Fosaprepitant Dimeglumine

ANDA 204015, held by Mylan Labs Ltd. Fosaprepitant Dimeglumine.

As of Nov 15, 2026, ANDA 204015 (Fosaprepitant Dimeglumine), held by Mylan Labs Ltd, was first approved by FDA on Sep 5, 2019, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2019
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
Sep 5, 2019	Original application	Approved	Letter

Products

2 strengths and forms


Fosaprepitant DimeglumineEQ 115MG BASE/VIAL · powder;intravenous	Fosaprepitant Dimeglumine	Discontinued
Fosaprepitant DimeglumineEQ 150MG BASE/VIAL · powder;intravenous	Fosaprepitant Dimeglumine	Rx

All 5 submissions, including labeling and manufacturing supplements


Aug 7, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Apr 8, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Apr 8, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Aug 17, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Sep 5, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 204015
Drugs@FDA: Overview at FDA
Company: Mylan 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