On this page
Digifab
Digoxin Immune Fab (Ovine)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Digifab
Proper name
Digoxin Immune Fab (Ovine)
Licence type
351(a)
BLA number
103910
Applicant
Salvagenix Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 40MG | For Injection | Intravenous | Single-Dose Vial | Rx | August 31, 2001 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |