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FDA NDA · NDA022157

XYZAL

Sponsor: CHATTEM SANOFI

APPLICATION
NDA022157
TYPE
NDA
ORIGINAL APPROVAL
2008-01-28
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

XYZAL · ReferenceDiscontinued
LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2025-07-11Labeling · Supplement 22 · 901 required — Letter ↗AP
2019-04-02Labeling · Supplement 20 · standard — Label ↗AP
2019-01-11Labeling · Supplement 19 · standard — Label ↗AP
2018-04-02Labeling · Supplement 18 · standard — Label ↗AP
2017-10-16Labeling · Supplement 17 · standard — Label ↗AP
2017-07-10Labeling · Supplement 16 · standard — Label ↗AP
2017-02-09Labeling · Supplement 14 · standard — Label ↗AP
2016-11-08Labeling · Supplement 15 · standard — Label ↗AP
2016-06-23Labeling · Supplement 13 · standard — Label ↗AP
2015-01-05Manufacturing (CMC) · Supplement 10 · standardAP
2014-02-14Manufacturing (CMC) · Supplement 11 · standardAP
2013-11-07Labeling · Supplement 12 · standard — Letter ↗AP
2012-09-06Labeling · Supplement 8 · standard — Label ↗AP
2011-03-07Labeling · Supplement 7 · standard — Letter ↗AP
2009-08-21Efficacy · Supplement 3 · priority — Letter ↗AP
2008-06-25Labeling · Supplement 1 · standard — Letter ↗AP
2008-01-28Type 3 - New Dosage Form · 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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