Approvals (Drugs@FDA)

REVTORPYK

CELCUITY · GEDATOLISIB

NDA219908Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA219908
Sponsor name
CELCUITY
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260714
    Review priority
    PRIORITY
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Application docs
    1. ID
      86578
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219908Orig1s000ltr.pdf
      Date
      20260715
      Type
      Letter
    2. ID
      86904
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/219908Orig1s000TOC.html
      Date
      20260814
      Type
      Review
    3. ID
      86966
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219908Orig1s000lbl.pdf
      Date
      20260818
      Type
      Label
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    REVTORPYK
    Reference standard
    Yes
    Dosage form
    POWDER
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      GEDATOLISIB
      Strength
      180MG/VIAL
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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.