First-Time Generic Drug Approvals: November 2010

• Gemcitabine Hydrochloride Injection 2 g base/vial
  Approved: November 15, 2010 - Hospira Inc.
  Generic for: Gemzar
• Zafirlukast Tablets 10 mg and 20 mg
  Approved: November 18, 2010 - Dr Reddys Laboratories Ltd.
  Generic for: Accolate
• Mefenamic Acid Capsules USP, 250 mg
  Approved: November 19, 2010 - Micro Labs Limited
  Generic for: Ponstel Capsules
• Donepezil Hydrochloride Tablets 5 mg and 10 mg
  Approved: November 26, 2010 - Ranbaxy Laboratories Limited
  Generic for: Aricept Tablets
• Levocetirizine Dihydrochloride Tablets 5 mg
  Approved: November 26, 2010 - Synthon Pharmaceuticals, Inc.
  Generic for: Xyzal
• Topotecan Hydrochloride Injection 4 mg base/vial
  Approved: November 29, 2010 - APP Pharmaceuticals, LLC; Fresenius Kabi
  Generic for: Hycamtin

Generic Approvals Archive