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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - March 2003

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-214 SOTALOL HYDROCHLORIDE TABLETS (AF) 80 MG, 120 MG, AND 160 MG TORPHARM 3/5/2003 
2 76-349 FLUDARABINE PHOSPHATE FOR INJECTION 50 MG/VIAL GENSIA SICOR PHARMACEUTICALS, INC. 3/12/2003 
3 75-728 LORATADINE SYRUP (OTC) 10 MG/10 ML L. PERRIGO COMPANY 3/12/2003 
4 76-269 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG TEVA PHARMACEUTICALS USA 3/25/2003 
5 76-128 OFLOXACIN OTIC SOLUTION 0.3% BAUSCH & LOMB PHARMACEUTICALS, INC. 3/31/2003 

 

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