Details for New Drug Application (NDA): 050778

NDA 050778 describes ELLENCE, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ELLENCE profile page.

The generic ingredient in ELLENCE is epirubicin hydrochloride. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.

Summary for 050778

Tradename:	ELLENCE
Applicant:	Pfizer Inc
Ingredient:	epirubicin hydrochloride
Patents:	0

Pharmacology for NDA: 050778

Mechanism of Action

Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 050778

Antibiotics, Antineoplastic

Topoisomerase II Inhibitors

Suppliers and Packaging for NDA: 050778

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778	NDA	Pharmacia & Upjohn Company LLC	0009-5091	0009-5091-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01) / 25 mL in 1 VIAL, SINGLE-DOSE
ELLENCE	epirubicin hydrochloride	INJECTABLE;INJECTION	050778	NDA	Pharmacia & Upjohn Company LLC	0009-5093	0009-5093-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-01) / 100 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/100ML (2MG/ML)
Approval Date:	Sep 15, 1999	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/25ML (2MG/ML)
Approval Date:	Sep 15, 1999	TE:	AP	RLD:	Yes

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