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
0a273a2d-a1ff-412a-925e-696648730dae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
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 Code70121-1236
Application NumberANDA208857
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clofarabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 23, 2023
FDA Product Classification
INGREDIENTS (3)
CLOFARABINEActive
Quantity: 1 mg in 1 mL
Code: 762RDY0Y2H
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT