Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Busulfex (busulfan) IV Injection, PDL BioPharma, Package Change | Busulfex (busulfan) Injection, Otsuka Pharmaceutical Development & Commercialization, Inc., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com