NELARABINE
These highlights do not include all the information needed to use Nelarabine injection see full prescribing information for intravenous use and "Initial U.S. Approval"
Approved
Approval ID
f27a3ae3-0827-3951-e053-2a95a90a46d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
AqVida GmbH
DUNS: 342875539
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nelarabine injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80978-111
Application NumberANDA214809
Product Classification
M
Marketing Category
C73584
G
Generic Name
nelarabine injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 9, 2023
FDA Product Classification
INGREDIENTS (3)
NELARABINEActive
Quantity: 250 mg in 50 mL
Code: 60158CV180
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT