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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - March 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-692AMLODIPINE BESYLATE TABLETS, 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)  DR. REDDY'S LABORATORIES, LTD.4/3/2006 
277-513RAMIPRIL CAPSULES 1.25 MG 2.5 MG 5 MG 10 MG  PUREPAC PHARMACEUTICAL CO.4/10/2006 
377-081FEXOFENADINE HYDROCHLORIDE TABLETS 30 MG 60 MG 180 MG  MYLAN PHARMACEUTICALS, INC.4/11/2006 
477-729ONDANSETRON HYDROCHLORIDE TABLETS 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE)  TARO PHARMACEUTICAL INDUSTRIES, LTD.4/14/2006 
577-387ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; PACKAGED IN 4 MG/2 ML SINGLE-DOSE VIALS.  PHARMAFORCE, INC.4/14/2006 
677-578FINASTERIDE TABLETS USP, 5 MG  MYLAN PHARMACEUTICALS, INC.4/14/2006 
777-691SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG  AUROBINDO PHARMA LIMITED4/19/2006 
877-057PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS 20 MG (BASE) AND 40 MG (BASE)  SANDOZ INC.4/19/2006 
977-056PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS 20 MG (BASE) AND 40 MG (BASE)  TEVA PHARMACEUTICALS USA4/19/2006 
1077-652LEVOFLOXACIN TABLETS 250 MG, 500 MG, AND 750 MG  ZYDUS PHARMACEUTICALS USA, INC.4/20/2006 
1176-287FLUOXETINE CAPSULES USP, 10 MG AND 20 MG (RLD = SARAFEM CAPSULES/LILLY)  TEVA PHARMACEUTICALS USA4/20/2006 
1277-780CARVEDILOL TABLETS 2.125 MG, 6.25 MG, 12.5 MG, AND 25 MG  TARO PHARMACEUTICAL INDUSTRIES, LTD.4/21/2006 
1376-311TOPIRAMATE TABLETS 50 MG  PAR PHARMACEUTICAL4/24/2006 
1476-341PRAVASTATIN SODIUM TABLETS 80 MG  APOTEX INC.4/25/2006 
1577-245CIPROFLOXACIN INJECTION USP, 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS  HOSPIRA INC.4/27/2006