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As of Nov 15, 2026, NDA 21052 (Vioxx), held by Merck, was first approved by FDA on May 20, 1999, with 19 approved supplements and 0 published complete response letters.
First approved: May 20, 1999
Review: Priority
Supplements approved: 19
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 20 submissions below
Aug 19, 2004
Supplement 19Efficacy (new indication or use) · Priority review
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
