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Last Updated: March 3, 2024

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 two suppliers. 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 fifty-three 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
Pharmacology for NDA: 021621
Medical Subject Heading (MeSH) Categories for 021621
Suppliers and Packaging for NDA: 021621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621 NDA A-S Medication Solutions 50090-6781 50090-6781-0 4 BLISTER PACK in 1 CARTON (50090-6781-0) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621 NDA A-S Medication Solutions 50090-6845 50090-6845-0 4 BLISTER PACK in 1 CARTON (50090-6845-0) / 6 TABLET, CHEWABLE in 1 BLISTER PACK

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CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-006 Nov 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-004 Nov 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.