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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2004

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-614 LEVOFLOXACIN INJECTION IN DEXTROSE 5% (PREMIX) 5 MG/ML; PACKAGED IN 250 MG (BASE)/50 ML, 500 MG (BASE)/100 ML, & 750 MG (BASE)/150 ML SINGLE-USE VIALS   BEDFORD LABORATORIES 5/14/2004 
2 76-599 LEVOFLOXACIN INJECTION 25 MG/ML; PACKAGED IN 500 MG (BASE)/20 ML & 750 MG (BASE)/30 ML SINGLE-USE VIALS   BEDFORD LABORATORIES 5/14/2004 
3 76-713 TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)   ANDRX PHARMACEUTICALS, LLC 5/19/2004 
4 76-658 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG   DR. REDDY'S LABORATORIES LIMITED 5/20/2004 
5 76-768 ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG (BASE), 35 MG (BASE), 40 MG (BASE) AND 70 MG (BASE)   WATSON LABORATORIES, INC. 5/25/2004 
6 76-694 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   MYLAN PHARMACEUTICALS, INC. 5/26/2004 
7 76-635 FENOFIBRATE TABLETS 54 MG, 107 MG, AND 160 MG RANBAXY LABORATORIES LIMITED 5/27/2004 

 

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