What's New on the FDA Drugs Site
September 29, 2009
CDER Key Officials Directory (updated) Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated)
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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