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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 065411

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NDA 065411 describes EPIRUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Totowa, Cipla Ltd, Ebewe Pharma, Epic Pharma Llc, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, and Pharmobedient, and is included in fourteen NDAs. Additional details are available on the EPIRUBICIN HYDROCHLORIDE profile page.

The generic ingredient in EPIRUBICIN HYDROCHLORIDE is epirubicin hydrochloride. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.

Summary for 065411

Tradename:	EPIRUBICIN HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	epirubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 065411

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	200MG/100ML (2MG/ML)
Approval Date:	Aug 20, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/25ML (2MG/ML)
Approval Date:	Aug 20, 2007	TE:		RLD:	No

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