Clofarabine

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

Company

DUNS: 918601238

Effective Date

November 21, 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

Gland Pharma Limited

DUNS Number

650540227

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

NDC Product Code

68083-386

Application Number

ANDA207831

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

November 22, 2022

Ingredients

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

SODIUM CHLORIDEInactive

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

WATERInactive

Code: 059QF0KO0RClass: IACT