APPLICATION
ANDA090392
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-24
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 6 · standardAP
2021-04-05Labeling · Supplement 4 · standardAP
2021-04-05Labeling · Supplement 5 · standardAP
2012-11-29Labeling · Supplement 2 · standardAP
2011-06-21Labeling · Supplement 1AP
2011-02-24OriginalAP
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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