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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
Tags: Pharma, ANDA, 2025
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- 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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