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General MedicationsORALStandard

WELIREG

BELZUTIFAN

Standard Dose
40MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview WELIREG is listed in Drugs@FDA under application 215383 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient BELZUTIFAN Form and strength TABLET;ORAL - 40MG Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2025-05-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview WELIREG is listed in Drugs@FDA under application 215383 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient BELZUTIFAN Form and strength TABLET;ORAL - 40MG Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2025-05-14 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.