Product Details for: Simlandi

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
40MG/0.4ML
Autoinjector
351(k) Interchangeable
Simlandi
Rx
002
Injection
Subcutaneous
40MG/0.4ML
Pre-Filled Syringe
351(k) Interchangeable
Simlandi
Rx
003
Injection
Subcutaneous
20MG/0.2ML
Pre-Filled Syringe
351(k) Interchangeable
Simlandi
Rx
004
Injection
Subcutaneous
80MG/0.8ML
Pre-Filled Syringe
351(k) Interchangeable
Simlandi
Rx
005
Injection
Subcutaneous
80MG/0.8ML
Autoinjector
351(k) Interchangeable
Simlandi
Rx
Proper Name
adalimumab-ryvk
Reference Product Proper Name
adalimumab
Reference Product Properietary Name
Humira
BLA Number
761299
Applicant
Alvotech USA Inc.
Original Approval Date
February 23, 2024
Date of First Licensure
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