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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 065288

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NDA 065288 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 are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.

Summary for 065288

Tradename:	IDARUBICIN HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	idarubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 065288

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5MG/5ML (1MG/ML)
Approval Date:	May 15, 2007	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	10MG/10ML (1MG/ML)
Approval Date:	May 15, 2007	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	20MG/20ML (1MG/ML)
Approval Date:	May 15, 2007	TE:	AP	RLD:	No

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