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2026-10-09 · Notice · Federal Register document 2026-20758

Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams

Health and Human Services Department, Food and Drug Administration

Official abstract: The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval of this application and has waived its opportunity for a hearing.

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