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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - September 2011


  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 LEVETIRACETAM EXTENDED-RELEASE TABLETS, 500 MG AND 750 MG       ACTAVIS ELIZABETH LLC. KEPPRA XR 9/12/2011 
2 LEVETIRACETAM EXTENDED-RELEASE TABLETS, 500 MG AND 750 MG       PAR PHARMACEUTICAL, INC. KEPPRA XR 9/12/2011 
3 LEVETIRACETAM EXTENDED-RELEASE TABLETS, 500 MG AND 750 MG       APOTEX, INC. KEPPRA XR 9/12/2011 
4 LEVETIRACETAM EXTENDED-RELEASE TABLETS, 500 MG AND 750 MG       WATSON LABORATORIES, INC. - FLORIDA KEPPRA XR 9/12/2011 
5 LEVETIRACETAM EXTENDED-RELEASE TABLETS, 500 MG AND 750 MG       MUTUAL PHARMACEUTICAL COMPANY, INC. KEPPRA XR 9/12/2011 
6 LEVETIRACETAM EXTENDED-RELEASE TABLETS, 500 MG AND 750 MG       TEVA PHARMACEUTICALS USA KEPPRA XR 9/12/2011 
7 FELBAMATE TABLETS, 600 MG        AMNEAL PHARMACEUTICALS FELBATROL TABLETS 9/13/2011 
8 DOXERCALCIFEROL CAPSULES, 0.5 MCG        ROXANE LABORATORIES, INC. HECTOROL CAPSULES 9/23/2011