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ADVIL CONGESTION RELIEF

NDA · New Drug Application · Sponsor: HALEON US HOLDINGS · Approved 2010-05-27

Drug application

FDA Application #

NDA022565

Application type

New Drug Application

Brand name

ADVIL CONGESTION RELIEF

Generic name

IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE

Active ingredients

IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

HALEON US HOLDINGS

Manufacturer

Haleon US Holdings LLC

First approval

2010-05-27

Source

Authoritative

Drugs@FDA application overview

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