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Penbraya
Meningococcal Groups A, B, C, W, and Y Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Penbraya
Proper name
Meningococcal Groups A, B, C, W, and Y Vaccine
Licence type
351(a)
BLA number
125770
Applicant
Pfizer Ireland Pharmaceuticals Unlimited Company
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 5UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | October 20, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |