APPLICATION
ANDA090766
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-07
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
CETIRIZINE HYDROCHLORIDEPrescription
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2025-07-11Labeling · Supplement 5 · standardAP
2020-03-12Labeling · Supplement 3 · standardAP
2016-11-08Labeling · Supplement 2 · standardAP
2009-10-07OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.