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zevaskyn
Prademagene zamikeracel
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
zevaskyn
Proper name
Prademagene zamikeracel
Licence type
351(a)
BLA number
125807
Applicant
Abeona Therapeutics Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 41.25CM^2 | Cellular Sheet | Topical | Tray & Lid | Rx | April 28, 2025 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | April 28, 1932 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |