First-Time Generic Drug Approvals: November 2011

• Tiagabine Hydrochloride Tablets 2 mg and 4 mg
  Approved: November 4, 2011 - Sun Pharmaceutical Industries, Ltd.
  Generic for: Gabitril
• Levocetirizine Dihydrochloride Oral Solution 2.5 mg/5 mL
  Approved: November 7, 2011 - Synthon Pharmaceuticals, Inc.
  Generic for: Xyzal Oral Solution
• Morphine Sulfate Extended-Release Capsules USP 20 mg, 30 mg, 50 mg, 60 mg, 80 mg and 100 mg
  Approved: November 10, 2011 - Watson Laboratories, Inc.
  Generic for: Kadian
• Eprosartan Mesylate Tablets 400 mg (base) and 600 mg (base)
  Approved: November 16, 2011 - Mylan Pharmaceuticals, Inc.
  Generic for: Teveten
• Imipenem and Cilastatin for Injection USP, (I.V.) 250 mg/250 mg (base) and 500 mg/500 mg (base)
  Approved: November 16, 2011 - Hospira Inc.
  Generic for: Primaxin I.V.
• Lamivudine Tablets 150 mg and 300 mg
  Approved: November 17, 2011 - Aurobindo Pharma USA, Inc.
  Generic for: Epivir Tablets
• Sodium Phenylbutyrate Tablets 500 mg
  Approved: November 18, 2011 - Amplogen Pharmaceuticals, LLC
  Generic for: Buphenyl Tablets
• Atorvastatin Calcium Tablets 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base)
  Approved: November 30, 2011 - Ranbaxy Laboratories Limited
  Generic for: Lipitor

Generic Approvals Archive