NDA 210064, held by Teva Pharms USA. Fosaprepitant Dimeglumine.
As of Nov 14, 2026, NDA 210064 (Fosaprepitant Dimeglumine), held by Teva Pharms USA, was first approved by FDA on Sep 5, 2019, with 0 approved supplements 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosaprepitant DimeglumineEQ 150MG BASE/VIAL · powder;intravenous | Fosaprepitant Dimeglumine | Rx |
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
