Treats mild to moderate active Crohn's disease involving the ileum and/or the ascending…. ANDA 206134, held by Zydus Pharms. Budesonide.
As of Nov 15, 2026, ANDA 206134 (Budesonide), held by Zydus Pharms, was first approved by FDA on May 4, 2017, with 4 approved supplements and 0 published complete response letters.
Budesonide delayed-release capsules are corticosteroid indicated for: Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, in patients 8 years and older. Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. 1.1 Treatment of Mild to Moderate Active Crohn’s Disease Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Budesonide3MG · capsule, delayed release;oral | Budesonide | Rx |
| Nov 7, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 12, 2021 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 12, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 12, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 4, 2017 | Original application | Approved | None posted |
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
