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ADZENYS XR-ODT

NDA · New Drug Application · Sponsor: NEOS THERAPS · Approved 2016-01-27

Drug application

FDA Application #

NDA204326

Application type

New Drug Application

Brand name

ADZENYS XR-ODT

Generic name

AMPHETAMINE EXTENDED-RELEASE

Active ingredients

AMPHETAMINE

Dosage form

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

NEOS THERAPS

Manufacturer

Neos Therapeutics, LP

First approval

2016-01-27

Source

Authoritative

Drugs@FDA application overview

Machine

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