First-Time Generic Drug Approvals: June 2012

• Armodafinil Tablets 50 mg, 150 mg and 250 mg
  Approved: June 1, 2012 - Mylan Pharmaceuticals, Inc.
  Generic for: Nuvigil
• Adapalene Gel 0.3%
  Approved: June 14, 2012 - Tolmar, Inc.
  Generic for: Differin Gel 0.3%
• Abacavir Sulfate Tablets 300 mg (base)
  Approved: June 18, 2012 - Mylan Pharmaceuticals Inc.
  Generic for: Ziagen
• Olanzapine and Fluoxetine Hydrochloride Capsules 25 mg (base)/6 mg (base), 25 mg (base)/12 mg (base), 50 mg (base)/6 mg (base) and 50 mg (base)/12 mg (base)
  Approved: June 19, 2012 - Teva Pharmaceuticals USA Inc.
  Generic for: Symbyax
• Dextroamphetamine 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
  Approved: June 22, 2012 - Actavis Elizabeth LLC
  Generic for: Adderall XR
• Metformin Hydrochloride and Pioglitazone Hydrochloride Tablets 500 mg/15 mg (base) and 850 mg/15 mg (base)
  Approved: June 26, 2012 - Mylan Pharmaceuticals, Inc.
  Generic for: Actoplus Met
• Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/5%
  Approved: June 26, 2012 - Perrigo Israel Pharmaceuticals Ltd.
  Generic for: Duac Topical Gel
• Linezolid Injection 200 mg/100 mL
  Approved: June 27, 2012 - Teva Pharmaceuticals USA Inc.
  Generic for: Zyvox Injection
• Cidofovir Injection 75 mg (base)/mL
  Approved: June 27, 2012 - Mylan Pharmaceuticals, Inc.
  Generic for: Vistide

Generic Approvals Archive