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Capvaxive

Pneumococcal 21-valent Conjugate Vaccine

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Capvaxive
Proper name
Pneumococcal 21-valent Conjugate Vaccine
Licence type
351(a)
BLA number
125814
Applicant
Merck Sharp & Dohme LLC
Center
CBER
Presentations
1
First licensure
June 17, 2024

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
84UG/.5ML Injection Intramuscular Pre-Filled Syringe Rx June 17, 2024

Sources for this page

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