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Baygam, Gamastan S/D
Immune Globulin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Baygam, Gamastan S/D
Proper name
Immune Globulin (Human)
Licence type
351(a)
BLA number
101134
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.165 | Injection | Intramuscular | Single-Dose Vial | Rx | January 11, 1944 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |