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Jetrea

ocriplasmin

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Jetrea

Proper name

ocriplasmin

Licence type

351(a)

BLA number

125422

Applicant

ThromboGenics 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
0.375MG/0.3ML (1.25MG/ML)	Injection	Intravitreal	Single-Dose Vial	Disc	February 22, 2017
0.5MG/0.2ML (2.5MG/ML)	Injection	Intravitreal	Single-Dose Vial	Disc	October 17, 2012

Sources for this page

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