Last Updated: September 24, 2026

Details for New Drug Application (NDA): 212957

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NDA 212957 describes FOSAPREPITANT DIMEGLUMINE, which is a drug marketed by Accord Hlthcare, Apotex, Aspiro, Baxter Hlthcare Corp, Be Pharms, Caplin, Chartwell Rx, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Lupin, MSN, Mylan Labs Ltd, Piramal Critical, Praxgen, Qilu Pharm Hainan, and Teva Pharms Usa, and is included in nineteen NDAs. It is available from seventeen suppliers. Additional details are available on the FOSAPREPITANT DIMEGLUMINE profile page.

The generic ingredient in FOSAPREPITANT DIMEGLUMINE is fosaprepitant dimeglumine. There is one drug master file entry for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.

Summary for 212957

Tradename:	FOSAPREPITANT DIMEGLUMINE
Applicant:	Chartwell Rx
Ingredient:	fosaprepitant dimeglumine
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 150MG BASE/VIAL
Approval Date:	Aug 20, 2020	TE:		RLD:	No

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