Details for New Drug Application (NDA): 021441

NDA 021441 describes ADVIL ALLERGY SINUS, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ADVIL ALLERGY SINUS profile page.

The generic ingredient in ADVIL ALLERGY SINUS is chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride profile page.

Summary for 021441

Tradename:	ADVIL ALLERGY SINUS
Applicant:	Haleon Us Holdings
Ingredient:	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021441

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021441

Mechanism of Action

Adrenergic alpha-Agonists Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 021441

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADVIL ALLERGY SINUS	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	021441	NDA	Haleon US Holdings LLC	0573-0188	0573-0188-10	20 BLISTER PACK in 1 CARTON (0573-0188-10) / 1 TABLET, COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	2MG;200MG;30MG
Approval Date:	Dec 19, 2002	TE:		RLD:	Yes
Patent:		Patent Expiration:	Feb 28, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

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