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General MedicationsORALStandard

AKEEGA

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Standard Dose
500MG;EQ 100MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview AKEEGA is listed in Drugs@FDA under application 216793 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient ABIRATERONE ACETATE; NIRAPARIB TOSYLATE Form and strength TABLET;ORAL - 500MG;EQ 100MG BASE Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-12-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview AKEEGA is listed in Drugs@FDA under application 216793 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient ABIRATERONE ACETATE; NIRAPARIB TOSYLATE Form and strength TABLET;ORAL - 500MG;EQ 100MG BASE Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-12-12 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.