Busulfan
These highlights do not include all the information needed to use BUSULFAN safely and effectively. See full prescribing information for BUSULFAN.BUSULFAN for injection, for intravenous useInitial U.S. Approval: 1999
Approved
Approval ID
8789b88c-ce41-477e-9194-31ae752dece0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 2023
Manufacturers
FDA
Nexus Pharmaceuticals LLC
DUNS: 620714787
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 Code14789-013
Application NumberANDA207794
Product Classification
M
Marketing Category
C73584
G
Generic Name
Busulfan
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 7, 2023
FDA Product Classification
INGREDIENTS (3)
BusulfanActive
Quantity: 60 mg in 10 mL
Code: G1LN9045DK
Classification: ACTIB
N,N-dimethylacetamideInactive
Code: JCV5VDB3HY
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT