Product Details for: mnexspike
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
10UG
Pre-Filled Syringe
351(a)
mnexspike
Rx
Proper Name
COVID-19 Vaccine, mRNA
COVID-19 Vaccine, mRNA
BLA Number
125835
125835
Applicant
ModernaTX, Inc.
ModernaTX, Inc.
Original Approval Date
May 30, 2025
May 30, 2025
Date of First Licensure