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U.S. Department of Health and Human Services

Drugs

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Approvals - September 2002

 ANDA NumberGeneric Drug NameApplicantApproval Date
165-058CEFACLOR EXTENDED-RELEASE TABLETS, USP 375 MG 500 MGTEVA PHARMACEUTICALS USA9/4/02
275-163TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP 0.5% (BASE)HI-TECH PHARMACAL CO., INC.9/10/02
375-893FLUVOXAMINE MALEATE TABLETS 25 MG 50 MG 100 MGTEVA PHARMACEUTICALS USA9/10/02
476-350POTASSIUM IODIDE TABLETS, USP 65 MGRECIP, AB9/10/02
575-819AMANTADINE HYDROCHLORIDE SYRUP, USP 50 MG/5 MLCAROLINA MEDICAL PRODUCTS COMPANY, INC.9/11/02
675-668NIZATIDINE CAPSULES, USP 150 MG AND 300 MGTEVA PHARMACEUTICALS USA9/12/02
765-102AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG AND 125 MG (BASE), RESPECTIVELYRANBAXY LABORATORIES, LTD.9/17/02
875-907HYDROCHLOROTHIAZIDE CAPSULES 12.5 MGVINTAGE PHARMACEUTICALS, INC.9/17/02
975-804NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.25 MG/0.035 MG, RESPECTIVELY, 28-DAY REGIMEN.BARR LABORATORIES, INC.9/25/02
1075-519RANITIDINE TABLETS, USP (OTC) 75 MGGENEVA PHARMACEUTICALS, INC.9/26/02
1175-526TICLOPIDINE HYDROCHLORIDE TABLETS 250 MGCARACO PHARMACEUTICAL LABORATORIES, LTD.9/26/02
1276-130ALBUTEROL EXTENDED-RELEASE TABLETS 4 MG AND 8 MGSIDMAK LABORATORIES, INC.9/26/02
1376-140SOTALOL HYDROCHLORIDE TABLETS 80 MG, 120 MG, 160 MG, AND 240 MGTORPHARM9/26/02
1440-470AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) TABLETS 5 MG (TOTAL)EON LABS, INC.9/27/02
1576-102LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG