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Activase

alteplase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Activase

Proper name

alteplase

Licence type

351(a)

BLA number

103172

Applicant

Genentech, Inc.

Center

CDER

Presentations

2

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
100MG	For Injection	Intravenous	Single-Dose Vial	Rx	November 13, 1987
50MG	For Injection	Intravenous	Single-Dose Vial	Rx	November 13, 1987

Sources for this page

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