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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 210625

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NDA 210625 describes FOSAPREPITANT DIMEGLUMINE, which is a drug marketed by Accord Hlthcare, Apotex, Aspiro, Baxter Hlthcare Corp, Be Pharms, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Lupin Ltd, MSN, Mylan Labs Ltd, Navinta Llc, Piramal Critical, Praxgen, Qilu Pharm Hainan, Sandoz, 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 are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.

Summary for 210625

Tradename:	FOSAPREPITANT DIMEGLUMINE
Applicant:	Eugia Pharma
Ingredient:	fosaprepitant dimeglumine
Patents:	0

Pharmacology for NDA: 210625

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

Suppliers and Packaging for NDA: 210625

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	210625	ANDA	Eugia US LLC	55150-299	55150-299-01	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-299-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 150MG BASE/VIAL
Approval Date:	Jan 12, 2021	TE:	AP	RLD:	No

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