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ryoncil
remestemcel-L-rknd
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
ryoncil
Proper name
remestemcel-L-rknd
Licence type
351(a)
BLA number
125706
Applicant
Mesoblast, Inc.
Center
CBER
Presentations
1
First licensure
December 18, 2024
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 6.68X10^CELL/ML | Suspension | Intravenous | Single-Dose Vial | Rx | December 18, 2024 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 18, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |