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 useInitial U.S. Approval: 2004
Approved
Approval ID
1f8ac128-c25d-41f4-9f90-410a792acd66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2022
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.
clofarabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-546
Application NumberANDA208860
Product Classification
M
Marketing Category
C73584
G
Generic Name
clofarabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 24, 2020
FDA Product Classification
INGREDIENTS (3)
CLOFARABINEActive
Quantity: 1 mg in 1 mL
Code: 762RDY0Y2H
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT