APPLICATION
ANDA090229
TYPE
ANDA
ORIGINAL APPROVAL
2010-11-26
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 19 · standardAP
2021-03-18Labeling · Supplement 17 · standardAP
2021-03-18Labeling · Supplement 18 · standardAP
2017-04-07Manufacturing (CMC) · Supplement 16 · unknownAP
2015-06-29Manufacturing (CMC) · Supplement 13 · unknownAP
2015-06-29Labeling · Supplement 7AP
2015-06-29Labeling · Supplement 8 · standardAP
2011-06-30Labeling · Supplement 4AP
2011-06-27Manufacturing (CMC) · Supplement 3AP
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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