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11 Drugs Not Withdrawn for S&E

10/01/2008

Federal Register Notice: FDA has determined that the 11 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. The products in certain formulations are: Boehringer Ingelheim’s Atrovent, Downstate Clinical Pet Center’s Fludeoxyglucose F-18, Shire’s Agrylin, Wyeth’s Cordarone, Eli Lilly’s Prozac, Monarch Pharmaceutical’s Neosporin, GlaxoSmithKline’s Ancef, Eli Lilly’s Ceclor, Warner Chilcott’s Duricef, and Monarch Pharmaceutical’s Polysporin. To view this notice, click here.

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