On this page
Ducord
HPC, Cord Blood
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Ducord
Proper name
HPC, Cord Blood
Licence type
351(a)
BLA number
125407
Applicant
Duke University School of Medicine
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| GREATER THAN OR EQUAL TO 2.5 X 10E7 PER KG CELLS PER KILOGRAM | Injection | Intravenous | Bag | Rx | October 4, 2012 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |