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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - June 2012

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1ARMODAFINIL TABLETS 50 MG 150 MG 250 MG     MYLAN PHARMACEUTICALS, INC.NUVIGIL TABLETS6/1/2012 
2ADAPALENE GEL, 0.3%       TOLMAR INC.DIFFERIN GEL, 0.3%6/14/2012 
3ABACAVIR TABLETS USP, 300 MG       MYLAN PHARMACEUTICALS, INC.ZIAGEN TABLETS6/18/2012 
4OLANZAPINE AND FLUOXETINE CAPSULES USP, 6 MG/25 MG (BASE), 12 MG/25 MG (BASE), 6 MG/50 MG (BASE) AND 12 MG/50 MG (BASE)    TEVA PHARMACEUTICALS USASYMBYAX CAPSULES6/19/2012 
5DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE EXTENDED- RELEASE CAPSULES, 5 MG, 10 MG, 15 MG, 20 MG, 25 MG AND 30 MG  ACTAVIS ELIZABETH LLCADDERALL XR CAPSULES6/22/2012 
6CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL, 1.2%/5%       PERRIGO ISRAEL PHARMACEUTICALS LTD.DUAC TOPICAL GEL6/26/2012 
7LINEZOLID INJECTION, 2 MG/ML; PACKAGED IN 600 MG/300 ML SINGLE-USE FLEXIBLE PLASTIC CONTAINERS    TEVA PHARMACEUTICALS USAZYVOX INJECTION 600 MG/300 ML6/27/2012 
8CIDOFOVIR INJECTION, 75 MG/ML; PACKAGED IN 375 MG/5 ML SINGLE-USE VIALS     MYLAN INSTITUTIONAL, LLCVISTIDE INJECTION6/27/2012