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 useInitial U.S. Approval: 2005
Approved
Approval ID
8cb23281-93ca-40b8-b8e0-c57dd4298322
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
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 Code70710-1839
Application NumberANDA215037
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nelarabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 22, 2023
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NELARABINEActive
Quantity: 5 mg in 1 mL
Code: 60158CV180
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT