← FDA DRUG APPROVALS

FDA NDA · NDA019835

ZYRTEC HIVES

cetirizine hydrochloride

Sponsor: KENVUE BRANDS

APPLICATION
NDA019835
TYPE
NDA
ORIGINAL APPROVAL
1995-12-08
LATEST ACTION
2026-06-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Over-the-counter

Products

ZYRTEC HIVES · ReferenceDiscontinued
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
ZYRTEC ALLERGY · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
ZYRTEC HIVES · ReferenceDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG · TABLET · ORAL
ZYRTEC ALLERGY · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2026-06-11Labeling · Supplement 55 · standard — Label ↗AP
2025-04-24Labeling · Supplement 53 · standard — Letter ↗AP
2025-03-25Labeling · Supplement 52 · standard — Letter ↗AP
2024-11-26Labeling · Supplement 50 · standard — Letter ↗AP
2024-03-28Manufacturing (CMC) · Supplement 47 — Label ↗AP
2023-12-01Labeling · Supplement 46 · standard — Letter ↗AP
2023-05-08Labeling · Supplement 45 · standard — Label ↗AP
2019-08-07Labeling · Supplement 40 · standard — Label ↗AP
2017-12-08Manufacturing (CMC) · Supplement 39AP
2016-04-04Manufacturing (CMC) · Supplement 36 · standardAP
2015-01-20Manufacturing (CMC) · Supplement 35 · standardAP
2014-09-26Manufacturing (CMC) · Supplement 34 · standardAP
2012-09-10Labeling · Supplement 32 · standard — Label ↗AP
2012-03-13Labeling · Supplement 30 · standard — Letter ↗AP
2012-01-26Labeling · Supplement 29 · standard — Letter ↗AP
2010-02-26Labeling · Supplement 26 · standardAP
2010-02-26Labeling · Supplement 28 · unknown — Letter ↗AP
2008-11-25Manufacturing (CMC) · Supplement 25 — Letter ↗AP
2007-11-16Efficacy · Supplement 22 · unknown — Review ↗AP
2006-04-04Manufacturing (CMC) · Supplement 20 · standard — Letter ↗AP
2004-03-17Labeling · Supplement 16 · standard — Review ↗AP
2002-10-21Efficacy · Supplement 15 · standard — Letter ↗AP
2000-09-19Manufacturing (CMC) · Supplement 13 · standardAP
2000-02-25Labeling · Supplement 10 · standardAP
2000-02-04Manufacturing (CMC) · Supplement 9 · standardAP
2000-02-01Manufacturing (CMC) · Supplement 11 · standardAP
1999-07-09Manufacturing (CMC) · Supplement 8 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 7 · standardAP
1998-05-22Manufacturing (CMC) · Supplement 6 · standardAP
1998-05-15Efficacy · Supplement 5 · unknown — Review ↗AP
1996-11-14Manufacturing (CMC) · Supplement 3 · standardAP
1996-11-01Labeling · Supplement 4 · standardAP
1996-09-23Labeling · Supplement 2 · standardAP
1996-05-23Manufacturing (CMC) · Supplement 1 · standardAP
1995-12-08Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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