Thrombin-Jmi, Thrombocoll Purple Book BLA 102865
- BLA number
- 102865
- Proprietary names
- Thrombin-Jmi, Thrombocoll
- Proper names
- Thrombin, Topical (Bovine)
- Applicant
- GenTrac, Inc.
- 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 | Thrombin-Jmi, Thrombocoll | Thrombin, Topical (Bovine) | 351(a) | 20,000IU | Powder | Topical | Vial | Rx | Licensed | 1986-02-03 | |
| 002 | Thrombin-Jmi, Thrombocoll | Thrombin, Topical (Bovine) | 351(a) | 5,000IU | Powder | Topical | Vial | Rx | Licensed | 2011-02-10 | |
| 003 | Thrombin-Jmi, Thrombocoll | Thrombin, Topical (Bovine) | 351(a) | 20,000IU | Solution | Topical | Single-Dose Vial | Rx | Licensed | 2026-04-10 | |
| 004 | Thrombin-Jmi, Thrombocoll | Thrombin, Topical (Bovine) | 351(a) | 5,000IU | Solution | Topical | Single-Dose Vial | Rx | Licensed | 2026-04-10 | |
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 |
|---|
| 2026-04-01 | U | 003 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | GenTrac, Inc. |
| 2026-04-01 | U | 004 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | GenTrac, Inc. |
| 2021-05-01 | U | 001 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | GenTrac, Inc. |
| 2021-05-01 | U | 002 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | GenTrac, Inc. |
| 2020-08-01 | R | 001 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | GenTrac, Inc. |
| 2020-08-01 | R | 002 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | GenTrac, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-04-01 | 003 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | Licensed | 2026-04-10 |
| 2026-04-01 | 004 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | Licensed | 2026-04-10 |
| 2020-08-01 | 001 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | Licensed | 1986-02-03 |
| 2020-08-01 | 002 | Thrombin-Jmi, Thrombocoll | 351(a) | Rx | Licensed | 2011-02-10 |