APPLICATION
ANDA091263
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-07
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVOCETIRIZINE DIHYDROCHLORIDEPrescription
LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML · SOLUTION · ORAL
Approval history
2025-07-11Labeling · Supplement 14 · standardAP
2020-07-10Labeling · Supplement 8 · standardAP
2020-07-10Labeling · Supplement 6 · standardAP
2020-07-10Labeling · Supplement 10 · standardAP
2020-07-10Labeling · Supplement 9 · standardAP
2020-07-10Labeling · Supplement 7 · standardAP
2020-07-10Labeling · Supplement 11 · standardAP
2015-04-15Labeling · Supplement 4 · standardAP
2014-10-27Manufacturing (CMC) · Supplement 2AP
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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