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Varizig
Varicella Zoster Immune Globulin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Varizig
Proper name
Varicella Zoster Immune Globulin (Human)
Licence type
351(a)
BLA number
125430
Applicant
Kamada Ltd.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 125IU | For Injection | Intramuscular | Vial | Disc | December 20, 2012 |
| 125IU | Injection | Intramuscular | Single-Dose Vial | Rx | September 29, 2014 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 20, 2019 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |