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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - April 2014

 Generic Drug NameGeneric ManufacturerBrand NameTentative Approval DateApproval Date
1SOLIFENACIN SUCCINATE TABLETS, 5 MG AND 10 MG      TEVA PHARMACEUTICALS USAVESICARE TABLETS 4/2/2014 
2CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 0.1 MG AND 0.2 MG      ANCHEN PHARMACEUTICALS, INC.JENLOGA MODIFIED-RELEASE TABLETS 4/2/2014 
3NEVIRAPINE EXTENDED-RELEASE TABLETS, 400 MG       SANDOZ INC.VIRAMUNE XR TABLETS 4/3/2014 
4NEVIRAPINE EXTENDED-RELEASE TABLETS, 400 MG       APOTEX CORP.VIRAMUNE XR TABLETS 4/3/2014 
5OMEGA-3-ACID ETHYL ESTERS CAPSULES USP, 1 GRAM       TEVA PHARMACEUTICALS USALOVAZA CAPSULES 4/7/2014 
6DIAZEPAM ORAL SOLUTION (CONCENTRATE), 5 MG/ML       LANNETT HOLDINGS, INC.DIAZEPAM INTENSOL ORAL SOLUTION (CONCENTRATE) 4/14/2014 
7NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM, 150 MCG/35 MCG PER DAY       MYLAN TECHNOLOGIES, INC.ORTHO EVRA TRANSDERMAL SYSTEM 4/16/2014 
8ATAZANAVIR SULFATE CAPSULES, 100 MG (BASE), 150 MG (BASE), 200 MG (BASE) AND 300 MG (BASE)    TEVA PHARMACEUTICALS USAREYATAZ CAPSULES 4/22/2014 
9NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS (CHEWABLE) AND FERROUS FUMARATE TABLETS (CHEWABLE) 0.8 MG/0.025 MG; 75 MG     FAMY CARE LTD.GENERESS FE CHEWABLE TABLETS 4/23/2014