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General MedicationsORALStandard

OPSYNVI

MACITENTAN; TADALAFIL

Standard Dose
10MG;40MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview OPSYNVI is listed in Drugs@FDA under application 218490 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient MACITENTAN; TADALAFIL Form and strength TABLET;ORAL - 10MG;40MG Sponsor ACTELION Submission history Latest submission status date: 2025-04-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview OPSYNVI is listed in Drugs@FDA under application 218490 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient MACITENTAN; TADALAFIL Form and strength TABLET;ORAL - 10MG;40MG Sponsor ACTELION Submission history Latest submission status date: 2025-04-02 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.