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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - July 2012

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1PREGABALIN CAPSULES, 75 MG, 100 MG, 150 MG, 200 MG, 225 MG AND 300 MG  TEVA PHARMACEUTICALS USALYRICA CAPSULES7/3/2012 
2PREGABALIN CAPSULES, 25 MG AND 50 MG      TEVA PHARMACEUTICALS USALYRICA CAPSULES, 25 MG AND 50 MG7/3/2012 
3PREGABALIN CAPSULES, 25 MG, 50 MG, 75 MG, 100 MG, 150 MG, 200 MG, 225 MG AND 300 MG WATSON LABORATORIES, INC.LYRICA CAPSULES7/3/2012 
4PREGABALIN CAPSULES, 25 MG, 50 MG, 75 MG, 100 MG, 150 MG, 200 MG, 225 MG AND 300 MG LUPIN LIMITEDLYRICA CAPSULES7/3/2012 
5DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS, 50 MG/0.2 MG AND 75 MG/0.2 MG      WATSON LABORATORIES, INC. - FLORIDAARTHROTEC TABLETS7/9/2012 
6LEVONORGESTREL TABLETS, (RX & OTC) 1.5 MG       WATSON LABORATORIES, INC.PLAN B ONE STEP7/12/2012 
7PHENOXYBENZAMINE HYDROCHLORIDE CAPSULES USP, 10 MG       ROXANE LABORATORIES, INC.DIBENZYLINE CAPSULES7/16/2012 
8MODAFANIL TABLETS USP, 100 MG AND 200 MG      MYLAN PHARMACEUTICALS, INC.PROVIGIL TABLETS7/16/2012 
9ENTACAPONE TABLETS USP, 200 MG       SUN PHARMA GLOBAL FZECOMTAN TABLETS7/16/2012 
10METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, (CD), 10 MG, 20 MG AND 30 MG (ONCE DAILY)     TEVA PHARMACEUTICALS USAMETADATE CD EXTENDED-RELEASE CAPSULES7/19/2012 
11METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, (CD), 40 MG, 50 MG AND 60 MG (ONCE DAILY)     TEVA PHARMACEUTICALS USAMETADATE CD EXTENDED-RELEASE CAPSULES7/19/2012 
12FEXOFENADINE HYDROCHLORIDE ORAL SUSPENSION, 30 MG/5 ML       ACTAVIS MID ATLANTIC, LLCALLEGRA ORAL SUSPENSION7/25/2012 
13OXYCODONE HYDROCHLORIDE ORAL SOLUTION USP, 100 MG/5 ML       VISTAPHARM INC.OXYCODONE HYDROCHLORIDE ORAL SOLUTION, USP7/30/2012