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Last Updated: July 2, 2020

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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 is included in four NDAs. There are two patents protecting this drug and three Paragraph IV challenges. 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. Thirty 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020346
Paragraph IV (Patent) Challenges for 020346
Tradename Dosage Ingredient NDA Submissiondate
ZYRTEC SYRUP;ORAL cetirizine hydrochloride 020346 2007-03-19

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 27, 1996TE:RLD:No

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