Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.