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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - February 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-745 OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS 5 MG, 10 MG, AND 15 MG   IMPAX LABORATORIES, INC. 2/1/2005 
2 76-594 MODAFINIL TABLETS 100 MG AND 200 MG   MYLAN PHARMACEUTICALS, INC. 2/9/2005 
3 76-854 LEVOFLOXACIN 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 
4 76-839 LEVOFLOXACIN 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 
5 76-786 DONEPEZIL HYDROCHLORIDE TABLETS 5 MG 10 MG   RANBAXY LABORATORIES LIMITED 2/23/2005 
6 76-993 CIPROFLOXACIN INJECTION, USP 10 MG/ML; PACKAGED IN 1200 MG/120 ML PHARMACY BULK PACKAGES   BEDFORD LABORATORIES 2/25/2005 
7 77-097 LEVOFLOXACIN TABLETS 750 MG   MYLAN PHARMACEUTICALS, INC. 2/25/2005 
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