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5 Drug Products Not Withdrawn for S&E
12/05/2011
 

Federal Register Notice: FDA has determined that five drug products were not withdrawn from sale for reasons of safety or effectiveness: G.D. Searle’s Demulen tablet, 1/50–28, 1/35–21, 1/35–28, and Wyeth’s Triphasil-28, and Triphasil-21. This determination means that FDA will not begin procedures to withdraw approval of ANDAs that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. To view this notice, click here.

 
 
 
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