APPLICATION
ANDA090362
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-31
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 14 · standardAP
2025-06-12Labeling · Supplement 13 · standardAP
2019-02-02Labeling · Supplement 7 · standardAP
2019-02-02Labeling · Supplement 8 · standardAP
2017-09-29Labeling · Supplement 5 · standardAP
2017-09-29Labeling · Supplement 6 · standardAP
2017-09-29Labeling · Supplement 4 · standardAP
2015-07-02Labeling · Supplement 3 · standardAP
2013-01-31OriginalAP
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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