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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078980

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NDA 078980 describes MITOXANTRONE HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, and Rising, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the MITOXANTRONE HYDROCHLORIDE profile page.

The generic ingredient in MITOXANTRONE HYDROCHLORIDE is mitoxantrone hydrochloride. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.

Summary for 078980

Tradename:	MITOXANTRONE HYDROCHLORIDE
Applicant:	Rising
Ingredient:	mitoxantrone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 078980

Analgesics
Antineoplastic Agents
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Approval Date:	Apr 13, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)
Approval Date:	Apr 13, 2009	TE:		RLD:	No

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