Product Details for: Garzulys

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous, Subcutaneous
1,000UNITS/10ML (100UNITS/ML)
Multi-Dose Vial
351(k) Biosimilar
Garzulys
Rx
002
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(k) Biosimilar
Garzulys
Rx
Proper Name
insulin aspart-fsan
Reference Product Proper Name
insulin aspart
Reference Product Properietary Name
Novolog
BLA Number
761497
Applicant
Emerge Bioscience Pte. Ltd.
Original Approval Date
July 24, 2026
Date of First Licensure
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