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    ANDA Approval Package – ANDA 075734 (Summary, Clinical Pharmacology, Chemistry, Label)

    ANDA Approval Package – ANDA 075734 (Summary, Clinical Pharmacology, Chemistry, Label)

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Request Contents: Drug Product approval package for ANDA 075734, including Summary Review, Clinical Pharmacology Review, Chemistry, and Summary Basis for Approval, along with initial and last approval product label by the FDA.
    • 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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