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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - March 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-214SOTALOL HYDROCHLORIDE TABLETS (AF) 80 MG, 120 MG, AND 160 MGTORPHARM3/5/2003 
276-349FLUDARABINE PHOSPHATE FOR INJECTION 50 MG/VIALGENSIA SICOR PHARMACEUTICALS, INC.3/12/2003 
375-728LORATADINE SYRUP (OTC) 10 MG/10 MLL. PERRIGO COMPANY3/12/2003 
476-269METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MGTEVA PHARMACEUTICALS USA3/25/2003 
576-128OFLOXACIN OTIC SOLUTION 0.3%BAUSCH & LOMB PHARMACEUTICALS, INC.3/31/2003