APPLICATION
ANDA076601
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-20
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 15 · standardAP
2020-03-03Labeling · Supplement 8 · standardAP
2016-11-08Labeling · Supplement 4 · standardAP
2008-06-20OriginalAP
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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