Clofarabine
These highlights do not include all the information needed to use CLOFARABINE INJECTION safely and effectively. See full prescribing information for CLOFARABINE INJECTION. CLOFARABINE injection, for intravenous use Initial U.S. Approval: 2004
Approved
Approval ID
b7d3a96e-0280-4f14-b921-795996f75950
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2022
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-386
Application NumberANDA207831
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clofarabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 22, 2022
FDA Product Classification
INGREDIENTS (3)
CLOFARABINEActive
Quantity: 1 mg in 1 mL
Code: 762RDY0Y2H
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT