BUSULFEX
These highlights do not include all the information needed to use BUSULFEX safely and effectively. See full prescribing information for BUSULFEX. BUSULFEX (busulfan) Injection, for intravenous use Initial U.S. Approval: 1999
Approved
Approval ID
5cb9d285-1803-4a99-946a-d0b239b32df6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Otsuka America Pharmaceutical, Inc.
DUNS: 008314390
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
busulfan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59148-070
Application NumberNDA020954
Product Classification
M
Marketing Category
C73594
G
Generic Name
busulfan
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 25, 2020
FDA Product Classification
INGREDIENTS (3)
BusulfanActive
Quantity: 6 mg in 1 mL
Code: G1LN9045DK
Classification: ACTIB
N,N-dimethylacetamideInactive
Code: JCV5VDB3HY
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT