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Laviv
Azficel-T
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Laviv
Proper name
Azficel-T
Licence type
351(a)
BLA number
125348
Applicant
Fibrocell Technologies, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 18MU CELL/ML | Injection | Intradermal | Vial | Disc | June 21, 2011 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |