Treats mild to moderate active Crohn’s disease involving the ileum and/or the ascending…. NDA 21324, held by Padagis US. Budesonide.
As of Nov 14, 2026, NDA 21324 (Entocort Ec), held by Padagis US, was first approved by FDA on Oct 2, 2001, with 13 approved supplements and 0 published complete response letters.
Budesonide delayed-release capsules are a 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.
| Apr 29, 2016 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Apr 29, 2016 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Apr 29, 2005 | Supplement 5Efficacy (new indication or use) | Approved | |
| Oct 2, 2001 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Entocort Ec3MG · capsule, delayed release;oral | Budesonide | RxReference drug |
| Jun 5, 2024 | Supplement 27Labeling · Standard review | Approved | |
| Jul 15, 2020 | Supplement 23Labeling · Standard review | Approved | |
| Jan 18, 2019 | Supplement 18Labeling · Standard review | Approved | |
| Oct 17, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Apr 29, 2016 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Apr 29, 2016 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2011 | Supplement 9Labeling | Approved | |
| Jun 22, 2009 | Supplement 8Labeling · Standard review | Approved | |
| Apr 29, 2005 | Supplement 5Efficacy (new indication or use) | Approved | |
| Mar 13, 2003 | Supplement 4Manufacturing · Priority review | Approved | |
| Oct 3, 2002 | Supplement 3Manufacturing · Priority review | Approved | |
| Aug 14, 2002 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Aug 9, 2002 | Supplement 1Manufacturing · Priority review | Approved | |
| Oct 2, 2001 | Original applicationNew dosage form · Priority 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
