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Zemaira
Alpha-1-Proteinase Inhibitor (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Zemaira
Proper name
Alpha-1-Proteinase Inhibitor (Human)
Licence type
351(a)
BLA number
125078
Applicant
CSL Behring LLC
Center
CBER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000MG | For Injection | Intravenous | Single-Dose Vial | Rx | July 8, 2003 |
| 4000MG | For Injection | Intravenous | Single-Dose Vial | Rx | April 16, 2019 |
| 5000MG | For Injection | Intravenous | Single-Dose Vial | Rx | April 16, 2019 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |