On this page

prolastin,prolastin-c,prolastin-c liquid

Alpha-1-Proteinase Inhibitor (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

prolastin,prolastin-c,prolastin-c liquid

Proper name

Alpha-1-Proteinase Inhibitor (Human)

Licence type

351(a)

BLA number

103174

Applicant

Grifols Therapeutics LLC

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1000MG	For Injection	Intravenous	Single-Dose Vial	Rx	December 2, 1987
1000MG/20ML	Injection	Intravenous	Single-Dose Vial	Rx	September 8, 2017
4000MG/80ML	Injection	Intravenous	Single-Dose Vial	Rx	March 5, 2020
500MG	For Injection	Intravenous	Single-Dose Vial	Disc	December 2, 1987
500MG/10ML	Injection	Intravenous	Single-Dose Vial	Rx	March 5, 2020

Source: Purple Book

Kind	Expires
Orphan exclusivity	December 2, 1994

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