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Trasylol

aprotinin

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Trasylol

Proper name

aprotinin

Licence type

351(a)

BLA number

020304

Applicant

Bayer HealthCare Pharmaceuticals 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
1,000,000KIU/100ML (10,000KIU/ML)	Injection	Intravenous	Single-Dose Vial	Disc	December 29, 1993
2,000,000KIU/200ML (10,000KIU/ML)	Injection	Intravenous	Single-Dose Vial	Disc	December 29, 1993

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	December 29, 2000

Sources for this page

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