Nelarabine
These highlights do not include all the information needed to use Nelarabine Injection safely and effectively. See full prescribing information for Nelarabine Injection.Nelarabine Injection, for intravenous use Initial U.S. Approval: 2005
Approved
Approval ID
869ac7ef-f16d-47d9-8897-29add0679dd7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Nexus Pharmaceuticals LLC
DUNS: 620714787
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nelarabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14789-114
Application NumberANDA215057
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nelarabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (4)
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
NelarabineActive
Quantity: 5 mg in 1 mL
Code: 60158CV180
Classification: ACTIB