Product Details for: Tyruko
RETURN TO SEARCH RESULTS
PRODUCT LABEL
Grayed out Product Label links indicate that there is no product label available for the product.
Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
300MG/15ML (20MG/ML)
Single-Dose Vial
351(k) Biosimilar
Tyruko
Rx
Proper Name
natalizumab-sztn
natalizumab-sztn
Reference Product Proper Name
natalizumab
natalizumab
Reference Product Properietary Name
Tysabri
Tysabri
BLA Number
761322
761322
Applicant
Sandoz Inc.
Sandoz Inc.
Original Approval Date
August 24, 2023
August 24, 2023
Date of First Licensure