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
54436453-882e-406b-87a3-049d150101c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2022
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
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 Code71288-128
Application NumberANDA213461
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clofarabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 23, 2020
FDA Product Classification
INGREDIENTS (3)
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium chlorideInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
clofarabineActive
Quantity: 1 mg in 1 mL
Code: 762RDY0Y2H
Classification: ACTIB