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U.S. Department of Health and Human Services

Drugs

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Approvals - April 2002

 ANDA Number Drug NameApplicantApproval Date
175-521BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MGTORPHARM4/5/02
275-863DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS 0.15 MG/0.02 MG AND 0.01 MG RESPECTIVELY (28-DAY CYCLE)BARR LABORATORIES, INC.4/5/02
376-044POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 20 mEq (1500 mg)KV PHARMACEUTICAL COMPANY4/5/02
475-588IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, USP 200 MG AND 30 MG, RESPECTIVELY (OTC); (ROUND AND CAPSULE-SHAPED TABLETS)PHARMACEUTICAL FORMULATIONS, INC.4/8/02
575-753FENOFIBRATE CAPSULES (MICRONIZED) 134 MG AND 200 MGNOVOPHARM LIMITED4/9/02
640-364PREDNISOLONE SYRUP, USP 15 MG/5 MLKV PHARMACEUTICAL COMPANY4/10/02
740-391HYDROXYZINE HYDROCHLORIDE SYRUP, USP 10 MG/5 MLVINTAGE PHARMACEUTICALS, INC.4/10/02
875-604POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 10 mEq (750 MG) AND 20 mEq (1500 MG)ANDRX PHARMACEUTICALS, INC.4/10/02
976-141CLOBETASOL PROPIONATE GEL 0.05%HEALTHPOINT, LTD.4/12/02
1040-297ESTRADIOL TABLETS, USP 0.5 MG, 1 MG, AND 2 MGUSL PHARMA, INC.4/17/02
1165-065AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP (CHEWABLE 200 MG/28.5 MG (BASE), RESPECTIVELY; & 400 MG/57 MG (BASE), RESPECTIVELY.GENEVA PHARMACEUTICALS, INC.4/18/02
1240-420PHENYTOIN ORAL SUSPENSION, USP 125 MG/5 MLMORTON GROVE PHARMACEUTICALS, INC.4/19/02
1375-929BUTALBITAL, ACETAMINOPHEN, CAFFEINE & CODEINE PHOS. CAPSULES 50 MG/325 MG/40 MG/30 MGVINTAGE PHARMACEUTICALS, INC.4/22/02
1475-984METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1000 MGTORPHARM4/23/02
1576-125FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MGMUTUAL PHARMACEUTICAL COMPANY, INC.4/29/02
1675-333CROMOLYN SODIUM INHALATION SOLUTION, USP 10 MG/ML (20 MG/2 ML UNIT-DOSE AMPULE)NOVEX PHARMA4/30/02
1775-789FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (2 ML VIALS)BAXTER HEALTHCARE CORPORATION4/30/02
1875-799FAMOTIDINE INJECTION 10 MG/ML (4 ML & 20 ML MULTIPLE-DOSE VIALS)BAXTER HEALTHCARE CORPORATION4/30/02
1975-873MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/MLROXANE LABORATORIES, INC.4/30/02