On this page
BabyBig
Botulism Immune Globulin Intravenous (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
BabyBig
Proper name
Botulism Immune Globulin Intravenous (Human)
Licence type
351(a)
BLA number
125034
Applicant
California Department of Public Health (CDPH)
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | October 23, 2003 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 23, 2010 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |