On this page
Maci
autologous cultured chondrocytes on porcine collagen membrane
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Maci
Proper name
autologous cultured chondrocytes on porcine collagen membrane
Licence type
351(a)
BLA number
125603
Applicant
Vericel Corporation
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 500,000 CM2 CM2 | Cell Sheets | Implantation | Pouch | Rx | December 13, 2016 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |