The Priority Review

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Celecoxib

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  1. Regulation

    FDA withdraws approval of Amneal's celecoxib ANDA

    FDA withdraws approval of abbreviated new drug application 208833 for celecoxib capsules 50 mg, 100 mg, 200 mg, and 400 mg held by Amneal Pharmaceuticals of New York, LLC. Amneal requested the withdrawal and waived its opportunity for a hearing.