Clofarabine

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

Company

DUNS: 080548348

Effective Date

December 12, 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

Meitheal Pharmaceuticals Inc.

DUNS Number

529111185

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

NDC Product Code

71288-128

Application Number

ANDA213461

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

October 23, 2020

Ingredients

waterInactive

Code: 059QF0KO0RClass: IACT

sodium chlorideInactive

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

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