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FDA ANDA · ANDA203003

MECLIZINE HYDROCHLORIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA203003
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-11
LATEST ACTION
2022-08-11
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

2022-08-11UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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