Fosaprepitant Dimeglumine

ANDA 214616, held by Aspiro. Fosaprepitant Dimeglumine.

As of Nov 15, 2026, ANDA 214616 (Fosaprepitant Dimeglumine), held by Aspiro, was first approved by FDA on Jul 29, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2021
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Jul 29, 2021	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 3 submissions, including labeling and manufacturing supplements


Apr 14, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Apr 14, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Jul 29, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 214616
Drugs@FDA: Overview at FDA
Company: Aspiro Pharma

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