Fludarabine Phosphate
These highlights do not include all the information needed to use FLUDARABINE PHOSPHATE safely and effectively. See full prescribing information for . Injection, for intravenous use only Initial U.S. Approval: 1991
Approved
Approval ID
0170c0f4-d502-4f8f-bdbf-6439f3ed33fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
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 Code0527-1242
Application NumberANDA090724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludarabine Phosphate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 13, 2022
FDA Product Classification
INGREDIENTS (4)
FLUDARABINE PHOSPHATEActive
Quantity: 25 mg in 1 mL
Code: 1X9VK9O1SC
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT