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    FDA Approval for ZORYVE issued to ARCUTIS BIOTHERAPEUTICS INC

    12/15/23 5:01:31 PM ET
    $ARQT
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ARQT alert in real time by email
    New Drug Application (NDA): 217242
    Company: ARCUTIS BIOTHERAPEUTICS INC
    • Email

    Products on NDA 217242

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    ZORYVE ROFLUMILAST 0.3% FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL Prescription None No No

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 217242

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    12/15/2023 ORIG-1 Approval Type 3 - New Dosage Form and Type 4 - New Combination STANDARD

    Label is not available on this site.

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