Andexxa Purple Book BLA 125586
- BLA number
- 125586
- Proprietary names
- Andexxa
- Proper names
- Coagulation Factor Xa (Recombinant), Inactivated-zhzo
- Applicant
- AstraZeneca AB
- 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 | Andexxa | Coagulation Factor Xa (Recombinant), Inactivated-zhzo | 351(a) | 100MG | Injection | Intravenous | Single-Dose Vial | Disc | Revoked | 2018-05-03 | |
| 002 | Andexxa | Coagulation Factor Xa (Recombinant), Inactivated-zhzo | 351(a) | 200MG | Injection | Intravenous | Single-Dose Vial | Disc | Revoked | 2018-12-31 | |
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 |
|---|
| 2025-12-01 | U | 001 | Andexxa | 351(a) | Disc | AstraZeneca AB |
| 2025-12-01 | U | 002 | Andexxa | 351(a) | Rx | AstraZeneca AB |
| 2024-02-01 | U | 001 | Andexxa | 351(a) | Disc | AstraZeneca AB |
| 2022-06-01 | U | 001 | Andexxa | 351(a) | Rx | AstraZeneca AB |
| 2022-06-01 | U | 002 | Andexxa | 351(a) | Rx | AstraZeneca AB |
| 2022-04-01 | U | 001 | Andexxa | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2022-04-01 | U | 002 | Andexxa | 351(a) | Rx | Alexion Pharmaceuticals, Inc. |
| 2021-09-01 | U | 001 | Andexxa | 351(a) | Rx | Portola Pharamceuticals |
| 2021-09-01 | U | 002 | Andexxa | 351(a) | Rx | Portola Pharamceuticals |
| 2021-05-01 | U | 001 | Andexxa | 351(a) | Rx | Portola Pharamceuticals |
| 2021-05-01 | U | 002 | Andexxa | 351(a) | Rx | Portola Pharamceuticals |
| 2021-04-01 | U | 001 | Andexxa | 351(a) | Rx | Portola Pharamceuticals |
| 2021-04-01 | U | 002 | Andexxa | 351(a) | Rx | Portola Pharamceuticals |
| 2020-08-01 | R | 001 | Andexxa | 351(a) | Rx | Portola Pharamceuticals |
| 2020-08-01 | R | 002 | Andexxa | 351(a) | Rx | Portola Pharamceuticals |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-01-01 | 002 | Andexxa | 351(a) | Disc | Revoked | 2018-12-31 |
| 2025-12-01 | 001 | Andexxa | 351(a) | Disc | Revoked | 2018-05-03 |
| 2025-12-01 | 002 | Andexxa | 351(a) | Rx | Revoked | 2018-12-31 |
| 2024-02-01 | 001 | Andexxa | 351(a) | Disc | Licensed | 2018-05-03 |
| 2020-08-01 | 001 | Andexxa | 351(a) | Rx | Licensed | 2018-05-03 |
| 2020-08-01 | 002 | Andexxa | 351(a) | Rx | Licensed | 2018-12-31 |