Busulfan
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1999
Approved
Approval ID
9955aced-ac32-43e6-b39a-c6c023a50dc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2020
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-893
Application NumberANDA208536
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 10, 2017
Generic NameBusulfan
INGREDIENTS (3)
BUSULFANActive
Quantity: 6 mg in 1 mL
Code: G1LN9045DK
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
N,N-DIMETHYLACETAMIDEInactive
Code: JCV5VDB3HY
Classification: IACT