epirubicin hydrochloride

FDA Drug Profile — Ellence

epirubicin hydrochloride is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Ellence. Available dosage form: injection, solution.

Drug Details

Generic Name
epirubicin hydrochloride
Brand Names
Ellence
Application Number
NDA050778
Sponsor
Pharmacia & Upjohn Company LLC
NDC Codes
4
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
EPIRUBICIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).