Product Details for: Comirnaty

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intramuscular
30UG/0.3ML
Multi-Dose Vial
351(a)
Comirnaty
Disc
002
For Injection
Intramuscular
30UG/0.3ML
Multi-Dose Vial
351(a)
Comirnaty
Disc
003
For Injection
Intramuscular
30UG/0.3ML
Single-Dose Vial
351(a)
Comirnaty
Disc
004
For Injection
Intramuscular
30UG/0.3ML
Pre-Filled Syringe
351(a)
Comirnaty
Disc
005
For Injection
Intramuscular
30UG/0.3ML
Pre-Filled Syringe
351(a)
Comirnaty
Rx
006
For Injection
Intramuscular
10UG/0.3ML
Single-Dose Vial
351(a)
Comirnaty
Rx
Proper Name
COVID-19 Vaccine, mRNA
BLA Number
125742
Applicant
BioNTech Manufacturing GmbH
Original Approval Date
August 23, 2021
Date of First Licensure
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