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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 065036

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NDA 065036 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 065036

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

Medical Subject Heading (MeSH) Categories for 065036

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	May 1, 2002	TE:	AP	RLD:	No

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