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ADVIL COLD AND SINUS

NDA · New Drug Application · Sponsor: HALEON US HOLDINGS · Approved 2002-05-30

Drug application

FDA Application #

NDA021374

Application type

New Drug Application

Brand name

ADVIL COLD AND SINUS

Generic name

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Active ingredients

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

HALEON US HOLDINGS

Manufacturer

Haleon US Holdings LLC

First approval

2002-05-30

Source

Authoritative

Drugs@FDA application overview

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