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FDA ANDA · ANDA213500

MEXILETINE HYDROCHLORIDE

Sponsor: CROSSMEDIKA SA

APPLICATION
ANDA213500
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-22
LATEST ACTION
2020-07-22
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

2020-07-22UNKNOWN · Original · standard — Letter ↗AP
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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