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    FDA Tentative Approval for YUTREPIA issued to Liquidia Technologies, Inc.

    11/18/21 2:49:33 PM ET
    $LQDA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $LQDA alert in real time by email
    New Drug Application (NDA): 213005
    Company: Liquidia Technologies, Inc.
    • Email

    Products on NDA 213005

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    YUTREPIA TREPROSTINIL UNKNOWN UNKNOWN None (Tentative Approval) None No No

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 213005

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    11/04/2021 ORIG-1 Tentative Approval Type 3 - New Dosage Form STANDARD Letter (PDF)

    Label is not available on this site.

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213005Orig1s000TAltr.pdf
    Get the next $LQDA alert in real time by email

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