Bextra

NDA 21341, held by Gd Searle. Valdecoxib.

As of Nov 14, 2026, NDA 21341 (Bextra), held by Gd Searle, was first approved by FDA on Nov 16, 2001, with 3 approved supplements and 0 published complete response letters.

• First approved: Nov 16, 2001
• Review: Standard
• Supplements approved: 3
• Complete response letters: 0

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters