Product Details for: Immgolis

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
50MG/0.5ML (100MG/ML)
Pre-Filled Syringe
351(k) Interchangeable
Immgolis
Rx
002
Injection
Subcutaneous
100MG/ML
Pre-Filled Syringe
351(k) Interchangeable
Immgolis
Rx
003
Injection
Intravenous
50MG/4ML (12.5MG/ML)
Single-Dose Vial
351(k) Interchangeable
Immgolis Intri
Rx
Proper Name
golimumab-sldi
Reference Product Proper Name
golimumab
Reference Product Properietary Name
Simponi
BLA Number
761452
Applicant
Accord BioPharma Inc.
Original Approval Date
May 15, 2026
Date of First Licensure
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