NDA 202129, held by Azurity. Ciclesonide.
As of Nov 13, 2026, NDA 202129 (Zetonna), held by Azurity, was first approved by FDA on Jan 20, 2012, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2014 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Oct 23, 2014 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Oct 23, 2014 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jan 20, 2012 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zetonna0.037MG/INH · aerosol, metered;nasal | Ciclesonide | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 16, 2023 | Supplement 9Labeling · Standard review | Approved | |
| Oct 23, 2014 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Oct 23, 2014 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Oct 23, 2014 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Apr 22, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 31, 2014 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Dec 20, 2012 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 20, 2012 | Original applicationNew dosage form · 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
