FDA Bioequivalence Study Data – Alembic Midodrine HCl 5mg (NDC 62332-339-31) – Plasma Profiles

FDA Bioequivalence Study Data – Alembic Midodrine HCl 5mg (NDC 62332-339-31) – Plasma Profiles

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Original Request: For a research project, I would like to request the ANDA information containing the pivotal bioequivalence studies of a generic drug product: 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. I would be glad to receive the document by email. Thank you for your effort.
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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