Product Details for: Erelzi

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
25MG/0.5ML
Pre-Filled Syringe
351(k) Biosimilar
Erelzi
Disc
002
Injection
Subcutaneous
50MG/ML
Pre-Filled Syringe
351(k) Biosimilar
Erelzi
Disc
003
Injection
Subcutaneous
50MG/ML
Autoinjector
351(k) Biosimilar
Erelzi Sensoready
Disc
004
For Injection
Subcutaneous
25MG
Multi-Dose Vial
351(k) Biosimilar
Erelzi
Disc
Proper Name
etanercept-szzs
Reference Product Proper Name
etanercept
Reference Product Properietary Name
Enbrel
BLA Number
761042
Applicant
Sandoz Inc.
Original Approval Date
August 30, 2016
Date of First Licensure
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