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FDA NDA · NDA021150

ZYRTEC-D

cetirizine hydrochloride and pseudoephedrine hydrochloride

Sponsor: KENVUE BRANDS

APPLICATION
NDA021150
TYPE
NDA
ORIGINAL APPROVAL
2001-08-10
LATEST ACTION
2026-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

ZYRTEC-D 12 HOUR · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-07-02Labeling · Supplement 25 · standard — Label ↗AP
2024-09-12Labeling · Supplement 22 · standard — Letter ↗AP
2021-11-03Labeling · Supplement 21 · standard — Letter ↗AP
2016-03-09Manufacturing (CMC) · Supplement 13 · standardAP
2015-08-03Manufacturing (CMC) · Supplement 12 · standardAP
2014-02-12Manufacturing (CMC) · Supplement 11 · standardAP
2013-10-23Manufacturing (CMC) · Supplement 10 · standardAP
2007-11-09Efficacy · Supplement 7 · unknown — Review ↗AP
2004-03-17Labeling · Supplement 5 · standard — Letter ↗AP
2003-04-14Efficacy · Supplement 2 · standard — Letter ↗AP
2002-02-14Manufacturing (CMC) · Supplement 1 · standardAP
2001-08-10Type 4 - New Combination · 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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