Approvals (Drugs@FDA)

HYRNUO

BAYER HEALTHCARE · SEVABERTINIB

NDA219972Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA219972
Sponsor name
BAYER HEALTHCARE
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20251119
    Review priority
    PRIORITY
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      84233
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219972s000lblCorrected.pdf
      Date
      20251120
      Type
      Label
    2. ID
      84246
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219972Orig1s000correctedltr.pdf
      Date
      20251121
      Type
      Letter
    3. ID
      84430
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219972Orig1s000TOC.html
      Date
      20251216
      Type
      Review
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260909
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      87178
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219972s001lbl.pdf
      Date
      20260910
      Type
      Label
    2. ID
      87179
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219972Orig1s001ltr.pdf
      Date
      20260910
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    HYRNUO
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEVABERTINIB
      Strength
      10MG
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.