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Serving leading biopharmaceutical companies globally:

Colorcon
Fish and Richardson
Covington
Queensland Health
Dow
Cantor Fitzgerald
Accenture
Mallinckrodt
Baxter
Moodys

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065361

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NDA 065361 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 065361
Tradename:EPIRUBICIN HYDROCHLORIDE
Applicant:Cipla Ltd
Ingredient:epirubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065361
Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 065361
Suppliers and Packaging for NDA: 065361
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065361 ANDA Sagent Pharmaceuticals 25021-203 N 25021-203-51
EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065361 ANDA Sagent Pharmaceuticals 25021-203 N 25021-203-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Oct 22, 2007TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Oct 22, 2007TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Federal Trade Commission
Medtronic
QuintilesIMS
Queensland Health
US Department of Justice
Citi
Merck

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