← FDA DRUG APPROVALS

FDA NDA · NDA214783

REZUROCK

belumosudil

Sponsor: KADMON PHARMS LLC

APPLICATION
NDA214783
TYPE
NDA
ORIGINAL APPROVAL
2021-07-16
LATEST ACTION
2026-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

REZUROCK · ReferencePrescription
BELUMOSUDIL MESYLATE EQ 200MG BASE · TABLET · ORAL

Approval history

2026-01-15Labeling · Supplement 12 · standard — Label ↗AP
2024-12-30Labeling · Supplement 7 · standard — Label ↗AP
2024-04-10Labeling · Supplement 5 · standard — Label ↗AP
2023-11-09Labeling · Supplement 3 · standard — Label ↗AP
2021-07-16Type 1 - New Molecular Entity · Original · priority — Letter ↗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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