Product Details for: Fasenra
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
30MG/ML
Pre-Filled Syringe
351(a)
Fasenra
Rx
002
Injection
Subcutaneous
30MG/ML
Autoinjector
351(a)
Fasenra
Rx
003
Injection
Subcutaneous
10MG/0.5ML
Pre-Filled Syringe
351(a)
Fasenra
Rx
Proper Name
benralizumab
benralizumab
BLA Number
761070
761070
Applicant
AstraZeneca AB
AstraZeneca AB
Original Approval Date
November 14, 2017
November 14, 2017
Date of First Licensure