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FDA ANDA · ANDA204599

LEVOCETIRIZINE DIHYDROCHLORIDE

Sponsor: CHARTWELL MOLECULAR

APPLICATION
ANDA204599
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-15
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 5 · standardAP
2025-06-10Labeling · Supplement 3 · standardAP
2025-06-10Labeling · Supplement 1 · standardAP
2025-06-10Labeling · Supplement 4 · standardAP
2025-06-10Labeling · Supplement 2 · standardAP
2017-05-15UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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