Fludarabine Phosphate
These highlights do not include all the information needed to use Fludarabine Phosphate safely and effectively. See full prescribing information for Fludarabine Phosphate. Fludarabine Phosphate Injection, for intravenous use only Initial U.S. Approval 1991
Approved
Approval ID
8039c2e3-ffe5-3997-e053-2991aa0ad9d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2023
Manufacturers
FDA
Areva Pharmaceuticals
DUNS: 833189835
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fludarabine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59923-604
Application NumberANDA090724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludarabine Phosphate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 14, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FLUDARABINE PHOSPHATEActive
Quantity: 25 mg in 1 mL
Code: 1X9VK9O1SC
Classification: ACTIB
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 1/24/2019