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    FDA Drug Approval, A074450, MEXILETINE HYDROCHLORIDE

    FDA Drug Approval, A074450, MEXILETINE HYDROCHLORIDE

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    Contents: Summary Basis of Approval

    ANDA: 074450
    Company: ANI PHARMS
    Drug Name: MEXILETINE HYDROCHLORIDE
    Active Ingredients: MEXILETINE HYDROCHLORIDE
    Strength: 250MG
    Dosage Form/Route: CAPSULE;ORAL
    Action Date: 05/16/1996
    Marketing Status: Prescription
    Submission Classification: ORIG-1 TE Code: AB
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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