHENIRAMINE | 10MG + 2MG / 5ML | PACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY LIQUIDS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/6740 | SCHERING N.V.SA... | SURGIPHARM (U) LIMITED | TRAVOGEN CREAM | ISOCONAZOLE NITRATE | 1%W/W | BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY | ITALY | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/6741 | NVS KENYA LTD | SURGIPHARM (U) LIMITED | ULTIBRO BREEZHALER | INDACATEROL MALEATE+GLYCOPYRRONIUM BROMIDE | 110MCG+50MCG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | LUNG ADMINISTRATION INHALER CAPSULES | 1.0X30.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6742 | PACIFIC PHARMACEUTICALS LTD | HEALTHCARE LTD. | RIFIN FORTE | RIFAMPICIN +ISONIAZID+ PYRAZINAMIDE+ETHAMBUTOL | 150MG + 75MG+400MG+275MG | PACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X8.0 TABLET BLISTER |
| NDA/MAL/HDP/6744 | M.J.BIOPHARM PVT LTD | TATA UGANDA LIMITED | CEFTRIAXONE FOR INJECTION | CEFTRIAXONE | 1G | M.J.BIOPHARM PVT LTD-L-7 MIDC INDUSTRIAL AREA TALOYA NAVI MUMBAI | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/6745 | PACIFIC PHARMACEUTICALS LTD | HEALTHCARE LTD. | TYZORIN MOUTH WASH | TIBEZONIUM IODIDE | 0.05G/100ML | PACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTAN | PAKISTAN | TOPICAL EXTERNAL LIQUIDS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/6746 | KOPRAN LTD | TATA UGANDA LIMITED | FLUPEN-250 | FLUCLOXACILLIN SODIUM | 250MG | KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6747 | PACIFIC PHARMACEUTICALS LTD | HEALTHCARE LTD. | TYZORIN | TIBEZONIUM IODIDE | 5MG | PACIFIC PHARMACEUTICALS LTD-30TH KILOMETRE NULTAN ROAD LAHORE PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY LOZENGES | 1.0X4.0X6.0 LOZENGE STRIP |
| NDA/MAL/HDP/6748 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | IBUFLAMAR 200 | IBUPROFEN | 200MG | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/6749 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | IBUFLAMAR-P | IBUPROFEN+PARACETAMOL | 400MG+500MG | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6750 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | NYTIN | NYSTATIN | 500,000IU | KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/6751 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | METCHEK 850 | METFORMIN | 850MG | INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6752 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | VITACEE | ASCORBIC ACID | 100MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6753 | BLUE CROSS LABARATORIES LIMITED | STAR PHARMACEUTICALS LTD | TUSQ X SYRUP | TERBUTALINE+BROMHEXINE+GUAIFENESIN | 1.25MG+4MG+50MG/5ML | BLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6755 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | FLAMAR | METHYL NICOTINATE+MEPHENESIN+METHYL SALICYLATE+MENTHOL | 1%W/W+5%W/W+8%W/W+2%W/W | INDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722 | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/6756 | BETA HEALTHCARE | BETA HEALTHCARE UGANDA LIMITED | FEVERIX TOTO SUSPENSION | PARACETAMOL | 120MG/5ML | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/6757 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | OSTEOFLAM | DICLOFENAC SODIUM | 50MG | INDOCOS REMEDIES LTD-L-14 VERNA INDUSTRIAL AREA VENA GOA-403722 | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6758 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | ADCO-NAPAMOL | PARACETAMOL | 500MG | ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6759 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | BETAPYN | PARACETAMOL+CODEINE PHOSPHATE+DOXYLAMINE+CAFFEINE | 450 MG+10 MG+5 MG+50 MG | ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 2.0X9.0 TABLET BLISTER,6.0X9.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER |
| NDA/MAL/HDP/6760 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | RIFAMPACIN/ ISONIAZID DISPERSIBLE TABLET | RIFAMPACIN + ISONIAZID | 60 MG + 30 MG | MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/6761 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | DAWANOL TABLETS | PARACETAMOL+ACETYLSALICYLIC ACID+CAFFEINE | 200MG+300MG+30MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET CARTON |
| NDA/MAL/HDP/6762 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | FLUCOLD CAPSULES | MULTIINGREDIENT | NA | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6763 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | COMPRAL HEADACHE TABLETS | PARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS | 100MG+400MG+130MG | ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE
560099, KARNATAKA STATE, INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X48.0X2.0 TABLET STRIP |
| NDA/MAL/HDP/6765 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | IBUCACH 200 | IBUPROFEN | 200MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/6766 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | LOCAINE A | LIDOCAINE HYDROCHLORIDE+ADRENALINE | 21.33MG/1.8ML + 0.025MG/1.8ML | PHARMA-Q (PTY) LTD -50 COMMANDO ROAD INDUSTRIAL WEST, JOHANNESBURG | SOUTH AFRICA | PARENTERAL ORDINARY CARTRIDGES | 1.0X100.0X1.8 ML CARTRIDGE |
| NDA/MAL/HDP/6767 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | MEDI-KEEL A | BENZOCAINE+CETYLPYRIDINIUM CHLORIDE | 12MG+1.5MG | UNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL
ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ? 396 210 INDIA
| INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X8.0 LOZENGE BLISTER |
| NDA/MAL/HDP/6768 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | MEDI-KEEL A BLACKCURRANT | BENZOCAINE+CETYLPYRIDINIUM CHLORIDE | 12MG+1.5MG | UNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL
ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ? 396 210 INDIA
| INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X8.0 LOZENGE BLISTER |
| NDA/MAL/HDP/6769 | ADCOCK INGRAM LIMITED | UGANDA HEALTH MARKETING GROUP LIMITED | MEDI-KEEL A HONEY & LEMON | BENZOCAINE+CETYLPYRIDINIUM CHLORIDE | 12MG+1.5MG | UNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL
ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ? 396 210 INDIA
| INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X8.0 LOZENGE BLISTER |
| NDA/MAL/HDP/6771 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIFLUVID | FLUCONAZOLE | 150MG | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY CAPSULES | 1.0X4.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6772 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | PIOSAFE 30 | PIOGLITAZONE HCL | 30MG | ARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6773 | ARISTO PHARMACEUTICALS PVT LTD | NORVIK ENTERPRISES LIMITED | ACECLO | ACECLOFENAC | 100MG | ARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6774 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL FLEMIN EXPECTORANT | DIPHENHYDRAMINE HYDROCHLORIDE +AMMONIUM CHLORIDE | 12.5MG+130MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6775 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYSOLONE | PREDNISOLONE ACETATE | 1%W/V | IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI | KENYA | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/6776 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | M-FORLIN 500 | METFORMIN | 500MG | LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6777 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL FUSIDIC ACID | FUSIDIC ACID | 2%W/W | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE,1.0X15.0 G TUBE |
| NDA/MAL/HDP/6778 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | AXCEL IBUPROFEN | IBUPROFEN | 100MG/5ML | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/6780 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYTIMOL | TIMOLOL MALEATE | 0.5%W/V | IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI | KENYA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6781 | IND-SWIFT LTD | TATA UGANDA LIMITED | NETAZOX-500 | NITAZOXANIDE | 500MG | IND-SWIFT LIMITED-INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/6782 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYXOLOL | BETAXOLOL HYDROCHLORIDE | 0.5%W/V | IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI | KENYA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6783 | ABBVIE (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | FORANE | ISOFLURANE | 99.9%W/V | AESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM | UNITED KINGDOM | OTHER SYSTEMIC LIQUID INHALATIONS | 1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/6784 | IVEE INFUSIONS EPZ LTD | ASTRA PHARMA (U) LIMITED | IVYZOXAN | CIPROFLOXACIN HYDROCHLORIDE | 0.3%W/V | IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI | KENYA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6785 | IND-SWIFT LTD | TATA UGANDA LIMITED | NETAZOX DT | NITAZOXANIDE | 200MG | IND-SWIFT LIMITED-INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/6787 | IND-SWIFT LTD | TATA UGANDA LIMITED | NETAZOX | NITAZOXANIDE | 100MG/5ML | IND-SWIFT LIMITED-INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/6788 | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO) | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ROYAL VIT G | MULTI-INGREDIENTS | MULTI-INGREDIENTS | SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, S" OF OCTOBER CITY, EGYPT.
PO. BOX 43, OCTOBER CITY. POSTAL CODE NO.12566
| EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6789 | STRIDES ARCOLAB LTD | ROYAL PHARMA 2011 LIMITED | DICLOSAL | DICLOFENAC SODIUM | 75MG/3ML | STRIDES ARCOLAB LTD. -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X5.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/6790 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ABACUS PHARMA (AFRICA) LIMITED | LIMZER | OMEPRAZOLE + DOMPERIDONE | 20MG + 30MG | INVENTIA HEALTHCARE PVT. LTD-FI ? FI /1 ADDITIONAL AMBERNATH,
M.I.D.C. AMBERNATH (EAST) ? 421 506, DIST. THANE, INDIA
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/6792 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | PREZISTA | DARUNAVIR | 400MG | JANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778 | UNITED STATES | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/6793 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | NEST | AMINOPHYLLINE | 100MG | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/6794 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | ZOLID | LINEZOLID | 600MG | HETERO 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 FILM-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6795 | PHARAONIA PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CRONOMESONE OINTMENT | BETAMETHASONE VALERATE | 1%W/W | PHARAONIA PHARMACEUTICALS-NEW BORG EL ARAB CITY-ALEXANDRIA | EGYPT | TOPICAL EXTERNAL OINTMENTS | 1.0*15.0 G TUBE |
| NDA/MAL/HDP/6796 | SANCE LABORATORIES PVT LTD | DELMAW ENTERPRISES LIMITED | SANCEPH DS | CEPHALEXIN | 125MG/5ML | SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA,
INDIA.
| INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6797 | MARTINDALE PHARMACEUTICALS LTD | LABOREX UGANDA LIMITED | PETHIDINE INJECTION | PETHIDINE | 100MG/2ML | MARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/6806 | F. HOFFMANN- LA ROCHE | LABOREX UGANDA LIMITED | RECORMON | EPOETIN BETA | 2000 IU/0.3ML | ROCHE DIAGNOSTICS GMBH MANNHEIM -SANDHOFER STRABE 116, 68305, MANNHEIM | GERMANY | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X6.0X0.3 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/6807 | GLAXOSMITHKLINE LTD | ERIS LTD | AUGMENTIN ES | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 600MG + 42.9MG | GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE | FRANCE | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6808 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | GLYGEN-500 | METFORMIN HYDROCHLORIDE | 500MG | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6810 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | CERVARIX | HUMAN PAPILLOMA VIRUS VACCINE (RDNA) | TYPE 16 L1 PROTEIN + TYPE 18 L1 PROTEIN + 3-0-DESACYL-4'MONOPHOSPHORYL LIPID A(MPL) | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X10.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE) + A 25 GAUGE NEEDLE |
| NDA/MAL/HDP/6811 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | COVALSAR- DENK 160/12.5 | VALSARTAN + HYDROCHLOROTHIAZIDE | 160MG +12.5MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6812 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | NOFLOX | NORFLOXACIN | 0.3%W/V | ABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191 | UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/6813 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | COVALSAR- DENK 320/12.5 | VALSARTAN + HYDROCHLOROTHIAZIDE | 320MG +12.5MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6814 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | COVALSAR- DENK 80/12.5 | VALSARTAN + HYDROCHLOROTHIAZIDE | 80MG +12.5MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6815 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABCROM EYE DROPS | SODIUM CROMOGLYCATE | 2%W/V | ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE,
MUKONO
| UGANDA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/6817 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | LETROZOLE DENK 2.5 | LETROZOLE | 2.5MG | HAUPT PHARMA M?NSTER GMBH-SCHLEEBR?GGENKAMP 15
48159 M?NSTER
GERMANY
| GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6818 | SANOFI PASTEUR | LABOREX UGANDA LIMITED | IMOVAX POLIO | POLIO VIRUS; (MAHONEY) TYPE 1- INACTIVE + (MEF-1) TYPE 2- INACTIVE + (SAUKETT) TYPE 3-INACTIVE | 40 D + 8D + 32 D ANTIGEN UNITS/ 0.5ML | SANOFI PASTEUR-M?RIEUX 69280 MARCY L?ETOILE | FRANCE | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL |
| NDA/MAL/HDP/6820 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABBORI EAR DROPS | BORIC ACID | 1.83%W/V | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OTIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/6821 | LABOREX UGANDA LIMITED | LABOREX UGANDA LIMITED | MAGNESIUM SULPHATE INJECTION | MAGNESIUM SULPHATE | 50%W/V | MARTINDALE PHARMACEUTICAL LIMITED -BAMPTON ROAD RMM38UG ENGLAND | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/6823 | LABOREX UGANDA LIMITED | LABOREX UGANDA LIMITED | EPHEDRINE HYDROCHLORIDE | EPHEDRINE HYDROCHLORIDE | 30MG/ML | MARTINDALE PHARMACEUTICALS .-ROMFORD ESSEX RM3 8UG UK | UNITED KINGDOM | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/6826 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ZINC SULFATE | ZINC SULFATE | 20MG | MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13
MIDC, WALUJ INDUSTRIAL AREA,
AURANGABAD. ? 431136,
MAHARASHTRA STATE, INDIA.
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6832 | PFIZER LABORATORIES LTD | ERIS LTD | NIMENRIX | MENINGOCOCCAL POLYSACCHARIDE SEROGROUPS A, C, W-135 & Y CONJUGATE VACCINE | 1 DOSE (0.5ML) CONTAINS 5MCG OF POLYSACCHARIDE FOR NEISSERIA MENINGITIDIS SEROGROUPS A,C,W-135 & Y | GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART | BELGIUM | PARENTERAL ORDINARY VIALS | 1.0X1.0 DOSE VIAL + 1 PRE-FILLED SYRINGE |
| NDA/MAL/HDP/6833 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | ON.SENTRON-DENK 8MG ODT | ONDANSETRON | 8MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/6834 | GLAXO SMITH KLINE LTD | ERIS LTD | RELVAR ELLIPTA 100/25 | FLUTICASONE FUROATE + VILANTEROL | 100MCG + 25MCG | GLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK | UNITED KINGDOM | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X1.0 CANNISTER CARTON |
| NDA/MAL/HDP/6836 | GLAXO SMITH KLINE LTD | ERIS LTD | RELVAR ELLIPTA 200/25 | FLUTICASONE FUROATE + VILANTEROL | 200MCG + 25MCG | GLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK | UNITED KINGDOM | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X30.0 DOSE CANNISTER |
| NDA/MAL/HDP/6837 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEEL KIT | CLARITHROMYCIN + METRONIDAZOLE + PANTOPRAZOLE SODIUM SESQUIHYDRATE | 250MG + 400MG +40MG | THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET STRIP |
| NDA/MAL/HDP/6838 | TORRENT PHARAMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | MEMENTOR 10 | MEMANTINE HYDROCHLORIDE | 10MG | TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-282721 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6840 | MEDICAL UNION PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | LIPINORM | ATORVASTATIN CALCIUM TRIHYDRATE | 20MG | MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/6843 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | FYTOBACT | CEFOPERAZONE + SULBACTAM | 0.5 G + 0.5 G | CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/6844 | IDA FOUNDATION | JOINT MEDICAL STORE (UPMB - UCMB) | BENZOIC ACID + SALICYLIC ACID | BENZOIC ACID + SALICYLIC ACID | 6%W/W + 3%W/W | GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X40.0 G TUBE,1.0X800.0 G CONTAINER |
| NDA/MAL/HDP/6845 | CADILA PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | FYTOBACT 2G | SULBACTAM SODIUM + CEFOPERAZONE SODIUM | 1G + 1G | CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X2.0 G VIAL |
| NDA/MAL/HDP/6857 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | BRUCIPRO TABLETS | CIPROFLOXACIN | 500MG | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6859 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LTD | BRUVEL-500 TABLETS | LEVOFLOXACIN HEMIHYDRATE | 500MG | BRAWN LABORATORIES LTD.
ADDRESS :13, NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001, HARYANA - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X10X10 TABLET BLISTER |
| NDA/MAL/HDP/6862 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | DITS GEL | DICLOFENAC DIETHYLAMINE | 1%W/W | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X15.0 G TUBE,1.0X10.0 G TUBE |
| NDA/MAL/HDP/6865 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | DITS INJECTION | DICLOFENAC SODIUM | 25MG/ML | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/6870 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | HYDROSONE 100MG | HYDROCORTISONE SODIUM SUCCINATE | 100MG | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X5.0 ML VIAL |
| NDA/MAL/HDP/6871 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LTD | VIVAX 100 | SILDENAFIL CITRATE | 100MG | BRAWN LABORATORIES LTD.
ADDRESS :13, NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001, HARYANA - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X1X4 TABLET BLISTER |
| NDA/MAL/HDP/6872 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | NETRACORTIL EYE/EAR SUSPENSION | OXYTETRACYCLINE HYDROCHLORIDE +HYDROCORTISONE ACETATE+POLYMYXIN B SULPHATE | 10MG+5MG+10000I.U | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | OPHTHALMIC SUSPENSIONS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/6873 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LTD | ROXITHIN TABLETS | ROXITHROMYCIN | 150MG | BRAWN LABORATORIES LTD.
ADDRESS :13, NEW INDUSTRIAL TOWNSHIP, FARIDABAD-121 001, HARYANA - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X10X10 TABLET BLISTER |
| NDA/MAL/HDP/6874 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | CEZIN TABLETS | CETIRIZINE HYDROCHLORIDE | 10MG | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6875 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | BRUMOX-250 CAPSULES | AMOXICILLIN TRIHYDRATE | 250MG | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | ORAL SOLID ORDINARY CAPSULES | 10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6876 | INDOCO REMEDIES LTD | TATA UGANDA LTD | ALERCHEK | OLOPATADINE HYDROCHLORIDE | 0.1%W/W | INDOCO REMEDIES LIMITED
L-32, 33,34 VERNA INDUSTRIAL ESTATE
VERNA, GOA, 403 722 - INDIA | INDIA | OPHTHALAMIC SOLUTION | 1X1X5 ML VIAL |
| NDA/MAL/HDP/6881 | ASTRA LIFECARE (INDIA) PVT. LTD | ASTRA PHARMA (U) LIMITED | ASTRALEVOFLOXA | LEVOFLOXACIN | 500MG | ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABAD | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6897 | BROOKES PHARMACEUTICAL LABORATORIES L | HARLEYS UGANDA LIMITED | PYODINE GARGLE & MOUTH WASH | POVIDONE IODINE | 1G/100ML | BROOKES PHARMACEUTICALS LABORATORIES (PAKISTAN) LTD-PLOT 58 SECTOR 15 KORANGI
INDUSTRIAL AREA, KARACHI-PAKISTAN | PAKISTAN | ORAL TOPICAL LIQUIDS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/6914 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | PANZOLE TABLETS | PANTOPRAZOLE | 40MG | CORONA REMEDIES PVT LIMITED-VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH ? 173223. INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6921 | GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DUFENAC | DICLOFENAC SODIUM | 75MG | GUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES | 1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/6924 | I CARE PHARMA LIMITED | AIVEEN (U) LIMITED | NAC MR | DICLOFENAC POTASSIUM+PARACETAMOL+CHLORZOXAZONE | 50MG+325MG+250MG | CORONA REMEDIES PVT LIMITED-VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH ? 173223. INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6932 | PSYCHOTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | VALATE-200 | SODIUM VALPROATE | 200 MG | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6933 | PSYCHOTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | VALATE 500 | SODIUM VALPROATE BP | 500MG | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/6934 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | ANASTROZOLE 1 MG | ANASTROZOLE | 1MG | SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE 1, 39179 BARLEBEN, | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6935 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | SIMVASTATIN 40 MG | SIMVASTATIN | 40MG | SANDOZ GRUP SAGLIK .-GEBZE 2 GOSB IHSAN DEDE CAD. 900. SOK 41480 GEBZE KOCAELI | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6948 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | D3 MUST 60 K | CHOLECALCIFEROL | 60000IU | MANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/6970 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND ORAL SOLUTION | ONDANSETRON | 4MG/5ML | MANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/6974 | MANKIND PHARMA LIMITED | TATA UGANDA LIMITED | VOMIKIND-MD 4 | ONDANSETRON | 4MG | MANKIND PHARMA LIMITED, UNIT-II. -VILLAGE KISHANPURA, P.O JAMNIWALA, PAONTA SAHIB IN H.P. | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6985 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | COLDRID SYRUP | CETIRIZINE DIHYDROCHLORIDE + PHENYLEPHRINE HCL + PARACETAMOL | 2.5MG + 5MG + 125MG | MEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/6986 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | REPRAZ 20 TABLETS | RABEPRAZOLE SODIUM | 20MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6987 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | PORAZ CAPSULES | OMEPRAZOLE | 20MG | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES | 1.0X10.0X10.0 CAPSULE STRIP |
| NDA/MAL/HDP/6997 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | EC-PRAM 10 | ESCITALOPRAM OXALATE | 10MG | HETERO 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 TABLETS | 1.0X3.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/6999 | CIRON DRUGS & PHARMACEUTICAL PVT LTD | ROYAL PHARMA 2011 LIMITED | NYSTATIN ORAL SUSPENSION | NYSTATIN | 100000 UNITS/5ML | MEPRO PHARMACEUTICALS LTD-N-118, N-119, N-113, MIDC TARAPUR, BOISAR DIST: THANE-401 506 MAHARASHTRA, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/7004 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | DUOCETZ | PARACETAMOL+TRAMADOL HYDROCHLORIDE | 325MG+37.5MG | MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED..-515/1 MOO 4, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG | THAILAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7012 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | MYHEP DVIR | DACLATASVIR + SOFOSBUVIR | 60MG + 400MG | MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON,
SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X28.0 TABLET BOTTLE |
| NDA/MAL/HDP/7013 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AZITHRAA 500 | AZITHROMYCIN | 500MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/7014 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | ACEAAR 100 TABLET | ACECLOFENAC | 100MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/7015 | KOPRAN LIMITED | TATA UGANDA LIMITED | LOKIT | OMEPRAZOLE | 20MG | KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7021 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PINNOFEC PLUS | ACECLOFENAC+PARACETAMOL | 100MG+500MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7022 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PINNAFLAM PLUS | DICLOFENAC SODIUM+PARACETAMOL | 50MG+500MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7023 | EXPHAR SA. | SURGIPHARM (U) LIMITED | VERZOL ORAL SUSPENSION | ALBENDAZOLE | 200 MG / 5 ML | GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/7024 | EXPHAR SA. | SURGIPHARM (U) LIMITED | MICOZAL | KETOCONAZOLE | 2%W/W | GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/7029 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | LIPIZAR 20 | ATORVASTATIN CALCIUM (TRIHYDRATE) | 20MG | ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR ? 441501,
DIST. NAGPUR,
MAHARASHTRA,
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7030 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GOODMAN INTERNATIONAL LTD | ADOL EXTRA | PARACETAMOL+CAFFEINE | 500MG+65MG | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/7035 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | GLYPRIDE 3MG | GLIMEPIRIDE | 3MG | GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7046 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | XEMADERM 0.1% CREAM | MOMETASONE FUROATE | 0.1%W/W | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | TOPICAL EXTERNAL CREAMS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/7047 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | XEMADERM0.1% OINTMENT | MOMETASONE FUROATE | 0.1%W/W | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | TOPICAL EXTERNAL OINTMENTS | 1.0X30.0 G TUBE |
| NDA/MAL/HDP/7050 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | PANDERM SKIN OINTMENT | NYSTATIN+NEOMYCIN SULFATE+GRAMICIDIN+TRIAMCINOLONE | 10,000,000I.U+2.5MG+0.25MG+1MG | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/7051 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | DEXIPAN CREAM | DEXPANTHENOL | 0.05%W/W | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | TOPICAL EXTERNAL CREAMS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/7053 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | KETOVID CREAM | KETOCONAZOLE | 2%W/W | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/7055 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | VIREST 400 | ACICLOVIR | 400MG | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 5.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/7057 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | VIREST CREAM 5% | ACICLOVIR | 5%W/W | HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | TOPICAL EXTERNAL CREAMS | 1.0X5.0 G TUBE |
| NDA/MAL/HDP/7063 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | GRISEOFULVIN 500MG FILM-COATED TABLET | GRISEOFULVIN | 500MG | HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7070 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIABETMIN 1000 MG FILM-COATED TABLET | METFORMIN HYDROCHLORIDE | 1000MG | HOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7071 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | FORACORT-200 | FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE | 6MCG + 200MCG | CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA. | INDIA | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/7074 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | FORACORT-100 | FORMETEROL FUMARATE DIHYDRATE + BUDESONIDE | 6 MCG+100 MCG | CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA. | INDIA | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/7077 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | FORACORT-400 | FORMOTEROL FUMARATE DIHYDRATE + BUDESONIDE | 6MCG + 400MCG | CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA. | INDIA | LUNG ADMINISTRATION METERED-DOSE POWDER INHALER | 1.0X1.0X120.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/7078 | ICPA HEALTH PRODUCTS LTD | METRO PHARMACEUTICALS LIMITED | HEXIDINE? | CHLORHEXIDINE GLUCONATE | 0.2 %W/V | ICPA HEALTH PRODUCTS LIMITED-286/287, GIDC, ANKLESHWAR-393002.
GUJARAT, INDIA.
| INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X160.0 ML BOTTLE |
| NDA/MAL/HDP/7088 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LTD - WILSON | PINNOX 200 | OFLOXACIN | 200MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7090 | BHARAT SERUMS AND VACCINES LIMITED, | GITTOES PHARMACEUTICALS LIMITED | ENDOPROST | CARBOPROST TROMETHAMINE | 125MCG/0.5ML | BHARAT SERUMS & VACCINES LTD.-PLOT NO. K?27, JAMBIVILI VILLAGE,
ANAND NAGAR, ADDITIONAL M.I.D.C., AMBERNATH (EAST)-INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/7091 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARLEFLOX 500 TABLETS | LEVOFLOXACIN HEMIHYDRATE | 500MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7093 | PHARCO PHARMACEUTICALS LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DECLOPHEN 25 MG INFANTILE SUPPOSITORIES | DICLOFENAC SODIUM | 25MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/7096 | GAMA PHARMACEUTICALS (U) LIMITED | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DEXAPHEN SYRUP | DEXAMETHASONE + CHLORPHENIRAMINE MALEATE | 10MG + 40MG/100ML | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/7098 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | ACEFORCE SP | ACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE | 100MG+325MG+15MG | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7100 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | COMBIART 80/480MG | ARTEMETHER + LUMEFANTRINE | 80MG + 480MG | STRIDES SHASUN LIMITED --36/7, SURAGAJAKKANAHALLI,
INDLAVADI CROSS, ANEKAL TALUK,
BANGALORE ? 562 106
INDIA | INDIA | ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES | 1.0X6.0 SACHET CARTON |
| NDA/MAL/HDP/7101 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | ASTHAREN | SALBUTAMOL SULPHATE | 4MG | RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7102 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REPRAZINE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7105 | CACHET PHARMACEUTICALS PVT LIMITED | ASTRA PHARMA (U) LIMITED | TRAMACETAL TABLETS | ACETAMINOPHEN +TRAMADOL HYDROCHLORIDE | 325MG+37.5MG | CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7106 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REVIVE | GLUCOSE ANHYDROUS + TRISODIUM CITRATE DIHYDRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE | 13.5G + 2.9G + 2.6G + 1.5G | RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA | UGANDA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X1.0 SACHET CARTON |
| NDA/MAL/HDP/7111 | INDOCO REMEDIES LIMITED | TATA UGANDA LIMITED | MOFLOREN ED | MOXIFLOXACIN HYDROCHLORIDE | 5MG/ML | INDOCO REMEDIES LTD---L-32, 33 & 34, VERNA IND. AREA, VERNA GOA-403722 | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/7123 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | MARTINEZ 10 | MONTELUKAST SODIUM | 10MG | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7124 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | VITAMIN E 400 MG. | VITAMIN E | 400 MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X2.0X12.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7128 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | COTRIKANT-960 | SULFAMETHOXAZOLE+ TRIMETHOPRIM | 800MG + 160MG | S KANT HEALTHCARE LIMITED. PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7130 | LIFEPHARM FZE | AIVEEN (U) LTD - WILSON ROAD | HEMOVIT CAPSULES | DRIED FERROUS SULPHATE + FOLIC ACID | 150MG +500MCG | ESKAYEF BANGLADESH LTD--400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH
| BANGLADESH | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7136 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | AMIKACIN 100 MG / 2ML | AMIKACIN SULPHATE | 100MG/2ML | EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO. E.I.P.C.O --10TH OF RAMADAN CITY ? INDUSTRIAL AREA B1- P.O BOX: 149 TENTH - EGYPT | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X1.0X2.0 ML VIAL |
| NDA/MAL/HDP/7139 | LIFEPHARM FZE | AIVEEN (U) LIMITED | COLDIFED SYRUP | PSEUDOEPHEDRINE HYDROCHLORIDE+HYTRIPROLIDINE HYDROCHLORIDE | 30MG+1.25MG/5ML | LIFEPHARMA FZE .-JEBEL ALI -DUBAI UAE | UNITED ARAB EMIRATES | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/7146 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | SUNTAC | RANITIDINE HYDROCHLORIDE | 150 MG | SUNRISE INTERNATIONAL LABS LTD.-PLOT NO. 100, LANE 5, SECTOR II, PHASE II
IDA CHERLAPALLY, HYDERABAD-500 051 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7147 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | BIMAT | BIMATOPROST | 0.03% W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X3.0 ML VIAL |
| NDA/MAL/HDP/7148 | SUNRISE INTERNATIONAL LABS LTD | ROYAL PHARMA 2011 LIMITED | OMEPSUN | OMEPRAZOLE | 20 MG | SUNRISE INTERNATIONAL LABS LTD.-PLOT NO. 100, LANE 5, SECTOR II, PHASE II
IDA CHERLAPALLY, HYDERABAD-500 051 | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7149 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | OLOPAT OD | OLOPATADINE HYDROCHLORIDE | 0.2% W/V | AJANTA PHARMA LIMITED-N-118, 119, MIDC, TARAPUR BOISAR, DIST. THANE 401506, MAHARASHTRA STATE, INDIA
| INDIA | OPHTHALMIC DROPS | 1.0X1.0X3.0 ML VIAL |
| NDA/MAL/HDP/7151 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | APDROPS DX | MOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE SODIUM PHOSPHATE | 5MG+1MG/ML | AJANTA PHARMA LIMITED-N-118, 119, MIDC, TARAPUR BOISAR, DIST. THANE 401506, MAHARASHTRA STATE, INDIA
| INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL |
| NDA/MAL/HDP/7153 | EXIR PHARMACEUTICAL COMPANY. | UNEED GLOBAL GROUP LIMITED | TYLOPHEN? | ACETAMINOPHEN | 120MG/5ML | EXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRAN | IRAN | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/7154 | ABARIS HEALTHCARE PVT. LTD | ROYAL PHARMA 2011 LIMITED | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | 2MG/ML | ABARIS HEALTHCARE PVT LTD - -SURVEY NO. 1407-11, VILLAGE RAJPUR, TALUKA KADI DIST. MEHSANA, GUJARAT-382740 | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7157 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | LINEZOLID TABLETS 600MG | LINEZOLID | 600MG | CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL
ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH ? 454 775, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BOTTLE,1.0X20.0 TABLET CONTAINER |
| NDA/MAL/HDP/7162 | ACG PHARMAPACK PVT. LTD | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | TEXAVIR | TENOFOVIR DISOPROXIL FUMARATE | 300MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/7164 | CIPLA LTD | QUALITY CHEMICALS LTD | ARTEMETHER /LUMEFANTRINE 60MG/360MG | ARTEMETHER + LUMEFANTRINE | 60MG + 360MG | CIPLA LIMITED - UNIT I,
VILLAGE UPPER MALPUR,
P.O. BHUD, TEHSIL NALAGARH,
DISTRICT SOLAN,
HIMACHAL PRADESH 173205,
INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1X30X6 TABLET BLISTERS |
| NDA/MAL/HDP/7166 | CIPLA LTD | QUALITY CHEMICALS LTD | ARTEMETHER /LUMEFANTRINE 40MG/240MG | ARTEMETHER + LUMEFANTRINE | 40MG + 240MG | CIPLA LIMITED - UNIT I,
VILLAGE UPPER MALPUR,
P.O. BHUD, TEHSIL NALAGARH,
DISTRICT SOLAN,
HIMACHAL PRADESH 173205,
INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1x30x6 TABLET BLISTERS |
| NDA/MAL/HDP/7175 | PSYCHOTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | TELPIL A 40/5 MG | TELMISARTAN + AMLODIPINE BESYLATE | 40MG + 5MG | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7189 | ACULIFE HEALTHCARE | SUPER MEDIC LTD | MERONIR | MEROPENEM SODIUM | 1000MG | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*20ML AMPOULE OF WFI |
| NDA/MAL/HDP/7202 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | VILDAGLIPTIN | VILDAGLIPTIN | 50MG | NOVARTIS 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 TABLETS | 1.0X4.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/7209 | BROOKES PHARMA (PRIVATE) LIMITED | JEET PHARMACEUTICALS LIMITED | MINOXIN SOLUTION | MINOXIDIL | 2%W/V | BROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/7210 | STRIDES SHASUN LIMITED | DELMAW ENTERPRISES LIMITED | ARTECAP | ARTESUNATE | 100MG | STRIDES SHASUN LIMITED --36/7, SURAGAJAKKANAHALLI,
INDLAVADI CROSS, ANEKAL TALUK,
BANGALORE ? 562 106
INDIA | INDIA | RECTAL SYSTEMIC CAPSULES | 1.0X1.0X2.0 SUPPOSITORY BLISTER,1.0X1.0X6.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/7212 | PHARMACO DISTRIBUTION (PTY) LTD | ECHO PHARMACY (U) LIMITED | PHARMALGAN | PARACETAMOL | 10MG/ML | AMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7217 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARPANTO 40 | PANTOPRAZOLE | 40MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7218 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARTMIN 500 | METFORMIN | 500MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7219 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOXONE -1 G | CEFTRIAXONE | 1G | THEON PHARMACEUTICALS LTD.-VILLAGE SAINI MAJRA, TEHSIL NALAGARH DIST, SOLAN- 174101,
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/7227 | NATIONAL HEALTHCARE PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | NEMADOL 50 | TRAMADOL HYDROCHLORIDE | 50MG | NATIONAL HEALTHCARE PVT. LTD.-(WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPAL | NEPAL | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7228 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | AMOXICILLIN 250MG DISPERSIBLE TABLETS | AMOXICILLIN TRIHYDRATE | 250 MG | SANDOZ GMBH BIOCHEMISTRASSE 10-6250 KUNDL, AUSTRIA | AUSTRIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7229 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | AARCIFLOX 500 | CIPROFLOXACIN | 500MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7230 | NATIONAL HEALTHCARE PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | HISTABLOC 2ML | RANITIDINE HYDROCHLORIDE | 25MG/ML | NATIONAL HEALTHCARE PVT. LTD.--WORKS: STERILE BLOCK CHHATAPIPRA-3, BARA, NEPAL | NEPAL | PARENTERAL ORDINARY VIALS | 1.0X10.0X2.0 ML VIAL |
| NDA/MAL/HDP/7231 | NATIONAL HEALTHCARE PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | LIGNAT 2% | LIDOCAINE HYDROCHLORIDE | 2% W/V | NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA | NEPAL | PARENTERAL ORDINARY VIALS | 1.0X30.0 ML VIAL |
| NDA/MAL/HDP/7233 | NATIONAL HEALTHCARE PVT LTD | ANDYCO PHARMACY (UGANDA) LTD | MIZOVA | MIDAZOLAM | 1MG/ML | NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA NEPAL | NEPAL | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL |
| NDA/MAL/HDP/7238 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-10 | NEBIVOLOL HYDROCHLORIDE | 10MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7241 | EXPHAR SA. | SURGIPHARM (U) LIMITED | GENTASOL | GENTAMICIN SULFATE | 0.3%W/V | AHLCON PARENTERAL (I) LTD.--SP-918,BHLWADI (RAJ) INDIA M.LIC.: RAJ 2002 | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/7243 | BAL PHARMA LIMITED | HEALTHCARE LTD. | EMTRIM | TRIMETHOPRIM + SULPHAMETHOXAZOLE | 80MG+ 400MG | BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR
UDHAM SINGH NAGAR, RUDRAPUR-263153
UTTARAKHAND-INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7244 | MANKIND PHARMA LTD | TATA UGANDA LTD | CEFAKIND-250 | CEFUROXIME AXETIL | 250MG | COPMED PHARMACEUTICAL PVT. LTD., UNIT-II
PLOT NO.50, GONDPUR INDUSTRIAL AREA, PAONTA SAHIB, DIST. SIRMOUR,
HIMACHAL PRADESH-173025 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X1X10 TABLET BLISTER |
| NDA/MAL/HDP/7246 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | GAMA PHARMACEUTICALS (U) LIMITED | DESLORAT | DESLORATIDINE | 5MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/7248 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | GAMA PHARMACEUTICALS (U) LIMITED | ESOMELODAN 20 | ESOMEPRAZOLE | 20MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7249 | EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES | GAMA PHARMACEUTICALS (U) LIMITED | ESOMELODAN 40 | ESOMEPRAZOLE MAGNESIUM | 40MG | EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT | EGYPT | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7255 | ACULIFE HEALTHCARE | SUPER MEDIC LTD | NIRIXONE | CEFTRIAXONE SODIUM | 1000MG | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*1 10ML WFI AMPOULE |
| NDA/MAL/HDP/7257 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | PAARPIN TABLET | PARACETAMOL | 650 MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7258 | GILEAD SCIENCE INC | MEDICAL ACCESS (UGANDA) LIMITED | DESCOVY 200MG/10MG | EMTRICITABINE + TENOFOVIR ALAFENAMIDE | 200MG/10MG | PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9,ROTTENDORF PHARMA GMBH-OSTENFELDER STRA?E 51-61,59320 ENNIGERLOH,GERMANY | CANADA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/7263 | NIPRO MIDDLE EAST FZE | ROYAL PHARMA 2011 LIMITED | VERMIKIL TABLET | ALBENDAZOLE | 400MG | NIPRO JMI PHARMA LTD.-CHAUDDAGRAM, COMILLA
BANGLADESH
| BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X25.0X1.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/7264 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | MIOPAN PLUS SUSPENSION | MAGALDRATE+SIMETHICONE | 540MG + 40MG/5ML | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7266 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ATAZANAVIR SULFATE AND RITONAVIR TABLETS | ATAZANAVIR SULFATE + RITONAVIR USP | 300 MG + 100 MG | CIPLA LTD(PATALGANGA)-CIPLA LIMITED,
PLOT NO. A-42 (UNIT II),MIDC,PATALGANGADISTRICT - RAIGAD, MAHARASHTRA,INDIA
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/7269 | EXPHAR SA. | SURGIPHARM (U) LIMITED | FEBRILEX SYRUP | PARACETAMOL+DEXTROMETORPHAN HYDROBROMIDE+CHLORPHENAMINE MALEATE | 125MG+5MG+1MG/5 ML | GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN) | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE |
| NDA/MAL/HDP/7274 | CIPLAQCIL | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | ZENTAIR 0.5MG | ENTECAVIR | 0.5MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7284 | ?LKO ?LA? SANAYI VE TICARET A. ?. | CORE ACCESS LTD | LIVERCOL 10 | ROSUVASTATIN CALCIUM | 10MG | ?LKO ?LA? SANAYI VE TICARET A. ?.-3. 42050
SEL?UKLU / KONYA
TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/7286 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | TOBRIN OPHTHALMIC OINTMENT | TOBRAMYCIN | 3MG/G | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B
EGYPT
| EGYPT | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE |
| NDA/MAL/HDP/7287 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | EPISTIGMIN 0.05% | NEOSTIGMINE METHYLSULPHATE | 0.05%W/V | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPT | EGYPT | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/7288 | MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | KETESSE FILM COATED TABLETS | DEXKETOPROFEN TROMETAMOL | 25MG | A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILA | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7291 | PHARCO PHARMACEUTICALS | GAMA PHARMACEUTICALS (U) LIMITED | DERMATIN CREAM | CLOTRIMAZOLE | 1%W/W | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | TOPICAL EXTERNAL CREAMS | 1.0X12.0 G TUBE |
| NDA/MAL/HDP/7293 | ?LKO ?LA? SANAYI VE TICARET A. ?. | CORE ACCESS LTD | ALRINAST | DESLORATADINE | 5MG | ?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1
SEL?UKLU / KONYA | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7298 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | NEBILONG-2.5 | NEBIVOLOL HYDROCHLORIDE | 2.5 MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7299 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | CLOTINEX 60 | ENOXAPARIN SODIUM | 60MG/PRE-FILLED SYRINGE | SQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 PREFILLED SYRINGE CARTON |
| NDA/MAL/HDP/7301 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | PACLITERO 300 | PACLITAXEL | 6 MG/ML | HETERO LABS LIMITED
UNIT VI, APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JEDCHERLA (MANDAL) MAHABOOB NAGER (DISTRICT) ANDHRA PRADESH-509 301 INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X50.0 ML VIAL |
| NDA/MAL/HDP/7304 | PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD.) | ROYAL PHARMA 2011 LTD | GABAZURE | GABAPENTIN | 300MG | ZIM LABORATORIES LTD.
B-21/22, M.I.D.C. AREA,
KALMESHWAR ? 441 501,
DIST. NAGPUR,
MAHARASHTRA,
INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X2X10 TABLET BLISTERS |
| NDA/MAL/HDP/7305 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | PACLITERO 30 | PACLITAXEL | 6 MG/ML | HETERO LABS LIMITED
UNIT VI, APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JEDCHERLA (MANDAL) MAHABOOB NAGER (DISTRICT) ANDHRA PRADESH-509 301 INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL |
| NDA/MAL/HDP/7306 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | PACLITERO 100 | PACLITAXEL | 6 MG/ML | HETERO LABS LIMITED
UNIT VI, APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JEDCHERLA (MANDAL) MAHABOOB NAGER (DISTRICT) ANDHRA PRADESH-509 301 INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X16.7 ML VIAL |
| NDA/MAL/HDP/7309 | SQUARE PHARMACEUTICALS LTD | GAMA PHARMACEUTICALS (U) LIMITED | BECLOMIN 250 HFA INHALER | BECLOMETASONE DIPROPIONATE | 250 ?CG/PUFF | SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR ? 1750, BANGLADESH | BANGLADESH | LUNG ADMINISTRATION METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/7312 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE OINTMENT 5%W/W | POVIDONE IODINE | 5%W/W | G.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | TOPICAL EXTERNAL OINTMENTS | 1.0X15.0 G TUBE,1.0X125.0 G TUBE,1.0X250.0 G JAR |
| NDA/MAL/HDP/7313 | PANACEA BIOTEC LTD | STAR PHARMACEUTICALS LTD | EASYFIVE-TT (FULLY LIQUID PENTAVALENT VACCINE) | DIPHTHERIA TOXOID + TETANUS TOXOID + INACTIVATED W-B, PERTUSSIS + HBSAG + HIB (PRP-TT) | 30 IU + 60 IU + 4 IU + 10MCG + 10 MCG | PANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH ? 173 205 | INDIA | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/7319 | DROGSAN ?LA?LARI SAN. VE TIC. A.?. | BUFFALO HEALTH CARE LTD | SIPROSAN 500 | CIPROFLOXACIN HYDROCHLORIDE | 500MG | DROGSAN ?LA?LARI SAN. VE TIC. A.?.-ESENBOGA MERKEZ MAH CUBUK CAD NO.31 CUBUK ANKARA -TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/7324 | MEDREICH PLC | SURGIPHARM (U) LTD, | AMOXICILLIN DISPERSIBLE TABLETS 250MG | MOXICILLIN TRIHYDRATE | 250MG | MEDREICH LIMITED, 12TH MILE, OLD MADRAS ROAD, VIRGONAGAR,
BANGALORE - 560 049.
KARNATAKA, INDIA. | INDIA | DISPERSIBLE TABLET | 1X10X10, 1X1X10 TABLET BLISTERS |
| NDA/MAL/HDP/7325 | DROGSAN ?LA?LARI SAN. VE TIC. A.?. | BUFFALO HEALTHCARE LTD | DALMAN AQ NASAL SPRAY | FLUTICASONE PROPIONATE | 0.05%W/V | DROGSAN ?LA?LARI SAN. VE TIC. A.?. --ESENBO?A MERKEZ MAH. ?UBUK CADDESI NO: 31
06760 ANKARA - TURKEY | TURKEY | NASAL SYSTEMIC UNIT DOSE AEROSOLS | 1.0X1.0X120.0 METERED DOSE BOTTLE |
| NDA/MAL/HDP/7328 | DROGSAN ?LA?LARI SAN. VE TIC. A.?. | BUFFALO HEALTHCARE LTD | CARDIOSAN 10MG | AMLODIPINE BESILATE | 10MG | DROGSAN ?LA?LARI SAN. VE TIC. A.?.-ESENBOGA MERKEZ MAH CUBUK CAD NO.31 CUBUK ANKARA -TURKEY | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7329 | DAWA LIMITED | SUPER MEDIC LTD | ACEPAR- MR | PARACETAMOL +ACECLOFENAC+CHLORZOXAZONE | 500 MG+100 MG +375 MG | DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7334 | IPCA LABORATORIES LTD | SURGIPHARM (U) LIMITED | ETOVA 400 | ETODOLAC | 400MG | IPCA LABORATORIESLIMITED-IPCA LABORATORIES LTD P.O SEJANTA DISTRICT RATLAM 457002 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7335 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE 5% | POVIDONE IODINE | 5%W/V | G.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/7336 | MODI NUNDIPHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE GERMICIDE GARGLE 2% MINT | POVIDONE IODINE | 2%W/V | G.S PHAMBUTOR PVT LTD-G.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | ORAL TOPICAL LIQUIDS | 1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7337 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | PREZISTA 150 | DARUNAVIR | 150MG | JANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778 | UNITED STATES | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X240.0 TABLET BOTTLE |
| NDA/MAL/HDP/7339 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ADERAN 16 | CANDESARTAN CILEXETIL | 16 MG | AJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7342 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | ZEALARGY | RUPATADINE FUMERATE | 10 MG | CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7344 | ACULIFE HEALTHCARE | SUPER MEDIC LTD | HEPANIR | HEPARIN SODIUM | 1000IU/ML | ACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X5.0 ML VIAL |
| NDA/MAL/HDP/7346 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | REZN TABLETS | ZINC SULFATE MONOHYDRATE | 20MG | RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA | UGANDA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7348 | MSD (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ISENTRESS 25 MG | RALTEGRAVIR POTASSIUM | 25MG | PATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA,MERCK SHARP & DOHME BV.-WAARDERWEG 39
HAARLEM, - 2031 BN, NETHERLANDS,MSD (PTY) LTD. -117-16TH ROAD, HALFWAY HOUSE, 1685
SOUTH AFRICA | UNITED STATES | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/7351 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | TRYFIX CV DS | CEFIXIME+CLAVULANIC ACID | 50MG+31.25MG | TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7353 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE XR 500MG | METFORMIN HYDROCHLORIDE | 500MG | MERCK KGAA--FRANKFURTER STR. 250
64293 DARMSTADT
GERMANY,MERCK SANT? S.A.S.-2 RUE DU PRESSOIR VERT
45400 SEMOY
FRANCE | GERMANY | ORAL SOLID RETARD TABLETS | 1.0X6.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/7355 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ARTEFAN SUSPENSION | ARTEMETHER+LUMEFANTRINE | 180MG+1080MG | AJANTA PHARMA LIMITED.-B-41516, MIDC INDUSTRIAL AREA,
PAITHAN, AURANGABAD-431 148 DIST: AURANGABAD MAHARASHTRA,INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/7356 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIABETMIN TABLET 500MG | METFORMIN HYDROCHLORIDE | 500MG | HOVID BERHAD-121, JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X20.0 TABLET BLISTER |
| NDA/MAL/HDP/7357 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | PAMAGIN-C SYRUP | CETIRIZINE HYDROCHLORIDE+DEXTROMETHORPHAN HYDROBROMIDE+ACETAMINOPHEN+PHENYLEPHRINE HYDROCHLORIDE+ZINC GLUCONATE+MENTHOL | 2.5MG+7.5MG+125MG+5MG+7.5MG+2.5MG/5ML | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/7359 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | TATA UGANDA LIMITED | INDCLAV 625 | AMOXICILLIN+CLAVULANATE POTASSIUM | 500MG+125MG | INDCHEMIE HEALTH SPECIALITIES PVT LTD-VILLAGE THANA TEHSIL BADDI DIST SOLAN HIMACHAL PRADESH 173 205
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7362 | RESONANT PHARMACEUTICALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | TRAM-DOL-50 | TRAMADOL HYDROCHLORIDE | 50MG | ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7363 | INDCHEMIE HEALTH SPECIALITIES PVT. LTD. | TATA UGANDA LIMITED | INDCLAV 228 | AMOXICILLIN+CLAVULANATE POTASSIUM | 200MG+28MG/5ML | INDCHEMIE HEALTH SPECIALITIES PVT. LTD.-VILLAGE & P.O ? THANA, TEHSIL ? BADDI,
DIST- SOLAN, HIMACHAL | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7364 | ?LKO ?LA? SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | MOKSEFEN 400 MG | MOXIFLOXACIN HYDROCHLORIDE | 400MG | ?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1
SEL?UKLU / KONYA | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/7365 | AUROCHEM PHAMACEAUTICALS (1) LTD) | SUPER MEDIC LTD | DOLOACT MR | PARACETAMOL+ DICLOFENAC POTASSIUM+CHLORZOXAZONE | 500 MG+50 MG+250 MG | KARALEX PHARMA-58, PALGHAR TALUKA,
INDUSTRIAL CO.-OP. ESTATE LTD.PALGHAR ?INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7366 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | TRYFIX | CEFIXIME | 200MG | TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/7367 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | TRYFIX 100 DS | CEFIXIME | 100MG/5ML | TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7369 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | XOMOX CV DS | AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE | 200MG+28.5MG/5ML | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7370 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | XOMOX CV 625 | AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE | 500MG+125MG | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/7376 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | XOMOX CV 375 | AMOXICILLIN+POTASSIUM CLAVULANATE | 250MG+125MG | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/7377 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | XOMOX DS | AMOXICILLIN TRIHYDRATE | 125MG/5ML | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7378 | AURONEXT PHARMA PRIVATE LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ERTAPIK | ERTAPENEM SODIUM | 1 G | AURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/7379 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | TRYDROX 250 | CEFADROXIL | 250MG | TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/7380 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | TRYDROX DS | CEFADROXIL | 125MG/5ML | TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7381 | MODI MUNDI PHARMA PVT LTD | SURGIPHARM (U) LIMITED | BETADINE ANTISEPTIC CREAM 5% | POVIDONE-IODINE | 5%W/W | G.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X10.0 G TUBE |
| NDA/MAL/HDP/7384 | YURIA PHARM LTD | YURIA PHARM EAST AFRICA LIMITED | TIVORTIN | ARGININE HYDROCHLORIDE | 42MG/ML | YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE | UKRAINE | PARENTERAL ORDINARY AMPOULES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7385 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | TRYOXIM DS | CEFUROXIME AXETL | 125MG/5ML | TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7386 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | TRYLEXIN 125 DS | CEFALEXIN MONOHYDRATE | 125MG/5ML | TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7388 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | TRYFIX CV 200 | CEFIXIME+CLAVULANIC ACID | 200MG+125MG | TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/7396 | GILEAD SCIENCE INC | MEDICAL ACCESS (UGANDA) LIMITED | HARVONI | SOFOSBUVIR+LEDIPASVIR | 400 MG+90 MG | PATHEON INC-MISSISSAUGA,ON L5N 7K9 CANADA | CANADA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X28.0 TABLET BOTTLE |
| NDA/MAL/HDP/7406 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ARENA | ADRENALINE | 0.1% W/V | LINCOLN PARENTERAL LTD -11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/7410 | MEDOPHARM, INDIA | PLANET PHARMACEUTICALS UGANDA LTD | COTRIMOXAZOLE TABLETS BP 960 MG | TRIMETHOPRIM +SULPHAMETHOXAZOLE | 960MG | MEDOPHARM --34 B, INDUSTRIAL AREA, MALUR - 563160,
KARNATAKA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/7421 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | GESIC ADL 200 | IBUPROFEN | 200MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7422 | CODAL-SYNTO LTD | RENE PHARMACY LTD | SYNTOCLAV 625MG | AMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM | 500MG+125MG | MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7424 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | ZINC SULFATE TABLETS USP 20MG | ZINC SULFATE MONOHYDRATE | 20MG | MACLEODS PHARMACEUTICALS LTD - - VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA 174101
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7431 | WIN-MEDICARE PVT. LTD | SURGIPHARM (U) LTD | MOVICOL | POLYETHYLENE GLYCOL + SODIUM CHLORIDE + SODIUM BICARBONATE + POTASSIUM CHLORIDE | 13.125G + 350.7MG + 178.5MG + 46.6MG /SACHET | WIN-MEDICARE PVT. LTD
MODIPURAM - 250 110,
UTTAR PRADESH, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1X10X13.81G, SACHETS |
| NDA/MAL/HDP/7441 | VIRCHOW HEALTHCARE PVT LTD | SURGIPHARM (U) LIMITED | HYORTH XL | SODIUM HYALURONATE | 8MG/ML | VIRCHOW BIOTECH PVT LTD-SURVEY NO. 172, PART GAGILLAPUR(P) QUTHBULLAPUR(MANDAL), R.R, DISTRICT, TELANGANA STATE, 500043.INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X6.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/7446 | AXA PARENTERALS LTD | GITTOES PHARMACEUTICALS LIMITED | CIPLUME | CIPROFLOXACIN HYDROCHLORIDE | 0.3% W/V | AXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/7449 | CIPLAQCIL | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | LAMIVUDINE/ TENOFOVIR DF 300/300MG | LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE | 300MG+300MG | CIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/7453 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ANTIDIAZOX | NITAZOXANIDE | 100MG/5ML | GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/7469 | BROOKES PHARMA (PRIVATE) LIMITED | HARLEYS UGANDA LIMITED | ECZEMUS 0.03% OINTMENT | TACROLIMUS MONOHYDRATE | 0.03%W/W | BROOKES PHARMA (PRIVATE) LIMITED-58-59, SECTOR NO. 15, KORANGI INDUSTRIAL AREA, KARACHI-74900 | PAKISTAN | TOPICAL EXTERNAL OINTMENTS | 1.0X1.0X10.0 G TUBE |
| NDA/MAL/HDP/7475 | UNI MEDICO LAB | SHREEJI PHARMACEUTICALS LIMITED | UMOCLOX 500 | AMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM | 250MG+250MG | UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7478 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | SIMVASTATIN 20 MG FILM-COATED TABLETS | SIMVASTATIN | 20MG | SANDOZ GRUP SAGLIK -GEBZE 2 GOSB IHSAN DEDE CAD. 900. SOK 41480 GEBZE KOCAELI | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7481 | ACCORD HEALTH CARE LTD | NORVIK ENTERPRISES LIMITED | SILDENAFIL ACCORD 100 | SILDENAFIL CIRATE | 100MG | INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/7488 | ACCORD HEALTH CARE LTD | NORVIK ENTERPRISES LIMITED | FINASTERIDE 5MG | FINASTERIDE | 5MG | INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/7490 | ACCORD HEALTH CARE LTD | NORVIK ENTERPRISES LIMITED | SILDENAFIL ACCORD 50 | SILDENAFIL CITRATE | 50MG | INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/7491 | DENK PHARMA GMBH & CO | BENLE CONSULT LIMITED | CIPRO-DENK 750 | CIPROFLOXACIN HYDROCHLORIDE | 750MG | ALLPHAMED PHARBIL ARZNEIMITTEL GMBH. -HILDEBRANDSTRABE 12 37081 GOTTINGEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7504 | KHANDELWAL LABORATORIES PVT. LTD. | SURGIPHARM (U) LTD | IMATINATE 400 | IMATINIB MESYLATE | 400MG | KHANDELWAL LABORATORIES PVT. LTD.
PLOT B-1, WAGLE INDUSTRIAL ESTATE,
THANE- 400 604. MAHARASHTRA INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1X1X10 CAPSULE CONTAINER |
| NDA/MAL/HDP/7523 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | LEVOFLOX-DENK 5 MG/ML | LEVOFLOXACIN HEMIHYDRATE | 5MG/ML | SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH--INDUSTRIESTR. 3 34212 MELSUNGEN GERMANY | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML VIAL |
| NDA/MAL/HDP/7531 | LINCOLN PHARMACEUTICALS LTD | ABACUS PARENTERAL DRUGS LIMITED | FRUSO | FUROSEMIDE | 10MG/ML | LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
| INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/7533 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ASUNATE 60 | ARTESUNATE | 60MG | LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1*5ML 0.9%W/W SODIUM CHLORIDE SOLUTION AMPOULE + 1*1ML 5.0%W/W SODIUM BICARBONATE SOLUTION AMPOULE |
| NDA/MAL/HDP/7536 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | NETVAICAIN | BUPIVACAINE HYDROCHLORIDE + DEXTROSE | 5MG + 80MG /ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X10.0X4.0 ML AMPOULE,1.0X10.0X4.0 ML AMPOULE |
| NDA/MAL/HDP/7539 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | COUGH LINCTUS | CHLORPHENIRAMINE | 2MG/5ML | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1000.0 ML JERRYCAN,1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/7541 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | CHLORHEXIDINE SCRUB | CHLORHEXIDINE GLUCONATE | 4%W/V | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X1000.0 ML JERRYCAN |
| NDA/MAL/HDP/7544 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | GLYCERIN OF BORAX | GLYCERINE+BORAX | 12%W/V | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X22.0 ML BOTTLE |
| NDA/MAL/HDP/7546 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | HYDROGEN PEROXIDE | HYDROGEN PEROXIDE | 6%W/V | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/7548 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | IODINE TINCTURE | IODINE + POTASSIUM IODIDE | 2.5%W/V+2.5%W/V | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X22.0 ML BOTTLE |
| NDA/MAL/HDP/7552 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | MAGNESIUM TRISILICATE MIXTURE | MAGNESIUM TRISILICATE + LIGHT MAGNESIUM CARBONATE + SODIUM BICARBONATE | 250MG + 250MG + 250MG/5ML | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/7554 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | POVIDONE IODINE BP | POVIDONE IODINE | 10%W/V | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE,1.0X1000.0 ML JERRYCAN |
| NDA/MAL/HDP/7556 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | SEVASTAT | CETRIMIDE + CHLORHEXIDINE | 3%W/V+0.3%W/V | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X1.0 L BOTTLE |
| NDA/MAL/HDP/7559 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | SURGICAL SPIRIT | METHYL SALICYLATE | 0.5%V/V | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL SPIRITS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7560 | SEV PHARMACEUTICALS LTD | SEV PHARMACEUTICALS LIMITED | VIOLGENT | CRYSTAL VIOLET | 0.5%W/V | SEV PHARMACEUTICALS LIMITED-PLOT 100 NALUKOLONGO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X25.0 ML BOTTLE |
| NDA/MAL/HDP/7569 | STRIDES SHASUN LIMITED . | DELMAW ENTERPRISES LIMITED | ARCOMETER | ARTEMETHER | 80MG/ML | STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD
BANGALORE 560076
INDIA
| INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X6.0 ML AMPOULE,1.0X1.0X8.0 ML AMPOULE |
| NDA/MAL/HDP/7571 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | NEUROVIT FILM-COATED TABLET | THIAMINE MONONITRATE + PYRIDOXINE HCL + CYANOCOBALAMINE | 97MG + 50MG + 100MG | HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7575 | ACME FORMULATION PVT. LTD. | MARIE STOPES UGANDA LIMITED | MEDIPRIST | MIFEPRISTONE | 200MG | ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7594 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | HYDROCHLOROTHIAZIDE 25MG TABLETS | HYDROCHLOROTHIAZIDE | 25MG | SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE 1, 39179 BARLEBEN, | GERMANY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER |
| NDA/MAL/HDP/7597 | CODAL-SYNTO LTD | RENE PHARMACY LTD | SYNTOCLAV | AMOXICILLIN SODIUM + CLAVULANIC ACID | 1000MG + 200MG | MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS | CYPRUS | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.2 G VIAL |
| NDA/MAL/HDP/7606 | ANKUR DRUGS AND PHARMA LTD | JOINT MEDICAL STORE (UPMB - UCMB) | KELVIMOL 500 | PARACETAMOL | 500MG | ANKUR DRUGS AND PHARMA LTD- UNIT I-VILLAGE ? MANAKPUR, PO ? LODHIMAJRA, NALAGARH DIST.
SOLAN (HP) ? 174 101(INDIA)
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7611 | FERRING GMBH | MACNAUGHTON LIMITED | PABAL | CARBETOCIN | 100MCG/ML | FERRING GMBH.-11, WITTLAND | GERMANY | PARENTERAL ORDINARY VIALS | 1.0X5.0X1.0 ML VIAL |
| NDA/MAL/HDP/7612 | PSYCHTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | SOTHREX -BR | TERBUTALINE SULFATE+BROMHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL | 2.5MG+8MG+100MG+5MG/10ML | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7613 | PSYCHTROPICS INDIA LTD | ABACUS PHARMA (AFRICA) LIMITED | KETOPIL | KETOCONAZOLE | 2%W/V | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | TOPICAL EXTERNAL LIQUID SOAPS/WASHES | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7617 | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | EFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG/300 MG /300 MG | EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 600 MG + 300 MG + 300 MG | CIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/7631 | ADWIA | WIDE SPECTRUM ENTERPRISES (U) LIMITED | AMADOL 100MG SR TABLET | TRAMADOL HYDROCHLORIDE | 100MG | ADWIA CO. S.A.E-10TH OF RAMADAN CITY, INDUSTRIAL AREA A2, EGYPT | EGYPT | ORAL SOLID RETARD TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7632 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | BISOPROLOL 2.5 MG FILM-COATED TABLETS | BISOPROLOL FUMARATE | 2.5MG | LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW
| POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/7634 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | BISOPROLOL | BISOPROLOL | 5 MG | LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW
| POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X25.0 TABLET BLISTER |
| NDA/MAL/HDP/7635 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | BISOPROLOL 10MG FILM-COATED TABLETS | BISOPROLOL FUMARATE | 10MG | LEK S.A-95 - 010 STRYK?W, PODLIPIE 16, POLAND,SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE | POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X25.0 TABLET BLISTER |
| NDA/MAL/HDP/7649 | SAKAR HEALTHCARE LIMITED | TATA UGANDA LIMITED | PARABUFEN SUSPENSION | IBUPROFEN + PARACETAMOL | (100MG + 162.5MG)/5ML | SAKAR HEALTHCARE LIMITED-BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY,
VILL: CHANGODAR, DIST: AHMEDABAD-382213,
GUJARAT ? INDIA. | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/7651 | MSD (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | JANUVIA 25 | SITAGLIPTIN | 25MG | MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685 | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/7652 | MSD (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | JANUVIA 100 | SITAGLIPTIN | 100MG | MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685 | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/7653 | MSD (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | JANUVIA 50 | SITAGLIPTIN | 50MG | MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685 | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/7656 | A.MENARINI INDUSTRIE FARMACEUTICHE RIUNITE | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | SPASMOMEN | OTILONIUM BROMIDE | 40MG | A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA CAMPO DI PILE, L?AQUILA (AQ), ITALY | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/7660 | SPECPHARM (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TENEMCOM | EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | 200MG + 300MG | HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/7663 | CIPLAQCIL | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | ZENTAIR | ENTECAVIR MONOHYDRATE | 1.0MG | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7667 | SAGA LABORATORIES | SUPER MEDIC LTD | ZIMYCIN 500 | AZITHROMYCIN DIHYDRATE | 500MG | SAGA LABORATORIES--SURVEY NO.198/2 & 198/3 CHACHRAWADI VASNA, TAL; SANAND AHMEDABAD 382210. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/7670 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | DICHLOR 50 | CHLORTHALIDONE | 50MG | IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7671 | IPCA LABORATORIES LTD | MEDVIN PHARMA LIMITED | DICHLOR-25 | CHLORTHALIDONE | 25MG | IPCA LABORATORIES LTD,PLOT NO. T-139 -SEJAVTA, RATLAM-457 002 (M.P.) INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7673 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | VALSARTAN | VALSARTAN | 80MG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/7674 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABLEVOX | LEVOFLOXACIN HEMIHYDRATE | 5G/L | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7675 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | VALSARTAN | VALSARTAN | 160MG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN | SPAIN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/7681 | ZEE PHARMACEUTICALS LTD | ZEE PHARMACEUTICALS LIMITED | ZEECEL 200 | CELECOXIB | 200MG | THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7683 | GLOBAL NAPI PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DELAREX | DESLORATADINE | 5MG | GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA, | EGYPT | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7686 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OPTGENT | GENTAMICIN SULPHATE | 0.3W/V | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/7688 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE 850MG TABLET | METFORMIN HYDROCHLORIDE | 850MG | NKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA | SOUTH AFRICA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X300.0 TABLET CONTAINER,1.0X60.0 TABLET CONTAINER,1.0X4.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/7689 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | CUFO LOZENGES(LEMON) | 2, 4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESOL | 1.2MG + 0.6MG | UNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL
ESTATE, AIRPORT ROAD, KADAIYA, DAMAN ? 396 210 INDIA
| INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X12.0 LOZENGE BLISTER |
| NDA/MAL/HDP/7692 | UNOSOURCE PHARMA LTD. | ESCORTS PHARMACEUTICALS LIMITED | CEFECTRON-S 1.5 G | CEFOPERAZONE SODIUM+SULBACTAM SODIUM | 1000MG + 500MG | AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.5 G VIAL + 1*10 ML LDPE AMPOULE OF SWFI |
| NDA/MAL/HDP/7695 | UNOSOURCE PHARMA LTD. | ESCORTS PHARMACEUTICALS LIMITED | CORTUM 500 | CEFUROXIME AXETIL | 500MG | AKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7701 | VISSCO REHAILITATION AIDS PVT LTD | KIMSY MEDS LTD | FLUCONAZOLE TABLETS 200 MG | FLUCONAZOLE | 200 MG | MYLAN LABORATORIES LIMITED, ?-PLOT NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA AURANGABBAD- 431136 MAHARASTRA STATE, INDIA. ? | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/7706 | CACHET PHARMACEUTICALS PVT LIMITED | ASTRA PHARMA (U) LIMITED | CACEF 200 | CEFPODOXIME PROXETIL | 200MG | ALKEM LABORATORIES LIMITED -VILLAGE- THANA BADDI, YEH
NALAGAR, DISTRICT SOLAN, HIMACHAL PRADESH
INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/7707 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | ZOLIGLIT 15 | PIOGLITAZONE | 15MG | AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BLISTER |
| NDA/MAL/HDP/7708 | LEBEN LABORATORIES PVT.LTD | ANDYCO PHARMACY (UGANDA) LTD | LAMPYKLOX CAPSULES | AMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM | 250MG+250MG | LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC,
AKOLA? 444 104 (MS).
| INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7709 | NITIN LIFESCIENCES LTD | HEALTHCARE LTD. | DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | 8MG/2ML | NITIN LIFESCIENCES LTD--RAMPUR ROAD PAONTA SAHIB DIST. SIRMOUR (H.P) 173 025 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X50.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/7710 | MYLAN LABORATORIES LIMITED. | KIMSY MEDS LTD | FLUCONAZOLE | FLUCONAZOLE | 50MG | MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13
MIDC, WALUJ INDUSTRIAL AREA,
AURANGABAD. ? 431136,
MAHARASHTRA STATE, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/7711 | HOVID BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | DIABETMIN 850 MG | METFORMIN HYDROCHLORIDE | 850MG | HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7715 | JANSSEN-CILAG INTERNATIONAL NV | LABOREX UGANDA LIMITED | SIRTURO | BEDAQUILINE FUMARATE | 100MG | RECIPHARM PHARMACEUTICALS PVT LTD-34TH KM, TUMKUR ROAD, T-BEGUR, NELAMANGALA TALUK BENGALURU, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X188.0 TABLET BOTTLE |
| NDA/MAL/HDP/7716 | CORE ACCESS LIMITED | CORE ACCESS LTD | ALRINAST 2.5 MG / 5 ML SYRUP | DESLORATIDINE | 2.5 MG / 5 ML | ?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1
SEL?UKLU / KONYA | TURKEY | ORAL LIQUID ORDINARY SYRUPS | 1.0X150.0 ML BOTTLE |
| NDA/MAL/HDP/7721 | SANOFI-AVENTIS KENYA | LABOREX UGANDA LIMITED | MAALOX LEMON FLAVORING | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE | 175MG + 200MG + 25MG/ 5ML | NATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANY | GERMANY | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X250.0 ML BOTTLE,1.0X355.0 ML AMPOULE |
| NDA/MAL/HDP/7722 | SANOFI-AVENTIS KENYA | LABOREX UGANDA LIMITED | MAALOX MINT FLAVORING | ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE | 175MG + 200MG/ 5ML | NATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANY | GERMANY | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X355.0 ML BOTTLE,1.0X250.0 ML AMPOULE |
| NDA/MAL/HDP/7724 | FERRING GMBH | MACNAUGHTON LIMITED | MENOPUR | HIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] | 75 IU + 75 IU/ 4ML VIAL | FERRING (PTY) LTD-WITTLAND II 24146 KIEL | GERMANY | PARENTERAL ORDINARY DRY VIALS | 10.0X4.0 ML VIAL 10*1ML CLEAR COLOURLESS GLASS AMPOULES CONTAINING 9.0MG/ML OF NACL |
| NDA/MAL/HDP/7726 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 100MG + 25MG | MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/7727 | SANDOZ KENYA LTD | SURGIPHARM (U) LIMITED | BIODROXIL 500MG/5ML | CEFADROXIL | 500MG/5ML | SANDOZ GMBH BIOCHEMISTRASSE 10-6250 KUNDL, AUSTRIA | AUSTRIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/7728 | NORVATIS PHARMA SERVICES INC. | SURGIPHARM (U) LIMITED | LINEX | LACTOBACILLUS ACIDOPHILUS + BIFIDOBACTERIUM INFANTIS + ENTEROCOCCUS FAECIUM | 1.2 * 10 TO POWER 7 COLONY FORMING UNITS OF VIABLE LACTIC ACID BACTERIA SPECIES | LEK PHARMACEUTICALS-D.D VEROV?KOVA 57, 1526 LJUBLJANA SLOVENIA | SLOVENIA | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X8.0 CAPSULE BLISTER |
| NDA/MAL/HDP/7735 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | IBUMOL 400 | PARACETAMOL + IBUPROFEN | 325MG + 400MG | AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7740 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | METHICOWEL 1500 | METHYLCOBALAMIN | 1500 MCG/ML | AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/7745 | UNOSOURCE PHARMA LTD. | ESCORTS PHARMACEUTICALS LIMITED | TAZOGARD | PIPERACILLIN + TAZOBACTAM | 4G + 0.5G | AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0x4.5 G Vial ,2X10ML LDPE AMPOULES OF WFI |
| NDA/MAL/HDP/7747 | UNOSOURCE PHARMA LTD. | ESCORTS PHARMACEUTICALS LIMITED | THERMODOL | PARACETAMOL | 1.0%W/V | AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7751 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | UNODEX COUGH SYRUP | BROMHEXINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + AMMONIUM CHLORIDE | 8MG + 10MG + 100MG | AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7760 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | OZACE MD 10 | OLANZAPINE | 10MG | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND,PSYCHOTROPICS INDIA LTD PLOT--NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7764 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS-H 40/12.5 | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7784 | DAFRA PHARMA GMBH | LABOREX UGANDA LIMITED | LORATOL | LORATADINE | 5MG/5ML | NOBEL ILAC DUZCE-SANAYIINVE TICARET A.S SANCAKLAR 81100 DUZCE | TURKEY | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7828 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | DIZTROL 24 | BETAHISTINE DIHYDROCHLORIDE | 24MG | AUROBINDO PHARMA LIMITED, UNIT ? III-SURVEY NO.:113 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7903 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | MELMET-1000SR | METFORMIN HYDROCHLORIDE | 1000MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID RETARD COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7905 | NABIQASIM INDUSTRIES (PVT) LTD. | JEET PHARMACEUTICALS LIMITED | ACEFYL | ACEFYLINE PIPERAZINE + DIPHENHYDRAMINE HYDROCHLORIDE | 45MG +8MG | NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN | PAKISTAN | ORAL LIQUID ORDINARY SYRUPS | 1.0X120.0 ML BOTTLE |
| NDA/MAL/HDP/7906 | AXA PARENTERALS LTD | GITTOES PHARMACEUTICALS LIMITED | IVMOL | PARACETAMOL | 10MG/ML | AXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA. | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/7907 | BHARAT SERUMS AND VACCINES LIMITED, | GITTOES PHARMACEUTICALS LIMITED | HUCOG 5000 HP | CHORIONIC GONADOTROPHIN | 5000 I.U/ VIAL | BHARAT SERUMS & VACCINES LIMITED -PLOT NO. K-27, ADDITIONAL MIDC,
AMBERNATH (E) MAHARASHTRA STATE 421501
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X5000.0 I.U VIAL + 1*1ML 0.9%W/V NACL AMBER GLASS AMPOULE |
| NDA/MAL/HDP/7909 | SANOFI-AVENTIS KENYA | LABOREX UGANDA LIMITED | LANTUS | INSULIN GLARGINE | 100 UNITS/ML | SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY | GERMANY | PARENTERAL ORDINARY S C VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/7910 | SANOFI-AVENTIS KENYA | LABOREX UGANDA LIMITED | LANTUS | INSULIN GLARGINE | 100 UNITS/ML | SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY | GERMANY | PARENTERAL ORDINARY CARTRIDGES | 1.0X5.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/7911 | SANOFI-AVENTIS KENYA | LABOREX UGANDA LIMITED | LANTUS SOLOSTAR | INSULIN GLARGINE | 100 UNITS/ML | SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY | GERMANY | PARENTERAL ORDINARY PRE-FILLED PENS | 1.0X5.0X3.0 ML PREFILLED PEN |
| NDA/MAL/HDP/7912 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | GLIMEWEL M-1 | GLIMEPIRIDE + METFORMIN HYDROCHLORIDE | 1MG + 500MG | AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/7928 | MACK BROWN PHARMACEUTICALS PVT LIMITED | SHURIK LTD | COLDROP HERBAL COUGH SYRUP | MULTINGREDIENT | MULTINGREDIENT | META HERBALS PVT LTD-G-523, G.I.D.C, LODHIKA, VILLAGE METODA, KALAWAD ROAD, DISTRICT RAJKOT, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8007 | BAYER AG | SURGIPHARM (U) LIMITED | ADALAT RETARD | NIFEDIPINE | 20MG | BAYER PHARMA AG-D-51368 LEVERKUSEN, GERMANY | GERMANY | ORAL SOLID RETARD OTHER COATED TABLETS | 6.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8009 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | GRISO-500 | GRISEOFULVIN | 500MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8010 | COSMOS LTD. | ASTRA PHARMA (U) LIMITED | METROZOLE TABLETS | METRONIDAZOLE | 200MG | COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/8015 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | D-FEN | DICLOFENAC SODIUM | 25MG/ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/8021 | CIPLA LIMITED | QUALITY CHEMICALS LTD - HUMAN | LAMIVIR-150 TABLETS | LAMIVUDINE | 150MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8022 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE | 30MG +50MG + 60MG | CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8023 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | AMOXICLAV-DENK 500/62.5 | AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE | 500 MG + 62.5 MG | PENCEF PHARMA GMBH-BRITENBACHSTR ASSE 13 D-13509 BERLIN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X8.0 TABLET BLISTER |
| NDA/MAL/HDP/8032 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ABACAVIR SULFATE/LAMIVUDINE | ABACAVIR SULFATE + LAMIVUDINE | 600 MG + 300 MG | CIPLA LTD-A-33 & A-37/2/2 MIDC PATALGANGA 410220 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8043 | DAFRA PHARMA GMBH | LABOREX UGANDA LIMITED | RABEZOL | RABEPRAZOLE SODIUM | 20MG | B?L?M PHARMACEUTICALS-GOSB 41480 GEBZE-KOCAEL?/TURKE | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8061 | PFIZER LABORATORIES (PTY) LTD | LABOREX UGANDA LIMITED | LYRICA 25MG | PREGABALIN | 25 MG | PFIZER GMBH ARZEIMITELWORK -MOOSWADALLE 179090, FREIBERG GERMANY | GERMANY | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X14.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8062 | PFIZER LABORATORIES (PTY) LTD BELGIUM | LABOREX UGANDA LIMITED | PROSTIN E2 | DINOPROSTONE | 3MG | PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS | BELGIUM | VAGINAL TABLETS | 1.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/8063 | PFIZER LABORATORIES (PTY) LTD ITALY | LABOREX UGANDA LIMITED | UNASYN 1.5 | AMPICILLIN + SULBACTAM | 1000 MG + 500 MG | HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE | ITALY | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X1.5 G VIAL |
| NDA/MAL/HDP/8073 | NOVARTIS PHARMA AG | SURGIPHARM (U) LIMITED | TRILEPTAL | OXCARBAZEPINE | 300MG | NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X50.0 TABLET CONTAINER |
| NDA/MAL/HDP/8078 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | APMOD 100/270 | ARTESUNATE + AMODIAQUINE | 100 MG + 270 MG | AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X6.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/8080 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CEFTONE | CEFTRIAXONE | 1G | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION |
| NDA/MAL/HDP/8082 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ABACAVIR SULFATE + LAMIVUDINE | ABACAVIR SULFATE + LAMIVUDINE | 60MG + 30MG | MYLAN LABORATORIES LIMITEDD ,-F-4 & F-12,MIDC,
MALEGAON,SIRRRRAR, NASHIK -422113
MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8084 | AGILA SPECIALTIES PRIVATE LIMITED | KIMSY MEDS LTD | TAZPEN | PIPERACILLIN + TAZOBACTAM | 4+0.5 G/VIAL | MYLAN LABORATORIES LIMITED(BETA LACTAM DIVISION)-NO. 152/6, 154/16 DORESANIPALYA, BILEKAHALLI, BANNERGHATTA ROAD BANGALORE - 560 076 INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X4.5 G VIAL |
| NDA/MAL/HDP/8085 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | CIPROL-500 | CIPROFLOXACIN | 500MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA | UGANDA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8087 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ONDEM INJECTION 4MG/2ML | ONDANSETRON | 4MG/2ML | ALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8088 | ALKEM LABORATORIES LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ONDEM INJECTION 8MG/4ML | ONDANSETRON | 8MG/4ML | ALKEM LABORATORIES LTD-VILLAGE ? THANA, BADDI TEHSIL ? NALAGARH, DIST-SOLAN (HP), INDIA ? 173205 | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X4.0 ML AMPOULE |
| NDA/MAL/HDP/8089 | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KAM-AMOXY | AMOXYCILLIN | 250MG | KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA | UGANDA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/8091 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | RENEGEL SUSPENSION | ALUMINIUM HYDROXIDE+MAGNESIUM TRISILICATE | 120MG+250MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8092 | LABORATORY & ALLIED LTD | HARLEYS UGANDA LIMITED | KEMOXYL 250MG | AMOXYCILLIN | 250MG | LABORATORY & ALLIED LTD-PLOT NO. 209/10349
OFF MOMBASA ROAD, NAIROBI
P.O. BOX 42875, NAIROBI, KENYA.
| KENYA | ORAL SOLID ORDINARY CAPSULES | 1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8093 | CIPLA LTD | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | DUOVIR-N | ZIDOVUDINE + LAMIVUDINE + NEVIRAPINE | 300MG + 150MG + 200MG | CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8095 | DENK PHARMA GMB H &CO. KG | BENLE CONSULT LIMITED | COLOSAR-DENK 100/12.5 | LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE | 100MG + 12.5MG | DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8096 | ABACUS PHARMA (A) LTD. | ABACUS PHARMA (AFRICA) LIMITED | BENZALIN | BENZATHINE BENZYLPENICILLIN SODIUM | 2.4MEGA/ VIAL | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100 | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0 VIAL CARTON |
| NDA/MAL/HDP/8097 | SERUM INSTITUTE OF INDIA LTD. | NORVIK ENTERPRISES LIMITED | REPOITIN 5000 | ERYTHROPOIETIN | 5000IU/ 0.5ML | SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X6.0X0.5 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/8100 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | AMPICLOX | AMPICILLIN/ CLOXACILLIN | 250MG/5ML | MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8103 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | WELQUINE 500 | LEVOFLOXACIN | 500MG | AKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8104 | ABACUS PHARMA (AFRICA) LIMITED | ABACUS PHARMA (AFRICA) LIMITED | TELPRESS 40 | TELMISARTAN | 40MG | PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8105 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | XERIN | LEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM | 5MG + 10MG | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8106 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | PLENMOXI | MOXIFLOXACIN HYDROCHLORIDE | 0.4%W/V | AKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8107 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | WELRAB 20 | RABEPRAZOLE SODIUM | 20MG | AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8108 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORS | GLUCOSE ANHYDROUS+TRISODIUM CITRATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE | 6.75G + 1.45G + 1.3G + 0.75G | : MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE
POSTAL ADDRESS : P.O.BOX 5917, KAMPALA.
| UGANDA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.0X25.0 G SACHET |
| NDA/MAL/HDP/8109 | ABACUS PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | IRON FOLATE | FERROUS IRON + FOLIC ACID | 65MG + 0.4MG | MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE ?IV,
INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8110 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | R.B.TONE SYRUP | MULTI-INGREDIENT | N/A | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X200.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8112 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | MOXICLAV | AMOXICILLIN + CLAVULANIC ACID | 156.25MG/5ML | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY.-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8113 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | MOXICLAV FORTE | AMOXICILLIN + CLAVULANIC ACID | 312.5MG/5ML | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA | CYPRUS | ORAL SOLID ORDINARY POWDERS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8115 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LAMIVUDINE | LAMIVUDINE | 150MG | MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8116 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | 200MG + 300MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8118 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 200MG + 50MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X120.0 TABLET BOTTLE |
| NDA/MAL/HDP/8119 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | 50MG/ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/8120 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | ABT | ALPHA-BETA ARTEETHER | 75MG/ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X3.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8121 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | SWISSQUINE | QUININE | 300MG/ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8123 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | MYCIDAC- C | MYCOBACTERIUM W (HEAT KILLED) + SODIUM CHLORIDE | 0.5 *10 TO POWER 9 BACILLI + 0.9%W/V | CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT | INDIA | PARENTERAL RETARD I M PRE-FILLED SYRINGES | 1.0X0.2 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/8124 | RENE PHARMACY(R) LTD.. | RENE PHARMACY LTD | CODEINE PHOSPHATE | CODEINE PHOSPHATE | 30 MG | CYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X100.0 TABLET BOTTLE |
| NDA/MAL/HDP/8125 | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD | KIMSY MEDS LTD | MATADOR | LEVOFLOXACIN | 500MG | DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD, -NA?UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN | JORDAN | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/8127 | SWISS PARENTERALS PVT. LTD. | SHREEJI PHARMACEUTICALS LIMITED | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% W/V | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X30.0 ML VIAL |
| NDA/MAL/HDP/8128 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | ATOREG 10 | ATORVASTATIN CALCIUM | 10MG | AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8129 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | ATOREG 20 | ATORVASTATIN CALCIUM | 20MG | AIZANT DRUG RESEARCH SOLUTIONS PVT LTD.-SY. N0. 172 & 173,PARK ROAD, DULAPALLY VILLAGE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8130 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | DEGRA 100 | SILDENAFIL CITRATE | 100MG | DEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/8131 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | DEGRA | SILDENAFIL CITRATE | 50MG | DEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/8132 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | ZOLIGLIT 30 | PIOGLITAZONE HYDROCHLORIDE | 30MG | AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8133 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | MYHEP | SOFOSBUVIR | 400MG | MYLAN LABORATORIES LIMITEDD ,-F-4 & F-12,MIDC,
MALEGAON,SIRRRRAR, NASHIK -422113
MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X28.0 TABLET BOTTLE |
| NDA/MAL/HDP/8134 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | SALPRAZ 40 | PANTOPRAZOLE | 40MG | AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA | INDIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/8135 | BAL PHARMA LIMITED | SHREEJI PHARMACEUTICALS LIMITED | REGAMOL | PARACETAMOL | 500MG | BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR
UDHAM SINGH NAGAR, RUDRAPUR-263153
UTTARAKHAND-INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8137 | IDA FOUNDATION | KIMSY MEDS LTD | DIAZEPAM | DIAZEPAM | 10MG | GLAND PHARMA LIMITED-D. P PALLY NARSAPUR ROAD, HYDERABAD ?
500 043, INDIA
| INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8140 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | FUROSEMIDE | FUROSEMIDE | 40MG | SANDOZ PVT LTD.--MIDC IND, AREA KALWE BLOCK VILLAGE DIGHE NAVI MUMBAI 400708 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X25.0 TABLET BLISTER |
| NDA/MAL/HDP/8142 | BAYER EAST AFRICA LTD | SURGIPHARM (U) LIMITED | XARELTO | RIVAROXABAN | 2.5MG | BAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8143 | NAARI LTD | ECHO PHARMACY (U) LIMITED | LYDIA POSTPIL | LEVONORGESTREL | 1.5MG | NAARI 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 TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/8144 | NAARI LTD | ECHO PHARMACY (U) LIMITED | MA KARE | MIFEPRISTONE + MISOPROSTOL | 200MG+ 200MCG | NAARI 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 TABLETS | 1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/8145 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DENK- AIR 10 | MONTELUKAST SODIUM | 10MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8146 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DENK- AIR JUNIOR 4 | MONTELUKAST SODIUM | 4MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8147 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | DENK- AIR JUNIOR 5 | MONTELUKAST SODIUM | 5 MG | DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING | GERMANY | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8148 | SPARSH BIO-TECH PVT LTD | ABACUS PHARMA (AFRICA) LIMITED | FLUCLOXACILLIN | FLUCLOXACILLIN | 500MG | SPARSH BIO-TECH PVT. LTD.--PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR ? 361006 GUJARAT INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8149 | GLAXO SMITHKLINE LTD | ERIS LTD | AVODART | DUTASTERIDE | 0.5MG | GLAXOSMITHKLINE PHARMACEUTICALS SA .-GRUNWALDZKA 189 STREET, 60-322 POZNANA
| POLAND | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8150 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | JAKAVI | RUXOLITINIB | 20MG | NOVARTIS PHARMA STEIN AG-CH. 4002 STEIN, SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8151 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGO-C (THANE) | VITAMIN C | 100MG | AGOG 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 TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/8152 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | JAKAVI | RUXOLITINIB | 15MG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8154 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | AGOGCORT | HYDROCORTISONE ACETATE | 1%W/W | AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA | INDIA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/8155 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | JAKAVI | RUXOLITINIB | 5MG | NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND | SWITZERLAND | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8156 | TATA UGANDA LIMITED | GITTOES PHARMACEUTICALS LIMITED | DIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE | DIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE | 25 LF (? 30 IU)+5.5 LF (? 40 IU)+16 IOU (? 4.0 IU)+12.5MCG+11MCG | BIOLOGICAL 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 I M VIALS | 1.0X48.0X0.5 ML VIAL (1 DOSE VIAL),1.0X24.0X5.0 ML VIAL (10 DOSE VIAL) |
| NDA/MAL/HDP/8157 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | D LYTE- PLAIN | ANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE + POTASSIUM CHLORIDE | 13.50G + 2.60G + 2.90G +1.50G/ 1L | 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 POWDERS | 1.0X20.5 G SACHET |
| NDA/MAL/HDP/8158 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | GLIMEPIRID SANDOZ | GLIMEPIRIDE | 3MG | LEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATES | POLAND | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8159 | AUROBINDO PHARMA LIMITED (UNIT III) | GITTOES PHARMACEUTICALS LIMITED | LOPINAVIR + RITONAVIR | LOPINAVIR + RITONAVIR | 100MG + 25MG | AUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8160 | FOUNTIL LIFE SCIENCES PVT LTD. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ULGICID (CHERRY FLAVOUR) | ALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE | 200MG+250MG+250MG+250MG+125MG/15ML | STEDMAN PHARMACEUTICALS PVT LTD...-C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/8162 | BHARAT SERUMS AND VACCINES LTD | GITTOES PHARMACEUTICALS LIMITED | HUMOG 75 HP | HIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] /150 I.U | 75 IU + 75 IU/ 150 I.U VIAL | BHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 1*1 ML AMPOULE OF 0.9%W/V NACL |
| NDA/MAL/HDP/8163 | MODI-MUNDIPHARMA PVT. LTD | SURGIPHARM (U) LTD | BETADINE SURGICAL SCRUB | POVIDONE-IODINE | 7.5%W/W | G.S. PHARMBUTOR PVT. LTD.,
B-172, INDUSTRIAL AREA,
BEHROR-301 701, RAJASTHAN, INDIA | INDIA | TOPICAL SOLUTION | 1X1X50ML, 1X500ML, PET BOTTLE |
| NDA/MAL/HDP/8164 | INDOCO REMEDIES LTD | TATA UGANDA LIMITED | ATM 200 | AZITHROMYCIN DIHYDRATE | 200MG/5ML | INDOCO REMEDIES LTD, B-20,-B-20 MIDC, WALUJ, AURANGABAB 431136 INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/8165 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | CUFO BLACK CURRANT | 2,4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESOL | 1.2MG + 0.6MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210 | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X12.0 LOZENGE BLISTER |
| NDA/MAL/HDP/8166 | UNIQUE PHARMACEUTICALS LABORATORIES | TATA UGANDA LIMITED | CUFO ORANGE | 2,4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESO | 1.2MG + 0.6MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210 | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X12.0 LOZENGE BLISTER |
| NDA/MAL/HDP/8167 | MODI-MUNDIPHARMA PVT. LTD | SURGIPHARM (U) LTD | BETADINE STANDARDISED MICROBICIDAL SOLUTION 10% W/V | POVIDONE-IODINE | 10%W/W | G.S. PHARMBUTOR PVT. LTD.,
B-172, INDUSTRIAL AREA,
BEHROR-301 701, RAJASTHAN, INDIA | INDIA | TOPICAL SOLUTION | 1X1X50ML, 1X1X100ML, 1X500ML BOTTLE |
| NDA/MAL/HDP/8168 | PFIZER LABORATORIES LTD | LABOREX UGANDA LIMITED | UNASYN 750MG | SULTAMICILLIN TOSYLATE | 750MG | HAUPT PHARMA LATINA S.R.L -STRADA STATALE 156 KM 47,600 04100 BORGO SAN MICHELE LATINA,ITALY. | ITALY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X4.0 TABLET STRIP |
| NDA/MAL/HDP/8169 | PALASH PHARMA.B | SUPER MEDIC LTD | ZIMYCIN | AZITHROMYCIN DIHYDRATE | 200MG /5ML | SAGA LABORATORIES
SURVEY NO. 198/2 & 198/3, CHACHRAWADI VASNA,
TAL.: SANAND, DIST.: AHMEDABAD 382 210, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1X1X5ML, PET BOTTLE |
| NDA/MAL/HDP/8170 | FOUNTIL LIFE SCIENCES PVT LTD. | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ULGICID (PINEAPPLE FLAVOUR) | ALGINIC + MAGNESIUM HYDROXIDE +DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE | 200MG+250MG+250MG+250MG+125MG/15ML | STEDMAN PHARMACEUTICALS PVT LTD...-C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/8171 | KHANDELWAL LABORATORIES PVT. LTD. | SURGIPHARM (U) LTD | PLATINEX 50 | CISPLATIN | 50MG/50ML | KHANDELWAL LABORATORIES PVT. LTD.
PLOT B-1, WAGLE INDUSTRIAL ESTATE,
THANE- 400 604. MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1X1X50ML, GLASS VIAL |
| NDA/MAL/HDP/8172 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | COAMOX-ACINO 875 | AMOXICILLIN + CLAVULANIC ACID | 875MG + 125 MG | LABESFAL LABORATORIES ALMIRO S.A-LAGEDOSANT, SOLVENIA | SLOVENIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/8177 | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | ASTRA PHARMA (U) LIMITED | CILZEC PLUS | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER, AMPOULE AMPOULE |
| NDA/MAL/HDP/8178 | AGOG PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | NYSTAGO TABLETS | NYSTATIN | 500,000I.U | AGOG 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 TABLETS | 1.0X1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8180 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | COSMOL TABLETS 500MG | PARACETAMOL | 500MG | COSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X2.0 TABLET STRIP,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/8182 | STRIDES ARCOLAB LTD | ROYAL PHARMA 2011 LIMITED | STRICORT | HYDROCORTISONE | 500MG | STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD
BANGALORE 560076
INDIA
| INDIA | PARENTERAL RETARD DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/8183 | STRIDES ARCOLAB LTD | ROYAL PHARMA 2011 LIMITED | STRICORT-100 | HYDROCORTISONE SODIUM SUCCINATE | 100MG | STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROAD
BANGALORE 560076
INDIA
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X100.0 MG VIAL |
| NDA/MAL/HDP/8184 | STRIDES ARCOLAB LIMITED | ROYAL PHARMA 2011 LIMITED | TETRACYCLINE | TETRACYCLINE HYDROCHLORIDE | 250MG | STRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/8185 | STRIDES ARCOLAB LTD | ROYAL PHARMA 2011 LIMITED | INDOMETHACIN CAPSULES | INDOMETHACIN | 25MG | STRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER |
| NDA/MAL/HDP/8186 | STRIDES ARCOLAB LTD | ROYAL PHARMA 2011 LIMITED | CELOVAN | VANCOMYCIN HYDROCHLORIDE | 500MG | STRIDES ARCOLAB LIMITED .-OPP. 11M BILEKAHALLI, BANNERG | INDIA | PARENTERAL ORDINARY VIALS | 1.0X500.0 G VIAL |
| NDA/MAL/HDP/8188 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE | LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE | 150MG + 300MG + 200MG | AUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8189 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | ABACAVIR SULPHATE TABLETS | ABACAVIR SULPHATE | 300MG | AUROBINDO PHARMA LIMITED (SEZ, UNIT ? VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8190 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | LAMIVUDINE TABLETS | LAMIVUDINE | 150 MG | AUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8191 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | DIDANOSINE DELAYED-RELEASE | DIDANOSINE DELAYED-RELEASE | 400MG | AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA | INDIA | ORAL SOLID RETARD CAPSULES | 1.0X30.0 CAPSULE BOTTLE |
| NDA/MAL/HDP/8192 | LINCOLN PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | L-KELFIN | SULPHADOXINE + PYRIMETHAMINE | 500MG + 25MG | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/8193 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | ECOX 400 | ETHAMBUTOL | 400MG | MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
,MACLEODS PHARMACEUTICALS LTD- -PLOT 25-27, SURVEY NO. 306, PREMIER INDUSTRIAL ESTATE, KACHIGAM, DAMAN (UT)- 396210, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/8194 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | SOLONEX-100 | ISONIAZID | 100MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 1 & 2 MAHIM ROAD NEAR KULDEEP NAGAR, PALGHAR (W) 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/8195 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | RH-COM | RIFAMPICIN & ISONIAZID | 150MG +75MG | MACLEODS PHARMACEUTICALS LTD .-PLOT 1 & 2 MAHIM ROAD NEAR KULDEEP NAGAR, PALGHAR (W) 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/8196 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | ANTI-THYROX | CARBIMAZOLE | 5MG | MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101,MACLEODS PHARMACEUTICALS LTD .-PLOT 1 & 2 MAHIM ROAD NEAR KULDEEP NAGAR, PALGHAR (W) 401 404 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8197 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | AMIKACIN | AMIKACIN SULPHATE | 500MG/2ML | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA | EGYPT | PARENTERAL ORDINARY VIALS | 1.0X2.0 ML VIAL |
| NDA/MAL/HDP/8198 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | XYMEX DROPS | MULTI-INGREDIENT | MULTI-INGREDIENT | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/8199 | MEDLEY PHARMACEUTICALS LTD | MEDVIN PHARMA LIMITED | XYMEX SYRUP | MULTIVITAMIN/ DIASTASE/PEPSIN | MULTI-INGREDIENT | MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/8200 | MEDIPHARM INDUSTRIES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | ORS ORANGE | GLUCOSE ANHYDROUS + TRISODIUM CITRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE | 6.75G + 1.45G + 1.3G + 0.75G / SACHET | MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | UGANDA | ORAL LIQUID ORDINARY SOLUBLE POWDERS | 1.0X10.4 G SACHET |
| NDA/MAL/HDP/8201 | CIRON DRUGS AND PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | CENTROZINE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | CIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/8202 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | ISONIAZID | ISONIAZID | 300MG | MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,
PREMIER INDUSTRIAL ESTATE, KACHIGAM,
DAMAN (UT) - 396210, INDIA.
,OXALIS LABS--VILLAGE THEDA,P.O.LODHIMAJRA ,TEHSIL BADDI,DIST .SOLAN (HIMACHAL PRADESH) - 174101
INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/8204 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | DOPAMINE HCL FRESENIUS | DOPAMINE HYDROCHLORIDE | 200MG/5ML | FRESNIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD KORSTEN PORT ELIZABETH 6020 | SOUTH AFRICA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X5.0 ML AMPOULE |
| NDA/MAL/HDP/8205 | Y.S.P INDUSTRIES (M) SDN BHD | ROYAL PHARMA 2011 LIMITED | ANLODIN | AMLODIPINE BESYLATE | 10MG | Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN | MALAYSIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8206 | BRAWN LABORATORIES LTD | ROYAL PHARMA 2011 LIMITED | BRULEXIN | CEFALEXIN MONOHYDRATE | 125MG/5ML | BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8207 | NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | ZOMETA | ZOLEDRONIC ACID | 4MG/5ML | NOVARTIS PHARMA STEIN AG ;-SCHAFFHAUSERSTRASSE
CH 4332 STEIN-SWITZERLAND | SWITZERLAND | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/8208 | CIRON DRUGS & PHARMACEUTICAL PVT LTD | RENE PHARMACY LTD | CHLORAMPHENICOL SODIUM SUCCINATE | CHLORAMPHENICOL SODIUM SUCCINATE | 1G | CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X25.0X1.0 G VIAL |
| NDA/MAL/HDP/8209 | CIRON DRUGS & PHARMACEUTICAL PVT LTD | RENE PHARMACY LTD | THIOPENTAL SODIUM INJECTION | THIOPENTAL SODIUM | 1GM / VIAL | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X50.0X1.0 G VIAL |
| NDA/MAL/HDP/8210 | CIRON DRUGS & PHARMACEUTICALS PVT LTD | RENE PHARMACY LTD | HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BP | HYDROCORTISONE | 100MG | CIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506 | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X50.0X100.0 MG VIAL |
| NDA/MAL/HDP/8211 | SHELYS PHARMACEUTICALS LTD | BETA HEALTHCARE UGANDA LIMITED | MUCO-ASTHALIN SYRUP | SALBUTAMOL + BROMHEXINE | 2MG/5ML + 4MG/5ML | BETA HEALTHCARE INTERNATIONAL LTD - -PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA, P.O.BOX 42569-001000 NAIROBI,KENYA | KENYA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8212 | FDC LTD | AIVEEN (U) LIMITED | BACTIGEN EYE/EAR DROPS | GENTAMICIN | 0.3%W/V | FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | OPHTHALMIC VIALS | 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL |
| NDA/MAL/HDP/8213 | FDC LTD | AIVEEN (U) LIMITED | ZOCON 200 | FLUCONAZOLE | 200MG | FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ ? AURANGABAD- 431 136 MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X5.0X2.0 TABLET BLISTER |
| NDA/MAL/HDP/8216 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | SEFOTAX | CEFOTAXIME SODIUM | 1G | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/8217 | S KAGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | METFOKANT | METFORMIN HYDROCHLORIDE | 850MG | S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8218 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DECLOPHEN 12.5 | DICLOFENAC SODIUM | 12.5MG | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/8219 | PHARCO B PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DERMATIN | CLOTRIMAZOLE | 1%W/V | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | TOPICAL EXTERNAL LIQUIDS | 1.0X20.0 ML BOTTLE |
| NDA/MAL/HDP/8221 | NATIONAL HEALTHCARE | ANDYCO PHARMACY (UGANDA) LTD | NEMADOL | TRAMADOL HYDROCHLORIDE | 50MG/ML | NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA | NEPAL | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8222 | MICRO LABS LTD | LABOREX UGANDA LIMITED | LUBREX | SODIUM CARBOXYMETHYL CELLULOSE | 0.5%W/V | MICRO LABS LTD ..NO 113 TO 116, 4TH PHASE, KIADB BOMMASANDRA INDUSTRIAL AREA, ANEKAL TALUK, BANGALORE-560099 | INDIA | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/8223 | IRAN MEDICAL GROUP COMPANY | UNEED GLOBAL GROUP LIMITED | LORAXIME | CEFOTAXIME | 1000MG/ML | EXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRAN | IRAN | PARENTERAL ORDINARY DRY VIALS | 1.0X1000.0 MG VIAL |
| NDA/MAL/HDP/8224 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | OPTIGENT | GENTAMICIN SULFATE | 0.3%W/W | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B
EGYPT
| EGYPT | OPHTHALMIC OINTMENTS | 1.0X5.0 G TUBE |
| NDA/MAL/HDP/8225 | LINCOLN PARENTERAL LIMITED | METRO PHARMACEUTICALS LIMITED | ARTELIN 60 | ARTESUNATE | 60MG | LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X60.0 MG VIAL + 1*1 ML AMPOULE OF 5.0%W/V SODIUM BICARBONATE INJECTION B.P + 1*5 ML AMPOULE OF 0.9%W/V NACL |
| NDA/MAL/HDP/8226 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | SALRES | SALBUTAMOL SULPHATE | 120.5MCG/SPRAY | DEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER | 1.0X200.0 METERED DOSE CANNISTER |
| NDA/MAL/HDP/8227 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | ALZER 5 | DONEPEZIL HYDROCHLORIDE | 5MG | HETERO 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 TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8228 | AFRICURE PHARMACEUTICALS (INDIA) LTD | ROYAL PHARMA 2011 LIMITED | VITAMIN B-COMPLEX (BEEKO) | VITAMINS B1 + B2 + B6 + NIACINAMIDE | 1MG +1MG +1MG +15MG | STRIDES SHASUN LTD .-PLOT 9-12 DEWAN & SONS INDL AREA VEOOR PALGHAR | INDIA | ORAL SOLID ORDINARY OTHER COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8229 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ABACAVIR SULFATE + LAMIVUDINE | ABACAVIR SULFATE + LAMIVUDINE | 60MG + 30MG | CIPLA LTD-A-33 & A-37/2/2 MIDC PATALGANGA 410220 | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8230 | LIFEPHARM FZE | AIVEEN (U) LIMITED | PANALIFE | PARACETAMOL | 500MG | LIFE PHARMA FZE --JEBEL ALI FREE ZONE, PLOT NO. MO 0502, P.O. BOX 17404, DUBAI-UAE | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/8231 | DENK PARMA GMBH & CO. KG | BENLE CONSULT LIMITED | ANASTROZOLE DENK | ANASTROZOLE | 1MG | HAUPT PHARMA GMBH & CO KG-SCHLEEBRUGGENKAMP 15, 48159 MUNSTER, GERMANY | GERMANY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8232 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | MOMATE | MOMETASONE FUROATE MONOHYDRATE | 50MCG/ SPRAY | GLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA,GLENMARK PHARMACEUTICALS LTD-VILLAGE, KISHANPURA, BADDI, NALAGARH ROAD, INDIA | INDIA | NASAL SYSTEMIC METERED-DOSE LIQUIDS | 1.0X120.0 METERED DOSE BOTTLE |
| NDA/MAL/HDP/8233 | CADILA HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | COLSTIM | FILGRASTIM | 300?G/ML | CADILA HEALTHCARE LTD.--PLOT SURVEY NO. 23, 25/P, 37, 40/P, 42 TO 47 SARKHEJ BAVLA N.H NO.8A OPP.RAMDEV MASALA CHANGODAR TAL. SANAND DIST AHMEDABAD 382213 | INDIA | PARENTERAL ORDINARY PRE-FILLED SYRINGES | 1.0X1.0 ML PRE- FILLED SYRINGE |
| NDA/MAL/HDP/8234 | ABBOT LABORATORIES S.A. (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | INFUVAC 2015 | INACTIVATED INFLUEZA VACCINE-SURFACE ANTIGEN [A/CALIFORNIA/7/2009(H1N1) PDM09 + A/SWITZERLAND/9715293/2013(H3N2) + B/PHUKET/3073/2013-LIKE STRAINS] | 15?G + 15?G +15?G | ABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLST | NETHERLANDS | PARENTERAL ORDINARY I M PRE-FILLED SYRINGES | 1.0X0.5 ML PRE- FILLED SYRINGE (1 DOSE) |
| NDA/MAL/HDP/8235 | DAWA LIMITED | SUPER MEDIC LTD | ACEPAR | ACECLOFENAC + SERRATIOPEPTIDASE + PARACETAMOL | 100MG + 15MG + 500MG | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8236 | KWALITY AFRO ASIA LIMITED | KWALITY AFRO ASIA LTD | HYDROGEN PEROXIDE | HYDROGEN PEROXIDE | 6%W/V | KWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROAD | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/8237 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GOODMAN INTERNATIONAL LTD | BCOOL | CETYLPYRIDINIUM CHLORIDE + LIDOCAINE HYDROCHLORIDE | 1MG +1MG | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,
DIGDAGA STREET
RAS AL KHAIMAH | UNITED ARAB EMIRATES | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X9.0 LOZENGE BLISTER |
| NDA/MAL/HDP/8238 | MERIDIAN ENTERPRISES PRIVATE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | METROSUPP 500 | METRONIDAZOLE | 500MG | MERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X2.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/8239 | GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD | ERIS LTD | UMBIPRO GEL | CHLORHEXIDINE | 4%W/W | GLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK | UNITED KINGDOM | TOPICAL EXTERNAL GELS AND SOLS | 1.0X7.0 SACHET CARTON |
| NDA/MAL/HDP/8240 | STRIDES ARCOLAB LIMITED | VEERAM HEALTHCARE (U) LIMITED | EFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ + EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE | 600MG + 200MG + 300MG | STRIDES ARCOLAB LIMITED -36/7 SURAGAJAKKANAHALLI INDLAVADI CROSS ANEKAL TALUK BANGALORE 562 106 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8241 | ACINO PHARMA AG | GOODMAN INTERNATIONAL LTD | CLOPACIN | CLOPIDOGREL BESILATE | 75MG | ACINO PHARMA AG .-BIRSWEG 2 4253 LIESBERG BASEL LAND | SWITZERLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8242 | IDA FOUNDATION | KIMSY MEDS LTD | TETRACYCLINE HYDROCHLORIDE | TETRACYCLINE HYDROCHLORIDE | 1%W/W | CENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526 | INDIA | OPHTHALMIC OINTMENTS | 1.0X50.0X5.0 G TUBE |
| NDA/MAL/HDP/8244 | MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA | KIMSY MEDS LTD | HERTRAZ 440 | TRASTUZUMAB (R-DNA ORIGIN) | 440MG | BIOCON LIMITED-SPECIAL ECONOMIC ZONE,
PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD
BANGALORE-560 099
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X440.0 MG VIAL ,1X2X10ML VIALS OF WFI |
| NDA/MAL/HDP/8245 | AXA PARENTERALS LTD | GITTOES PHARMACEUTICALS LIMITED | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | 0.5%W/V | AXA PARENTERAL LIMITED-PLOT NO.936,937&939,
VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR
(UTTARAKHAND) INDIA. | INDIA | OPHTHALMIC DROPS | 1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/8246 | PHARMACIA S.P.A | ERIS LTD | ALDACTONE | SPIRONOLACTONE | 25MG | PIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND | UNITED KINGDOM | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8247 | SAKAR HEALTH CARE PVT .LTD | ROYAL PHARMA 2011 LIMITED | E-DOL | TRAMADOL HYDROCHLORIDE | 50MG/ML | SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0X5.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8248 | CACHET PHARMACEUTICALS PVT LIMITED | ASTRA PHARMA (U) LIMITED | CLAVACE SUSPENSION | AMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM | 457MG/5ML | ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8249 | RESONANT PHARMACEUTICALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | PANZOL-D | PANTOPRAZOLE+DOMPERIDONE | 20MG + 10MG | ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8250 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | LUMARTEM DT | ARTEMETHER+LUMEFANTRINE | 20MG+120MG | CIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775 | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER |
| NDA/MAL/HDP/8251 | HEALTHCARE PHARMACEUTICALS LTD | ECHO PHARMACY (U) LIMITED | FUROTIL | CEFUROXIME AXETIL | 250MG | HEALTHCARE PHARMACEUTICALS LTD -RAJENDRAPUR GAZIPUR | BANGLADESH | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/8252 | FRESENIUS KABI MANUFACTURING S.A (PTY) LTD | SURGIPHARM (U) LIMITED | PARACETAMOL FRESENIUS | PARACETAMOL | 10MG/ML | FRESENIUS KABI AUSTRIA GMBH-AUSTRIA GMBH HAFNERSTRASSEM 36 8055 GRAZ | AUSTRIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X10.0X50.0 ML VIAL |
| NDA/MAL/HDP/8253 | REYOUNG PHARMACEUTICAL CO LTD | ROYAL PHARMA 2011 LIMITED | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG/ML | REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100 | CHINA | PARENTERAL ORDINARY AMPOULES | 10.0X10.0X3.0 ML AMPOULE |
| NDA/MAL/HDP/8254 | MICRO LABS LTD | LABOREX UGANDA LIMITED | GRAMOCEF-CV | CEFIXIME TRIHYDRATE + CLAVULANIC ACID | 200MG + 125MG | MICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/8255 | KORLYNS THERAPEUTICS LTD | MEDICATRIX (U) LTD | PROSTAN ED | LATANOPROST | 0.005%W/V | LUNAN BETTER PHARMACEUTICAL CO., LTD.-NO.209, HONGQI AVENUE, LANSHAN DISTRICT
LINYI, SHANDONG, 276006 CHINA
+86-5398331258 ? | CHINA | OPHTHALMIC DROPS | 1.0X6.0X2.5 ML BOTTLE |
| NDA/MAL/HDP/8264 | CACHET PHARMA PVT LTD | ASTRA PHARMA (U) LIMITED | EMITINO ORAL SOLUTION | ONDANSETRON | 2MG/5ML | CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA | INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/8274 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | BICATERO 50 | BICALUTAMIDE | 50MG | HETERO LABS LTD (UNIT-VI)-"SY.NO. 439, 440 & 458,APIIC FORMULATION
SEZ, POLEPALLY (V), JEDCHERLA (M)
MAHABOOBNAGAR DISTRICT ANDHRA PRADESH-509301 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8275 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | LETERO | LETROZOLE | 2.5MG | HETERO LABS LTD (UNIT-VI)-"SY.NO. 439, 440 & 458,APIIC FORMULATION
SEZ, POLEPALLY (V), JEDCHERLA (M)
MAHABOOBNAGAR DISTRICT ANDHRA PRADESH-509301 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8276 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | GEMTERO 1G | GEMCITABINE | 1G | HETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/8277 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | GEMTERO 200MG | GEMCITABINE | 200MG | HETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA. | INDIA | PARENTERAL ORDINARY VIALS | 1.0X200.0 MG VIAL |
| NDA/MAL/HDP/8278 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | ANATERO | ANASTROZOLE | 1MG | HETERO LABS LTD, UNIT VI, INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8279 | SAKAR HEALTHCARE PVT LTD | ROYAL PHARMA 2011 LIMITED | GENTACIN | GENTAMICIN SULPHATE | 80MG/2ML | SAKAR 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 AMPOULES | 1.0X2.0X6.0X2.0 ML AMPOULE IN BLISTERS |
| NDA/MAL/HDP/8281 | UNIMED INDIA | METAPLUS (U) LIMITED | CO-TRIMOXAZOLE TABLET BP | CO-TRIMOXAZOLE | 480MG | UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROAD
ANDHERE(E)MUMBAI 400059 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/8282 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | BINOZYT 500 | AZITHROMYCIN | 500MG | SANDOZ SRL LTD-LIVEZENI STREET 7A540472 TARGU MURES ROMANIA | ROMANIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/8283 | ASTRA PHARMA (U) LIMITED | ASTRA PHARMA (U) LIMITED | QUINAS | QUININE SULPHATE BP | 300MG | ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ ? BAVLA HIGHWAY, POST. RAJODA ? 382220, TALUKA: BAVLA, DIST. AHMEDABAD | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8284 | PHARMEDIC LABORATORIES(PVT) LIMITED | HEALTHCARE LTD. | CIPLOX-5OO TABLETS | CIPROFLOXACIN | 500MG | PHARMEDIC LABORATORIES LIMITED-16KM MULTAN ROAD,LAHORE-PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1.0X1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/8285 | TATA UGANDA LIMITED | TATA UGANDA LIMITED | CUFO LOZENGES(HONEY LEMON) | 2,4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESOL | 1.2MG+ 0.6MG | UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210 | INDIA | ORAL SOLID ORDINARY LOZENGES | 1.0X2.0X12.0 LOZENGE BLISTER |
| NDA/MAL/HDP/8287 | PHARCO PHARMACEUTICALS | GAMA PHARMACEUTICALS (U) LIMITED | DERMATIN 1% POWDER | CLOTRIMAZOLE+ZINC OXIDE | 0.01G + 2.500G | PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.
P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT
| EGYPT | TOPICAL EXTERNAL POWDERS | 1.0X10.0 G CONTAINER |
| NDA/MAL/HDP/8292 | META PRODUCTS UGANDA LTD | METAPLUS (U) LIMITED | PARACETAMOL | PARACETAMOL | 500MG | HEBEI JIHENG (GROUP) PHARMACEUTICAL CO LTD 368-HEBEI JIHENG (GROUP) PHARMACEUTICAL CO LTD 368 JIANSHE ST HENGSHUI CITY HEBEI 053000 | CHINA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/8297 | COSMOS LTD | ASTRA PHARMA (U) LIMITED | ISONIAZIDE TABLETS | ISONIAZID | 100MG | COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA | KENYA | ORAL SOLID ORDINARY TABLETS | 10.0X10.0 TABLET BLISTER,1000.0 TABLET CONTAINER |
| NDA/MAL/HDP/8306 | GILEAD SCIENCES, INC. | UNITED HEALTHCARE DISTRIBUTORS LTD | SOVALDI | SOFOSBUVIR | 400MG | PATHEON INC.
2100 SYNTEX COURT
MISSISSAUGA, ONTARIO
ON L5N 7K9 CANADA
GILEAD SCIENCES IRELAND UC
IDA BUSINESS AND TECHNOLOGY PARK
CARRIGTOHILL, CO. CORK
IRELAND | CANADA IRELAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1X1X28 TABLET BOTTLE |
| NDA/MAL/HDP/8309 | INDUS PHARMA PVT LTD | HEALTHCARE LTD. | SNOLIP 20MG | ATORVASTATIN | 200MG | INDUS PHARMA (PVT) LTD ,-PLOTS NO. 64, 65, 66 & 67, SECTOR -27, KORANGI INDUSTRIAL AREA, KARACHI - 74900 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8310 | INDUS PHARMA PVT LTD | HEALTHCARE LTD. | MAXPAN-100 | CEFIXIME | 100MG/5ML | INDUS PHARMA (PVT) LTD ,-PLOTS NO. 64, 65, 66 & 67, SECTOR -27, KORANGI INDUSTRIAL AREA, KARACHI - 74900 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/8312 | CADILA PHARMACEUTICALS | KARURI PHARMACEUTICALS LTD. | TRICORT 40 | TRIAMCINOLONE ACETONIDE | 40MG/ML | CADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA ? 387 810, AHMEDABAD, GUJARAT STATE
INDIA
| INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0 ML VIAL |
| NDA/MAL/HDP/8313 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | FULYZAQ DELAYED RELEASE TABLETS | CROFELEMER | 125 MG | PATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA | UNITED STATES | ORAL SOLID RETARD ENTERIC-COATED TABLETS | 1.0X60.0 TABLET CONTAINER |
| NDA/MAL/HDP/8314 | ZIFAM PINNACLE PTY. LTD. | BOOTS PHARMACEUTICALS LIMITED | CIPROZIF ? 500 | CIPROFLOXACIN HYDROCHLORIDE | 500MG | FREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8315 | JANSSEN-CILAG INTERNATIONAL NV | MEDICAL ACCESS (UGANDA) LIMITED | PREZISTA 75 | DARUNAVIR | 75MG | JANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778 | UNITED STATES | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X480.0 TABLET BOTTLE |
| NDA/MAL/HDP/8316 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | DOLUTEGRAVIR 50 MG/ LAMIVUDINE 300 MG/ TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETS | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50MG + 300MG + 300MG | "AUROBINDO PHARMA LIMITED-UNIT ?VII, SEZ, TSIIC, PLOT NO. SI,S. NO.?S 411/P, 425/P, 434/P, 435/P & 458/P,GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL,
MAHABOOB NAGAR DISTRICT -509 302
TELANGANA STATE, INDIA"
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8317 | ACULIFE HEALTHCARE | SUPER MEDIC LTD | MERONIR 500 | MEROPENEM | 500MG | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL + 1*10ML AMPOULE OF WFI |
| NDA/MAL/HDP/8318 | ACULIFE HEALTHCARE | SUPER MEDIC LTD | B-CANE HEAVY | BUPIVACAINE HYDROCHLORIDE BP | 5 MG/ML | ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X4.0 ML AMPOULE |
| NDA/MAL/HDP/8319 | KOPRAN LIMITED | TATA UGANDA LIMITED | ERYKO-250 | ERYTHROMYCIN STEARATE TABLETS BP | 250MG | KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER |
| NDA/MAL/HDP/8320 | NATIONAL HEALTHCARE | ANDYCO PHARMACY (UGANDA) LTD | STACEF 1 GM | CEFTRIAXONE SODIUM | 1 GM | NATIONAL HEALTHCARE PVT. LTD.-(WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPAL | NEPAL | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/8321 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | PROSTER- 200 CAPSULES | PROGESTERONE | 200 MG | AKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8322 | GLENMARK PHARMACEUTICALS LTD | STAR PHARMACEUTICALS LTD | GLEMONT L | MONTELUKAST SODIUM+LEVOCETIRIZINE DIHYDROCHLORIDE | 10 MG + 5 MG | GLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X14.0 TABLET BOTTLE |
| NDA/MAL/HDP/8324 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | LOOBID TABLETS | OFLOXACIN + ORNIDAZOLE | 200MG + 500 MG | CACHET PHARMACEUTICAL PVT LTD. HIMACHAL-THANA, BADDI, HIMACHAL PRADESH-173 205,
INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8325 | PFIZER LABORATORIES LTD | LABOREX UGANDA LIMITED | UNASYN | SULTAMICILLIN | 250MG/5ML | HAUPT PHARMA LATINA S.R.L -STRADA STATALE 156 KM 47,600 04100 BORGO SAN MICHELE LATINA,ITALY. | ITALY | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/8326 | MEDOPHARM PRIVATE LIMITED | PLANET PHARMACEUTICALS UGANDA LTD | MEDOMOX 250 DT | AMOXICILLIN | 250MG | MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8327 | ARYOGEN PHARMED CO. | UNEED GLOBAL GROUP LIMITED | ZYTUX | RITUXIMAB | 500MG/50ML | ARYOGEN PHARMED CO. NO. 140, TAJBAKHSH STREET, 24TH KILOMETER TEHRAN-KARAJ MAKHSOUS ROAD, ALBORZ,IRAN | IRAN | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES? | 1.0x1.0x50.0 ML VIAL |
| NDA/MAL/HDP/8328 | RESONANT PHARMACEUTICALS | SHREEJI PHARMACEUTICALS LIMITED | AZITHROCIN | AZITHROMYCIN | 500MG | ACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/8329 | LEBEN LABORATORIES PVT. LTD., INDIA | ANDYCO PHARMACY (UGANDA) LTD | ARTEFLO - 40 | PROPRANOLOL HYDROCHLORIDE | 40 MG | LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8330 | RESONANT PHARMACEUTICALS | SHREEJI PHARMACEUTICALS LIMITED | COART | LUMEFANTRINE + ARTEMETHER | 480 MG + 80 MG | ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/8331 | MICRO LABS LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | TORSINEX-20 | TORSEMIDE | 20MG | MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8332 | DEVA HOLDING A.S | SHREEJI PHARMACEUTICALS LIMITED | AZITRO 500 MG | AZITHROMYCIN | 500MG | DEVA HOLDING A. S.-?ERKEZK?Y ORGANIZE SANAYI BOLGESI. KARAA?A? MAH. ATAT?RK CAD. NO: 32 KAPAKLI- TEKIRDA?/ TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/8333 | MICRO LABS LTD 92 SIPCOT INDUSTRIAL | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AVAS-20 | ATORVASTATIN | 20MG | MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8334 | PRIDE INTERNATIONAL | ROYAL PHARMA 2011 LIMITED | S-AUGPRO | AMOXICILLIN TRIHYDRATE+CLAVULANIC ACID | 200MG+ 28.5MG | ALKEM LABORATORIES LTD-PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210 | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8335 | RIVA PHARMA FREE ZONE | WIDE SPECTRUM ENTERPRISES (U) LIMITED | RIVAMOX | AMOXICILLIN TRIHYDRATE | 500MG | RIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT | EGYPT | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8336 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KPI HEALTHCARE LIMITED | LACINE ? 50 | LOSARTAN POTASSIUM | 50MG | THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY.-UM-AL-AMAD/PLANT ( RAZI ).P.O.BOX 151 UM-AL-AMAD 16197 JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8337 | SWISS PARENTERALS PVT LTD 304 | ROYAL PHARMA 2011 LIMITED | ARTESUNATE 120 MG | ARTESUNATE | 120 MG | SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X120.0 MG VIAL + 1*2 ML AMPOULE OF SODIUM BICARBONATE + 1*10 ML VIAL OF 0.9%W/V SODIUM CHLORIDE |
| NDA/MAL/HDP/8338 | PINNACLE LIFE SCIENCE PVT. LTD. | METRO PHARMACEUTICALS LIMITED | ACEAAR P | ACECLOFENAC + PARACETAMOL | 100MG +325MG | PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X20.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8339 | SPECPHARM (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | EFTENEM | EFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXIL FUMARATE | 600MG+200MG+300MG | HETERO 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 TABLETS | 1.0X30.0 TABLET CONTAINER |
| NDA/MAL/HDP/8340 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | MONTEMAC 5 | MONTELUKAST SODIUM | 5 MG | MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8341 | GILEAD SCIENCE INC | MEDICAL ACCESS (UGANDA) LIMITED | GENVOYA | ELVITEGRAVIR+COBICISTAT+EMTRICISTABINE+TENOFOVIR ALAFENAMIDE | 150MG + 150MG + 200MG + 10MG | PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | CANADA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8342 | PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD) | ROYAL PHARMA 2011 LIMITED | ANCOLIN 75 | PREGABALIN | 75MG | PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS & PHARMACEUTICALS PVT. LTD.) -B-21/22, MIDC AREA, KALMESHWAR-441 501, NAGPUR, MAHARASHTRA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8343 | TROIKAA PHARMACEUTICALS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | XYKAA EXTEND 1000 | PARACETAMOL BP(IMMEDIATE RELEASE)+ PARACETAMOL BP(EXTENDED RELEASE) | 325MG+675MG | TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA | INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER, 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8344 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | CELZA DRY SYRUP | CEFUROXIME AXETIL USP | 125 MG/5 ML | ALKEM LABORATORIES LTD--PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESH | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/8345 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | CELZA 500 | CEFUROXIME AXETIL USP | 500 MG | ALKEM LABORATORIES LTD--PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESH | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8346 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ADERAN 8 | CANDESARTAN CILEXETIL | 8MG | AJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8347 | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD. | KAIYUANTANG (U) LIMITED | FENTWELL 0.05MG/ML | FENTANYL CITRATE | 0.05MG/ML | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD.-NO.19,DALIAN ROAD, YICHANG DEVELOPING ZONE,HUBEI PROVINCE ,CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X5.0X10.0 ML AMPOULE |
| NDA/MAL/HDP/8348 | ?LKO ?LA? SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | IRBECOR PLUS 300MG/12.5MG | IRBESARTAN + HYDROCHLOROTHIAZIDE | 300MG + 12.5MG | ?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1
SEL?UKLU / KONYA | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8349 | TIL HEALTHCARE PVT LTD | KPI HEALTHCARE LIMITED | ASTYMIN-C DROPS | L-LEUCINE USP + L-ISOLEUCINE USP + L-LYSINE HYDROCHLORIDE USP + L-PHENYLALANINE USP + L-THREONINE USP + L-VALINE USP+ L-TRYPTOPHAN USP + DL-METHIONINE USP + ASCORBIC ACID BP | 0.84M+1.43MG+1.84MG+1.18MG+3.66MG+1.00MG+1.00MG+5.00MG+100MG | TIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA | INDIA | ORAL LIQUID ORDINARY DROPS | 1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/8350 | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD. | KAIYUANTANG (U) LIMITED | FENTWELL 0.05MG/ML | FENTANYL CITRATE | 0.05MG/ML | YICHANGHUMANWELL PHARMACEUTICAL CO., LTD.-NO.19,DALIAN ROAD, YICHANG DEVELOPING ZONE,HUBEI PROVINCE ,CHINA | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8351 | TIL HEALTHCARE PVT LTD | KPI HEALTHCARE LIMITED | ASTYMIN SYRUP | L-LEUCINE+L-ISOLEUCINE+L-LYSINE HYDROCHLORIDE+L-PHENYLALNINE+L-THREONINE+L-METHIONINE+L-TRYPTOPHAN+L-VALINE+THIAMINE HYDROCHLORIDE+RIBOFLAVING HYDROCHLORIDE+NICOTINAMIDE+CALCIUM PANTOTHENATE+CYANOCOBALAMIN+FOLIC ACID+COLECALCIFEROL+ALPHATOCOPHERYLACETATE | 10.3MG + 5.9MG + 25MG + 5MG + 4.2MG + 9.2MG + 5MG + 6.7MG + 5MG + 1.5MG +25MG + 5MG + 2.5MCG + 0.75MG + 200IU AND 7.5IU | TIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/8353 | AJANTA PHARMA LIMITED | ABACUS PHARMA (AFRICA) LIMITED | NURIFER CAPSULES | CARBONYL IRON + FOLIC ACID + VITAMIN B12 + VITAMIN C + ZINC SULFATE MONOHYDRATE | 100MG+1.5 MG + 15 MCG + 75 MG + 61.8 MG | AJANTA PHARMA LIMITED-AJANTA PHARMA LIMITED B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA. | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8354 | MEGA LIFESCIENCES PUBLIC COMPANY LTD | ABACUS PHARMA (AFRICA) LIMITED | ZORUXA | ZOLEDRONIC ACID | 5MG/100ML | GLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8355 | AUROBINDOM PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ONECLAPZ 75 | CLOPIDOGREL | 75MG | AUROBINDO PHARMA LTD--UNIT VII SEZ PLOT S1 SPECIAL ECONOMIC ZONE | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8356 | UNOSOURCE PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LORFACT-D | DESLORATIDINE | 5MG, | AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8357 | FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED | SURGIPHARM (U) LIMITED | FRESENIUS PROPOVEN 1% | PROPOFOL | 1% W/V | FRESENIUS KABI AUSTRIA GMBH PLANT GRAZ-HAFNERSTRASSE 36 A-8055 GRAZ AUSTRIA,FRESENIUS KABI AB PLANT UPPSALA-RAPSGATAN 7S-75174 UPPSALA SWEDEN | AUSTRIA | PARENTERAL ORDINARY OTHER INFUSIONS | 1.0X10.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL,1.0X10.0X100.0 ML VIAL |
| NDA/MAL/HDP/8358 | TIL HEALTHCARE PVT LTD | KPI HEALTHCARE LIMITED | ASTYMIN FORTE | MULTI-INGREDIENT | MULTI-INGREDIENT | TIL 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 CAPSULES | 1.0X5.0X3.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8359 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ASUNATE 120 | ARTESUNATE | 120MG | LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
| INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X120.0 MG VIAL + 1*10 ML SODIUM CHLORIDE IN GLASS AMPOULE + 1*2 ML SODIUM BICARBONATE IN GLASS AMPOULE |
| NDA/MAL/HDP/8392 | ?LKO ?LA? SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | IRBECOR PLUS 150MG/12.5MG | IRBESARTAN + HYDROCHLOROTHIAZIDE | 150MG + 12.5MG | ?LKO ?LA? SANAYI VE TICARET A. ?-3. ORGANIZE SANAYI B?LGESI KUDDUSI CAD. 23. SOK. NO:1
SEL?UKLU / KONYA | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8393 | NATIONAL HEALTHCARE | ANDYCO PHARMACY (UGANDA) LTD | NACLOR EYE DROPS 10ML | CHLORAMPHENICOL | 0.5% W/V | NATIONAL HEALTHCARE PVT. LTD.--WORKS: STERILE BLOCK CHHATAPIPRA-3, BARA, NEPAL | NEPAL | OPHTHALMIC DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/8394 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | RIFAMPICIN 75 MG ISONIAZID 50 MG AND PYRAZINAMIDE 150 MG DISPERSIBLE TABLETS | RIFAMPICIN + ISONIAZID + PYRAZINAMIDE | 75MG + 50MG + 150MG | MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X100.0 TABLET CONTAINER, 1.0X3.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/8395 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | RIFAMPICIN 75 MG ISONIAZID 50 MG DISPERSABLE TABLETS | RIFAMPICIN + ISONIAZID | 75MG + 50MG | MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN | INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X100.0 TABLET CONTAINER,1.0X3.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/8396 | MARIE STOPES INTERNATIONAL | MARIE STOPES UGANDA LIMITED | BACK-UP | LEVONORGESTREL | 1.5MG | ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0 TABLET BLISTER |
| NDA/MAL/HDP/8401 | KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED | KPI HEALTHCARE LIMITED | AZOX-500 | AZITHROMYCIN DIHYDRATE | 500MG | THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY.-UM-AL-AMAD/PLANT ( RAZI ).P.O.BOX 151 UM-AL-AMAD 16197 JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/8406 | HETERO LABS LTD UNIT IX | ABACUS PHARMA (AFRICA) LIMITED | PIOGEN45 | PIOGLITAZONE HYDROCHLORIDE | 45MG | HETERO LABS LIMITED .-S.NO.10, I.D.A., GADDAPOTHARAM VILLAGE,
JINNARAM MANDAL,MEDAK DISTRICT, ANDHRA PRADESH,
INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8407 | INTAS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | TORTAS 20 | TORSEMIDE | 20MG | INTAS PHARMACEUTICALS LTD -CAMP ROAD, SELAQUI ? 248 197
DEHRADUN (UK) | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8411 | LABORATORY AND ALLIED LTD | HARLEYS UGANDA LIMITED | RHEUMAC GEL | DICLOFENAC | 1%W/W | LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA | KENYA | TOPICAL EXTERNAL GELS AND SOLS | 1.0X20.0 G TUBE |
| NDA/MAL/HDP/8419 | ROYAL PHARMA 2011 LIMITED | ROYAL PHARMA 2011 LIMITED | VB COMPLEX | VIT B1+ VIT B2 +VIT B3 + NICOTINAMIDE+PANTOTHENOL | 10MG +1MG +1MG +16MG +0.5MG | KIVI PHARM CO. LTD .-NO.5 HANGTIAN STREET,
DONGSHAN HIGH TECH INDUSTRIAL DEVELOPMENT ZONE,SHALINGZI TOWN, XUANHUA,ZHANGJIAKOU CITY,HEBEI 075100, CHINA
* | CHINA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8424 | LINCOLN PARENTERAL LIMITED | METRO PHARMACEUTICALS LIMITED | HAEMRICH | FERRIC AMMONIUM CITRATE+ FOLIC ACID+PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE | 50MG + 0.55MG +2.4MG + 1.2MG +11MG /5ML | LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARAT | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X90.0 ML BOTTLE |
| NDA/MAL/HDP/8432 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | DECLOPHEN | DICLOFENAC SODIUM | 100MG | PHARCO PHARMACEUTICALS-KILO 31 ALEXANDRIA-CAIRO DESERT ROAD AMRIYA ALEXANDRIA | EGYPT | RECTAL SYSTEMIC ADULT SUPPOSITORIES | 1.0X5.0 SUPPOSITORY STRIP |
| NDA/MAL/HDP/8434 | DAWA LIMITED | SUPER MEDIC LTD | DACINAZOLE | MICONAZOLE NITRATE | 2%W/W | DAWA LTD-BABA DOGO ROAD RUARAKA | KENYA | TOPICAL EXTERNAL CREAMS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/8443 | BLUE CROSS LABORATORIES LTD | STAR PHARMACEUTICALS LTD | EKON-D TABLETS | CETIRIZINE | 10 MG | BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET STRIP,1.0X10.0X12.0 TABLET STRIP |
| NDA/MAL/HDP/8466 | CIPLA LIMITED | QUALITY CHEMICALS LTD - HUMAN | LUMARTEM HS 80 | ARTEMETHER + LUMEFANTRINE | 80MG + 480MG | CIPLA LIMITED--UNIT 1,VILLAGE UPPER MALPUR, P.O. BHUD, TEHSIL NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 173205, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/8467 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE XR 750MG | METFORMIN HYDROCHLORIDE | 750MG | MERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY,MERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT | FRANCE | ORAL SOLID ORDINARY TABLETS | 1.0X4.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/8468 | THEON PHARMACEUTICALS LIMITTED | AIVEEN (U) LIMITED | THEOMOX-500 | AMOXICILLIN | 500 MG | THEON PHARMACEUTICALS LIMITED.-
VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8469 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | METHICOWEL INJECTION | METHYLCOBALAMIN | 500MCG/ML | AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT III, PLOT NO 2,3,4 &5, SECTOR 6-B, IIE, SIDCUL RANIPUR HARIDWAR-249403 UTTARAKHAND INDIA | INDIA | PARENTERAL ORDINARY I M AMPOULES | 1.0X5.0X1.0 ML AMPOULE |
| NDA/MAL/HDP/8470 | LUPIN LIMITED | AIVEEN (U) LIMITED | IXIME 400 | CEFIXIME | 400MG | LUPIN LIMITED--198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/8471 | LUPIN LIMITED | AIVEEN (U) LIMITED | IXIME FOR ORAL SUSPENSION | CEFIXIME | 100MG/5ML | LUPIN LIMITED--198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X75.0 ML BOTTLE |
| NDA/MAL/HDP/8472 | CODAL-SYNTO LTD | RENE PHARMACY LTD | SYNTOCLAV 375MG | AMOXICILLIN + CLAVULANIC ACID | 250MG + 125MG | MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8473 | S K AGE EXPORTS | ABACUS PHARMA (AFRICA) LIMITED | NYSTATIN VAGINAL INSERTS | NYSTATIN | 100000 I.U | S KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | VAGINAL TABLETS | 1.0X10.0X10.0 TABLET STRIP |
| NDA/MAL/HDP/8474 | GLAXOSMITH KLINE LTD | ERIS LTD | AUGMENTIN SACHETS 1G/125MG | AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE | 1000MG + 125MG | GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE | FRANCE | ORAL LIQUID ORDINARY UNIT DOSE POWDERS | 1.0X12.0 SACHET CARTON |
| NDA/MAL/HDP/8475 | LINCOLN PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | OROCAN | MICONAZOLE | 2%W/W | LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA | INDIA | ORAL TOPICAL GELS AND SOLS | 1.0X15.0 G TUBE |
| NDA/MAL/HDP/8476 | AUROBINDO PHARMA LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | AURODANZ 8 | ONDANSETRON HYDROCHLORIDE DIHYDRATE | 8MG | AUROBINDO PHARMA LTD--UNIT-III SURVEY NO. 313 & 314, BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT TELANGANA STATE INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8477 | WOCKHARDT LTD | TATA UGANDA LIMITED | GLARITUS 100IU/ML | INSULIN GLARGINE | 100IU/ML | WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA | INDIA | PARENTERAL ORDINARY CARTRIDGES | 1.0X3.0 ML CARTRIDGE |
| NDA/MAL/HDP/8480 | SUN PHARMACEUTICAL INDUSTRIES LTD | STAR PHARMACEUTICALS LTD | ERTIVIX 1MG | ENTECAVIR MONOHYDRATE | 1MG | SUN PHARMACEUTICALS INDUSTRIES LIMITED--SEZ UNIT 1,A-41,INDUSTRIAL AREA, PHASE VIIIA,S.A.S NAGAR,MOHALI-160071,PUNJAB,INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8481 | LINCOLN PARENTERAL LIMITED | METRO PHARMACEUTICALS LIMITED | PARACETAMOL BP INJECTION | PARACETAMOL | 150MG/ML | LINCOLN PARENTERAL LTD -11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARAT | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X10.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8483 | SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC | SURGIPHARM (U) LIMITED | GLIMEPIRID SANDOZ? 2MG TABLETS | GLIMEPIRIDE | 2MG | LEK S.A--U1, PODLIPIE 16, 95-0140 STRYKOW POLAND | POLAND | ORAL SOLID ORDINARY TABLETS | 1.0X9.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8484 | MEDOCHEMIE LTD | BOOTS PHARMACEUTICALS LIMITED | AVERNOL | CARVEDILOL | 25MG | MEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOL | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8485 | CACHET PHARMACEUTICALS PVT LIMITED | ASTRA PHARMA (U) LIMITED | TRIAXON | CEFIXIME | 400MG | ALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205 | INDIA | ORAL SOLID ORDINARY COATED TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8487 | BAL PHARMA LIMITED | HEALTHCARE LTD. | EMTRIM FORTE | SULFAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGAR
UDHAM SINGH NAGAR, RUDRAPUR-263153
UTTARAKHAND-INDIA
| INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8488 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | CEFRAZ 200 | CEFIXIME TRIHYDRATE | 200MG | ZIM LABORATORIES LIMITED-B-21122, MIDC AREA,
KALMESHWAR -441 501,
DIST. NAGPUR,INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8489 | SWISS PARENTERALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | T-DOL | TRAMADOL HYDROCHLORIDE | 100 MG / 2 ML | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X2.0 ML AMPOULE |
| NDA/MAL/HDP/8490 | ALTHEA PHARMA PVT LTD. | JOINT MEDICAL STORE (UPMB - UCMB) | SODIUM CHLORIDE | SODIUM CHLORIDE | 0.9% W/V | ALTHEA PHARMA PVT LTD --PLOT NO. 374 SHED NO. E,.ALPHA INDUSTRIAL PARK ,
ATHIYAWAD DABHEL ,NANI DAMAN (U.T) 396210, INDIA | INDIA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/8491 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CETROTIDE 0.25MG | CETRORELIX | 0.25MG | ABBOTT BIOLOGICALS B.V VEERWEG -12,NL-8121 AA OLST
THE NETHERLANDS,PIERRE FABRE MEDICAMENT -AQUITAINE PHARM INTERNATIONAL SITE 1 | FRANCE | PARENTERAL ORDINARY COMBINATION PACK VIALS | 1.0X1.0 VIAL CARTON,1.0X1.0 PREFILLED SYRINGE CARTON |
| NDA/MAL/HDP/8493 | GILEAD SCIENCE INC | MEDICAL ACCESS (UGANDA) LIMITED | DESCOVY 200MG/25MG | EMTRICITABINE/TENOFOVIR ALAFENAMIDE | 200MG + 25 MG | PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9,ROTTENDORF PHARMA GMBH-OSTENFELDER STRA?E 51-61,59320 ENNIGERLOH,GERMANY | CANADA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8494 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | VAXCEL CEFOBACTAM | CEFOPERAZONE SODIUM+SULBACTAM SODIUM | 500MG + 500MG | KOTRA PHARMA (M) SDN.BHD,-1,2 & 3 JALAN TTC 12 CHENG INDUSTRIAL ESTATE 75250 MELAKA | MALAYSIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 G VIAL |
| NDA/MAL/HDP/8495 | CACHET PHARMACEUTICALS PRIVATE LIMITED | ASTRA PHARMA (U) LIMITED | CACEF 50 | CEFPODOXIME PROXETIL USP | 50MG / 5ML | ALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA. | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/8496 | THEON PHARMACEUTICALS LIMITTED | AIVEEN (U) LIMITED | THEOXONE-500MG | CEFTRIAXONE | 500MG | THEON PHARMACEUTICALS LIMITED.-
VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 MG VIAL |
| NDA/MAL/HDP/8497 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | SWASTIK PHARMACEUTICAL LTD | TRYOXIM 500 | CEFUROXIME AXETIL | 500 MG | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD - -UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE-247668. DIST.-HARIDWAR, UTTA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8498 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR) | GOODMAN INTERNATIONAL LTD | TRIAXONE 0.5G | CEFTRIAXONE | 0.5G | GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E | UNITED ARAB EMIRATES | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON + 5 ML AMPOULE OF WATER FOR INJECTION |
| NDA/MAL/HDP/8499 | YELURI FORMULATIONS PVT LTD | ESCORTS PHARMACEUTICALS LIMITED | SOLOCEF 1000 MG | CEFTRIAXONE SODIUM | 1000MG | YELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6
IDA BOLLARAM,MEDAK DIST.502325,
TELANGANA,INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/8500 | AURONEXT PHARMA PRIVATE LIMITED | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | INEMPLUS 500 | IMIPENEM+CILASTATIN | 500MG +500MG | AURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA. | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X500.0 G VIAL |
| NDA/MAL/HDP/8501 | MEDREICH PLC | LABOREX UGANDA LIMITED | BIOZOLE | METRONIDAZOLE | 125MG/5ML | MEDREICH LTD-4/3 OFF KANAPURA ROAD, AVALAHALLI, A, TEJKAMAL PHARMACEUTICAL PVT, SURVEY NO.6/2 ALADAHALLI,SOMAPURAHOBIL,NELAMANGALA TALUK,BANGALORE RURAL-562111,INDIA | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8502 | MEDREICH PLC | LABOREX UGANDA LIMITED | FLEMING | AMOXICILLIN + POTASSIUM CLAVULANATE | 400MG/5ML + 57MG/5ML | MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X70.0 ML BOTTLE |
| NDA/MAL/HDP/8503 | MEDREICH PLC | LABOREX UGANDA LIMITED | NORZOL | NORFLOXACIN + TINIDAZOLE | 400MG + 600MG | MEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8504 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | LEDVIR | LEDIPASVIR + SOFOSBUVIR | 90MG + 400MG | MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON,
SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X28.0 TABLET BOTTLE |
| NDA/MAL/HDP/8522 | PLANET PHARMACEUTICALS UGANDA LTD | PLANET PHARMACEUTICALS UGANDA LTD | DAYPENAM | MEROPENEM | 500MG | SWISS PARENTERALS LTD-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 382220 GUJARAT INDIA | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X500.0 MG VIAL |
| NDA/MAL/HDP/8601 | DROGSAN ?LA?LARI SAN. VE TIC. A.?. | BUFFALO HEALTH CARE LTD | CARDIOSAN 5MG | AMLODIPINE BESILATE | 5 MG | DROGSAN ?LA?LARI SAN. VE TIC. A.?.-06760 ?UBUK ?ANKARA / TURKEY | TURKEY | ORAL SOLID ORDINARY TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8602 | MAVID PHARMACEUTICALS LIMITED | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | KOFLIN COUGH FLU LINCTUS | CHLOPHENIRAMINE | 2MG | MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8603 | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAGNESIUM TRISILICATE SUSPENSION | SODIUM BICARBONATE + LIGHT MAGNESIUM CARBONATE + MAGNESIUM | 250 MG + 250 MG + 250 MG | MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO | UGANDA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/8604 | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | PYODINE | POVIDINE-IODINE | 10 %W/V | MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X60.0 ML BOTTLE |
| NDA/MAL/HDP/8605 | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | HYDROGEN PEROXIDE | HYDROGEN PEROXIDE | 6 %W/V | MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X250.0 ML BOTTLE |
| NDA/MAL/HDP/8606 | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | DIPHEX COUGH EXPECTORANT | DIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + AMMONIUM CHLORIDE | 0.014 MG / 5 ML + 0.057 MG / 5 ML + 0.135 MG / 5 ML | MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO | UGANDA | ORAL LIQUID ORDINARY SYRUPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8611 | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | SURGICAL SPIRIT | MULT-INGREDIENT | N/A | MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8615 | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | CALAMINE LOTION | CALAMINE + ZINC OXIDE | 0.75 MG / 5 ML + 0.25 MG / 5 ML | MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO | UGANDA | TOPICAL EXTERNAL SUSPENSIONS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8617 | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAVID PHARMACEUTICAL INDUSTRIES LIMITED | MAVID'S KEVLON | CHLORHEXIDINE GLUCONATE 20% + CETRIMIDE | 0.015 G / 5 ML +0.15 G / 5 ML | MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO | UGANDA | TOPICAL EXTERNAL LIQUIDS | 1.0X125.0 ML BOTTLE |
| NDA/MAL/HDP/8637 | BLISS GVS PHARMA LIMITED | DELMAW ENTERPRISES LIMITED | AGYCIN | AZITHROMYCIN DIHYDRATE | 40MG/ML | BLISS 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/DROPS | 1.0X1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/8639 | MSD (PTY) LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ISENTRESS 100MG | RALTEGRAVIR POTASSIUM | 100MG | PATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA,MERCK SHARP & DOHME BV.-WAARDERWEG 39
HAARLEM, - 2031 BN, NETHERLANDS,MSD (PTY) LTD. -117-16TH ROAD, HALFWAY HOUSE, 1685
SOUTH AFRICA | UNITED STATES | ORAL SOLID ORDINARY CHEWABLE TABLETS | 1.0X1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8640 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | CORTUM 250 | CEFUROXIME AXETIL | 250MG | AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8641 | CADILA PHARMACEUTICALS LIMITED | KARURI PHARMACEUTICALS LTD. | TELI H | TELMISARTAN + HYDROCHLOROTHIAZIDE | 40MG + 12.5MG | CADILA PHARMACEUTICALS LIMITED-1389,TRASAD ROAD, DHOLKA-382 225, AHMEDABAD GUJARAT STATE, INDIA. | INDIA | ORAL SOLID ORDINARY LAYERED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8643 | SWISS PARENTERALS PVT LTD | ROYAL PHARMA 2011 LIMITED | ARTESUNATE 60MG | ARTESUNATE | 60MG | SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT | INDIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0X60.0 MG VIAL + 1*1*5ML AMPOULE OF 0.9%W/V NACL + 1*1*1ML AMPOULE OF 5%W/V NAHCO3 |
| NDA/MAL/HDP/8644 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | LOOBID SUSPENSION | OFLOXACIN + ORNIDAZOLE | 50MG + 125MG / 5ML | CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL LIQUID ORDINARY SUSPENSIONS | 1.0X1.0X30.0 ML BOTTLE |
| NDA/MAL/HDP/8648 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | UNODEX PLUS | TERBUTALINE SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN | 2.5MG + 8MG + 100MG | AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8649 | INJECTCARE PARENTERALS PVT. LTD | MATRIX (U) LTD | CEFCARE | CEFTRIAXONE SODIUM | 1G | INJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT | INDIA | PARENTERAL ORDINARY VIALS | 1.0X10.0 ML VIAL |
| NDA/MAL/HDP/8650 | ?LKO ?LA? SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | CEFDIA 400MG | CEFIXIME TRIHYDRATE | 400MG | NOBEL ?LA? SAN. VE TIC. A.?.-81100
SANCAKLAR, D?ZCE-TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X5.0 TABLET BLISTER |
| NDA/MAL/HDP/8653 | PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD) | ROYAL PHARMA 2011 LIMITED | LEFLOXIN 500 | LEVOFLOXACIN HEMIHYDRATE | 500MG | ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR ? 441501,
DIST. NAGPUR,
MAHARASHTRA,
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8655 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | GLUCOPHAGE XR 1000MG | METFORMIN HYDROCHLORIDE | 1000MG | MERCK KGAA--FRANKFURTER STR. 250
64293 DARMSTADT
GERMANY,MERCK SANT? S.A.S.-2 RUE DU PRESSOIR VERT
45400 SEMOY
FRANCE | GERMANY | ORAL SOLID RETARD TABLETS | 1.0X4.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/8658 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | METFORMIN 1000MG | METFORMIN HYDROCHLORIDE | 1000MG | LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW
| POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X4.0X15.0 TABLET BLISTER |
| NDA/MAL/HDP/8659 | SANDOZ GMBH, KUNDL | SURGIPHARM (U) LIMITED | METFORMIN 500MG | METFORMIN HYDROCHLORIDE | 500MG | LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW
| POLAND | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X6.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8660 | GILEAD SCIENCE INC | MEDICAL ACCESS (UGANDA) LIMITED | VEMLIDY | TENOFOVIR ALAFENAMIDE | 25MG | PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | CANADA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8661 | AUROBINDO PHARMA LTD | GITTOES PHARMACEUTICALS LIMITED | DOLUTEGRAVIR TABLETS 50MG | DOLUTEGRAVIR SODIUM | 50MG | AUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8662 | RENE INDUSTRIES LTD | RENE INDUSTRIES LIMITED | AMOXIREN-DS | AMOXICILLIN TRIHYDRATE | 250MG/5ML | RENE INDUSTRIES LTD .-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA | UGANDA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8665 | CACHET PHARMACEUTICALS PVT LTD | ASTRA PHARMA (U) LIMITED | PAMAGIN-C | CETIRIZINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + ACETAMINOPHEN + PHENYLEPHRINE HYDROCHLORIDE + ZINC GLUCONATE | 5.0 MG +15 MG + 500 MG + 5 MG + 7.5 MG | CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205 | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8679 | KWALITY AFRO ASIA LIMITED | KWALITY AFRO ASIA LTD | K COUGH-D | BROMOHEXINE HYDROCHLORIDE + AMMONIUM CHLORIDE + DEXTROMETHORPHAN HYDOBROMIDE + MENTHOL | 8MG + 10MG + 100MG + 5MG | KWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROAD | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8685 | MSN LABORATORIES PRIVATE LIMITED | GOOD DAY PHARMACY LIMITED | RANCV 500 | RANOLAZINE | 500 MG | MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICT
PIN CODE 502 325
ANDHRA PRADESH, INDIA.
| INDIA | ORAL SOLID RETARD FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8686 | CODAL-SYNTO LTD | RENE PHARMACY LTD | CODANOL | ATENOLOL | 100 MG | MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8688 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | DURART 600 | DARUNAVIR | 600 MG | MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8689 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | DURART 800 | DARUNAVIR | 800 MG | MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8690 | CIPLA LTD | QUALITY CHEMICALS LTD | ARTESUNATE SUPPOSITORIES 100MG | ARTESUNATE | 100MG | CIPLA LIMITED,
PLOT NO. D-7
MIDC INDUSTRIAL AREA,
KURKUMBH,
DIST: PUNE 413 802,
INDIA | INDIA | RECTAL SYSTEMIC SUPPOSITORIES | 1X1X2 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/8691 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | QUETRA 1000 | LEVETIRACETAM | 1000MG | REMEDICA LTD.-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE,3056 LIMASSOL CYPRUS | CYPRUS | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8692 | GOODMAN INTERNATIONAL (U) LTD | GOODMAN INTERNATIONAL LTD | PARAFUSIV | PARACETAMOL | 10 MG/ML | S.M FARMACEUTICI SRL-ZONA INDUSTRIALE,
85050 TITO-POTENZA
(PZ) ITALY
| ITALY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X50.0 ML VIAL,1.0X100.0 ML VIAL |
| NDA/MAL/HDP/8693 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | QUETRA 100MG/ML | LEVETIRACETAM | 100 MG/ML | REMEDICA LTD.-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE,3056 LIMASSOL CYPRUS | CYPRUS | ORAL LIQUID ORDINARY LIQUIDS | 1.0X300.0 ML BOTTLE |
| NDA/MAL/HDP/8696 | PHARCO PHARMACEUTICALS | WIDE SPECTRUM ENTERPRISES (U) LIMITED | BABY COL | SIMETHICONE | 40MG/0.6ML | PHARCO PHARMACEUTICALS-KILO 31 ALEXANDRIA-CAIRO DESERT ROAD AMRIYA ALEXANDRIA | EGYPT | ORAL LIQUID ORDINARY EMULSIONS | 1.0X1.0X15.0 ML BOTTLE |
| NDA/MAL/HDP/8697 | CADILA HEALTHCARE LIMITED. | ABACUS PHARMA (AFRICA) LIMITED | ZYPIRON 20 | IRON SUCROSE | 20MG/ML | CADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210 | INDIA | PARENTERAL ORDINARY VIALS | 1.0X1.0X5.0 ML VIAL |
| NDA/MAL/HDP/8699 | REMEDICA LTD | GOODMAN INTERNATIONAL LTD | ACETAZOLAMIDE | ACETAZOLAMIDE | 250 MG | REMEDICA LTD.-AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE,3056 LIMASSOL CYPRUS | CYPRUS | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8743 | CADILA PHARMACEUTICALS LTD | KARURI PHARMACEUTICALS LTD. | ISONIAZID | ISONIAZID | 300 MG | CADILA PHARMACEUTICALS LIMITED.-1389, DHOLKA-387810, INDIA OPP.RAJVANSH APARTMENT,
SATYA MARG, BODAKDEV, AHMEDABAD ? 380054,
GUJARAT, INDIA. | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X24.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/8814 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | ACRIPTEGA | DOLUTEGRAVIR SODIUM + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE | 50MG + 300MG + 300MG | MYLAN LABORATORIES LIMITEDD ,-PLOT NO.11, 12 & 13, INDORE SPECIAL
ECONOMIC ZONE, PHARMA ZONE, PHASE-II, SECTOR-III, PITHAMPUR-454775
DIST. DHAR, MADHYA PRADESH, INDIA.
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8815 | ZIM LABORATORIES LTD | GITTOES PHARMACEUTICALS LIMITED | ZIMAGRA ? ODS 50 | SLIDENAFIL CITRATE | 50 MG | ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,
KALMESHWAR ? 441501,
DIST. NAGPUR,
MAHARASHTRA,
| INDIA | OTHER SYSTEMIC SPECIAL SOLIDS | 1.0X1.0X10.0 SACHET CARTON |
| NDA/MAL/HDP/8816 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | ABPARA | PARACETAMOL | 1%W/V | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | PARENTERAL ORDINARY INFUSION BAGS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8817 | MEDIPHARM INDUSTRIES (E.A) LTD | MEDIPHARM SALES LIMITED | MEDISOLONE-15 | PREDNISOLONE SODIUM PHOSPHATE | 15MG/5ML | MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA | UGANDA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X5.0 ML BOTTLE |
| NDA/MAL/HDP/8818 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LEVOTOP-PF | LEVOFLOXACIN HEMIHYDRATE | 1.5%W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | OPHTHALMIC DROPS | 1.0X1.0X5.0 ML VIAL |
| NDA/MAL/HDP/8819 | UNOSOURCE PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | LORFACT-D SYRUP | DESLORATADINE | 5MG/5ML | AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA | INDIA | ORAL LIQUID ORDINARY SYRUPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8820 | TROIKAA PHARMACEUTICALS LTD | ABACUS PHARMA (AFRICA) LIMITED | T-DOL P RAPID | TRAMADOL HYDROCHLORIDE + PARACETAMOL | 37.5MG + 325MG | TROIKAA PHARMACEUTICALS LTD .-C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8821 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ROFAST 10 | ROSUVASTATIN CALCIUM | 10MG | "AUROBINDO PHARMA LIMITED-UNIT ?VII, SEZ, TSIIC, PLOT NO. SI,S. NO.?S 411/P, 425/P, 434/P, 435/P & 458/P,GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL,
MAHABOOB NAGAR DISTRICT -509 302
TELANGANA STATE, INDIA"
| INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8822 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PHARMA (AFRICA) LIMITED | ALIDO | LIDOCAINE HYDROCHLORIDE | 2%W/V | LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
| INDIA | PARENTERAL ORDINARY AMPOULES | 1.0X1.0X30.0 ML VIAL |
| NDA/MAL/HDP/8823 | GILEAD SCIENCE INC | MEDICAL ACCESS (UGANDA) LIMITED | EPCLUSA | SOFOSBUVIR + VELPATASIR | 400MG + 100MG | PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9 | CANADA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE |
| NDA/MAL/HDP/8824 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | NEPAFLAM | NEPAFENAC | 0.1% W/V | CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA | INDIA | OPHTHALMIC SUSPENSIONS | 1.0X1.0X5.0 ML VIAL |
| NDA/MAL/HDP/8825 | LINCOLN PHARMACEUTICALS LTD | METRO PHARMACEUTICALS LIMITED | LAXALINK | LACTULOSE | 3.35G/5ML | LINCOLN PARENTERAL LIMITED- 11, TRIMUL ESTATE, KHATRAJ, TAL. KALOL,
DIST. GANDHINAGAR,
GUJARAT, INDIA.
| INDIA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X170.0 ML BOTTLE |
| NDA/MAL/HDP/8826 | CIPLA LTD. | QUALITY CHEMICALS LTD - HUMAN | ABACAVIR SULFATE AND LAMIVUDINE TABLETS FOR ORAL SUSPENSION 120/60 MG | ABACAVIR SULFATE + LAMIVUDINE | 120MG + 60MG | CIPLA LIMITED -PLOT NO A ? 33, A ? 2 (UNIT ? I),
MIDC PATALGANGA,
DISTRICT RAIGAD, 410 220
MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS | 1.0X1.0X60.0 TABLET BOTTLE |
| NDA/MAL/HDP/8827 | HETERO LABS LTD | ABACUS PHARMA (AFRICA) LIMITED | SOFGEN | SOFOSBUVIR | 400 MG | HETERO LABS LIMITED UNIT-VI --APIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR DIST -509301, TELANGANA, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X28.0 TABLET BOTTLE |
| NDA/MAL/HDP/8835 | RESONANT PHARMACEUTICALS | SHREEJI PHARMACEUTICALS LIMITED | TRIO-FAS(KIT) | AZITHROMYCIN DIHYDRATE + FLUCONAZOLE + SECNIDAZOLE | 1000MG + 150MG + 2G | ACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/8914 | RENE INDUSTRIES LIMITED | RENE INDUSTRIES LIMITED | PEFLOREN 400 | PEFLOXACIN MESILATE DIHYDRATE | 400 MG | RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA | UGANDA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8915 | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD | WIDE SPECTRUM ENTERPRISES (U) LIMITED | ATOXIA 120 MG | ETORICOXIB | 120 MG | UNITED PHARMACEUTICAL MANUFACTURING CO. LTD--P.O. BOX 69 AMMAN 11591 - AL-RAGEEM SAHAB - JORDAN | JORDAN | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X7.0 TABLET BLISTER |
| NDA/MAL/HDP/8916 | MACLEODS PHARMACEUTICALS LTD. | NORVIK ENTERPRISES LIMITED | TAMSUMAC 0.4 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA
TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH ? 174101
INDIA
| INDIA | ORAL SOLID RETARD CAPSULES | 1.0X1.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8917 | SVIZERA LABS PRIVATE LTD | GITTOES PHARMACEUTICALS LIMITED | SCC-2 LLW TABLETS | RIFAMPICIN + ISONIAZID | 150MG + 75MG | SVIZERA LABS PRIVATE LIMITED-PLOT D-16/6 TTC INDUSTRIAL AREA MIDC TURBHE NAVI MUMBAI
400703, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/8918 | SVIZERA LABS PRIVATE LTD | GITTOES PHARMACEUTICALS LIMITED | SCC-3 LLW TABLETS | RIFAMPICIN + ISONIAZID + ETHAMBUTOL HYDROCHLORIDE | 150MG + 75MG + 275MG | SVIZERA LABS PRIVATE LIMITED-PLOT D-16/6 TTC INDUSTRIAL AREA MIDC TURBHE NAVI MUMBAI
400703, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/8919 | SVIZERA LABS PRIVATE LTD | GITTOES PHARMACEUTICALS LIMITED | SCC-4 TABLETS | RIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL HYDROCHLORIDE | 150MG + 75MG + 400MG + 275MG | SVIZERA LABS PRIVATE LIMITED-PLOT D-16/6 TTC INDUSTRIAL AREA MIDC TURBHE NAVI MUMBAI
400703, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X24.0X28.0 TABLET BLISTER |
| NDA/MAL/HDP/8920 | MERCK (PTY) LTD | UNITED HEALTHCARE DISTRIBUTORS LTD | CRINONE 8% GEL | PROGESTERONE | 90MG/APPLICATOR | FLEET LABORATORIES LTD 94 RICKMANSWORTH ROAD, WATFORD, HERT, WD18 7JJ, UNITED KINGDOM | UNITED KINGDOM | VAGINAL GEL | 1X1X15G APPLICATOR |
| NDA/MAL/HDP/8921 | SUN PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | VESIZEN 5 | SOLIFENACIN SUCCINATE | 5 MG | SUN PHARMACEUTICALS LTD-,-SEZ UNIT ?I, PLOT NO. A-41,
INDUSTRIAL AREA, PHASE VIIIA
S.A.S NAGAR MOHALI-160 071
PUNJAB, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8923 | SUN PHARMACEUTICAL LTD | STAR PHARMACEUTICALS LTD | VESIZEN 10 | SOLIFENACIN SUCCINATE | | SUN PHARMACEUTICALS LTD-,-SEZ UNIT ?I, PLOT NO. A-41,
INDUSTRIAL AREA, PHASE VIIIA
S.A.S NAGAR MOHALI-160 071
PUNJAB, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8925 | ZIFAM PINNACLE PTY. LTD. | BOOTS PHARMACEUTICALS LIMITED | ZIFAMET 250 | METRONIDAZOLE | 250 MG | FREDUN PHARMACEUTICALS LTD --14, 15, 16, ZORABIAN INDUSTRIAL COMPLEX,
VILLAGE, VEOOR, PALGHAR (EAST)
DIST: THANE ? 401 404 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8926 | MSN LABORATORIES PRIVATE LIMITED | GOOD DAY PHARMACY LIMITED | GLUSIS 1000 ER | METFORMIN HYDROCHLORIDE | 1000 MG | MSN LABORATORIES PRIVATE LIMITED (FORMULATIONS DIVISION) - -PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, INDIA | INDIA | ORAL SOLID RETARD TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8927 | BIOLOGICAL E. LTD | PILLAR LOGISTICS LIMITED | DIPHTHERIA AND TETANUS VACCINE (ADSORBED REDUCED ANTIGEN(S) CONTENT) | DIPHTHERIA TOXOID + TETANUS TOXOID | 2 LF ( NOT LESS THAN 2 IU) + 8.8 LF (NOT LESS THAN 20 IU)/ 0.5ML | BIOLOGICAL E. LIMITED--PLOT NO.1 SHAPOORJI PALLONJI BIOTECH PARK
PHASE II, KOLTHUR VILLAGE, SHAMEERPET,
MANDAL, R.R. DISTRICT, ANDRA PRADESH 500078, INDIA | INDIA | PARENTERAL ORDINARY VIALS | 1.0X24.0X1.0X10.0 DOSE VIAL,1.0X48.0X1.0 DOSE VIAL |
| NDA/MAL/HDP/8928 | CODAL-SYNTO LTD | RENE PHARMACY LTD | SYNTOCLAV | AMOXICILLIN TRIHYDRATE + CLAVULANIC ACID | 125MG+31.25MG / 5ML | MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS | CYPRUS | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8929 | OCTAPHARMA AG | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | ALBUNORM | HUMAN ALBUMIN | 20%W/V | OCTAPHARMA PRODUKTIONSGESELLSCHAFT DEUTSCHLAND MBH--WOLFGANG-MARGUERRE-ALLEE 1 31832 SPRINGE
GERMANY | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8930 | RESONANT PHARMACEUTICALS PVT LTD | SHREEJI PHARMACEUTICALS LIMITED | GASTRISAFE-(KIT) | CLARTHROMYCIN + ESOMEPRAZOLE MAGNESIUM DIHYDRATE + TINIDAZOLE | 5000MG + 40MG + 500MG | ACME PHARMACEUTICAL PVT. LTD.-ROPAR ROAD NALAGARH, DIST. SOLAN,
HIMACHAL PRADESH ? 174101 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X7.0X6.0 TABLET STRIP (2 TABLETS + 2 TABLETS + 2 CAPSULES) |
| NDA/MAL/HDP/8931 | CARITAS HEALTHCARE PVT. LTD | REDDYS PHARMA LIMITED | SODIUM CHLORIDE INTRAVENOUS INFUSION BP | SODIUM CHLORIDE | 0.9%W/V | SICHUAN KELUN PHARMACEUTICAL CO., LTD-SOUTH OF NO.2 ROAD, XINDU SATELLITE CITY INDUSTRIAL DEVELOPMENT ZONE, CHENGDU, SICHUAN PROVINCE 610500, P. R. CHINA | CHINA | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X500.0 ML BOTTLE |
| NDA/MAL/HDP/8932 | S KANT HEALTHCARE LTD | ABACUS PHARMA (AFRICA) LIMITED | PRAZIQUANTEL | PRAZIQUANTEL | 600 MG | S KANT HEALTHCARE LTD-1802-1805 GIDC PHASE III VAPI 396 195 GUJARAT | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X25.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/8933 | CIPLA LTD | QUALITY CHEMICALS LTD - HUMAN | Q-TIB | SULFAMETHOXAZOLE + TRIMETHOPRIM + ISONIAZID + PYRIDOXINE HYDROCHLORIDE | 800MG + 160MG + 300MG +25MG | CIPLA LIMITED>-A-33, A-37/2/2 & A-2, M.I.D.C, PATALANGA 410 220, DISTRICT RAIGAD, M.S, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/8934 | ABACUS PARENTERAL DRUGS LIMITED | ABACUS PARENTERAL DRUGS LIMITED | CYCLO P EYE DROPS | CYCLOPENTOLATE HYDROCHLORIDE | 1.0%W/V | ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA. | UGANDA | OPHTHALMIC DROPS | 1.0X1.0X10.0 ML VIAL |
| NDA/MAL/HDP/8935 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD | HEALTHCARE LTD. | FECLO GEL | DICLOFENAC DIETHYLAMMONIUM SALT | 1%W/W | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTAN | PAKISTAN | TOPICAL EXTERNAL EMULSION GELS | 1.0X1.0X20.0 G TUBE,1.0X1.0X15.0 G TUBE |
| NDA/MAL/HDP/8936 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD | HEALTHCARE LTD. | ESOFOLE | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 40MG | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8937 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD | HEALTHCARE LTD. | ESOFOLE | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 20MG | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTAN | PAKISTAN | ORAL SOLID ORDINARY CAPSULES | 1.0X2.0X7.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8938 | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD | HEALTHCARE LTD. | SULPHASIL | SILVER SULPHADIAZINE | 1%W/W | AL-FAZAL PHARMA INDUSTRIES (PVT.) LTD-PLOT 20,21,22- DEFENCE INDUSTRIAL ZONE-MOMAN PURA, 16KM SHEIKHUPURA ROAD, (LAHORE) - PAKISTAN | PAKISTAN | TOPICAL EXTERNAL CREAMS | 1.0X1.0X20.0 G TUBE,1.0X1.0X50.0 G TUBE |
| NDA/MAL/HDP/8939 | FREDUN PHARMACEUTICALS LTD | MEDICIVE PHARMACEUTICALS LTD | FREMOL PLUS | PARACETAMOL + PHENYLEPHRINE HYDROCHLORIDE + CHLORPHENIRAMINE MALEATE + CAFFEINE (ANHYDROUS) | 500MG + 10MG + 2MG + 30MMG | FREDUN PHARMACEUTICALS LTD --14, 15, 16, ZORABIAN INDUSTRIAL COMPLEX,
VILLAGE, VEOOR, PALGHAR (EAST)
DIST: THANE ? 401 404 - INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X50.0X1.0X4.0 TABLET BLISTER |
| NDA/MAL/HDP/8940 | ?LKO ?LA? SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | RABIZA 20MG | RABEPRAZOLE SODIUM | 20MG | ?LKO ?LA? SANAYI VE TICARET A. ?.-3. 42050
SEL?UKLU / KONYA
TURKEY | TURKEY | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8941 | ?LKO ?LA? SANAYI VE TICARET A. ?. | CORE ACCESS LIMITED | LIVERCOL 20MG | ROSUVASTATIN CALCIUM | 20MG | ?LKO ?LA? SANAYI VE TICARET A. ?.-3. 42050
SEL?UKLU / KONYA
TURKEY | TURKEY | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X14.0 TABLET BLISTER |
| NDA/MAL/HDP/8944 | GUILIN PHARMACEUTICALS CO.LTD. | STAR PHARMACEUTICALS LTD | GAMOK 625MG | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 500MG + 125MG | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8946 | GUILIN PHARMACEUTICALS CO.LTD. | STAR PHARMACEUTICALS LTD | GAMOK 0.6G | AMOXICILLIN SODIUM + CLAVULANATE POTASSIUM | 500MG + 100MG | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X0.6 G VIAL |
| NDA/MAL/HDP/8947 | GUILIN PHARMACEUTICALS CO.LTD. | STAR PHARMACEUTICALS LTD | GAMOK 1.2G | AMOXICILLIN SODIUM + CLAVULANATE POTASSIUM | 1G + 0.2G | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA | CHINA | PARENTERAL ORDINARY DRY VIALS | 1.0X10.0X1.2 G VIAL |
| NDA/MAL/HDP/8948 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR). | GAMA PHARMACEUTICALS (U) LIMITED | JULMENTIN ES | AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM | 600 MG / 5 ML + 42.9 MG / 5 ML | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR) --DIGDAGA, AIRPORT STREET
RAS AL KHAIMAH
UNITED ARAB EMIRATES | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8949 | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY | WIDE SPECTRUM ENTERPRISES (U) LIMITED | CETAL SUPOSITORIES | PARACETAMOL | 120MG | EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPT | EGYPT | RECTAL SYSTEMIC SUPPOSITORIES | 1.0X1.0X5.0 SUPPOSITORY BLISTER |
| NDA/MAL/HDP/8950 | KOTRA PHARMA (M) SDN,BHD | UNITED HEALTHCARE DISTRIBUTORS LTD | VAXCEL CEFEPIME-1G INJECTION | CEFEPIME HYDROCHLORIDE | 1 G | KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA | MALAYSIA | PARENTERAL ORDINARY DRY VIALS | 1.0X1.0 VIAL CARTON |
| NDA/MAL/HDP/8951 | MATRIX UGANDA LTD | MATRIX (U) LTD | VOREN ENTERIC MICROEN CAPSULATED CAPSULE | DICLOFENAC SODIUM | 50MG | Y.S P INDUSTRIES (M) SDN BHD-PLOT NO. 3, 5 & 7, JALAN P/7, SECTION 13, KAWASAN, PERINDUSTRIAN BANDAR BARU BANGI, 43000 KAJANG, SELANGOR DARUL EHSAN, MALAYSIA | MALAYSIA | ORAL SOLID ORDINARY ENTERIC-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/8952 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFLEX -500 | CEFALEXIN MONOHYDRATE | 500 MG | THEON PHARMACEUTICALS LIMITED.-
VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA | INDIA | ORAL SOLID ORDINARY OTHER CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/8953 | JOHNSON &JOHNSON (PTY) LTD | ERIS LTD | BENYLIN CHILDREN'S WET COUGH | GUAIFENESIN | 100MG PER 10ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X100.0 ML BOTTLE |
| NDA/MAL/HDP/8954 | JOHNSON &JOHNSON (PTY) LTD | ERIS LTD | BENYLIN WET COUGH | GUAIFENESIN | 200MG PER 10ML | JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA | SOUTH AFRICA | ORAL LIQUID ORDINARY LIQUIDS | 1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE |
| NDA/MAL/HDP/8955 | GULF PHARMACEUTICAL INDUSTRIES(JULPHAR) | GOODMAN INTERNATIONAL LTD | CEFUZIME | CEFUROXIME AXETIL | 125MG/5ML | GULF PHARMACEUTICAL INDUSTRIES (JULPHAR) --DIGDAGA, AIRPORT STREET
RAS AL KHAIMAH
UNITED ARAB EMIRATES | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X50.0 ML BOTTLE |
| NDA/MAL/HDP/9051 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | SULFAMETHOXAZOLE/ TRIMETHOPRIM TABLETS USP | SULFAMETHOXAZOLE + TRIMETHOPRIM | 400MG + 80MG | MYLAN LABORATORIES LTD-PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/9052 | MYLAN LABORATORIES LIMITED | KIMSY MEDS LTD | SULFAMETHOXAZOLE/ TRIMETHOPRIM TABLETS USP | SULFAMETHOXAZOLE + TRIMETHOPRIM | 800MG + 160MG | MYLAN LABORATORIES LTD-PLOT NO.11, 12 & 13, INDORE SPECIAL ECONOMIC ZONE, PHARMA ZONE, PHASE II, SECTOR III, PITHAMPUR -454775; DIST; DHAR; MADHYA PRADESH; | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X1.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/9053 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | MABTHERA? 100MG/10ML | RITUXIMAB | 100MG/10ML | ROCHE DIAGNOSTICS GMBH MANNHEIM--SANDHOFER STRASSE 116 -68305 MANNHEIM GERMANY. | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X2.0X10.0 ML VIAL |
| NDA/MAL/HDP/9054 | F. HOFFMANN LA-ROCHE | LABOREX UGANDA LIMITED | MABTHERA? 500MG/50ML | RITUXIMAB | 500MG/50ML | ROCHE DIAGNOSTICS GMBH MANNHEIM--SANDHOFER STRASSE 116 -68305 MANNHEIM GERMANY. | GERMANY | PARENTERAL ORDINARY INFUSION VIALS/BOTTLES | 1.0X1.0X50.0 ML VIAL |
| NDA/MAL/HDP/9055 | MACLEODS PHARMACEUTICALS LTD | NORVIK ENTERPRISES LIMITED | PYRAZINAMIDE TABLETS BP 150MG | PYRAZINAMIDE | 150MG | "MACLEODS PHARMACEUTICALS LTD,--BLOCK N2, VILLAGE THEDA, POST OFFICE LODHIMAJRA, TEHSIL BADDI, DISTRICT SOLAN,
HIMACHAL PRADESH ? 174101
INDIA."
| INDIA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X100.0 TABLET CONTAINER |
| NDA/MAL/HDP/9056 | AUROBINDO PHARMA LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | VALSAR-AM 160/5 | AMLODIPINE + VALSARTAN | 5MG + 160MG | AUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/9057 | GUILIN PHARMACEUTICAL CO.LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | D-ARTEPP? | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 60MG + 480MG | GUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X6.0 TABLET BLISTER |
| NDA/MAL/HDP/9058 | GUILIN PHARMACEUTICAL CO.LTD | PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED | D-ARTEPP? DISPERSIBLE | DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE | 30MG + 240MG | GUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI | CHINA | ORAL SOLID ORDINARY SOLUBLE TABLETS | 1.0X2.0X3.0 TABLET BLISTER |
| NDA/MAL/HDP/9059 | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD | METRO PHARMACEUTICALS LIMITED | CLASSMOX DROPS | AMOXICILLIN TRIHYDRATE | 125MG/ML | TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD - -UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE-247668. DIST.-HARIDWAR, UTTA | INDIA | ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS | 1.0X10.0 ML BOTTLE |
| NDA/MAL/HDP/9060 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | RESPIWEL 2 | RESPERIDONE | 2 MG | AKUMS DRUGS & PHARMACEUTICALS LTD.
SITE ADDRESS :19, 20, 21, SEC-6A, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249 403 -INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X10.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/9061 | UNOSOURCE PHARMA LTD. | ABACUS PHARMA (AFRICA) LIMITED | UNOROCK KIT | IBANDRONATE SODIUM MONOHYDRATE AND [CALCIUM CITRATE MALATE + CALCITRIOL] | [150MG] AND [250MG + 0.25MG] | AKUMS DRUGS & PHARMACEUTICALS LTD.
SITE ADDRESS :19, 20, 21, SEC-6A, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249 403 -INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0 TABLET BLISTER + 1X30 TABLET BLISER COMBIPACK |
| NDA/MAL/HDP/9062 | AJANTA PHARMA LTD | ABACUS PHARMA (AFRICA) LIMITED | ADERAN 32 | CANDESARTAN CILEXETIL | 32 MG | AJANTA PHARMA LIMITED
B-1-5-6, MIDC AREA
PAITHAN, AURANGABAD, 431 148
DIST: AURANGABAD
MAHARASHTRA, INDIA | INDIA | ORAL SOLID ORDINARY TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/9063 | LAURUS LABS LTD | BEYOND LOGISTICS LTD | TENOFOVIR DISOPROXIL FUMARATE TABLETS 300 MG | TENOFOVIR DISOPROXIL FUMARATE | 300 MG | LAURUS LABS LIMITED (UNIT II) PLOT NO.: 19,20,&21, WESTERN SECTOR, APSEZ, ATCHUTAPURAM MANDAL, VISAKHAPATNAM DISTRICT, 531 011, ANDRA PRADESH, INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X30.0 TABLET BOTTLE |
| NDA/MAL/HDP/9064 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOMOX-250 | AMOXICILLIN TRIHYDRATE | 250 MG | THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN HIMACHAL PRADESH - 174 101 - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/9065 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFLEX -250 | CEFALEXIN MONOHYDRATE | 250 MG | THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN HIMACHAL PRADESH - 174 101 - INDIA | INDIA | ORAL SOLID ORDINARY CAPSULES | 1.0X10.0X10.0 CAPSULE BLISTER |
| NDA/MAL/HDP/9066 | THEON PHARMACEUTICALS LTD | AIVEEN (U) LIMITED | THEOFIX-200 | CEFIXIME TRIHYDRATE | 200 MG | THEON PHARMACEUTICALS LIMITED VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN HIMACHAL PRADESH - 174 101 - INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X2.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/9067 | MEDISEL (K) LTD | AIVEEN (U) LIMITED | BRONCHOWIN | DOXOFYLLINE | 400 MG | CORONA REMEDIES PVT LTD
VILLAGE JATOLI,
POST OFFICE - OACHGHAT,
TEHSIL SOLAN, DIST. SOLAN
HIMACHAL PRADESH ? 173223.
INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X3.0X10.0 TABLET BLISTER |
| NDA/MAL/HDP/9068 | MEDISEL (K) LTD | AIVEEN (U) LIMITED | MOXODOC TABLET | MOXIFLOXACIN HYDROCHLORIDE | 400 MG | CORONA REMEDIES PVT LTD
VILLAGE JATOLI,
POST OFFICE - OACHGHAT,
TEHSIL SOLAN, DIST. SOLAN
HIMACHAL PRADESH ? 173223.
INDIA | INDIA | ORAL SOLID ORDINARY FILM-COATED TABLETS | 1.0X1.0X10.0 TABLET BLISTER |