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FDA Approval

TYSABRI

CompanyBiogen Inc. (DUNS: 121376230)

Effective Date

October 27, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Natalizumab(300 mg in 15 mL)

Products (1)

TYSABRI

NDC Product Code

64406-008

Application Number

BLA125104

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

June 22, 2022

Ingredients

sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

sodium phosphate, monobasic, monohydrateInactive

Code: 593YOG76RNClass: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

NatalizumabActive

Code: 3JB47N2Q2PClass: ACTIBQuantity: 300 mg in 15 mL

sodium phosphate, dibasic, heptahydrateInactive

Code: 70WT22SF4BClass: IACT

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