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
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