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General MedicationsORALStandard

TRIKAFTA (COPACKAGED)

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

Standard Dose
100MG, 75MG, 50MG;75MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview TRIKAFTA (COPACKAGED) is listed in Drugs@FDA under application 217660 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR Form and strength GRANULES;ORAL - 100MG, 75MG, 50MG;75MG Sponsor VERTEX PHARMS INC Submission history Latest submission status date: 2026-03-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview TRIKAFTA (COPACKAGED) is listed in Drugs@FDA under application 217660 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR Form and strength GRANULES;ORAL - 100MG, 75MG, 50MG;75MG Sponsor VERTEX PHARMS INC Submission history Latest submission status date: 2026-03-27 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.