Last Updated: November 8, 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 three suppliers. Additional details are available on the IFOSFAMIDE profile page.

The generic ingredient in IFOSFAMIDE is ifosfamide; mesna. There are two drug master file entries for this compound. Two suppliers are 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

Pharmacology for NDA: 076657

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 076657

Antineoplastic Agents, Alkylating

Suppliers and Packaging for NDA: 076657

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076657	ANDA	Meitheal Pharmaceutical Inc.	71288-180	71288-180-20	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-180-20) / 20 mL in 1 VIAL, SINGLE-DOSE
IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076657	ANDA	Meitheal Pharmaceutical Inc.	71288-181	71288-181-51	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-181-51) / 60 mL in 1 VIAL, SINGLE-DOSE

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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