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    FDA CMC Review Summary for Nitrofurantoin Capsules ANDA 217073 – Omsav Pharma

    FDA CMC Review Summary for Nitrofurantoin Capsules ANDA 217073 – Omsav Pharma

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Original Request: Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg - Basis of Approval - CMC review summary for ANDA 217073 - Omsav Pharma Research Private Ltd.
    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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