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Glassia

Alpha-1-Proteinase Inhibitor (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Glassia

Proper name

Alpha-1-Proteinase Inhibitor (Human)

Licence type

351(a)

BLA number

125325

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1G	Injection	Intravenous	Single-Dose Vial	Rx	July 1, 2010
4G	Injection	Intravenous	Single-Dose Vial	Rx	February 27, 2025
5G	Injection	Intravenous	Single-Dose Vial	Rx	February 27, 2025

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