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FDA NDA · NDA218490

OPSYNVI

macitentan and tadalafil

Sponsor: ACTELION

APPLICATION
NDA218490
TYPE
NDA
ORIGINAL APPROVAL
2024-03-22
LATEST ACTION
2025-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OPSYNVI · ReferencePrescription
MACITENTAN 10MG, TADALAFIL 40MG · TABLET · ORAL
OPSYNVI · ReferencePrescription
MACITENTAN 10MG, TADALAFIL 20MG · TABLET · ORAL

Approval history

2025-04-02REMS · Supplement 2 — Label ↗AP
2024-12-12REMS · Supplement 1 — Letter ↗AP
2024-03-22Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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