Treats mild to moderate ulcerative colitis. ANDA 219046, held by Rising. Sulfasalazine.
As of Nov 15, 2026, ANDA 219046 (Sulfasalazine), held by Rising, was first approved by FDA on Nov 4, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sulfasalazine tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 4, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sulfasalazine500MG · 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
