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regenecyte
HPC, Cord Blood
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
regenecyte
Proper name
HPC, Cord Blood
Licence type
351(a)
BLA number
125764
Applicant
StemCyte, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| >/=1.25x10E6 VIABLE CD34+ CELLS/UNIT IN >/=9x10E8 TNCs/UNIT | Injection | Intravenous | Bag | Rx | November 21, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |