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FDA Product

FASENRA

Product approved by U.S. Food and Drug Administration (US)

Basic Information

FASENRA

0310-1730

Regulatory Information

0310-1730

BLA761070

C73585

February 23, 2021

USA

These highlights do not include all the information needed to use FASENRA safely and effectively. See full prescribing information for FASENRA.FASENRA (benralizumab) injection, for subcutaneous useInitial U.S. Approval: 2017

HUMAN PRESCRIPTION DRUG LABEL

20

Company Information

054743190

Active Ingredients

HISTIDINE MONOHYDROCHLORIDE

Quantity: 2.3 mg in 1 mL

Code: 1D5Q932XM6

Class Code: IACT

BENRALIZUMAB

Quantity: 30 mg in 1 mL

Code: 71492GE1FX

Class Code: ACTIB

WATER

Quantity: 910 mg in 1 mL

Code: 059QF0KO0R

Class Code: IACT

POLYSORBATE 20

Quantity: 0.06 mg in 1 mL

Code: 7T1F30V5YH

Class Code: IACT

HISTIDINE

Quantity: 1.4 mg in 1 mL

Code: 4QD397987E

Class Code: IACT

TREHALOSE DIHYDRATE

Quantity: 95 mg in 1 mL

Code: 7YIN7J07X4

Class Code: IACT

Active Moieties

BENRALIZUMAB

Code: 71492GE1FX

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