NUVAXOVID Purple Book BLA 125817
- BLA number
- 125817
- Proprietary names
- NUVAXOVID
- Proper names
- COVID-19 Vaccine, Adjuvanted
- Applicant
- Sanofi Vaccines US Inc.
- Center
- CBER
- First observed release
- 2025-05-01
- 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 | NUVAXOVID | COVID-19 Vaccine, Adjuvanted | 351(a) | 5UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | 2025-05-16 | |
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 |
|---|
| 2026-05-01 | U | 001 | NUVAXOVID | 351(a) | Rx | Sanofi Vaccines US Inc. |
| 2025-05-01 | N | 001 | NUVAXOVID | 351(a) | Rx | Novavax, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-05-01 | 001 | NUVAXOVID | 351(a) | Rx | Licensed | 2025-05-16 |