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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - October 2001

  ANDA Number Drug Name Applicant Tentative Approval Date
1 75-944 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, AND 40 MG RANBAXY LABORATORIES LIMITED 10/9/01
2 75-674 FAMOTIDINE TABLETS, USP (OTC) 10 MG GENPHARM INC. 10/12/01
3 76-001 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG SIDMAK LABORATORIES, INC. 10/16/01
4 75-926 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG GENEVA PHARMACEUTICALS TECHNOLOGY CORP. 10/17/01
5 75-936 MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; 10 MG(BASE)/10 ML, 20 MG (BASE)/20 ML, AND 50 MG (BASE)/50 ML SINGLE-UNIT VIALS AMERICAN PHARMACEUTICAL PARTNERS, INC. 10/17/01
6 75-834 MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML; PACKAGED IN 20 MG/100 ML AND 40 MG/200 ML PLASTIC CONTAINERS BAXTER HEALTHCARE CORPORATION 10/30/01

 

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