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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091599

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NDA 091599 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 091599

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

Medical Subject Heading (MeSH) Categories for 091599

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/25ML (2MG/ML)
Approval Date:	Mar 12, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	200MG/100ML (2MG/ML)
Approval Date:	Mar 12, 2012	TE:		RLD:	No

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