APPLICATION
ANDA201451
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-23
LATEST ACTION
2023-09-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MECLIZINE HYDROCHLORIDEPrescription
MECLIZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL
MECLIZINE HYDROCHLORIDEPrescription
MECLIZINE HYDROCHLORIDE 25MG · TABLET · ORAL
MECLIZINE HYDROCHLORIDEPrescription
MECLIZINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2023-09-22Labeling · Supplement 7 · standardAP
2023-09-22Labeling · Supplement 8 · standardAP
2023-09-22Labeling · Supplement 6 · standardAP
2013-08-15Labeling · Supplement 2 · standardAP
2011-02-23Not Applicable · 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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