First-Time Generic Drug Approvals: June 2009

• Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg; 0.215 mg/0.025 mg and 0.250 mg/0.025 mg (28-Day Regimen)
  Approved: June 29, 2009 Barr Laboratories, Inc.
  Generic for: Ortho Tri Cyclen Lo
• Oxcarbazepine Oral Suspension 300 mg/5 mL
  Approved: June 26, 2009 Ranbaxy Laboratories Limited
  Generic for: Trileptal Oral Suspension
• Levonorgestrel Tablets (Rx) 0.75 mg
  Approved: June 24, 2009 Watson Laboratories, Inc.
  Generic for: Plan B (levonorgestrel) Tablets, 0.75 mg
• Melphalan Hydrochloride for Injection 50 mg (base)/vial
  Approved: June 9, 2009 Synerx Pharma, LLC
  Generic for: Alkeran for Injection
• Omeprazole Magnesium Delayed-Release Capsules (OTC) 20 mg (base)
  Approved: June 6, 2009 Dr. Reddy's Laboratories Limited
  Generic for: Prilosec OTC Delayed-Release Capsules
• Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL; packaged in 40 mg/1 mL vials and 200 mg/5 mL and 400 mg/10 mL multiple-dose vials
  Approved: June 1, 2009 Sandoz Canada Inc.
  Generic for: Kenalog-40 Injectable Suspension

Generic Approvals Archive