First-Time Generic Drug Approvals: July 2012

• Pregabalin Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
  Approved: July 3, 2012 - Lupin Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc.
  Generic for: Lyrica
• Diclofenac Sodium and Misoprostol Delayed Release Tablets 50 mg/0.2 mg and 75 mg/0.2 mg
  Approved: July 9, 2012 - Watson Pharmaceuticals, Inc.
  Generic for: Arthrotec
• Levonorgestrel Tablets (Next Choice One Dose) 1.5 mg
  Approved: July 12, 2012 - Watson Pharmaceuticals, Inc.
  Generic for: Plan B One-Step
• Phenoxybenzamine Hydrochloride Capsules USP, 10 mg
  Approved: July 16, 2012 - Roxane Laboratories, Inc.
  Generic for: Dibenzyline
• Modafinil Tablets 100 mg and 200 mg
  Approved: July 16, 2012 - Mylan Pharmaceuticals, Inc.
  Generic for: Provigil
• Entacapone Tablets 200 mg
  Approved: July 16, 2012 - Sun Pharma Global
  Generic for: Comtan
• Methylphenidate Hydrochloride Extended-Release Capsules (CD) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg
  Approved: July 19, 2012 - Teva Pharmaceuticals USA
  Generic for: Metadate CD
• Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL
  Approved: July 25, 2012 - Actavis Mid Atlantic
  Generic for: Allegra Oral Suspension

Generic Approvals Archive