Fosaprepitant Dimeglumine

ANDA 210689, held by Lupin. Fosaprepitant Dimeglumine.

As of Nov 15, 2026, ANDA 210689 (Fosaprepitant Dimeglumine), held by Lupin, was first approved by FDA on Sep 5, 2019, with 5 approved supplements and 0 published complete response letters.

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

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 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	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Apr 30, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Apr 30, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Apr 30, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Apr 30, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Jan 6, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Sep 5, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210689
Drugs@FDA: Overview at FDA
Company: Lupin

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