First-Time Generic Drug Approvals: April 2008

• Cetirizine Hydrochloride Oral Solution 1 mg/mL (OTC)
  Approved: April 9, 2008 Perrigo R&D Company
  Generic for: Children's Zyrtec Allergy And Hives-Relief
• Levalbuterol Hydrochloride Inhalation Solution 0.31 mg (base), 0.63 mg (base), and 1.25 mg (base); packaged in 3 mL Unit-Dose Vials
  Approved: April 9, 2008 Breath Limited
  Generic for: Xopenex Inhalation Solution
• Fluorouracil Cream USP, 5%
  Approved: April 11, 2008 Spear Pharmaceuticals, Inc.
  Generic for: Efudex Topical Cream, 5%
• Estradiol And Norethindrone Acetate Tablets 1 mg/0.5 mg
  Approved: April 17, 2008 Breckenridge Pharmaceutical, Inc.
  Generic for: Activella Tablets
• Ribavirin Tablets 500 mg (New Strength)
  Approved: April 18, 2008 Zydus Pharmaceuticals USA, Inc.
  Generic for: Copegus Tablets
• Epoprostenol Sodium for Injection 0.5 Mg (base)/vial and 1.5 mg (base)/vial
  Approved: April 23, 2008 Teva Parenteral Medicines, Inc.
  Generic for: Flolan for Injection
• Donepezil Hydrochloride Tablets 5 mg and 10 mg
  Approved: April 28, 2008 Teva Pharmaceuticals USA
  Generic for: Aricept Tablets

Generic Approvals Archive