Product Details for: Zemaira

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
1000MG
Single-Dose Vial
351(a)
Zemaira
Rx
002
For Injection
Intravenous
4000MG
Single-Dose Vial
351(a)
Zemaira
Rx
003
For Injection
Intravenous
5000MG
Single-Dose Vial
351(a)
Zemaira
Rx
Proper Name
Alpha-1-Proteinase Inhibitor (Human)
BLA Number
125078
Applicant
CSL Behring LLC
Original Approval Date
July 8, 2003
Date of First Licensure