Fludarabine Phosphate
Fludarabine Phosphate Injection Unapproved Drug_Shortage
Approved
Approval ID
ebff8bde-0e6e-4689-bf8c-5c56c119e323
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2023
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
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 Code0480-9772
Product Classification
G
Generic Name
Fludarabine Phosphate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 25, 2023
FDA Product Classification
INGREDIENTS (4)
FLUDARABINE PHOSPHATEActive
Quantity: 25 mg in 1 mL
Code: 1X9VK9O1SC
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT