StrataGraft Purple Book BLA 125730
- BLA number
- 125730
- Proprietary names
- StrataGraft
- Proper names
- Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
- Applicant
- Stratatech Corporation
- Center
- CBER
- First observed release
- 2021-06-01
- 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 | StrataGraft | Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat | 351(a) | 100CM SQUARED | Cell Sheets | Topical | Pouch | Disc | Voluntarily Revoked | 2021-06-15 | |
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 |
|---|
| 2026-01-01 | U | 001 | StrataGraft | 351(a) | Disc | Stratatech Corporation |
| 2025-02-01 | U | 001 | StrataGraft | 351(a) | Disc | Stratatech Corporation |
| 2025-01-01 | U | 001 | StrataGraft | 351(a) | Disc | Stratatech Corporation |
| 2024-07-01 | U | 001 | StrataGraft | 351(a) | Disc | Stratatech Corporation |
| 2023-05-01 | U | 001 | StrataGraft | 351(a) | Rx | Stratatech Corporation |
| 2021-09-01 | U | 001 | StrataGraft | 351(a) | Rx | Stratatech Corporation |
| 2021-07-01 | U | 001 | StrataGraft | 351(a) | Rx | Stratatech Corporation |
| 2021-06-01 | N | 001 | StrataGraft | 351(a) | Rx | Stratatech Corporation |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-01-01 | 001 | StrataGraft | 351(a) | Disc | Voluntarily Revoked | 2021-06-15 |
| 2025-01-01 | 001 | StrataGraft | 351(a) | Disc | Revoked | 2021-06-15 |
| 2024-07-01 | 001 | StrataGraft | 351(a) | Disc | Licensed | 2021-06-15 |
| 2021-07-01 | 001 | StrataGraft | 351(a) | Rx | Licensed | 2021-06-15 |
| 2021-06-01 | 001 | StrataGraft | 351(a) | Rx | Licensed | 2021-06-15 |