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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - July 2013

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1RASAGILINE MESYLATE TABLETS, 0.5 MG (BASE) AND 1 MG (BASE)      WATSON LABORATORIES, INC.AZILECT TABLETS7/1/2013 
2DECITABINE FOR INJECTION, 50 MG/VIAL; PACKAGED IN SINGLE-USE VIALS      DR. REDDY'S LABORATORIES, LIMITEDDACOGEN INJECTION7/11/2013 
3REPAGLINIDE TABLETS USP, 1 MG AND 2 MG      CARACO PHARMACEUTICAL LABORATORIES, LTD.PRANDIN TABLETS7/11/2013 
4LAMOTRIGINE ORALLY DISINTEGRATING TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG    WATSON LABORATORIES, INC.LAMICTAL ODT7/15/2013 
5ACAMPROSATE CALCIUM DELAYED-RELEASE TABLETS, 333 MG       GLENMARK GENERICS LIMITEDCAMPRAL TABLETS7/16/2013 
6REPAGLINIDE TABLETS USP, 0.5 MG       PADDOCK LABORATORIES, LLCPRANDIN TABLETS7/17/2013 
7TRETINOIN GEL USP, (MICROSPHERES) 0.1%       SPEAR PHARMACEUTICALS, INC.RETIN-A MICRO7/17/2013 
8TRETINOIN GEL USP, 0.04%       SPEAR PHARMACEUTICALS, INC.RETIN-A MICRO GEL7/17/2013 
9FENOFIBRIC ACID DELAYED-RELEASE CAPSULES, 45 MG AND 135 MG      ANCHEN PHARMACEUTICALS, INC.TRILIPIX DELAYED-RELEASE CAPSULES7/18/2013 
10METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 500 MG AND 1000 MG      LUPIN LIMITEDGLUMETZA TABLETS7/19/2013 
11DONEPEZIL HYDROCHLORIDE TABLETS 23 MG       PAR PHARMACEUTICAL, INC.ARICEPT TABLETS7/23/2013