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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Citi
Harvard Business School
Merck
Queensland Health
AstraZeneca
Healthtrust
Chinese Patent Office
Cerilliant

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065408

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NDA 065408 describes EPIRUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Totowa, Akorn Inc, Cipla Ltd, Ebewe Pharma, Fresenius Kabi Oncol, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Mustafa Nevsat, Mylan Institutional, Mylan Labs Ltd, and West-ward Pharms Int, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the EPIRUBICIN HYDROCHLORIDE profile page.

The generic ingredient in EPIRUBICIN HYDROCHLORIDE is epirubicin hydrochloride. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.
Summary for 065408
Tradename:EPIRUBICIN HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:epirubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 065408

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/5ML (2MG/ML)
Approval Date:Oct 15, 2007TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Oct 15, 2007TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150MG/75ML (2MG/ML)
Approval Date:Oct 15, 2007TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
US Department of Justice
Accenture
Daiichi Sankyo
Chubb
Deloitte
Boehringer Ingelheim
Colorcon
Mallinckrodt

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