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FDA NDA · NDA022429

CETIRIZINE HCL

Sponsor: BIONPHARMA

APPLICATION
NDA022429
TYPE
NDA
ORIGINAL APPROVAL
2009-07-23
LATEST ACTION
2026-01-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

CETIRIZINE HYDROCHLORIDE ALLERGY · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · CAPSULE · ORAL
CETIRIZINE HYDROCHLORIDE HIVES RELIEF · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · CAPSULE · ORAL
CETIRIZINE HYDROCHLORIDE HIVES RELIEF · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG · CAPSULE · ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY · ReferenceOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG · CAPSULE · ORAL

Approval history

2026-01-30Labeling · Supplement 26 · standard — Letter ↗AP
2020-12-07Labeling · Supplement 17 · standard — Letter ↗AP
2019-12-13Manufacturing (CMC) · Supplement 14 — Label ↗AP
2013-02-06Labeling · Supplement 9 · standard — Label ↗AP
2010-04-06Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
2009-07-23Type 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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