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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - July 2003

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-309 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG   DR. REDDY'S LABORATORIES LIMITED 7/7/2003 
2 76-188 FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG   GENEVA PHARMACEUTICALS TECHNOLOGY CORP. 7/10/2003 
3 76-139 FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG   TEVA PHARMACEUTICALS USA 7/10/2003 
4 76-332 FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML AND 40 MG/ML   RANBAXY LABORATORIES LIMITED 7/11/2003 
5 76-578 ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG   MYLAN PHARMACEUTICALS, INC. 7/17/2003 
6 76-087 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML PACKAGED IN 200 MG /100ML 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS   BEDFORD LABORATORIES 7/17/2003 
7 76-199 PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG   IVAX PHARMACEUTICALS, INC. 7/31/2003

 

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