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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 065331

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NDA 065331 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, Norvium Bioscience, and Zennova, and is included in fourteen NDAs. It is available from one supplier. 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. Two suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.

Summary for 065331

Tradename:	EPIRUBICIN HYDROCHLORIDE
Applicant:	Impax Labs Inc
Ingredient:	epirubicin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 065331

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:	Aug 9, 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:	Aug 9, 2007	TE:	AP	RLD:	No

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