For active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal…. ANDA 215328, held by Padagis Israel. Budesonide.
As of Nov 15, 2026, ANDA 215328 (Budesonide), held by Padagis Israel, was first approved by FDA on Apr 12, 2023, with 0 approved supplements and 0 published complete response letters.
Budesonide 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 |
|---|---|---|---|
| Apr 12, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Budesonide2MG/ACTUATION · aerosol, foam;rectal | 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
