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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - April 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-881 SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE) 50 MG (BASE) 100 MG (BASE)   ROXANE LABORATORIES, INC. 4/11/2005 
2 77-195 TERBINAFINE HYDROCHLORIDE TABELTS 250 MG (BASE)   MYLAN PHARMACEUTICALS INC. 4/12/2005 
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