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NUEDEXTA

NDA · New Drug Application · Sponsor: AVANIR PHARMS · Approved 2010-10-29

Drug application

FDA Application #

NDA021879

Application type

New Drug Application

Brand name

NUEDEXTA

Generic name

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Active ingredients

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

AVANIR PHARMS

Manufacturer

Otsuka America Pharmaceutical, Inc

First approval

2010-10-29

Source

Authoritative

Drugs@FDA application overview

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