ARZERRA

Basic Information

Product Name

ARZERRA

FDA Product Code

0078-0669

Regulatory Information

NDC Product Code

0078-0669

Application Number

BLA125326

Marketing Category

C73585

Effective Date

January 19, 2016

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ARZERRA safely and effectively. See full prescribing information for ARZERRA. ARZERRA (ofatumumab) injection, for intravenous useInitial U.S. Approval: 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

OFATUMUMAB

Quantity: 20 mg in 1 mL

Code: M95KG522R0

Class Code: ACTIB

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

ARGININE

Code: 94ZLA3W45F

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

SODIUM ACETATE

Code: 4550K0SC9B

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

OFATUMUMAB

Code: M95KG522R0

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYDROCHLORIC ACID

POLYSORBATE 80

ARGININE

EDETATE DISODIUM

SODIUM ACETATE

SODIUM CHLORIDE

WATER

Active Moieties

OFATUMUMAB