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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - February 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-745OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS 5 MG, 10 MG, AND 15 MG  IMPAX LABORATORIES, INC.2/1/2005 
276-594MODAFINIL TABLETS 100 MG AND 200 MG  MYLAN PHARMACEUTICALS, INC.2/9/2005 
376-854LEVOFLOXACIN INJECTION IN DEXTROSE 5% (PREMIX) 5 MG (BASE)/ML; PACKAGED IN 250 MG (BASE)/50 ML AND 500 MG (BASE)/100 ML SINGLE-USE PLASTIC CONTAINERS  SICOR PHARMACEUTICALS, INC.2/10/2005 
476-839LEVOFLOXACIN INJECTION 25 MG (BASE)/ML; PACKAGED IN 500 MG (BASE)/20 ML AND 750 MG (BASE)/30 ML SINGLE-DOSE VIALS  SICOR PHARMACEUTICALS, INC.2/10/2005 
576-786DONEPEZIL HYDROCHLORIDE TABLETS 5 MG 10 MG  RANBAXY LABORATORIES LIMITED2/23/2005 
676-993CIPROFLOXACIN INJECTION, USP 10 MG/ML; PACKAGED IN 1200 MG/120 ML PHARMACY BULK PACKAGES  BEDFORD LABORATORIES2/25/2005 
777-097LEVOFLOXACIN TABLETS 750 MG  MYLAN PHARMACEUTICALS, INC.2/25/2005