For active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal…. NDA 205613, held by Salix. Budesonide.
As of Nov 14, 2026, NDA 205613 (Uceris), held by Salix, was first approved by FDA on Oct 7, 2014, with 2 approved supplements and 0 published complete response letters.
UCERIS rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 2014 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Uceris2MG/ACTUATION · aerosol, foam;rectal | Budesonide | RxReference drug |
| Apr 9, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Nov 13, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 7, 2014 | Original applicationNew dosage form · Standard 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
