busulfan

FDA Drug Profile — Busulfan, BUSULFEX, MYLERAN

Drug Details

Generic Name
busulfan
Brand Names
Busulfan, BUSULFEX, MYLERAN
Application Number
ANDA210148
Sponsor
Excella GmbH & Co KG
NDC Codes
5
Dosage Forms
TABLET, FILM COATED, INJECTION
Routes
INTRAVENOUS, ORAL
Active Ingredients
BUSULFAN

Indications and Usage

1 INDICATIONS AND USAGE Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Busulfan injection is an alkylating drug indicated for: Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML) ( 1 )