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AMELUZ

NDA · New Drug Application · Sponsor: BIOFRONTERA · Approved 2016-05-10

Drug application

FDA Application #

NDA208081

Application type

New Drug Application

Brand name

AMELUZ

Generic name

AMINOLEVULINIC ACID HYDROCHLORIDE

Active ingredients

AMINOLEVULINIC ACID HYDROCHLORIDE

Dosage form

GEL

Route

TOPICAL

Marketing status

Prescription

Sponsor

BIOFRONTERA

Manufacturer

Biofrontera Inc.

First approval

2016-05-10

Source

Authoritative

Drugs@FDA application overview

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