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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065411

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NDA 065411 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 065411
Tradename:EPIRUBICIN HYDROCHLORIDE
Applicant:Fresenius Kabi Oncol
Ingredient:epirubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065411
Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 065411
Suppliers and Packaging for NDA: 065411
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065411 ANDA Fresenius Kabi USA, LLC 63323-151 N 63323-151-25
EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065411 ANDA Fresenius Kabi USA, LLC 63323-151 N 63323-151-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Aug 20, 2007TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Aug 20, 2007TE:APRLD:No

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