Approvals (Drugs@FDA)

TAUKLARIFY

CERVEAU LANTHEUS · FLORQUINITAU F-18

NDA220496Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA220496
Sponsor name
CERVEAU LANTHEUS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260813
    Review priority
    STANDARD
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Application docs
    1. ID
      86907
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220496Orig1s000ltr.pdf
      Date
      20260817
      Type
      Letter
    2. ID
      86961
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220496Orig1s000lbl.pdf
      Date
      20260818
      Type
      Label
    3. ID
      87251
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/220496Orig1s000TOC.html
      Date
      20260923
      Type
      Review
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    TAUKLARIFY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      FLORQUINITAU F-18
      Strength
      1-40mCi/ML
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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.