Fludarabine Phosphate
These highlights do not include all the information needed to use FLUDARABINE phosphate injection safely and effectively. See full prescribing information for FLUDARABINE phosphate injection. FLUDARABINE phosphate injection, for intravenous use onlyInitial U.S. Approval: 1991
Approved
Approval ID
20e5acf0-90b7-45c8-be78-91eaf77c9ac0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 22, 2021
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 080579617
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 Code25021-242
Application NumberANDA076661
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludarabine Phosphate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 22, 2021
FDA Product Classification
INGREDIENTS (4)
Fludarabine PhosphateActive
Quantity: 25 mg in 1 mL
Code: 1X9VK9O1SC
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT