NDA 22484, held by Sebela Ireland Ltd. Itraconazole.
As of Nov 14, 2026, NDA 22484 (Onmel), held by Sebela Ireland Ltd, was first approved by FDA on Apr 29, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2010 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Onmel200MG · tablet;oral | Itraconazole | DiscontinuedReference drug |
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
