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Carticel Sm Service
Autologous Cultured Chondrocytes
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Carticel Sm Service
Proper name
Autologous Cultured Chondrocytes
Licence type
351(a)
BLA number
103661
Applicant
Vericel Corporation
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 12MIU/VL | Injection | Implantation | Single-Dose Vial | Disc | August 22, 1997 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |