First-Time Generic Drug Approvals: January 2009

• Galantamine Hydrobromide Oral Solution 4 mg/mL
  Approved: January 30, 2009 Roxane Laboratories, Inc.
  Generic for: Razadyne Oral Solution
• Risperidone Oral Solution 1 mg/mL
  Approved: January 30, 2009 Teva Pharmaceuticals USA
  Generic for: Risperdal Oral Solution
• Divalproex Sodium Extended-Release Tablets 250 mg and 500 mg
  Approved: January 29, 2009 Mylan Pharmaceuticals, Inc.
  Generic for: Depakote ER Tablets, 250 mg and 500 mg
• Divalproex Sodium Delayed Release Capsules (Sprinkle) 125 mg (valproic acid equivalent)
  Approved: January 23, 2009 Dr. Reddy's Laboratories, Inc.
  Generic for: Depakote Sprinkle Capsules, 125 mg
• Levetiracetam Oral Solution 100 mg/mL
  Approved: January 15, 2009 Roxane Laboratories, Inc.; Tolmar Inc.; Aurobindo Pharma Ltd.; Actavis Mid Atlantic LLC
  Generic for: Keppra Oral Solution
• Alprazolam Orally Disintegrating Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg
  Approved: January 9, 2009 Kali Laboratories, Inc.
  Generic for: Niravam Orally Disintegrating Tablets

Generic Approvals Archive