On this page
Pneumovax 23
Pneumococcal Vaccine, Polyvalent
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Pneumovax 23
Proper name
Pneumococcal Vaccine, Polyvalent
Licence type
351(a)
BLA number
101094
Applicant
Merck Sharp & Dohme LLC
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 25UG/.5ML | Injection | Intramuscular | Vial | Rx | November 21, 1977 |
| 25UG/.5ML | Injection | Subcutaneous | Vial | Rx | November 21, 1977 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |