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Increlex

mecasermin

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Increlex

Proper name

mecasermin

Licence type

351(a)

BLA number

021839

Applicant

Eton Pharmaceuticals, Inc.

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
40MG/4ML (10MG/ML)	Injection	Subcutaneous	Multi-Dose Vial	Rx	August 30, 2005

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	August 30, 2012

Sources for this page

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