Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Dow
Cerilliant
Chinese Patent Office
US Department of Justice
Cantor Fitzgerald
Fish and Richardson
Healthtrust
Daiichi Sankyo
Boehringer Ingelheim

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065339

« Back to Dashboard

NDA 065339 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 seven 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. Nine suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.
Summary for 065339
Tradename:EPIRUBICIN HYDROCHLORIDE
Applicant:Ebewe Pharma
Ingredient:epirubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065339
Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 065339
Suppliers and Packaging for NDA: 065339
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065339 ANDA Sandoz Inc 66758-042 E 66758-042-01
EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065339 ANDA Sandoz Inc 66758-042 E 66758-042-02

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Dec 22, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Dec 22, 2009TE:RLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Deloitte
Baxter
Teva
McKinsey
Queensland Health
Covington
Chinese Patent Office
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.