Clofarabine
These highlights do not include all the information needed to use clofarabine safely and effectively. See full prescribing information for clofarabine. Clofarabine injection, for intravenous use Initial U.S. Approval: 2004
Approved
Approval ID
7912ab7f-efe0-460c-9eb9-7d2c7d37548a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Winthrop U.S, a business of sanofi-aventis U.S. LLC
DUNS: 824676584
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clofarabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-1746
Application NumberNDA021673
Product Classification
M
Marketing Category
C73605
G
Generic Name
clofarabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CLOFARABINEActive
Quantity: 1 mg in 1 mL
Code: 762RDY0Y2H
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT