FDA Approval Activities for this Drug…

BUSULFEX (busulfan) Injection, Orphan Medical, NDA 20-954/S5 11/13/02 11/22/02 11/14/02 7/8/03 BUSULFEX (busulfan) Injection, Orphan Medical, NDA 20-954/S4 1/13/03 1/23/03 1/23/03 BUSULFEX (busulfan) Injection, Orphan Medical, NDA 20-954/S3 4/24/02 5/2/02 BUSULFEX (busulfan) Injection, Orphan Medical, NDA 20-954/S1 12/23/02 1/29/03 BUSULFEX (busulfan) Injection, intravenous, Orphan Medical, NDA 20-954 2/4/99 2/5/99 2/10/99 6/14/99 BUSULFEX Indication: For use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Myleran (busulfan) Tablets, GlaxoSmithKline NDA 09-386/S-021 4/16/03 4/17/03 Myleran (busulfan) Tablets, GlaxoSmithKline NDA 09-386/S-020 9/20/02 Myleran (busulfan) Tablets, GlaxoSmithKline NDA 09-386/S-019 BUSULFAN Injection 6MG/ML BUSULFEX ESP 009386 BUSULFAN Tablet; 2MG MYLERAN GLAXOSMITHKLINE Myleran (busulfan) Tablets, GlaxoSmithKline

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