NDA 20465, held by Pharmacia And Upjohn. Sulfasalazine.
As of Nov 13, 2026, NDA 20465 (Azulfidine), held by Pharmacia And Upjohn, was first approved by FDA on Oct 17, 1996, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 1996 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azulfidine500MG · tablet; oral | Sulfasalazine | Rx |
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
