Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 Purple Book BLA 103955
- BLA number
- 103955
- Proprietary names
- Albuminar, Albuminar-20, Albuminar-25, Albuminar-5
- Proper names
- Albumin (Human)
- Applicant
- CSL Behring 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 | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 001 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 10G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-03-17 | |
| 002 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 20G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-03-17 | |
| 003 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 25G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-07-17 | |
| 004 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 5G/20ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-03-17 | |
| 005 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-03-17 | |
| 006 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-07-17 | |
| 007 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 12.5G/250ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-07-17 | |
| 008 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 25G/500ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-07-17 |
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 | Name | License type | Status | Applicant |
|---|---|---|---|---|---|---|
| 2023-07-01 | U | 001 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | CSL Behring LLC |
| 2023-07-01 | U | 002 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | CSL Behring LLC |
| 2023-07-01 | U | 003 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | CSL Behring LLC |
| 2023-07-01 | U | 004 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | CSL Behring LLC |
| 2023-07-01 | U | 005 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | CSL Behring LLC |
| 2023-07-01 | U | 006 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | CSL Behring LLC |
| 2023-07-01 | U | 007 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | CSL Behring LLC |
| 2023-07-01 | U | 008 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | CSL Behring LLC |
| 2022-08-01 | U | 001 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2022-08-01 | U | 002 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2022-08-01 | U | 003 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2022-08-01 | N | 004 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2022-08-01 | N | 005 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2022-08-01 | N | 006 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2022-08-01 | N | 007 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2022-08-01 | N | 008 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2021-05-01 | U | 001 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2021-05-01 | U | 002 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2021-05-01 | U | 003 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2020-08-01 | R | 001 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2020-08-01 | R | 002 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
| 2020-08-01 | R | 003 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | CSL Behring LLC |
Observed Product State History#
| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|---|---|---|---|---|---|
| 2023-07-01 | 001 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | Voluntarily Revoked | 2000-03-17 |
| 2023-07-01 | 002 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | Voluntarily Revoked | 2000-03-17 |
| 2023-07-01 | 003 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | Voluntarily Revoked | 2000-07-17 |
| 2023-07-01 | 004 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | Voluntarily Revoked | 2000-03-17 |
| 2023-07-01 | 005 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | Voluntarily Revoked | 2000-03-17 |
| 2023-07-01 | 006 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | Voluntarily Revoked | 2000-07-17 |
| 2023-07-01 | 007 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | Voluntarily Revoked | 2000-07-17 |
| 2023-07-01 | 008 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Disc | Voluntarily Revoked | 2000-07-17 |
| 2022-08-01 | 004 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | Licensed | 2000-03-17 |
| 2022-08-01 | 005 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | Licensed | 2000-03-17 |
| 2022-08-01 | 006 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | Licensed | 2000-07-17 |
| 2022-08-01 | 007 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | Licensed | 2000-07-17 |
| 2022-08-01 | 008 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | Licensed | 2000-07-17 |
| 2020-08-01 | 001 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | Licensed | 2000-03-17 |
| 2020-08-01 | 002 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | Licensed | 2000-03-17 |
| 2020-08-01 | 003 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | 351(a) | Rx | Licensed | 2000-07-17 |