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FDA ANDA · ANDA219987

MEXILETINE HYDROCHLORIDE

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA219987
TYPE
ANDA
ORIGINAL APPROVAL
2026-03-23
LATEST ACTION
2026-03-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MEXILETINE HYDROCHLORIDEPrescription
MEXILETINE HYDROCHLORIDE 200MG · CAPSULE · ORAL
MEXILETINE HYDROCHLORIDEPrescription
MEXILETINE HYDROCHLORIDE 250MG · CAPSULE · ORAL
MEXILETINE HYDROCHLORIDEPrescription
MEXILETINE HYDROCHLORIDE 150MG · CAPSULE · ORAL

Approval history

2026-03-23UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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