Product Details for: Merilog
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
1,000UNITS/10ML (100UNITS/ML)
Multi-Dose Vial
351(k) Biosimilar
Merilog
Rx
002
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(k) Biosimilar
Merilog
Rx
Proper Name
insulin aspart-szjj
insulin aspart-szjj
Reference Product Proper Name
insulin aspart
insulin aspart
Reference Product Properietary Name
Novolog
Novolog
BLA Number
761325
761325
Applicant
Sanofi-Aventis U.S. LLC
Sanofi-Aventis U.S. LLC
Original Approval Date
February 14, 2025
February 14, 2025
Date of First Licensure