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    FDA ANDA 077454 Original Application and Amendments for Hydrocodone/Ibuprofen by ANI

    FDA ANDA 077454 Original Application and Amendments for Hydrocodone/Ibuprofen by ANI

    $69.00 USD
    $69.00 USD
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    Original Request: ANI Pharmaceuticals, Inc. is the owner of ANDA 077454 Hydrocodone Bitartrate and Ibuprofen Tablets, 5 mg/200 mg and is requesting the following documents: Original ANDA and bioequivalence studies including the Clinical Summary Study Reports and any clinical study data and tables submitted by the sponsor. All ANDA Amendments including CMC, labeling and bioequivalence amendments submitted by the sponsor. All FDA correspondence/letters sent to the sponsor during the review of the original ANDA.
    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. Learn more about Fast-Track Requests here.

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