APPLICATION
ANDA200294
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-13
LATEST ACTION
2019-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MECLIZINE HYDROCHLORIDEPrescription
MECLIZINE HYDROCHLORIDE 25MG · TABLET · ORAL
MECLIZINE HYDROCHLORIDEPrescription
MECLIZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL
Approval history
2019-12-23Labeling · Supplement 6 · standardAP
2019-12-23Labeling · Supplement 5 · standardAP
2019-12-23Labeling · Supplement 3 · standardAP
2012-12-28Labeling · Supplement 1 · 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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