Product Details for: Digifab
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
40MG
Single-Dose Vial
351(a)
Digifab
Rx
Proper Name
Digoxin Immune Fab (Ovine)
Digoxin Immune Fab (Ovine)
BLA Number
103910
103910
Applicant
Salvagenix Inc.
Salvagenix Inc.
Original Approval Date
August 31, 2001
August 31, 2001
Date of First Licensure