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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - June 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
175-727ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG, AND 10 MG/25 MGTEVA PHARMACEUTICALS USA6/8/01
275-743LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGPAR PHARMACEUTICAL, INC.6/22/01
375-576OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MGDR. REDDY'S LABORATORIES LIMITED6/25/01
475-465FLUOXETINE CAPSULES, USP 10 MG, 20 MG, AND 40 MGDR. REDDY'S LABORATORIES LIMITED6/26/01
575-775POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 10 mEq, AND 20 mEqELAN PHARMACEUTICAL RESEARCH CORPORATION6/28/01
675-755FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) 20 MG (BASE)ALPHAPHARM PTY. LTD.6/29/01