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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - August 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-132RISEDRONATE SODIUM TABLETS, 5 MG, 30 MG, AND 35 MG  TEVA PHARMACEUTICALS USA8/11/2005 
277-297GRANISETRON HYDROCHLORIDE INJECTION, 1MG/ML; 4 ML VIALS  SICOR PHARMACEUTICALS, INC.8/16/2005 
377-165GRANISETRON HYDROCHLORIDE INJECTION, 1 MG/ML; 1 ML VIALS  SICOR PHARMACEUTICALS, INC.8/16/2005 
477-367FAMOTIDINE TABLETS USP (OTC), 20 MG  DR. REDDY'S LABORATORIES LIMITED8/17/2005 
577-295GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG  INVAGEN PHARMACEUTICALS, INC.8/18/2005 
677-091GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG  DR. REDDY'S LABORATORIES LIMITED8/18/2005 
777-359ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.8/19/2005 
877-177GRANISETRON HYDROCHLORIDE INJECTION, 1 MG (BASE)/ML; 4 ML VIALS  BAXTER HEALTHCARE CORPORATION8/23/2005 
977-267ZIDOVUDINE TABLETS USP, 300 MG  AUROBINDO PHARMA LIMITED8/25/2005 
1076-930ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG, 8 MG, 16 MG, AND 24 MG  MYLAN PHARMACEUTICALS, INC.8/25/2005 
1177-262AMLODIPINE BESYLATE TABLETS, 2.5 MG, 5 MG, AND 10 MG  ROXANE LABORATORIES, INC.8/31/2005