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Aralast, Aralast Np
Alpha-1-Proteinase Inhibitor (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Aralast, Aralast Np
Proper name
Alpha-1-Proteinase Inhibitor (Human)
Licence type
351(a)
BLA number
125039
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5G | For Injection | Intravenous | Single-Dose Vial | Rx | December 23, 2002 |
| 1.0G | For Injection | Intravenous | Single-Dose Vial | Rx | December 23, 2002 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |