For active. ANDA 208851, held by Mylan. Budesonide.
As of Nov 15, 2026, ANDA 208851 (Budesonide), held by Mylan, was first approved by FDA on Sep 17, 2020, with 0 approved supplements and 0 published complete response letters.
Budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Budesonide9MG · tablet, extended release;oral | Budesonide | 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
