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    FDA Approval for KORSUVA issued to CARA THERAPEUTICS INC

    8/24/21 12:36:58 PM ET
    $CARA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $CARA alert in real time by email
    New Drug Application (NDA): 214916
    Company: CARA THERAPEUTICS INC
    • Email

    Products on NDA 214916

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    KORSUVA DIFELIKEFALIN 65MCG/1.3ML (50MCG/ML) SOLUTION;INTRAVENOUS Prescription TBD TBD No

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 214916

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    08/23/2021 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

    Label is not available on this site.

    Therapeutic Equivalents for NDA 214916

    KORSUVA

    There are no Therapeutic Equivalents.

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