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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

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Fludarabine Phosphate - FDA Drug Approval Details