FDA Withdraws Approval for Amneal Pharmaceuticals' Celecoxib Capsules

The Food and Drug Administration (FDA) has officially withdrawn its approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules (50 mg, 100 mg, 200 mg, and 400 mg) held by Amneal Pharmaceuticals of New York, LLC. The withdrawal is effective as of October 9, 2026. This action follows reports that the drug products approved under this ANDA have not been commercially manufactured since their initial approval in May 2018.