Product Details for: Abrilada
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
40MG/0.8ML
Autoinjector
351(k) Interchangeable
Abrilada
Rx
002
Injection
Subcutaneous
40MG/0.8ML
Pre-Filled Syringe
351(k) Interchangeable
Abrilada
Rx
003
Injection
Subcutaneous
20MG/0.4ML
Pre-Filled Syringe
351(k) Interchangeable
Abrilada
Rx
004
Injection
Subcutaneous
10MG/0.2ML
Pre-Filled Syringe
351(k) Interchangeable
Abrilada
Disc
005
Injection
Subcutaneous
40MG/0.8ML
Single-Dose Vial
351(k) Interchangeable
Abrilada
Rx
Proper Name
adalimumab-afzb
adalimumab-afzb
Reference Product Proper Name
adalimumab
adalimumab
Reference Product Properietary Name
Humira
Humira
BLA Number
761118
761118
Applicant
Pfizer Inc.
Pfizer Inc.
Original Approval Date
November 15, 2019
November 15, 2019
Date of First Licensure