Details for New Drug Application (NDA): 020346

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NDA 020346 describes ZYRTEC, which is a drug marketed by J And J Consumer Inc and Kenvue Brands and is included in four NDAs. Additional details are available on the ZYRTEC profile page.

The generic ingredient in ZYRTEC 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 020346

Tradename:	ZYRTEC
Applicant:	J And J Consumer Inc
Ingredient:	cetirizine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 020346

Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 27, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020346

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	ZYRTEC	cetirizine hydrochloride	SOLUTION;ORAL	020346-001	Sep 27, 1996	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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