ANDA 211160, held by Dr Reddys. Fosaprepitant Dimeglumine.
As of Nov 15, 2026, ANDA 211160 (Fosaprepitant Dimeglumine), held by Dr Reddys, was first approved by FDA on Dec 9, 2020, with 2 approved supplements and 0 published complete response letters.
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older 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 |
|---|---|---|---|
| Dec 9, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosaprepitant DimeglumineEQ 150MG BASE/VIAL · powder;intravenous | Fosaprepitant Dimeglumine | Rx |
| Jul 21, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 21, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 9, 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
