Opportunity
Federal Register #2026-20758
FDA Withdrawal of Amneal’s Celecoxib Capsule Application
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 09, 2026
Identifier
2026-20758
This FDA notice concerns the withdrawal of approval for Amneal’s generic celecoxib capsule application, not a government purchase.
Description
The FDA is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths, held by Amneal Pharmaceuticals of New York, LLC. Amneal requested withdrawal of the application’s approval and waived its opportunity for a hearing. The withdrawal is effective October 9, 2026.