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FDA NDA · NDA209089

XYZAL ALLERGY 24HR

levocetirizine dihydrochloride

Sponsor: CHATTEM SANOFI

APPLICATION
NDA209089
TYPE
NDA
ORIGINAL APPROVAL
2017-01-31
LATEST ACTION
2026-05-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

XYZAL ALLERGY 24HR · ReferenceOver-the-counter
LEVOCETIRIZINE DIHYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2026-05-20Labeling · Supplement 10 · standard — Letter ↗AP
2024-07-11Labeling · Supplement 7 · standard — Label ↗AP
2017-01-31Type 8 - Partial Rx to OTC Switch · Original · standard — Label ↗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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