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General MedicationsORALStandard

COPIKTRA

DUVELISIB

Standard Dose
25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview COPIKTRA is listed in Drugs@FDA under application 211155 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient DUVELISIB Form and strength CAPSULE;ORAL - 25MG Sponsor SECURA Submission history Latest submission status date: 2025-10-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview COPIKTRA is listed in Drugs@FDA under application 211155 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient DUVELISIB Form and strength CAPSULE;ORAL - 25MG Sponsor SECURA Submission history Latest submission status date: 2025-10-24 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.