Details for New Drug Application (NDA): 076068

NDA 076068 describes DEXRAZOXANE HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Gland, and Hikma, and is included in three NDAs. It is available from six suppliers. Additional details are available on the DEXRAZOXANE HYDROCHLORIDE profile page.

The generic ingredient in DEXRAZOXANE HYDROCHLORIDE is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.

Summary for 076068

Tradename:	DEXRAZOXANE HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	dexrazoxane hydrochloride
Patents:	0

Pharmacology for NDA: 076068

Medical Subject Heading (MeSH) Categories for 076068

Antineoplastic Agents

Cardiotonic Agents

Topoisomerase II Inhibitors

Suppliers and Packaging for NDA: 076068

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	076068	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9247	0143-9247-01	1 VIAL in 1 BOX (0143-9247-01) / 25 mL in 1 VIAL
DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	076068	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9248	0143-9248-01	1 VIAL in 1 BOX (0143-9248-01) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/VIAL
Approval Date:	Sep 28, 2004	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Sep 28, 2004	TE:	AP	RLD:	No

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