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    FDA ANDA 213191 Approval Package for Mesalamine 800 mg DR Tablets – Approved 08/22/2024

    FDA ANDA 213191 Approval Package for Mesalamine 800 mg DR Tablets – Approved 08/22/2024

    $69.00 USD
    $69.00 USD
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    Original Request: The drug approval package for ANDA 213191 Mesalamine 800 mg Delayed Release Tablets, held by Teva Pharmaceuticals USA, approved 22 August 2024, including but not limited to: Product Quality Review(s) Multi-discipline Review(s) Other Review(s) Administrative and Correspondence Documents
    Tags: Pharma, ANDA, 2024
    • 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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