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Oxervate

cenegermin-bkbj

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Oxervate

Proper name

cenegermin-bkbj

Licence type

351(a)

BLA number

761094

Applicant

Domp farmaceutici S.p.A.

Center

CDER

Presentations

1

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
0.002% (20MCG/ML)	Solution	Topical	Multi-Dose Vial	Rx	August 22, 2018

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	August 22, 2025

Sources for this page

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