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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2001

  ANDA Number Drug Name Applicant Tentative Approval Date
1 75-410 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG KREMERS URBAN DEVELOPMENT COMPANY 5/3/01
2 75-521 BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG, 10 MG, AND 15 MG TORPHARM 5/9/01
3 75-690 FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML ALPHARMA, U.S. PHARMACEUTICALS DIVISION 5/10/01
4 75-762 OFLOXACIN INJECTION 40 MG/ML (10 ML SINGLE-DOSE VIAL) BEDFORD LABORATORIES 5/23/01
5 75-356 PAROXETINE HYDROCHLORIDE TABLETS 10 MG, 20 MG, 30 MG, AND 40 MG TORPHARM 5/24/01
6 75-994 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG EON LABS MANUFACTURING, INC. 5/24/01
7 75-939 CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG GENEVA PHARMACEUTICALS, INC. 5/30/01
8 75-112 DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP EQUIVALENT TO 125 MG, 250 MG, AND 500 MG VALPROIC ACID TORPHARM 5/31/01
9 75-872 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) TEVA PHARMACEUTICALS USA 5/31/01
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