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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-893
Application NumberANDA208536
Product Classification
M
Marketing Category
C73584
G
Generic Name
Busulfan
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 10, 2017
FDA Product Classification
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