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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Argus Health
Boehringer Ingelheim

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201014

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NDA 201014 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 four 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. Four suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.
Summary for 201014
Applicant:Mylan Labs Ltd
Ingredient:mitoxantrone hydrochloride
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 201014
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 201014
Suppliers and Packaging for NDA: 201014
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MITOXANTRONE HYDROCHLORIDE mitoxantrone hydrochloride INJECTABLE;INJECTION 201014 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0080 0069-0080-01 10 mL in 1 VIAL (0069-0080-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Approval Date:Dec 11, 2012TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim

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