NDA 218754, held by Azurity. Aprepitant.
As of Nov 13, 2026, NDA 218754 (Aprepitant), held by Azurity, was first approved by FDA on Jun 16, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aprepitant130MG/18ML (7.2MG/ML) · emulsion;intravenous | Aprepitant | RxReference 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
