Fosaprepitant Dimeglumine

ANDA 209965, held by Msn. Fosaprepitant Dimeglumine.

As of Nov 15, 2026, ANDA 209965 (Fosaprepitant Dimeglumine), held by Msn, was first approved by FDA on Sep 5, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2019
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 5, 2019	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fosaprepitant DimeglumineEQ 150MG BASE/VIAL · powder;intravenous	Fosaprepitant Dimeglumine	Rx

All 4 submissions, including labeling and manufacturing supplements


Aug 7, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Aug 7, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 1Manufacturing	Approved	None posted
Sep 5, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 209965
Drugs@FDA: Overview at FDA
Company: MSN Laboratories

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