Floxuridine
FLOXURIDINE FOR INJECTION USP
Approved
Approval ID
4681f23e-6b5e-433b-b245-3d0b4e64ebb2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2022
Manufacturers
FDA
Cerona Therapeutics, Inc.
DUNS: 117909145
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Floxuridine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81643-9270
Application NumberANDA075387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Floxuridine
Product Specifications
Route of AdministrationINTRA-ARTERIAL
Effective DateJune 13, 2022
FDA Product Classification
INGREDIENTS (2)
FLOXURIDINEActive
Quantity: 500 mg in 1 1
Code: 039LU44I5M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT