On this page
Gammagard, Gammagard S/D, Iveegam
Immune Globulin Intravenous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Gammagard, Gammagard S/D, Iveegam
Proper name
Immune Globulin Intravenous (Human)
Licence type
351(a)
BLA number
103133
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CBER
Presentations
8
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5G | For Injection | Intravenous | Single-Use Bottle | Disc | February 18, 1986 |
| 1000MG | For Injection | Intravenous | Single-Use Bottle | Disc | February 18, 1986 |
| 10G | For Injection | Intravenous | Single-Use Bottle | Rx | July 27, 2000 |
| 2.5G | For Injection | Intravenous | Single-Use Bottle | Disc | July 27, 2000 |
| 2500MG | For Injection | Intravenous | Single-Use Bottle | Disc | February 18, 1986 |
| 5.0G | For Injection | Intravenous | Single-Use Bottle | Rx | July 27, 2000 |
| 5000MG | For Injection | Intravenous | Single-Use Bottle | Disc | February 18, 1986 |
| 500MG | For Injection | Intravenous | Single-Use Bottle | Disc | February 18, 1986 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |