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    FDA Approval for UKONIQ

    2/5/21 1:35:26 PM ET
    $TGTX
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $TGTX alert in real time by email
    New Drug Application (NDA): 213176
    Company: TG THERAPEUTICS INC
    • Email

    Products on NDA 213176

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    UKONIQ UMBRALISIB 200MG TABLET;ORAL Prescription None TBD No

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 213176

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    02/05/2021 ORIG-2 Approval Type 1 - New Molecular Entity PRIORITY

    Label is not available on this site.

    02/05/2021 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

    Label is not available on this site.

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