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ADVIL PM

NDA · New Drug Application · Sponsor: HALEON US HOLDINGS · Approved 2005-12-21

Drug application

FDA Application #

NDA021393

Application type

New Drug Application

Brand name

ADVIL PM

Generic name

DIPHENHYDRAMINE HCL, IBUPROFEN

Active ingredients

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Dosage form

CAPSULE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

HALEON US HOLDINGS

Manufacturer

Haleon US Holdings LLC

First approval

2005-12-21

Source

Authoritative

Drugs@FDA application overview

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