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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077496

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NDA 077496 describes MITOXANTRONE HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Oncol, Fresenius Kabi Usa, Hospira, Mylan Institutional, Mylan Labs Ltd, Teva Pharms Usa, and West-ward Pharms Int, 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 077496
Tradename:MITOXANTRONE HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:mitoxantrone hydrochloride
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077496
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 077496
Suppliers and Packaging for NDA: 077496
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 077496 ANDA Fresenius Kabi USA, LLC 63323-132 N 63323-132-10
MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 077496 ANDA Fresenius Kabi USA, LLC 63323-132 N 63323-132-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Approval Date:Apr 11, 2006TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
Approval Date:Apr 11, 2006TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 30MG BASE/15ML (EQ 2MG BASE/ML)
Approval Date:Apr 11, 2006TE:APRLD:No

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