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First-Time Generic Drug Approvals: May 2012

  • Vardenafil Tablets 2.5 mg, 5 mg, 10 mg and 20 mg
    Approved: May 3, 2012 - Teva Pharmaceuticals USA
    Generic for: Levitra
  • Carbidopa, Entacapone and Levodopa Tablets 25 mg/200 mg/100 mg and 37.5 mg/200 mg/150 mg
    Approved: May 10, 2012 - Sun Pharma Global FZE
    Generic for: Stalevo 100 and Stalevo 150
  • Clopidogrel Tablets 75 mg (base) and 300 mg (base)
    Approved: May 17, 2012 - Apotex Inc.; Aurobindo Pharma Limited; Dr.Reddy's Laboratories Limited; Gate Pharmaceuticals; Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Sun Pharma Global FZE; Teva Pharmaceuticals, USA Inc.; Torrent Pharmaceuticals Limited
    Generic for: Plavix
  • Ropinirole Hydrochloride Extended-Release 2 mg (base), 4 mg (base), 6 mg (base), 8 mg (base) and 12 mg (base)
    Approved: May 17, 2012 - Actavis Elizabeth LLC
    Generic for: Requip XL
  • Butoconazole Vaginal Cream 2%
    Approved: May 18, 2012 - Perrigo Israel
    Generic for: Gynazole-1
  • Minocycline Hydrochloride Extended-Release Tablets 65 mg (base) and 115 mg (base)
    Approved: May 18, 2012 - Barr Laboratories, Inc.
    Generic for: Solodyn
  • Lansoprazole Delayed-Release Capsules 15 mg (OTC)
    Approved: May 18, 2012 - Dr.Reddy's Laboratories Limited; Perrigo; Wockhardt Ltd.
    Generic for: Prevacid 24HR
  • Nevirapine Tablets 200 mg
    Approved: May 22, 2012 - Apotex Corp.; Aurobindo Pharma Limited; Camber Pharmaceuticals, Inc.; Cipla Limited; Micro Labs Limited; Mylan Pharmaceuticals, Inc.; Prinston Pharmaceutical Inc.; Sciegen Pharmaceuticals
    Generic for: Viramune Tablets
  • Nevirapine Oral Suspension 50 mg/5 mL
    Approved: May 22, 2012 - Aurobindo Pharma Limited
    Generic for: Viramune Oral Suspension
  • Dextromethorphan Polistirex Extended Release Suspension eq 30 mg dextromethorphan hydrobromide /5 mL
    Approved: May 25, 2012 - Tris Pharma, Inc.
    Generic for: Delsym 12 Hour Cough Relief
  • Voriconazole for Injection 200 mg/vial
    Approved: May 30, 2012 - Sandoz, Inc.
    Generic for: Vfend I.V.
  • Calcipotriene Cream 0.005%
    Approved: May 30, 2012 - Tolmar, Inc.
    Generic for: Dovonex Cream
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