Product Details for: Spikevax

RETURN TO SEARCH RESULTS
PRODUCT LABEL Grayed out Product Label links indicate that there is no product label available for the product.
Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
100UG
Multi-Dose Vial
351(a)
Spikevax
Disc
002
Injection
Intramuscular
50UG/0.5mL
Pre-Filled Syringe
351(a)
Spikevax
Rx
003
Injection
Intramuscular
50UG
Single-Dose Vial
351(a)
Spikevax
Disc
004
Injection
Intramuscular
50UG
Multi-Dose Vial
351(a)
Spikevax
Disc
005
Injection
Intramuscular
25UG/0.25mL
Pre-Filled Syringe
351(a)
Spikevax
Rx
Proper Name
COVID-19 Vaccine, mRNA
BLA Number
125752
Applicant
ModernaTX, Inc.
Original Approval Date
January 31, 2022
Date of First Licensure
RETURN TO SEARCH RESULTS