NDA 21156, held by Gd Searle LLC. Celecoxib.
As of Nov 14, 2026, NDA 21156 (Celebrex), held by Gd Searle LLC, was first approved by FDA on Dec 23, 1999, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 1999 | Original applicationTYPE 6 · Priority review | Approved |
| Feb 4, 2011 | Supplement 3Labeling | Approved | |
| Aug 29, 2002 | Supplement 2Manufacturing · Priority review | Approved | |
| Aug 29, 2002 | Supplement 1Manufacturing · Priority review | Approved | |
| Dec 23, 1999 | Original applicationTYPE 6 · Priority review | Approved |
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
