Last Updated: November 8, 2026

Details for New Drug Application (NDA): 065289

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NDA 065289 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 is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.

Summary for 065289

Tradename:	EPIRUBICIN HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	epirubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 065289

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/25ML (2MG/ML)
Approval Date:	Jun 27, 2007	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/100ML (2MG/ML)
Approval Date:	Jun 27, 2007	TE:	AP	RLD:	No

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