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ZORYVE

NDA · New Drug Application · Sponsor: ARCUTIS · Approved 2022-07-29

Drug application

FDA Application #

NDA215985

Application type

New Drug Application

Brand name

ZORYVE

Generic name

ROFLUMILAST

Active ingredients

ROFLUMILAST

Dosage form

CREAM

Route

TOPICAL

Marketing status

Prescription

Sponsor

ARCUTIS

Manufacturer

Arcutis Biotherapeutics, Inc.

First approval

2022-07-29

Source

Authoritative

Drugs@FDA application overview

Machine

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