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Hydase

hyaluronidase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Hydase

Proper name

hyaluronidase

Licence type

351(a)

BLA number

021716

Applicant

Akorn, Inc.

Center

CDER

Presentations

1

First licensure

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Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
150UNITS/ML	Injection	Subcutaneous	Single-Dose Vial	Disc	October 25, 2005

Sources for this page

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