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U.S. Department of Health and Human Services

Drugs

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Approvals April 2001

 ANDA NumberDrug NameApplicantApproval Date
175-547THIOTEPA FOR INJECTION, USP 15 MG/VIALBEDFORD LABORATORIES4/2/01
275-498TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE) 2 MG (BASE) 5 MG (BASE) 10 MG (BASE)TORPHARM4/12/01
375-630BETAXOLOL OPHTHALMIC SOLUTION, USP 0.5% (5 ML, 10 ML, & 15 ML)BAUSCH & LOMB PHARMACEUTICALS, INC.4/12/01
475-842OXAPROZIN TABLETS 600 MGINVAMED, INC.4/12/01
575-062FAMOTIDINE TABLETS, USP 20 MG 40 MGDANBURY PHARMACAL, INC.4/16/01
675-302FAMOTIDINE TABLETS, USP 20 MG 40 MGGENEVA PHARMACEUTICALS, INC.4/16/01
775-311FAMOTIDINE TABLETS, USP 20 MG 40 MGTEVA PHARMACEUTICALS USA4/16/01
875-486FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALSESI LEDERLE4/16/01
975-488FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS)ESI LEDERLE4/16/01
1075-511FAMOTIDINE TABLETS, USP 20 MG 40 MGZENITH GOLDLINE PHARMACEUTICALS, INC.4/16/01
1175-622FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML VIALS)BEDFORD LABORATORIES4/16/01
1275-651FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS)BEDFORD LABORATORIES4/16/01
1375-669FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALSFAULDING PHARMACEUTICAL COMPANY4/16/01
1475-684FAMOTIDINE INJECTION 10 MG/ML (500 MG/50 ML) PHARMACY BULK PACKAGEBEDFORD LABORATORIES4/16/01
1575-704FAMOTIDINE TABLETS, USP 20 MG 40 MGMYLAN PHARMACEUTICALS, INC.4/16/01
1675-705FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS)FAULDING PHARMACEUTICAL COMPANY4/16/01
1775-707FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS)APOTHECON INC.4/16/01
1875-708FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALSAPOTHECON INC.4/16/01
1975-709FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS)AMERICAN PHARMACEUTICAL PARTNERS, INC.4/16/01
2075-718FAMOTIDINE TABLETS, USP 20 MG 40 MGDR. REDDY'S LABORATORIES LIMITED4/16/01
2175-786FAMOTIDINE TABLETS, USP 20 MG 40 MGWOCKHARDT AMERICAS, INC.4/16/01
2275-793FAMOTIDINE TABLETS, USP 20 MG 40 MGEON LABS MANUFACTURING, INC.4/16/01
2375-805FAMOTIDINE TABLETS, USP 20 MG 40 MGCARLSBAD TECHNOLOGY, INC.4/16/01
2475-813FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALSAMERICAN PHARMACEUTICAL PARTNERS, INC.4/16/01
2574-567IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, USP 200 MG/30 MGOHM LABORATORIES, INC.4/17/01
2675-825FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (500 MG/50 ML) PHARMACY BULK PACKAGEBEN VENUE LABORATORIES, INC.4/17/01
2775-457FAMOTIDINE TABLETS, USP 20 MG 40 MGGENPHARM INC.4/18/01
2875-894FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MGWATSON LABORATORIES, INC.4/18/01
2975-390NAPROXEN DELAYED RELEASE TABLETS 375 MG 500 MGALPHAPHARM PTY. LTD.4/19/01
3075-730THIOTEPA FOR INJECTION, USP 15 MG/VIAL 30 MG/VIALGENSIA SICOR PHARMACEUTICALS, INC.4/20/01
3175-906PROGESTERONE INJECTION, USP 50 MG/ML (MULTIPLE-DOSE VIAL)AMERICAN PHARMACEUTICAL PARTNERS, INC.4/25/01
3275-811MESNA INJECTION 100 MG/ML; (10 ML MULTIPLE-DOSE VIAL)AMERICAN PHARMACEUTICAL PARTNERS, INC.4/26/01
3375-058FLURBIPROFEN TABLETS, USP 50 MG 100 MGCARACO PHARMACEUTICAL LABORATORIES, LTD.4/27/01
3475-423CLONAZEPAM TABLETS, USP 0.5 MG, 1 MG, AND 2 MGCARACO PHARMACEUTICAL LABORATORIES, LTD.4/27/01
3575-500SOTALOL HYDROCHLORIDE TABLETS 80 MG 120 MG 160 MG 240 MGUPSHER-SMITH LABORATORIES, INC.4/27/01
3675-764MESNA INJECTION 100 MG/ML (10 ML MULTIPLE-DOSE VIAL)GENSIA SICOR PHARMACEUTICALS, INC.4/27/01
3775-850OXAPROZIN TABLETS 600 MGGENEVA PHARMACEUTICALS, INC.4/27/01
3875-290PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL, AND 90 MG/VIALBEDFORD LABORATORIES4/30/01
3975-796LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG/0.02 MG, RESPECTIVELY; (21-DAY AND 28-DAY CYCLES)DURAMED PHARMACEUTICALS, INC.4/30/01