ANDA 204025, held by Accord Hlthcare. Fosaprepitant Dimeglumine.
As of Nov 15, 2026, ANDA 204025 (Fosaprepitant Dimeglumine), held by Accord Hlthcare, was first approved by FDA on Aug 26, 2020, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosaprepitant DimeglumineEQ 150MG BASE/VIAL · powder;intravenous | Fosaprepitant Dimeglumine | Discontinued |
| May 19, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 26, 2020 | Original application | Approved | None posted |
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
