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FDA Withdraws Oxycontin NDA

04/18/2013

Federal Register Notice: FDA has determined that Oxycontin (oxycodone hydrochloride) extended-release tablets (10, 15, 20, 30, 40, 60, 80, and 160 mg) approved under NDA 20-553 were withdrawn from sale for reasons of safety or effectiveness. The agency will not accept or approve ANDAs for products that reference NDA 20-553. To view this notice, click here.

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