CLOFARABINE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 968961354

Effective Date

October 10, 2022

Labeling Type

Human Prescription Drug Label

Active Ingredients

Clofarabine(1 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Eugia US LLC

DUNS Number

872201704

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

55150-326

Application Number

ANDA212457

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

January 21, 2020

Ingredients

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: 762RDY0Y2HClass: ACTIBQuantity: 1 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL