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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
175-410OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MGKREMERS URBAN DEVELOPMENT COMPANY5/3/01
275-521BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG, 10 MG, AND 15 MGTORPHARM5/9/01
375-690FLUOXETINE ORAL SOLUTION, USP 20 MG/5 MLALPHARMA, U.S. PHARMACEUTICALS DIVISION5/10/01
475-762OFLOXACIN INJECTION 40 MG/ML (10 ML SINGLE-DOSE VIAL)BEDFORD LABORATORIES5/23/01
575-356PAROXETINE HYDROCHLORIDE TABLETS 10 MG, 20 MG, 30 MG, AND 40 MGTORPHARM5/24/01
675-994LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGEON LABS MANUFACTURING, INC.5/24/01
775-939CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MGGENEVA PHARMACEUTICALS, INC.5/30/01
875-112DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP EQUIVALENT TO 125 MG, 250 MG, AND 500 MG VALPROIC ACIDTORPHARM5/31/01
975-872FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE)TEVA PHARMACEUTICALS USA5/31/01