On this page

avance nerve graft

acellular nerve allograft-arwx

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

avance nerve graft

Proper name

acellular nerve allograft-arwx

Licence type

351(a)

BLA number

125816

Applicant

Axogen Corporation

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
1 LENGTHS: 15 MM, 30 MM, 50 MM, AND 70 MM DIAMETERS: 1 TO 2 MM, 2 TO 3 MM, 3	Implant	Implantation	Pouch	Rx	December 3, 2025

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