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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021374

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NDA 021374 describes ADVIL COLD AND SINUS, which is a drug marketed by Haleon Us Holdings and is included in two NDAs. It is available from one supplier. Additional details are available on the ADVIL COLD AND SINUS profile page.

The generic ingredient in ADVIL COLD AND SINUS is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

Summary for 021374

Tradename:	ADVIL COLD AND SINUS
Applicant:	Haleon Us Holdings
Ingredient:	ibuprofen; pseudoephedrine hydrochloride
Patents:	0

Pharmacology for NDA: 021374

Mechanism of Action	Adrenergic alpha-Agonists Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 021374

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374	NDA	Haleon US Holdings LLC	0573-0184	0573-0184-16	16 BLISTER PACK in 1 CARTON (0573-0184-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374	NDA	Haleon US Holdings LLC	0573-0184	0573-0184-32	32 BLISTER PACK in 1 CARTON (0573-0184-32) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
Approval Date:	May 30, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021374

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002	5,071,643*PED	⤷ Get Started Free
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002	5,360,615*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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