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Yimmugo
immune globulin intravenous, human-dira
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Yimmugo
Proper name
immune globulin intravenous, human-dira
Licence type
351(a)
BLA number
125810
Applicant
Biotest AG
Center
CBER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10G/100ML | For Injection | Intravenous | Single-Dose Vial | Rx | June 13, 2024 |
| 20G/200ML | For Injection | Intravenous | Single-Dose Vial | Rx | June 13, 2024 |
| 5G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | June 13, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |