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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - October 2004

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-878 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG   PUREPAC PHARMACEUTICAL COMPANY 10/4/2004 
2 76-221 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1 MG/0.005 MG   BARR LABORATORIES, INC. 10/5/2004 
3 76-912 CIPROFLOXACIN TABLETS, USP 100 MG   TARO PHARMACEUTICAL INDUSTRIES LTD. 10/6/2004 
4 76-047 CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10 MG  PAR PHARMACEUTICAL, INC. 10/6/2004 
5 76-873 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   EON LABS MANUFACTURING, INC. 10/13/2004 
6 76-436 FINASTERIDE TABLETS, USP 1 MG   DR. REDDY'S LABORATORIES LIMITED 10/14/2004 
7 75-485 GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG WATSON LABORATORIES, INC. 10/18/2004 
8 76-989 CARVEDILOL TABLETS 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG   RANBAXY LABORATORIES LIMITED 10/22/2004 
9 76-511 FINASTERIDE TABLETS, USP 5 MG   TEVA PHARMACEUTICALS USA 10/26/2004 
10 76-744 TESTOSTERONE GEL 1%   PADDOCK LABORATORIES, INC. 10/27/2004 

 

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