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U.S. Department of Health and Human Services

Drugs

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Approvals - February 2002

 ANDA NumberDrug NameApplicantApproval Date
175-810FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE)BARR LABORATORIES, INC.2/1/02
276-165FLUOXETINE CAPSULES, USP 10 MG, AND 20 MGRANBAXY LABORATORIES LIMITED2/1/02
340-321METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 20 MGPUREPAC PHARMACEUTICAL CO.2/5/02
440-428PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 25 MGG &W LABORATORIES, INC.2/5/02
576-097CARTEOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 1%NOVEX PHARMA2/6/02
676-114INDOMETHACIN EXTENDED-RELEASE CAPSULES, USP 75 MGABLE LABORATORIES, INC.2/6/02
775-292FLUOXETINE ORAL SOLUTION, USP 20 MG(BASE)/5 MLNOVEX PHARMA2/7/02
875-364KETOPROFEN TABLETS 12.5 MG TABLETS AND CAPLETSL. PERRIGO COMPANY2/7/02
976-193PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MGKV PHARMACEUTICAL COMPANY2/7/02
1040-422AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 5 MG (TOTAL), 10 MG (TOTAL), 20 MG (TOTAL) AND 30 MG (TOTAL)BARR LABORATORIES, INC.2/11/02
1175-281DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 50 MG, AND 75 MGALPHAPHARM PTY. LTD.2/12/02
1265-043CEFUROXIME AXETIL TABLETS , USP 125 MG (BASE), 250 MG (BASE), AND 500 MG (BASE).RANBAXY LABORATORIES, LTD.2/15/02
1375-997MEGESTROL ACETATE ORAL SUSPENSION 40 MG/MLROXANE LABORATORIES, INC.2/15/02
1474-805FLUNISOLIDE NASAL SOLUTION, USP 0.025% (25 MCG/SPRAY), 200 METERED SPRAY CONTAINERBAUSCH & LOMB PHARMACEUTICALS2/20/02
1575-679KETOPROFEN EXTENDED-RELEASE CAPSULES 100 MG, 150 MG, AND 200 MGMYLAN PHARMACEUTICALS, INC.2/20/02
1676-175MEFLOQUINE HYDROCHLORIDE TABLETS 250 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORP.2/20/02
1775-470DICLOFENAC POTASSIUM TABLETS 50 MGMUTUAL PHARMACEUTICAL COMPANY, INC.2/21/02
1875-911LACTULOSE SOLUTION, USP 10 G/15 MLNOVEX PHARMA2/21/02
1976-038METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1000 MGMUTUAL PHARMACEUTICAL COMPANY, INC.2/21/02
2065-087TOBRAMYCIN OPHTHALMIC SOLUTION, USP 0.3%NOVEX PHARMA2/25/02
2175-280NABUMETONE TABLETS 500 MG 750 MGEON LABS MANUFACTURING, INC.2/25/02
2275-590NABUMETONE TABLETS 500 MG AND 750 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORP.2/25/02
2375-874IFOSFAMIDE INJECTION/MESNA INJECTION KIT 50 MG/ML (1 G/20 ML OR 3 G/60 ML), AND 100 MG/ML (1 G/10 ML), RESPECTIVELYGENSIA SICOR PHARMACEUTICALS, INC.2/26/02
2465-022BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINT, USP 500 UNITS/G AND 10,000 UNITS/G, RESPECTIVELYALTANA INC.2/27/02
2575-572BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MGKV PHARMACEUTICAL CO.2/27/02
2675-948CARBAMAZEPINE TABLETS, USP 200 MGAPOTEX INC.2/27/02
2775-022BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MGTEVA PHARMACEUTICALS USA2/28/02
2875-865FLUOXETINE HYDROCHLORIDE TABLETS 10 MGZENITH GOLDLINE PHARMACEUTICALS, INC.2/28/02