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Panzyga
Immune Globulin Intravenous (Human)-ifas
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Panzyga
Proper name
Immune Globulin Intravenous (Human)-ifas
Licence type
351(a)
BLA number
125587
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Center
CBER
Presentations
6
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10G ML | Injection | Intravenous | Single-Use Bottle | Rx | August 2, 2018 |
| 1G ML | Injection | Intravenous | Single-Use Bottle | Rx | August 2, 2018 |
| 2.5G ML | Injection | Intravenous | Single-Use Bottle | Rx | August 2, 2018 |
| 20G ML | Injection | Intravenous | Single-Use Bottle | Rx | August 2, 2018 |
| 30 G ML | Injection | Intravenous | Single-Use Bottle | Rx | August 2, 2018 |
| 5G ML | Injection | Intravenous | Single-Use Bottle | Rx | August 2, 2018 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |