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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - May 2011

  Generic Drug Name  Generic Manufacturer Brand Name Approval Date
 1 METHYLERGONOVINE MALEATE TABLETS USP, 0.2 MG NOVEL LABORATORIES, INC. METHERGINE TABLETS 5/2/2011
 2 FLUTICASONE PROPIONATE LOTION, 0.05% GLENMARK GENERICS LIMITED CUTIVATE LOTION 5/2/2011
 3 NITROFURANTOIN ORAL SUSPENSION USP, 25 MG/5 ML AMNEAL PHARMACEUTICALS FURADANTIN ORAL SUSPENSION 5/11/2011
 4 BROMFENAC OPHTHALMIC SOLUTION, 0.09% (TWICE-DAILY)  COASTAL PHARMACEUTICALS XIBROM OPHTHALMIC SOLUTION (TWICE-DAILY) 5/11/2011
 5 BUDESONIDE CAPSULES, (ENTERIC COATED) 3 MG MYLAN PHARMACEUTICALS, INC. ENTOCORT EC CAPSULES 5/16/2011
 6 CARBAMAZEPINE EXTENDED-RELEASE CAPSULES, 100 MG, 200 MG, AND 300 MG NOSTRUM PHARMACEUTICALS, LLC CARBATROL CAPSULES 5/20/2011
 7 ESZOPICLONE TABLETS, 1 MG, 2 MG, AND 3 MG TEVA PHARMACEUTICALS USA LUNESTA TABLETS 5/23/2011
 8 LAMIVUDINE AND ZIDOVUDINE TABLETS, 150 MG/300 MG TEVA PHARMACEUTICALS USA COMBIVIR TABLETS 5/25/2011
 9 LEVONORGESTREL AND ETHINYL ESTRADIOL (EE) TABLETS & EE TABLE 0.15 MG/0.03 MG; 0.01 MG WATSON LABORATORIES, INC. SEASONIQUE TABLETS 5/31/2011