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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2004

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-739 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG and 20 MG/12.5 MG   RANBAXY PHARMACEUTICALS, INC. 9/1/2004 
2 76-874 LEVOFLOXACIN TABLETS 250 MG, 500 MG, AND 750 MG   RANBAXY LABORATORIES LIMITED 9/9/2004 
3 76-537 GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 9/20/2004 
4 76-581 CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10 MG   TEVA PHARMACEUTICALS USA 9/21/2004 
5 76-475 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 37.5 MG/325 MG   KALI LABORATORIES 9/22/2004 
6 76-992 CIPROFLOXACIN INJECTION, USP 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-DOSE VIALS   BEDFORD LABORATORIES 9/23/2004 
7 76-872 HALOBETASOL PROPIONATE OINTMENT 0.05%   AGIS INDUSTRIES (1983) LTD. 9/24/2004 
8 76-277 RIBAVIRIN CAPSULES 200 MG   TEVA PHARMACEUTICALS USA 9/24/2004 
9 76-818 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   COBALT PHARMACEUTICALS, INC. 9/27/2004 
10 76-869 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG   ANDRX PHARMACEUTICALS LLC 9/29/2004 

 

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