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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - August 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-132 RISEDRONATE SODIUM TABLETS, 5 MG, 30 MG, AND 35 MG   TEVA PHARMACEUTICALS USA 8/11/2005 
2 77-297 GRANISETRON HYDROCHLORIDE INJECTION, 1MG/ML; 4 ML VIALS   SICOR PHARMACEUTICALS, INC. 8/16/2005 
3 77-165 GRANISETRON HYDROCHLORIDE INJECTION, 1 MG/ML; 1 ML VIALS   SICOR PHARMACEUTICALS, INC. 8/16/2005 
4 77-367 FAMOTIDINE TABLETS USP (OTC), 20 MG   DR. REDDY'S LABORATORIES LIMITED 8/17/2005 
5 77-295 GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG   INVAGEN PHARMACEUTICALS, INC. 8/18/2005 
6 77-091 GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG   DR. REDDY'S LABORATORIES LIMITED 8/18/2005 
7 77-359 ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG   CARACO PHARMACEUTICAL LABORATORIES, LTD. 8/19/2005 
8 77-177 GRANISETRON HYDROCHLORIDE INJECTION, 1 MG (BASE)/ML; 4 ML VIALS   BAXTER HEALTHCARE CORPORATION 8/23/2005 
9 77-267 ZIDOVUDINE TABLETS USP, 300 MG   AUROBINDO PHARMA LIMITED 8/25/2005 
10 76-930 ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG, 8 MG, 16 MG, AND 24 MG   MYLAN PHARMACEUTICALS, INC. 8/25/2005 
11 77-262 AMLODIPINE BESYLATE TABLETS, 2.5 MG, 5 MG, AND 10 MG   ROXANE LABORATORIES, INC. 8/31/2005 
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