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AZELEX

NDA · New Drug Application · Sponsor: ALMIRALL · Approved 1995-09-13

Drug application

FDA Application #

NDA020428

Application type

New Drug Application

Brand name

AZELEX

Generic name

AZELAIC ACID

Active ingredients

AZELAIC ACID

Dosage form

CREAM

Route

TOPICAL

Marketing status

Prescription

Sponsor

ALMIRALL

Manufacturer

Almirall, LLC

First approval

1995-09-13

Source

Authoritative

Drugs@FDA application overview

Machine

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