General MedicationsORALStandard

MEXILETINE HYDROCHLORIDE

Standard Dose

250MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview MEXILETINE HYDROCHLORIDE is listed in Drugs@FDA under application 219987 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MEXILETINE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 250MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2026-03-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview MEXILETINE HYDROCHLORIDE is listed in Drugs@FDA under application 219987 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MEXILETINE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 250MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2026-03-23 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.