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Nexobrid
anacaulase-bcdb
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Nexobrid
Proper name
anacaulase-bcdb
Licence type
351(a)
BLA number
761192
Applicant
Vericel Corporation
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 8.8% (1.94GM) | For Topical Gel | Topical | Single-Use Jar | Disc | December 28, 2022 |
| 8.8% (4.85GM) | For Topical Gel | Topical | Single-Use Jar | Rx | December 28, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | August 15, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |