Fosaprepitant Dimeglumine

ANDA 203939, held by Caplin. Fosaprepitant Dimeglumine.

As of Nov 15, 2026, ANDA 203939 (Fosaprepitant Dimeglumine), held by Caplin, was first approved by FDA on Dec 8, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 8, 2020
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 8, 2020	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 4 submissions, including labeling and manufacturing supplements


Jul 28, 2026	Supplement 4Labeling · Standard review	Approved	None posted
May 1, 2023	Supplement 3Labeling · Standard review	Approved	None posted
May 1, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Dec 8, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 203939
Drugs@FDA: Overview at FDA
Company: Caplin Steriles

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