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Floxuridine

FLOXURIDINE FOR INJECTION USP

Approved
Approval ID

e3c2e3e7-bc83-465d-b615-3ad56580b3a7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 15, 2023

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 001230762

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 Code0143-9270
Application NumberANDA075387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Floxuridine
Product Specifications
Route of AdministrationINTRA-ARTERIAL
Effective DateMay 15, 2023
FDA Product Classification

INGREDIENTS (2)

FLOXURIDINEActive
Quantity: 100 mg in 1 mL
Code: 039LU44I5M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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