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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - March 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
175-478NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP 0.5MG/0.035MG 0.75MG/0.035MG 1MG/0.035MGBARR LABORATORIES INC.3/9/01
275-707FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS)APOTHECON INC.3/13/01
375-659NIFEDIPINE EXTENDED-RELEASE TABLETS 60 MGELAN PHARMACEUTICAL RESEARCH CORPORATION3/20/01
475-590NABUMETONE TABLETS 500 MG 750 MGINVAMED INC.3/21/01
575-298FLUTAMIDE CAPSULES, USP 125 MGTEVA PHARMACEUTICALS USA3/23/01
675-818FLUTAMIDE CAPSULES, USP 125 MGEON LABS MANUFACTURING, INC.3/26/01
774-253BUSPIRONE HYDROCHLORIDE TABLETS, USP 15 MGDANBURY PHARMACAL, INC.3/28/01
875-786FAMOTIDINE TABLETS, USP 20 MG 40 MGWOCKHARDT AMERICAS, INC.3/28/01
975-747CIPROFLOXACIN TABLETS, USP 250 MG 500 MG 750 MGRANBAXY PHARMACEUTICALS, INC.3/30/01