Details for New Drug Application (NDA): 207321

NDA 207321 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 207321

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

Pharmacology for NDA: 207321

Medical Subject Heading (MeSH) Categories for 207321

Antineoplastic Agents

Cardiotonic Agents

Topoisomerase II Inhibitors

Suppliers and Packaging for NDA: 207321

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	207321	ANDA	Gland Pharma Limited	68083-195	68083-195-01	1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIAL
DEXRAZOXANE HYDROCHLORIDE	dexrazoxane hydrochloride	INJECTABLE;INJECTION	207321	ANDA	Gland Pharma Limited	68083-388	68083-388-01	1 VIAL in 1 CARTON (68083-388-01) / 25 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Nov 28, 2016	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/VIAL
Approval Date:	Dec 16, 2019	TE:	AP	RLD:	No

Complete Access Available with Subscription