← FDA DRUG APPROVALS

FDA NDA · NDA022155

CHILDRENS ZYRTEC

cetirizine hydrochloride

Sponsor: KENVUE BRANDS

APPLICATION
NDA022155
TYPE
NDA
ORIGINAL APPROVAL
2007-11-16
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S ZYRTEC HIVES · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
CHILDREN'S ZYRTEC ALLERGY · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL

Approval history

2026-07-13Labeling · Supplement 31 · standard — Label ↗AP
2025-12-24Manufacturing (CMC) · Supplement 29 — Label ↗AP
2024-11-26Labeling · Supplement 27 · standard — Label ↗AP
2024-11-13Labeling · Supplement 25 · standard — Letter ↗AP
2018-10-11Labeling · Supplement 15 · standard — Label ↗AP
2016-04-14Manufacturing (CMC) · Supplement 10 · standard — Label ↗AP
2015-09-10Manufacturing (CMC) · Supplement 11 · standardAP
2014-05-16Labeling · Supplement 9 · standard — Letter ↗AP
2012-05-22Labeling · Supplement 7 · unknown — Letter ↗AP
2009-03-13Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2009-03-04Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2008-08-14Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2008-08-14Labeling · Supplement 2 · standard — Letter ↗AP
2007-11-16Type 8 - Partial Rx to OTC Switch · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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