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mnexspike
COVID-19 Vaccine, mRNA
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
mnexspike
Proper name
COVID-19 Vaccine, mRNA
Licence type
351(a)
BLA number
125835
Applicant
ModernaTX, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | May 30, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |