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FDA ANDA · ANDA202640

MECLIZINE HYDROCHLORIDE

meclizine

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA202640
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-17
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 50MG · TABLET · ORAL
MECLIZINE HYDROCHLORIDEPrescription
MECLIZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL

Approval history

2019-12-23Labeling · Supplement 2 · standardAP
2019-12-23Labeling · Supplement 3 · standardAP
2012-09-17UNKNOWN · OriginalAP
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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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