HPC, Cord Blood Purple Book BLA 125391
- BLA number
- 125391
- Proper names
- HPC, Cord Blood
- Applicant
- Clinimmune Labs
- 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 | | HPC, Cord Blood | 351(a) | 5X10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25X10^6 VIABLE CD34+ CELLS | Injection | Intravenous | Bag | Rx | Licensed | 2012-05-24 | |
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 |
|---|
| 2025-05-01 | U | 001 | HPC, Cord Blood | 351(a) | Rx | Clinimmune Labs |
| 2025-04-01 | U | 001 | HPC, Cord Blood | 351(a) | Rx | Clinimmune Labs |
| 2021-05-01 | U | 001 | HPC, Cord Blood | 351(a) | Rx | Clinimmune Labs |
| 2020-08-01 | R | 001 | HPC, Cord Blood | 351(a) | Rx | Clinimmune Labs |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | HPC, Cord Blood | 351(a) | Rx | Licensed | 2012-05-24 |