APPLICATION
NDA021621
TYPE
NDA
ORIGINAL APPROVAL
2004-03-16
LATEST ACTION
2026-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Over-the-counter, Discontinued
Products
CHILDREN'S ZYRTEC ALLERGY · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 2.5MG · TABLET, CHEWABLE · ORAL
CHILDREN'S ZYRTEC HIVES RELIEF · ReferenceDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
CHILDREN'S ZYRTEC ALLERGY · ReferenceDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
CHILDREN'S ZYRTEC HIVES RELIEF · ReferenceDiscontinued
CETIRIZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
CHILDREN'S ZYRTEC ALLERGY · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET, CHEWABLE · ORAL
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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