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FDA ANDA · ANDA214089

MEXILETINE HYDROCHLORIDE

Sponsor: SENORES PHARMS

APPLICATION
ANDA214089
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-01
LATEST ACTION
2021-10-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2021-10-01UNKNOWN · Original · standardAP
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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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