Clolar
These highlights do not include all the information needed to use CLOLAR safely and effectively. See full prescribing information for CLOLAR. CLOLAR (clofarabine) injection, for intravenous use Initial U.S. Approval: 2004
Approved
Approval ID
55d3c78b-dca5-436b-97b5-73d166217415
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
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 Code0024-5860
Application NumberNDA021673
Product Classification
M
Marketing Category
C73594
G
Generic Name
clofarabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CLOFARABINEActive
Quantity: 1 mg in 1 mL
Code: 762RDY0Y2H
Classification: ACTIB