Albuminex Purple Book BLA 125644
- BLA number
- 125644
- Proprietary names
- Albuminex
- Proper names
- Albumin (Human)-kjda
- Applicant
- Bio Products Laboratory Limited
- 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 | Albuminex | Albumin (Human)-kjda | 351(a) | 12.5G/50ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | 2018-06-19 | |
| 002 | Albuminex | Albumin (Human)-kjda | 351(a) | 25G/100ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | 2018-06-19 | |
| 003 | Albuminex | Albumin (Human)-kjda | 351(a) | 12.5G/250ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | 2018-06-19 | |
| 004 | Albuminex | Albumin (Human)-kjda | 351(a) | 25G/500ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | 2018-06-19 | |
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 |
|---|
| 2024-08-01 | U | 001 | Albuminex | 351(a) | Rx | Bio Products Laboratory Limited |
| 2024-08-01 | U | 002 | Albuminex | 351(a) | Rx | Bio Products Laboratory Limited |
| 2024-08-01 | U | 003 | Albuminex | 351(a) | Rx | Bio Products Laboratory Limited |
| 2024-08-01 | U | 004 | Albuminex | 351(a) | Rx | Bio Products Laboratory Limited |
| 2022-08-01 | U | 001 | Albuminex | 351(a) | Rx | Bio Products Laboratory |
| 2022-08-01 | U | 002 | Albuminex | 351(a) | Rx | Bio Products Laboratory |
| 2022-08-01 | N | 003 | Albuminex | 351(a) | Rx | Bio Products Laboratory |
| 2022-08-01 | N | 004 | Albuminex | 351(a) | Rx | Bio Products Laboratory |
| 2021-05-01 | U | 001 | Albuminex | 351(a) | Rx | Bio Products Laboratory |
| 2021-05-01 | U | 002 | Albuminex | 351(a) | Rx | Bio Products Laboratory |
| 2020-08-01 | R | 001 | Albuminex | 351(a) | Rx | Bio Products Laboratory |
| 2020-08-01 | R | 002 | Albuminex | 351(a) | Rx | Bio Products Laboratory |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-08-01 | 003 | Albuminex | 351(a) | Rx | Licensed | 2018-06-19 |
| 2022-08-01 | 004 | Albuminex | 351(a) | Rx | Licensed | 2018-06-19 |
| 2020-08-01 | 001 | Albuminex | 351(a) | Rx | Licensed | 2018-06-19 |
| 2020-08-01 | 002 | Albuminex | 351(a) | Rx | Licensed | 2018-06-19 |