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Proleukin
aldesleukin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Proleukin
Proper name
aldesleukin
Licence type
351(a)
BLA number
103293
Applicant
Iovance Biotherapeutics Manufacturing LLC
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 22MILLION INTERNATIONAL UNITS (1.3MG) | For Injection | Intravenous | Single-Dose Vial | Rx | May 5, 1992 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | January 9, 2005 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |