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Adagen

pegademase bovine

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Adagen

Proper name

pegademase bovine

Licence type

351(a)

BLA number

019818

Applicant

Leadiant Biosciences, Inc

Center

CDER

Presentations

1

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
375UNITS/1.5ML (250UNITS/ML)	Injection	Intramuscular	Single-Dose Vial	Disc	March 21, 1990

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 21, 1997

Sources for this page

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