On this page
StrataGraft
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
StrataGraft
Proper name
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
Licence type
351(a)
BLA number
125730
Applicant
Stratatech Corporation
Center
CBER
Presentations
1
First licensure
June 15, 2021
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100CM SQUARED | Cell Sheets | Topical | Pouch | Disc | June 15, 2021 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | June 15, 2028 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |