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Abrysvo

Respiratory Syncytial Virus Vaccine

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Abrysvo
Proper name
Respiratory Syncytial Virus Vaccine
Licence type
351(a)
BLA number
125769
Applicant
Pfizer Inc.
Center
CBER
Presentations
1
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
120UG Injection Intramuscular Single-Dose Vial Rx May 31, 2023

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity