Details for New Drug Application (NDA): 076078

NDA 076078 describes IFOSFAMIDE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Meitheal, Rising, 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. Three suppliers are listed for this compound. Additional details are available on the ifosfamide; mesna profile page.

Summary for 076078

Tradename:	IFOSFAMIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	ifosfamide
Patents:	0

Pharmacology for NDA: 076078

Mechanism of Action

Alkylating Activity

Medical Subject Heading (MeSH) Categories for 076078

Antineoplastic Agents, Alkylating

Suppliers and Packaging for NDA: 076078

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076078	ANDA	Fresenius Kabi USA, LLC	63323-142	63323-142-12	1 VIAL, SINGLE-DOSE in 1 BOX (63323-142-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076078	ANDA	Fresenius Kabi USA, LLC	63323-142	63323-142-10	1 VIAL, SINGLE-DOSE in 1 BOX (63323-142-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/VIAL
Approval Date:	May 28, 2002	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3GM/VIAL
Approval Date:	May 28, 2002	TE:	AP	RLD:	No

Complete Access Available with Subscription