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    FDA Approval for BREXAFEMME issued to SCYNEXIS, INC

    6/2/21 9:57:42 AM ET
    $SCYX
    Biotechnology: Pharmaceutical Preparations
    Health Care
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    New Drug Application (NDA): 214900
    Company: SCYNEXIS, INC
    • Email

    Products on NDA 214900

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    BREXAFEMME IBREXAFUNGERP 150MG TABLET; ORAL Prescription None No No

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 214900

    Supplements
    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
    06/01/2021 SUPPL-1 Letter (PDF)

    Label is not available on this site.

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214900Orig1s000ltr.pdf
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