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

Generic Approvals Archive