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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065445

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NDA 065445 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 065445
Tradename:EPIRUBICIN HYDROCHLORIDE
Applicant:Actavis Totowa
Ingredient:epirubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065445
Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 065445
Suppliers and Packaging for NDA: 065445
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065445 ANDA Impax Generics 0115-1675 N 0115-1675-72
EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065445 ANDA Impax Generics 0115-1675 N 0115-1675-73

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/5ML (2MG/ML)
Approval Date:Sep 18, 2008TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Sep 18, 2008TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Sep 18, 2008TE:APRLD:No

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