APPLICATION
ANDA091264
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-29
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVOCETIRIZINE DIHYDROCHLORIDEPrescription
LEVOCETIRIZINE DIHYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2025-07-11Labeling · Supplement 13 · standardAP
2019-06-28Labeling · Supplement 8 · standardAP
2019-06-28Labeling · Supplement 10 · standardAP
2017-09-18Labeling · Supplement 5 · standardAP
2015-11-24Labeling · Supplement 3 · standardAP
2013-01-30Labeling · Supplement 2 · standardAP
2012-11-29Labeling · Supplement 1 · standardAP
2012-06-29OriginalAP
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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