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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 201689

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NDA 201689 describes IFOSFAMIDE, which is a drug marketed by Extrovis, Fresenius Kabi Usa, Hikma, Meitheal, and Teva Pharms Usa, and is included in six NDAs. It is available from two suppliers. Additional details are available on the IFOSFAMIDE profile page.

The generic ingredient in IFOSFAMIDE is ifosfamide; mesna. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ifosfamide; mesna profile page.

Summary for 201689

Tradename:	IFOSFAMIDE
Applicant:	Extrovis
Ingredient:	ifosfamide
Patents:	0

Medical Subject Heading (MeSH) Categories for 201689

Antineoplastic Agents, Alkylating

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1GM/20ML (50MG/ML)
Approval Date:	Nov 26, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	3GM/60ML (50MG/ML)
Approval Date:	Nov 26, 2012	TE:		RLD:	No

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