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
NDC Product Code14789-013
Application NumberANDA207794
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 7, 2023
Generic NameBusulfan
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