ANDA 205020, held by Apotex. Fosaprepitant Dimeglumine.
As of Nov 15, 2026, ANDA 205020 (Fosaprepitant Dimeglumine), held by Apotex, was first approved by FDA on Sep 5, 2019, with 1 approved supplement and 0 published complete response letters.
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting. Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s Emend (fosaprepitant) for injection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosaprepitant DimeglumineEQ 150MG BASE/VIAL · powder;intravenous | Fosaprepitant Dimeglumine | Discontinued |
| Oct 25, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 5, 2019 | 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
