Approvals (Drugs@FDA)

LYRFIGTU

ELEVAR THERAPEUTICS INC · LIRAFUGRATINIB HYDROCHLORIDE

NDA220425Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA220425
Sponsor name
ELEVAR THERAPEUTICS INC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260923
    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
      87274
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220425Orig1s000ltr.pdf
      Date
      20260925
      Type
      Letter
    2. ID
      87299
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220425Orig1s000lbl.pdf
      Date
      20260928
      Type
      Label
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    LYRFIGTU
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      LIRAFUGRATINIB HYDROCHLORIDE
      Strength
      20MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    LYRFIGTU
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      LIRAFUGRATINIB HYDROCHLORIDE
      Strength
      30MG
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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.