← FDA Drug Approvals (Drugs@FDA)

EDARAVONE

NDA · New Drug Application · Sponsor: AZURITY PHARMACEUTICALS INC · Approved 2026-07-17

Drug application

FDA Application #

NDA221059

Application type

New Drug Application

Brand name

EDARAVONE

Generic name

Edaravone

Active ingredients

EDARAVONE

Dosage form

SOLUTION

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

AZURITY PHARMACEUTICALS INC

First approval

2026-07-17

Source

Authoritative

Drugs@FDA application overview

Machine

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