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FDA NDA · NDA215383

WELIREG

belzutifan

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA215383
TYPE
NDA
ORIGINAL APPROVAL
2021-08-13
LATEST ACTION
2026-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

WELIREG · ReferencePrescription
BELZUTIFAN 40MG · TABLET · ORAL

Approval history

2026-06-12Efficacy · Supplement 15 · priority — Letter ↗AP
2025-05-14Efficacy · Supplement 12 · priority — Label ↗AP
2025-04-15Efficacy · Supplement 10 · standard — Letter ↗AP
2025-04-15Efficacy · Supplement 11 · standard — Letter ↗AP
2024-02-26Labeling · Supplement 7 · standard — Letter ↗AP
2023-12-14Efficacy · Supplement 6 · priority — Label ↗AP
2021-08-13Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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