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
NDC Product Code0527-1242
Application NumberANDA090724
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateSeptember 13, 2022
Generic NameFludarabine Phosphate
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