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FDA NDA · NDA216403

FILSPARI

sparsentan

Sponsor: TRAVERE

APPLICATION
NDA216403
TYPE
NDA
ORIGINAL APPROVAL
2023-02-17
LATEST ACTION
2026-04-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FILSPARI · ReferencePrescription
SPARSENTAN 400MG · TABLET · ORAL
FILSPARI · ReferencePrescription
SPARSENTAN 200MG · TABLET · ORAL

Approval history

2026-04-13Efficacy · Supplement 6 · standard — Letter ↗AP
2025-08-27Efficacy · Supplement 5 · standard — Label ↗AP
2024-09-05Efficacy · Supplement 3 · priority — Label ↗AP
2023-10-18REMS · Supplement 2 — Letter ↗AP
2023-02-17Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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