Details for New Drug Application (NDA): 021150

NDA 021150 describes ZYRTEC-D 12 HOUR, which is a drug marketed by Kenvue Brands and is included in one NDA. It is available from one supplier. Additional details are available on the ZYRTEC-D 12 HOUR profile page.

The generic ingredient in ZYRTEC-D 12 HOUR is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for 021150

Tradename:	ZYRTEC-D 12 HOUR
Applicant:	Kenvue Brands
Ingredient:	cetirizine hydrochloride; pseudoephedrine hydrochloride
Patents:	0

Pharmacology for NDA: 021150

Mechanism of Action

Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 021150

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150	NDA	Kenvue Brands LLC	50580-719	50580-719-12	2 BLISTER PACK in 1 CARTON (50580-719-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150	NDA	Kenvue Brands LLC	50580-719	50580-719-24	4 BLISTER PACK in 1 CARTON (50580-719-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG;120MG
Approval Date:	Nov 9, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 021150

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007

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