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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - October 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
175-944LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, AND 40 MGRANBAXY LABORATORIES LIMITED10/9/01
275-674FAMOTIDINE TABLETS, USP (OTC) 10 MGGENPHARM INC.10/12/01
376-001FLUOXETINE CAPSULES, USP 10 MG AND 20 MGSIDMAK LABORATORIES, INC.10/16/01
475-926LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORP.10/17/01
575-936MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; 10 MG(BASE)/10 ML, 20 MG (BASE)/20 ML, AND 50 MG (BASE)/50 ML SINGLE-UNIT VIALSAMERICAN PHARMACEUTICAL PARTNERS, INC.10/17/01
675-834MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML; PACKAGED IN 20 MG/100 ML AND 40 MG/200 ML PLASTIC CONTAINERSBAXTER HEALTHCARE CORPORATION10/30/01