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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2001

  ANDA Number Drug Name Applicant Tentative Approval Date
1 76-071 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG MYLAN PHARMACEUTICALS INC. 9/10/01
2 75-807 FLUOXETINE CAPSULES, USP 10 MG, AND 20 MG EON LABS MANUFACTURING, INC. 9/12/01
3 76-024 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) EON LABS MANUFACTURING, INC. 9/12/01
4 76-101 FAMOTIDINE TABLETS, USP (OTC) 10 MG EON LABS MANUFACTURING, INC. 9/14/01
5 75-662 FLUOXETINE CAPSULES, USP 10 MG, AND 20 MG CHELSEA LABORATORIES, INC. 9/17/01
6 75-920 FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML MALLINCKRODT, INC. 9/28/01
7 75-934 NIZATIDINE CAPSULES, USP 150 MG, AND 300 MG GENPHARM INC. 9/28/01

 

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