Campath

Manufacturing Establishments (3)

Labeler

Genzyme Corporation

DUNS Number

340700520

Labeler

Genzyme Corporation

DUNS Number

313218430

Labeler

Genzyme Corporation

DUNS Number

229522842

NDC Product Code

58468-0357

Application Number

BLA103948

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

April 1, 2023

Ingredients

Code: 3A189DH42VClass: ACTIBQuantity: 30 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL

MONOBASIC POTASSIUM PHOSPHATEInactive

Code: 4J9FJ0HL51Class: IACTQuantity: 0.2 mg in 1 mL

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACTQuantity: 0.1 mg in 1 mL

POTASSIUM CHLORIDEInactive

Code: 660YQ98I10Class: IACTQuantity: 0.2 mg in 1 mL

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACTQuantity: 1.44 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.0187 mg in 1 mL