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General MedicationsORALStandard

SYMDEKO (COPACKAGED)

IVACAFTOR; IVACAFTOR, TEZACAFTOR

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

Approval overview SYMDEKO (COPACKAGED) is listed in Drugs@FDA under application 210491 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient IVACAFTOR; IVACAFTOR, TEZACAFTOR Form and strength TABLET;ORAL - 75MG;75MG, 50MG Sponsor VERTEX PHARMS INC Submission history Latest submission status date: 2026-03-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview SYMDEKO (COPACKAGED) is listed in Drugs@FDA under application 210491 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IVACAFTOR; IVACAFTOR, TEZACAFTOR Form and strength TABLET;ORAL - 75MG;75MG, 50MG Sponsor VERTEX PHARMS INC Submission history Latest submission status date: 2026-03-17 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.