NDA 22124, held by Nycomed US Inc. Ciclesonide.
As of Nov 13, 2026, NDA 22124 (Omnaris), held by Nycomed US Inc, was first approved by FDA on Nov 21, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2007 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omnaris50MCG · spray; nasal | Ciclesonide | 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
