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General MedicationsORALStandard

NUBEQA

DAROLUTAMIDE

Standard Dose
300MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NUBEQA is listed in Drugs@FDA under application 212099 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DAROLUTAMIDE Form and strength TABLET;ORAL - 300MG Sponsor BAYER HEALTHCARE Submission history Latest submission status date: 2025-06-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview NUBEQA is listed in Drugs@FDA under application 212099 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DAROLUTAMIDE Form and strength TABLET;ORAL - 300MG Sponsor BAYER HEALTHCARE Submission history Latest submission status date: 2025-06-03 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.