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APADAZ

NDA · New Drug Application · Sponsor: ZEVRA THERAP · Approved 2018-02-23

Drug application

FDA Application #

NDA208653

Application type

New Drug Application

Brand name

APADAZ

Generic name

BENZHYDROCODONE AND ACETAMINOPHEN

Active ingredients

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Discontinued

Sponsor

ZEVRA THERAP

Manufacturer

Zevra Therapeutics, Inc.

First approval

2018-02-23

Source

Authoritative

Drugs@FDA application overview

Machine

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