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Last Updated: March 30, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021621


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NDA 021621 describes CHILDREN'S ZYRTEC HIVES RELIEF, which is a drug marketed by J And J Consumer Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the CHILDREN'S ZYRTEC HIVES RELIEF profile page.

The generic ingredient in CHILDREN'S ZYRTEC HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and forty-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 021621
Tradename:CHILDREN'S ZYRTEC HIVES RELIEF
Applicant:J And J Consumer Inc
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021621
Paragraph IV (Patent) Challenges for 021621
Tradename Dosage Ingredient NDA Submissiondate
CHILDREN'S ZYRTEC ALLERGY TABLET, CHEWABLE;ORAL cetirizine hydrochloride 021621 2005-03-25
CHILDREN'S ZYRTEC HIVES RELIEF TABLET, CHEWABLE;ORAL cetirizine hydrochloride 021621 2005-03-25

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes

Expired US Patents for NDA 021621

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-003 Nov 16, 2007   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-004 Nov 16, 2007   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-006 Nov 16, 2007   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-005 Nov 16, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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