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    Communications – FDA & ANI Pharmaceuticals (ANDA 208607, Methylphenidate ER Tablets, Feb–Apr 2019)

    Communications – FDA & ANI Pharmaceuticals (ANDA 208607, Methylphenidate ER Tablets, Feb–Apr 2019)

    $89.00 USD
    $89.00 USD
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    Request Contents: Copies of all written communications between FDA and ANI Pharmaceuticals, Inc. from February 2, 2019, to April 24, 2019, related to ANDA Application No. 208607 and/or ANI’s generic version of Methylphenidate Hydrochloride Extended-Release (ER) tablets (18 mg, 27 mg, 36 mg, 54 mg).
    • 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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