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AZSTARYS

NDA · New Drug Application · Sponsor: COMMAVE THERAP · Approved 2021-03-02

Drug application

FDA Application #

NDA212994

Application type

New Drug Application

Brand name

AZSTARYS

Generic name

SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE

Active ingredients

DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

COMMAVE THERAP

Manufacturer

Commave Sub, LLC

First approval

2021-03-02

Source

Authoritative

Drugs@FDA application overview

Machine

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