APPLICATION
ANDA202673
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-26
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LEVOCETIRIZINE DIHYDROCHLORIDEDiscontinued
LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML · SOLUTION · ORAL
Approval history
2025-07-11Labeling · Supplement 11 · standardAP
2020-01-13Labeling · Supplement 7 · standardAP
2020-01-13Labeling · Supplement 5 · standardAP
2020-01-13Labeling · Supplement 3 · standardAP
2020-01-13Labeling · Supplement 6 · standardAP
2020-01-13Labeling · Supplement 4 · standardAP
2015-11-13Labeling · Supplement 1 · standardAP
2013-07-26UNKNOWN · OriginalAP
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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