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Gammaked, Gamunex-C
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Gammaked, Gamunex-C
Proper name
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
Licence type
351(a)
BLA number
125046
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
19
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10G/100ML | Injection | Intravenous | Single-Use Bottle | Rx | August 27, 2003 |
| 10G/100ML | Injection | Subcutaneous | Single-Use Bottle | Rx | August 27, 2003 |
| 10G/100ML | Injection | Intravenous | Bag | Rx | October 20, 2025 |
| 10G/100ML | Injection | Subcutaneous | Bag | Rx | October 20, 2025 |
| 1G/10ML | Injection | Intravenous | Bottle | Rx | August 27, 2003 |
| 2.5G/25ML | Injection | Intravenous | Single-Use Bottle | Rx | August 27, 2003 |
| 2.5G/25ML | Injection | Subcutaneous | Single-Use Bottle | Rx | August 27, 2003 |
| 20G/200ML | Injection | Intravenous | Single-Use Bottle | Rx | August 27, 2003 |
| 20G/200ML | Injection | Subcutaneous | Single-Use Bottle | Rx | August 27, 2003 |
| 20G/200ML | Injection | Intravenous | Bag | Rx | October 20, 2025 |
| 20G/200ML | Injection | Subcutaneous | Bag | Rx | October 20, 2025 |
| 40G/400ML | Injection | Intravenous | Single-Use Bottle | Rx | August 27, 2003 |
| 40G/400ML | Injection | Subcutaneous | Single-Use Bottle | Rx | August 27, 2003 |
| 40G/400ML | Injection | Intravenous | Bag | Rx | October 20, 2025 |
| 40G/400ML | Injection | Subcutaneous | Bag | Rx | October 20, 2025 |
| 5G/50ML | Injection | Intravenous | Single-Use Bottle | Rx | August 27, 2003 |
| 5G/50ML | Injection | Subcutaneous | Single-Use Bottle | Rx | August 27, 2003 |
| 5G/50ML | Injection | Intravenous | Bag | Rx | October 20, 2025 |
| 5G/50ML | Injection | Subcutaneous | Bag | Rx | October 20, 2025 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | September 12, 2015 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |