APPLICATION
ANDA210914
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-01
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVOCETIRIZINE HYDROCHLORIDEPrescription
LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML · SOLUTION · ORAL
Approval history
2025-07-11Labeling · Supplement 4 · standardAP
2019-09-23Labeling · Supplement 1 · standardAP
2019-04-01UNKNOWN · Original · standardAP
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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