For active. NDA 203634, held by Salix. Budesonide.
As of Nov 14, 2026, NDA 203634 (Uceris), held by Salix, was first approved by FDA on Jan 14, 2013, with 7 approved supplements and 0 published complete response letters.
UCERIS extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Uceris9MG · tablet, extended release;oral | Budesonide | RxReference drug |
| Jun 5, 2024 | Supplement 12Labeling · Standard review | Approved | |
| Jul 6, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 9, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Oct 13, 2016 | Supplement 4Labeling · Standard review | Approved | |
| Jun 12, 2015 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 25, 2014 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 22, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 14, 2013 | Original applicationNew formulation or manufacturer · 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
