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FDA NDA · NDA219301

EKTERLY

sebetralstat

Sponsor: KALVISTA

APPLICATION
NDA219301
TYPE
NDA
ORIGINAL APPROVAL
2025-07-03
LATEST ACTION
2025-07-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EKTERLY · ReferencePrescription
SEBETRALSTAT 300MG · TABLET · ORAL

Approval history

2025-07-03Type 1 - New Molecular Entity · Original · standardLetterAP
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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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