Tuesday, September 29, 2009

CDER New September 29, 2009

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

September 29, 2009


New and Generic Drug Approvals

September 29, 2009

  • Alendronate Sodium Tablets, AustarPharma, LLC, Approval
  • Darvon (propoxyphene hydrochloride) Capsules, Xanodyne Pharmaceutical, Inc., Labeling Revision
  • Darvon-N (propoxyphene napsylate) Tablets, Xanodyne Pharmaceutical, Inc., Labeling Revision
  • Darvocet-N (acetaminophen and propoxyphene napsylate) Tablets, Xanodyne Pharmaceutical, Inc., Labeling Revision
  • Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Teva Parenteral, Approval 
  • Gemcitabine Injection, APP Pharmaceuticals, LLC, Tentative Approval
  • Neoral (cyclosporine) Capsules, Novartis Corp., Labeling Revision
  • Neoral (cyclosporine) Oral Solution, Novartis Corporation, Labeling Revision
  • Polyethylene Glycol 3350 Oral Solution, Novel Laboratories, Inc., Tentative Approval
  • Ramipril Tablets, Zydus Pharmaceuticals Inc., Approval
  • Tamsulosin Hydrochloride Capsules, Wockhardt Ltd., Tentative Approval
  • Timolol Maleate Ophthalmic Solution, Wockhardt Ltd., Approval


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