CAPVAXIVE Purple Book BLA 125814
- BLA number
- 125814
- Proprietary names
- CAPVAXIVE
- Proper names
- Pneumococcal 21-valent Conjugate Vaccine
- Applicant
- Merck Sharp & Dohme LLC
- Center
- CBER
- First observed release
- 2024-06-01
- 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| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | CAPVAXIVE | Pneumococcal 21-valent Conjugate Vaccine | 351(a) | 84UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | 2024-06-17 | |
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| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2024-09-01 | U | 001 | CAPVAXIVE | 351(a) | Rx | Merck Sharp & Dohme LLC |
| 2024-08-01 | U | 001 | CAPVAXIVE | 351(a) | Rx | Merck Sharp & Dohme LLC |
| 2024-06-01 | N | 001 | CAPVAXIVE | 351(a) | Rx | Merck Sharp & Dohme LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-06-01 | 001 | CAPVAXIVE | 351(a) | Rx | Licensed | 2024-06-17 |