FDA.reportPublic FDA data

Pneumovax 23 Purple Book BLA 101094

BLA number
101094
Proprietary names
Pneumovax 23
Proper names
Pneumococcal Vaccine, Polyvalent
Applicant
Merck Sharp & Dohme LLC
Center
CBER
First observed release
2020-08-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Pneumovax 23Pneumococcal Vaccine, Polyvalent351(a)25UG/.5MLInjectionIntramuscularVialRxLicensed1977-11-21
002Pneumovax 23Pneumococcal Vaccine, Polyvalent351(a)25UG/.5MLInjectionSubcutaneousVialRxLicensed1977-11-21

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2023-03-01U001Pneumovax 23351(a)RxMerck Sharp & Dohme LLC
2023-03-01U002Pneumovax 23351(a)RxMerck Sharp & Dohme LLC
2022-01-01U001Pneumovax 23351(a)RxMerck Sharp & Dohme Corp.
2022-01-01U002Pneumovax 23351(a)RxMerck Sharp & Dohme Corp.
2021-05-01U001Pneumovax 23351(a)RxMerck Sharp & Dohme Corp.
2020-08-01R001Pneumovax 23351(a)RxMerck Sharp & Dohme Corp.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2022-01-01002Pneumovax 23351(a)RxLicensed1977-11-21
2020-08-01001Pneumovax 23351(a)RxLicensed1977-11-21