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    FDA Approval for REZDIFFRA issued to MADRIGAL PHARMACEUTICALS INC

    3/14/24 3:35:50 PM ET
    $MDGL
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $MDGL alert in real time by email
    New Drug Application (NDA): 217785
    Company: MADRIGAL PHARMACEUTICALS INC
    • Email

    Products on NDA 217785

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    REZDIFFRA RESMETIROM 60MG TABLET;ORAL Prescription None No No
    REZDIFFRA RESMETIROM 80MG TABLET;ORAL Prescription None No No
    REZDIFFRA RESMETIROM 100MG TABLET;ORAL Prescription None No No

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 217785

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    03/14/2024 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217785s000lbl.pdf

    Labels for NDA 217785

    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
    Patient Package Insert
    Note Url
    03/14/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217785s000lbl.pdf
    Get the next $MDGL alert in real time by email

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