Approvals (Drugs@FDA)

CTEXLI

MIRUM · CHENODIOL

NDA219488Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA219488
Sponsor name
MIRUM
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250221
    Review priority
    PRIORITY
    Submission class code
    TYPE 5
    Submission class code description
    Type 5 - New Formulation or New Manufacturer
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      81309
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219488s000lbl.pdf
      Date
      20250221
      Type
      Label
    2. ID
      81310
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219488Orig1s000ltr.pdf
      Date
      20250221
      Type
      Letter
    3. ID
      84907
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/219488Orig1s000TOC.html
      Date
      20260204
      Type
      Review
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    CTEXLI
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      CHENODIOL
      Strength
      250MG
Harmonized identifiers (openFDA)
Application number
NDA219488
Brand name
CTEXLI
Generic name
CHENODIOL
Manufacturer name
Mirum Pharmaceuticals Inc.
Product NDC
79378-310
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
CHENODIOL
RxCUI
618469, 2710422
SPL ID
71b050b3-07a6-401f-9526-104383bff7b7
SPL set ID
015384e7-4ac5-4782-a309-e40cd1421c5b
Package NDC
79378-310-90
Nui
N0000175802, M0002475
Pharm class epc
Bile Acid [EPC]
Pharm class cs
Bile Acids and Salts [CS]
UNII
0GEI24LG0J
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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.