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    FDA Approval for LIBERVANT issued to AQUESTIVE THERAPEUTICS INC

    4/29/24 7:48:13 AM ET
    $AQST
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $AQST alert in real time by email
    New Drug Application (NDA): 218623
    Company: AQUESTIVE THERAPEUTICS INC
    • Email
    • Medication Guide

    Products on NDA 218623

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    LIBERVANT DIAZEPAM 5MG FILM;BUCCAL Prescription None No No
    LIBERVANT DIAZEPAM 7.5MG FILM;BUCCAL Prescription None No No
    LIBERVANT DIAZEPAM 10MG FILM;BUCCAL Prescription None No No
    LIBERVANT DIAZEPAM 12.5MG FILM;BUCCAL Prescription None No No
    LIBERVANT DIAZEPAM 15MG FILM;BUCCAL Prescription None No No

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 218623

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    04/26/2024 ORIG-1 Approval STANDARD Label (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218623s000lbl.pdf

    Labels for NDA 218623

    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
    Patient Package Insert
    Note Url
    04/26/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218623s000lbl.pdf
    Get the next $AQST alert in real time by email

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