Product Details for: Hulio

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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
Hulio
Rx
002
Injection
Subcutaneous
40MG/0.8ML
Pre-Filled Syringe
351(k) Interchangeable
Hulio
Rx
003
Injection
Subcutaneous
20MG/0.4ML
Pre-Filled Syringe
351(k) Interchangeable
Hulio
Rx
Proper Name
adalimumab-fkjp
Reference Product Proper Name
adalimumab
Reference Product Properietary Name
Humira
BLA Number
761154
Applicant
Biocon Biologics Inc.
Original Approval Date
July 6, 2020
Date of First Licensure
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