Product Details for: Tyenne

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
80MG/4ML (20MG/ML)
Single-Dose Vial
351(k) Biosimilar
Tyenne
Rx
002
Injection
Intravenous
200MG/10ML (20MG/ML)
Single-Dose Vial
351(k) Biosimilar
Tyenne
Rx
003
Injection
Intravenous
400MG/20ML (20MG/ML)
Single-Dose Vial
351(k) Biosimilar
Tyenne
Rx
Proper Name
tocilizumab-aazg
Reference Product Proper Name
tocilizumab
Reference Product Properietary Name
Actemra
BLA Number
761275
Applicant
Fresenius Kabi USA, LLC
Original Approval Date
March 5, 2024
Date of First Licensure
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