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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - April 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-881SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE) 50 MG (BASE) 100 MG (BASE)  ROXANE LABORATORIES, INC.4/11/2005 
277-195TERBINAFINE HYDROCHLORIDE TABELTS 250 MG (BASE)  MYLAN PHARMACEUTICALS INC.4/12/2005