BUSULFAN
These highlights do not include all the information needed to use BUSULFAN INJECTION safely and effectively. See full prescribing information for BUSULFAN INJECTION. BUSULFAN INJECTION, for intravenous use Initial U.S. Approval: 1999
Approved
Approval ID
b9c7f0dc-988d-466e-8031-400ec4f60f21
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2021
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
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 Code0409-1112
Application NumberANDA205672
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUSULFAN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 10, 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