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FDA NDA · NDA219488

CTEXLI

chenodiol

Sponsor: MIRUM

APPLICATION
NDA219488
TYPE
NDA
ORIGINAL APPROVAL
2025-02-21
LATEST ACTION
2025-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CTEXLI · ReferencePrescription
CHENODIOL 250MG · TABLET · ORAL

Approval history

2025-02-21Type 5 - New Formulation or New Manufacturer · Original · priorityLabelAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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