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Mitoxantrone hydrochloride - Generic Drug Details

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Mitoxantrone hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Oncol, West-ward Pharms Int, Mylan Labs Ltd, Teva Pharms Usa, Hospira, Mylan Institutional, Fresenius Kabi Usa, and Emd Serono, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for mitoxantrone hydrochloride. Four suppliers are listed for this compound.

Summary for Generic Name: mitoxantrone hydrochloride

Tradenames:2
Patents:0
Applicants:8
NDAs:8
Drug Master File Entries: see list7
Suppliers / Packaging: see list4
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: mitoxantrone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
MITOXANTRONE HYDROCHLORIDE
mitoxantrone hydrochloride
INJECTABLE;INJECTION076871-001Apr 11, 2006RXYes► subscribe► subscribe
Hospira
MITOXANTRONE HYDROCHLORIDE
mitoxantrone hydrochloride
INJECTABLE;INJECTION076871-003Apr 11, 2006RXYes► subscribe► subscribe
Teva Pharms Usa
MITOXANTRONE HYDROCHLORIDE
mitoxantrone hydrochloride
INJECTABLE;INJECTION077356-001Apr 11, 2006RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: mitoxantrone hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-001Dec 23, 19874,138,415► subscribe
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-003Dec 23, 19874,820,738► subscribe
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-001Dec 23, 19874,820,738► subscribe
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