Last Updated: September 24, 2026

Details for New Drug Application (NDA): 065037

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

The generic ingredient in IDARUBICIN HYDROCHLORIDE is idarubicin hydrochloride. There is one drug master file entry for this compound. Three 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:	POWDER;INTRAVENOUS			Strength	20MG/VIAL
Approval Date:	May 1, 2002	TE:		RLD:	No

Profile for product number 002

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

Profile for product number 003

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

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