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Last Updated: November 21, 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-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 021621
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CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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CHEWABLE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-006 Nov 16, 2007 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-005 Nov 16, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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