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Lantidra
donislecel-jujn
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Lantidra
Proper name
donislecel-jujn
Licence type
351(a)
BLA number
125734
Applicant
CellTrans Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1X10E6EQUIVALENT ISLET NUMBER (EIN) | Suspension | Intravenous | Bag | Rx | June 28, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |