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DYANAVEL XR 20

NDA · New Drug Application · Sponsor: TRIS PHARMA INC · Approved 2021-11-04

Drug application

FDA Application #

NDA210526

Application type

New Drug Application

Brand name

DYANAVEL XR 20

Generic name

AMPHETAMINE

Active ingredients

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

TRIS PHARMA INC

Manufacturer

NextWave Pharmaceuticals, Inc

First approval

2021-11-04

Source

Authoritative

Drugs@FDA application overview

Machine

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