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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 065037

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NDA 065037 describes IDARUBICIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Meitheal, Rising, Sandoz, and Teva Parenteral, and is included in seven NDAs. It is available from one supplier. Additional details are available on the IDARUBICIN HYDROCHLORIDE profile page.

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

Summary for 065037

Tradename:	IDARUBICIN HYDROCHLORIDE
Applicant:	Teva Parenteral
Ingredient:	idarubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 065037

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/VIAL
Approval Date:	May 1, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/VIAL
Approval Date:	May 1, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	5MG/VIAL
Approval Date:	May 1, 2002	TE:		RLD:	No

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