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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
176-071LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGMYLAN PHARMACEUTICALS INC.9/10/01
275-807FLUOXETINE CAPSULES, USP 10 MG, AND 20 MGEON LABS MANUFACTURING, INC.9/12/01
376-024FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE)EON LABS MANUFACTURING, INC.9/12/01
476-101FAMOTIDINE TABLETS, USP (OTC) 10 MGEON LABS MANUFACTURING, INC.9/14/01
575-662FLUOXETINE CAPSULES, USP 10 MG, AND 20 MGCHELSEA LABORATORIES, INC.9/17/01
675-920FLUOXETINE ORAL SOLUTION, USP 20 MG/5 MLMALLINCKRODT, INC.9/28/01
775-934NIZATIDINE CAPSULES, USP 150 MG, AND 300 MGGENPHARM INC.9/28/01