Quadracel Purple Book BLA 125525
- BLA number
- 125525
- Proprietary names
- Quadracel
- Proper names
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
- Applicant
- Sanofi Vaccines Canada Ltd.
- 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| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Quadracel | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | 2015-03-24 | |
| 002 | Quadracel | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | 2022-01-25 | |
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 | Quadracel | 351(a) | Disc | Sanofi Vaccines Canada Ltd. |
| 2026-05-01 | U | 002 | Quadracel | 351(a) | Rx | Sanofi Vaccines Canada Ltd. |
| 2025-12-01 | U | 001 | Quadracel | 351(a) | Disc | Sanofi Pasteur Limited |
| 2025-12-01 | U | 002 | Quadracel | 351(a) | Rx | Sanofi Pasteur Limited |
| 2021-05-01 | U | 001 | Quadracel | 351(a) | Rx | Sanofi Pasteur Limited |
| 2020-08-01 | R | 001 | Quadracel | 351(a) | Rx | Sanofi Pasteur Limited |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-12-01 | 001 | Quadracel | 351(a) | Disc | Licensed | 2015-03-24 |
| 2025-12-01 | 002 | Quadracel | 351(a) | Rx | Licensed | 2022-01-25 |
| 2020-08-01 | 001 | Quadracel | 351(a) | Rx | Licensed | 2015-03-24 |