← FDA DRUG APPROVALS

FDA NDA · NDA022064

XYZAL

levocetirizine dihydrochloride

Sponsor: CHATTEM SANOFI

APPLICATION
NDA022064
TYPE
NDA
ORIGINAL APPROVAL
2007-05-25
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

XYZAL · ReferenceDiscontinued
LEVOCETIRIZINE DIHYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-07-11Labeling · Supplement 40 · 901 required — Letter ↗AP
2019-04-02Labeling · Supplement 38 · standard — Label ↗AP
2019-01-11Labeling · Supplement 37 · standard — Label ↗AP
2018-04-02Labeling · Supplement 36 · standard — Label ↗AP
2017-10-16Labeling · Supplement 34 · standard — Label ↗AP
2017-07-10Labeling · Supplement 33 · standard — Label ↗AP
2017-02-09Labeling · Supplement 31 · standard — Label ↗AP
2016-11-08Labeling · Supplement 32 · standard — Label ↗AP
2016-06-23Labeling · Supplement 30 · standard — Letter ↗AP
2014-02-14Manufacturing (CMC) · Supplement 27 · priorityAP
2013-11-07Labeling · Supplement 28 · standard — Label ↗AP
2012-11-20Manufacturing (CMC) · Supplement 26 · priorityAP
2012-09-06Labeling · Supplement 24 · standard — Label ↗AP
2011-03-07Labeling · Supplement 20 · standard — Letter ↗AP
2009-08-21Efficacy · Supplement 17 · priority — Label ↗AP
2008-03-31Labeling · Supplement 9 · standard — Label ↗AP
2008-02-01Labeling · Supplement 5 · standard — Letter ↗AP
2007-10-18Manufacturing (CMC) · Supplement 2AP
2007-05-25Type 5 - New Formulation or New Manufacturer · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →