ANDA 214683, held by Piramal Critical. Fosaprepitant Dimeglumine.
As of Nov 15, 2026, ANDA 214683 (Fosaprepitant Dimeglumine), held by Piramal Critical, was first approved by FDA on May 16, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 16, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosaprepitant DimeglumineEQ 150MG BASE/VIAL ยท powder;intravenous | Fosaprepitant Dimeglumine | Discontinued |
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