Tachosil Purple Book BLA 125351
- BLA number
- 125351
- Proprietary names
- Tachosil
- Proper names
- Fibrin Sealant Patch
- Applicant
- Corza Medical GmbH
- 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 | Tachosil | Fibrin Sealant Patch | 351(a) | 4.8 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN | Patch | Topical | Tray & Lid | Rx | Licensed | 2010-04-05 | |
| 002 | Tachosil | Fibrin Sealant Patch | 351(a) | 9.5 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN | Patch | Topical | Tray & Lid | Rx | Licensed | 2010-04-05 | |
| 003 | Tachosil | Fibrin Sealant Patch | 351(a) | 3.0 CM X 2.5 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN | Patch | Topical | Tray & Lid | Disc | Licensed | 2010-04-05 | |
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 |
|---|
| 2022-04-01 | U | 001 | Tachosil | 351(a) | Rx | Corza Medical GmbH |
| 2022-04-01 | U | 002 | Tachosil | 351(a) | Rx | Corza Medical GmbH |
| 2022-04-01 | U | 003 | Tachosil | 351(a) | Disc | Corza Medical GmbH |
| 2021-05-01 | U | 001 | Tachosil | 351(a) | Rx | Takeda Pharma A/S |
| 2021-05-01 | U | 002 | Tachosil | 351(a) | Rx | Takeda Pharma A/S |
| 2021-05-01 | U | 003 | Tachosil | 351(a) | Disc | Takeda Pharma A/S |
| 2020-08-01 | R | 001 | Tachosil | 351(a) | Rx | Takeda Pharma A/S |
| 2020-08-01 | R | 002 | Tachosil | 351(a) | Rx | Takeda Pharma A/S |
| 2020-08-01 | R | 003 | Tachosil | 351(a) | Disc | Takeda Pharma A/S |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Tachosil | 351(a) | Rx | Licensed | 2010-04-05 |
| 2020-08-01 | 002 | Tachosil | 351(a) | Rx | Licensed | 2010-04-05 |
| 2020-08-01 | 003 | Tachosil | 351(a) | Disc | Licensed | 2010-04-05 |