Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205020

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NDA 205020 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 205020

Tradename:	FOSAPREPITANT DIMEGLUMINE
Applicant:	Apotex
Ingredient:	fosaprepitant dimeglumine
Patents:	0

Pharmacology for NDA: 205020

Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 150MG BASE/VIAL
Approval Date:	Sep 5, 2019	TE:		RLD:	No

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