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Kinlytic

urokinase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Kinlytic

Proper name

urokinase

Licence type

351(a)

BLA number

021846

Applicant

Microbix Biosystems Inc.

Center

CDER

Presentations

3

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
250,000IU	For Injection	Intravenous	Single-Dose Vial	Disc	January 16, 1978
5,000IU	For Injection	Intravenous	Single-Dose Vial	Disc	January 16, 1978
9,000IU	For Injection	Intravenous	Single-Dose Vial	Disc	January 16, 1978

Sources for this page

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