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FDA NDA · NDA022578

ZYRTEC ALLERGY

cetirizine hydrochloride

Sponsor: KENVUE BRANDS

APPLICATION
NDA022578
TYPE
NDA
ORIGINAL APPROVAL
2010-09-03
LATEST ACTION
2026-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Over-the-counter

Products

ZYRTEC ALLERGY · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2026-07-02Labeling · Supplement 15 · standard — Letter ↗AP
2024-11-15Labeling · Supplement 14 · standard — Label ↗AP
2016-08-23Labeling · Supplement 7 · standard — Label ↗AP
2016-08-01Manufacturing (CMC) · Supplement 6 · standardAP
2014-02-24Manufacturing (CMC) · Supplement 3 · standardAP
2014-02-21Manufacturing (CMC) · Supplement 4 · standardAP
2011-12-01Labeling · Supplement 1 · unknown — Letter ↗AP
2010-09-03Type 3 - New Dosage Form · Original · standard — Summary 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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