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Farmers Insurance
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Fish and Richardson
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076611

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NDA 076611 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 076611
Applicant:West-ward Pharms Int
Ingredient:mitoxantrone hydrochloride
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076611

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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