Raplixa Purple Book BLA 125523
- BLA number
- 125523
- Proprietary names
- Raplixa
- Proper names
- Fibrin Sealant (Human)
- Applicant
- Mallinckrodt Pharma IP Trading DAC
- Center
- CBER
- First observed release
- 2022-05-01
- 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 | Raplixa | Fibrin Sealant (Human) | 351(a) | 0.5G | Powder | Topical | Vial | Disc | Voluntarily Revoked | 2015-04-30 | |
| 002 | Raplixa | Fibrin Sealant (Human) | 351(a) | 1G | Powder | Topical | Vial | Disc | Voluntarily Revoked | 2015-04-30 | |
| 003 | Raplixa | Fibrin Sealant (Human) | 351(a) | 2G | Powder | Topical | Vial | Disc | Voluntarily Revoked | 2015-04-30 | |
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 |
|---|
| 2023-06-01 | U | 001 | Raplixa | 351(a) | Disc | Mallinckrodt Pharma IP Trading DAC |
| 2023-06-01 | U | 002 | Raplixa | 351(a) | Disc | Mallinckrodt Pharma IP Trading DAC |
| 2023-06-01 | U | 003 | Raplixa | 351(a) | Disc | Mallinckrodt Pharma IP Trading DAC |
| 2022-05-01 | N | 001 | Raplixa | 351(a) | Rx | Mallinckrodt Pharma IP Trading DAC |
| 2022-05-01 | N | 002 | Raplixa | 351(a) | Rx | Mallinckrodt Pharma IP Trading DAC |
| 2022-05-01 | N | 003 | Raplixa | 351(a) | Rx | Mallinckrodt Pharma IP Trading DAC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-06-01 | 001 | Raplixa | 351(a) | Disc | Voluntarily Revoked | 2015-04-30 |
| 2023-06-01 | 002 | Raplixa | 351(a) | Disc | Voluntarily Revoked | 2015-04-30 |
| 2023-06-01 | 003 | Raplixa | 351(a) | Disc | Voluntarily Revoked | 2015-04-30 |
| 2022-05-01 | 001 | Raplixa | 351(a) | Rx | Voluntarily Revoked | 2015-04-30 |
| 2022-05-01 | 002 | Raplixa | 351(a) | Rx | Voluntarily Revoked | 2015-04-30 |
| 2022-05-01 | 003 | Raplixa | 351(a) | Rx | Voluntarily Revoked | 2015-04-30 |