First-Time Generic Drug Approvals: July 2008

• Indomethacin for Injection USP 1 mg/vial
  Approved: July 16, 2008 Bedford Laboratories
  Generic for: Indocin IV, 1 mg/Vial
• Doxycycline for Oral Suspension USP, 25 mg/5 mL
  Approved: July 16, 2008 IVAX Pharmaceuticals, Inc.
  Generic for: Vibramycin for Oral Suspension, 25 mg/5 mL
• Nisoldipine Extended Release Tablets 20 mg, 30 mg and 40 mg
  Approved: July 25, 2008 Mylan Pharmaceuticals, Inc.
  Generic for: Sular Extended-Release Tablets
• Mycophenolate Mofetil Capsules 250 mg
  Approved: July 29, 2008 Roxane Laboratories, Inc.
  Generic for: Cellcept Capsules, 250 mg
• Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 250 mg and 500 mg (Valproic Acid Activity)
  Approved: July 29, 2008 Dr. Reddy's Laboratories Limited; Sun Pharmaceutical Industries, Ltd.; Genpharm ULC; Upsher-Smith Laboratories, Inc.; Sandoz Inc.; Teva Pharmaceuticals USA; Lupin Limited
  Generic for: Depakote Delayed-Release Tablets
• Mycophenolate Mofetil Tablets 500 mg
  Approved: July 29, 2008 Roxane Laboratories, Inc.
  Generic for: Cellcept Tablets, 500 mg
• Eplerenone Tablets 25 mg and 50 mg
  Approved: July 30, 2008 Apotex, Inc.
  Generic for: Inspra Tablets, 25 mg and 50 mg

Generic Approvals Archive