Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 Purple Book BLA 101138
- BLA number
- 101138
- Proprietary names
- Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5
- Proper names
- Albumin (Human)
- Applicant
- Grifols Therapeutics LLC
- 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 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 2.5G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1942-10-21 | |
| 002 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 25G/100ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1942-10-21 | |
| 003 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 20G/100ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1942-10-21 | |
| 004 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 10G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1942-10-21 | |
| 005 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 12.5G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1942-10-21 | |
| 006 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 5G/20ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1942-10-21 | |
| 007 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 25G/500ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1942-10-21 | |
| 008 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 12.5G/250ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 1942-10-21 | |
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 |
|---|
| 2022-08-01 | U | 001 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-08-01 | U | 002 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-08-01 | U | 003 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-08-01 | N | 004 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-08-01 | N | 005 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-08-01 | N | 006 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-08-01 | N | 007 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-08-01 | N | 008 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 001 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 002 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 003 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 001 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 002 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 003 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Grifols Therapeutics LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-08-01 | 004 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Licensed | 1942-10-21 |
| 2022-08-01 | 005 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Licensed | 1942-10-21 |
| 2022-08-01 | 006 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Licensed | 1942-10-21 |
| 2022-08-01 | 007 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Licensed | 1942-10-21 |
| 2022-08-01 | 008 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Licensed | 1942-10-21 |
| 2020-08-01 | 001 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Licensed | 1942-10-21 |
| 2020-08-01 | 002 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Licensed | 1942-10-21 |
| 2020-08-01 | 003 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | 351(a) | Rx | Licensed | 1942-10-21 |