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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - June 2001

  ANDA Number Drug Name Applicant Tentative Approval Date
1 75-727 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG, AND 10 MG/25 MG TEVA PHARMACEUTICALS USA 6/8/01
2 75-743 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG PAR PHARMACEUTICAL, INC. 6/22/01
3 75-576 OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MG DR. REDDY'S LABORATORIES LIMITED 6/25/01
4 75-465 FLUOXETINE CAPSULES, USP 10 MG, 20 MG, AND 40 MG DR. REDDY'S LABORATORIES LIMITED 6/26/01
5 75-775 POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 10 mEq, AND 20 mEq ELAN PHARMACEUTICAL RESEARCH CORPORATION 6/28/01
6 75-755 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) 20 MG (BASE) ALPHAPHARM PTY. LTD. 6/29/01
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