APPLICATION
ANDA078757
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-28
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CETIRIZINE HYDROCHLORIDEDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2025-07-11Labeling · Supplement 2 · standardAP
2016-11-08Labeling · Supplement 1 · standardAP
2009-08-28OriginalAP
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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