Last Updated: May 13, 2026

Details for New Drug Application (NDA): 076657

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NDA 076657 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 076657

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

Medical Subject Heading (MeSH) Categories for 076657

Antineoplastic Agents, Alkylating

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/20ML (50MG/ML)
Approval Date:	Apr 4, 2007	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3GM/60ML (50MG/ML)
Approval Date:	Apr 4, 2007	TE:	AP	RLD:	No

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