Details for New Drug Application (NDA): 022565

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NDA 022565 describes ADVIL CONGESTION RELIEF, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from two suppliers. Additional details are available on the ADVIL CONGESTION RELIEF profile page.

The generic ingredient in ADVIL CONGESTION RELIEF is ibuprofen; phenylephrine hydrochloride. There are sixty-four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ibuprofen; phenylephrine hydrochloride profile page.

Summary for 022565

Tradename:	ADVIL CONGESTION RELIEF
Applicant:	Haleon Us Holdings
Ingredient:	ibuprofen; phenylephrine hydrochloride
Patents:	0

Pharmacology for NDA: 022565

Mechanism of Action	Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 022565

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADVIL CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565	NDA	Haleon US Holdings LLC	0573-0199	0573-0199-01	50 POUCH in 1 TRAY (0573-0199-01) / 1 TABLET, COATED in 1 POUCH
ADVIL CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565	NDA	Haleon US Holdings LLC	0573-0199	0573-0199-03	3000 POUCH in 1 CARTON (0573-0199-03) / 1 TABLET, COATED in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	200MG;10MG
Approval Date:	May 27, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 022565

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565-001	May 27, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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