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Generated: June 24, 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-type	Anthracyclines
Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 065361

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

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	25021-203-25
EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065361	ANDA	Sagent Pharmaceuticals	25021-203	N	25021-203-51

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/25ML (2MG/ML)
Approval Date:	Oct 22, 2007	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/100ML (2MG/ML)
Approval Date:	Oct 22, 2007	TE:	AP	RLD:	No

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