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Digibind

Digoxin Immune Fab (Ovine)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Digibind

Proper name

Digoxin Immune Fab (Ovine)

Licence type

351(a)

BLA number

103141

Applicant

Wellcome Foundation Limited Wellcome Research Laboratories

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
38MG	For Injection	Intravenous	Single-Dose Vial	Disc	April 22, 1986

Source: Purple Book

Kind	Expires
Orphan exclusivity	April 22, 1993

Purple Book	FDA	Licence type, presentations, reference product, exclusivity