Details for New Drug Application (NDA): 019297

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NDA 019297 describes NOVANTRONE, which is a drug marketed by Emd Serono and is included in one NDA. Additional details are available on the NOVANTRONE profile page.

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

Summary for 019297

Tradename:	NOVANTRONE
Applicant:	Emd Serono
Ingredient:	mitoxantrone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 019297

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		Strength	EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 1987	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 1987	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 30MG BASE/15ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 1987	TE:		RLD:	Yes

Expired US Patents for NDA 019297

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987	⤷ Sign Up	⤷ Sign Up
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987	⤷ Sign Up	⤷ Sign Up
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-001	Dec 23, 1987	⤷ Sign Up	⤷ Sign Up
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-003	Dec 23, 1987	⤷ Sign Up	⤷ Sign Up
Emd Serono	NOVANTRONE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	019297-002	Dec 23, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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