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    Tentative Approval Letter Request – ANDA 217989 (Mirabegron ER Tablets, QILU for Lupin Pharmaceuticals)

    Tentative Approval Letter Request – ANDA 217989 (Mirabegron ER Tablets, QILU for Lupin Pharmaceuticals)

    $69.00 USD
    $69.00 USD
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    Request Contents: Tentative Approval Letter request: ANDA #217989, Mirabegron ER Tablets (Generic of Myrbetriq), QILU Pharmaceuticals Co., Ltd., on behalf of Lupin Pharmaceuticals, Inc.
    • 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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