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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 090163

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NDA 090163 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 090163

Tradename:	EPIRUBICIN HYDROCHLORIDE
Applicant:	Epic Pharma Llc
Ingredient:	epirubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 090163

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 24, 2009	TE:	AP	RLD:	No

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