Clevecord Purple Book BLA 125594
- BLA number
- 125594
- Proprietary names
- Clevecord
- Proper names
- HPC, Cord Blood
- Applicant
- Cleveland Cord Blood Center
- 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 | Clevecord | HPC, Cord Blood | 351(a) | 5 x 10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25 x 106 VIABLE CD34+ CELLS | Injection | Intravenous | Bag | Rx | Licensed | 2016-09-01 | |
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 |
|---|
| 2021-05-01 | U | 001 | Clevecord | 351(a) | Rx | Cleveland Cord Blood Center |
| 2020-08-01 | R | 001 | Clevecord | 351(a) | Rx | Cleveland Cord Blood Center |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Clevecord | 351(a) | Rx | Licensed | 2016-09-01 |