ANDA 218851, held by Mylan. Aprepitant.
As of Nov 13, 2026, ANDA 218851 (Aprepitant), held by Mylan, was first approved by FDA on Mar 5, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 5, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aprepitant32MG/4.4ML (7.2MG/ML) ยท emulsion;intravenous | Aprepitant | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
