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Hizentra
Immune Globulin Subcutaneous (Human), 20% Liquid
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Hizentra
Proper name
Immune Globulin Subcutaneous (Human), 20% Liquid
Licence type
351(a)
BLA number
125350
Applicant
CSL Behring AG
Center
CBER
Presentations
8
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10G/50ML | Injection | Subcutaneous | Single-Dose Vial | Rx | March 4, 2010 |
| 10G/50ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 13, 2023 |
| 1G/5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | March 4, 2010 |
| 1G/5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 13, 2023 |
| 2G/10ML | Injection | Subcutaneous | Single-Dose Vial | Rx | March 4, 2010 |
| 2G/10ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 13, 2023 |
| 4G/20ML | Injection | Subcutaneous | Single-Dose Vial | Rx | March 4, 2010 |
| 4G/20ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 13, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 15, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |