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    FDA BE Study Data for Zydus and Alembic Midodrine Hydrochloride Tablets 5 mg

    FDA BE Study Data for Zydus and Alembic Midodrine Hydrochloride Tablets 5 mg

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Original Request: For a research project aiming towards improving drug product testing methods, I would like to request the ANDA information containing the pivotal bioequivalence studies of two generic drug products: Zydus Midodrine hydrochloride tablets 5 mg (NDC 68382-738-01) and Alembic Midodrine hydrochloride tablets 5 mg (NDC 62332-339-31). Most important are the plasma concentration profiles of the bioequivalence studies in both fasted and fed state, if available.
    Tags: Pharma, ANDA, 2025
    • 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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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