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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - February 2001

 ANDA NUMBERDRUG NAMEAPPLICANTTENTATIVE APPROVAL DATE
175-464FLUOXETINE CAPSULES, USP 10 MG 20 MGAPOTHECON INC.2/2/01
275-577FLUOXETINE CAPSULES, USP 10 MG 20 MGALPHAPHARM PTY. LTD.2/6/01
375-704FAMOTIDINE TABLETS, USP 20 MG 40 MGMYLAN PHARMACEUTICALS, INC.2/6/01
475-708FAMOTIDINE INJECTION (PRESERVATIVE-FREE)         10 MG/ MLAPOTHECON INC.2/7/01
575-797TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE)TEVA PHARMACEUTICALS USA2/14/01
675-709FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS)AMERICAN PHARMACEUTICAL PARTNERS, INC.2/28/01