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U.S. Department of Health and Human Services

Drugs

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Approvals - May 2001

 ANDA NumberDrug NameApplicantApproval Date
175-902FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MGTORPHARM5/7/01
276-032METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 20 MGABLE LABORATORIES, INC.5/9/01
375-591FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 0.4 MG/ML (20 MG/50 ML) SINGLE-DOSE IN GALAXY PLASTIC CONTAINER.BAXTER HEALTHCARE CORPORATION5/10/01
475-607FAMOTIDINE TABLETS, USP 20 MG, AND 40 MGINVAMED INC.5/10/01
575-602AMINOCAPROIC ACID TABLETS, USP 500 MGMIKART, INC.5/24/01
640-360PERPHENAZINE ORAL SOLUTION, USP 16 MG/5 ML (CONCENTRATE)PHARMACEUTICAL ASSOCIATES, INC.5/25/01
775-951NORETHINDRONE ACETATE TABLETS, USP 5 MGBARR LABORATORIES, INC.5/25/01
875-673CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP 1%/0.05% (BASE)TARO PHARMACEUTICALS U.S.A., INC.5/29/01
965-001CEFUROXIME FOR INJECTION, USP 750 MG/10 ML (VIAL); 1.5 G/20 ML (VIAL); 750 MG/100 ML (INFUSION BOTTLE); AND 1.5 G/100 ML (INFUSION BOTTLE).AMERICAN PHARMACEUTICAL PARTNERS, INC.5/30/01
1040-419ACETAMINOPHEN AND CODEINE TABLETS, USP 300 MG/15 MG, 300 MG/30 MG, AND 300 MG/60 MG.MALLINCKRODT, INC.5/31/01
1175-312FAMOTIDINE TABLETS, USP 10 MG (OVER-THE COUNTER USE)TEVA PHARMACEUTICALS, USA5/31/01