First-Time Generic Drug Approvals: October 2007

• Nifedipine Extended-Release Tablets USP, 90 mg
  Approved: October 3, 2007 Osmotica Pharmaceutical Corp.
  Generic for: Procardia XL Tablets
• Risedronate Sodium Tablets 5 mg, 30 mg, and 35 mg
  Approved: October 5, 2007 Teva Pharmaceuticals USA
  Generic for: Actonel Tablets
• Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg
  Approved: October 9, 2007 Roxane Laboratories, Inc.; Glenmark Pharmaceuticals, Ltd; Sun Pharmaceutical Industries Ltd.
  Generic for: Trileptal Tablets
• Hydrocodone Bitartrate and Ibuprofen Tablets 2.5 mg/200 mg (New Strength)
  Approved: October 19, 2007 Interpharm Inc.
  Generic for: Vicoprofen Tablets
• Rivastigmine Tartrate Capsules 1.5 mg (base), 3 mg (base), 4.5 mg (base), and 6 mg (base)
  Approved: October 22, 2007 Sun Pharmaceutical Industries, Ltd.
  Generic for: Exelon Capsules
• Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg, 1 mg/0.03 mg, 1 mg/0.035 mg (21-Day and 28-Day)
  Approved: October 26, 2007 Barr Laboratories, Inc.
  Generic for: Estrostep-21 and Estrostep Fe Tablets

Generic Approvals Archive