Details for New Drug Application (NDA): 076619

NDA 076619 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 076619

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

Pharmacology for NDA: 076619

Mechanism of Action

Alkylating Activity

Medical Subject Heading (MeSH) Categories for 076619

Antineoplastic Agents, Alkylating

Suppliers and Packaging for NDA: 076619

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076619	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9530	0143-9530-01	1 VIAL in 1 BOX (0143-9530-01) / 60 mL in 1 VIAL
IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076619	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9531	0143-9531-01	1 VIAL in 1 BOX (0143-9531-01) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/20ML (50MG/ML)
Approval Date:	Jun 29, 2011	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3GM/60ML (50MG/ML)
Approval Date:	Jun 29, 2011	TE:	AP	RLD:	No

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