Home Applications 218490 Application 218490
Type NDA
Sponsor ACTELION Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OPSYNVI MACITENTAN; TADALAFIL TABLET;ORAL 10MG;20MG Yes No 002 OPSYNVI MACITENTAN; TADALAFIL TABLET;ORAL 10MG;40MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218490-001 OPSYNVI MACITENTAN; TADALAFIL 10MG;20MG TABLET / ORAL RLD 2024-03-22 N218490-002 OPSYNVI MACITENTAN; TADALAFIL 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218490-001 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 N218490-001 7094781*PED 2026-06-05 Pediatric extension N218490-001 10946015 2026-09-11 U-3881 Drug product 2024-04-18 N218490-001 10946015*PED 2027-03-11 Pediatric extension N218490-001 8268847 2029-04-18 U-3882 Drug product 2024-04-18 N218490-001 8268847*PED 2029-10-18 Pediatric extension N218490-002 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 N218490-002 7094781*PED 2026-06-05 Pediatric extension N218490-002 10946015 2026-09-11 U-3881 Drug product 2024-04-18 N218490-002 10946015*PED 2027-03-11 Pediatric extension N218490-002 8268847 2029-04-18 U-3882 Drug product 2024-04-18 N218490-002 8268847*PED 2029-10-18 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N218490-001 OPSYNVI 10MG;20MG TABLET / ORAL RLD 2024-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-002 OPSYNVI 10MG;40MG TABLET / ORAL RLD, RS 2024-03-22 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N218490-001 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-001 7094781*PED 2026-06-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-001 10946015 2026-09-11 U-3881 Drug product 2024-04-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-001 10946015*PED 2027-03-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-001 8268847 2029-04-18 U-3882 Drug product 2024-04-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-001 8268847*PED 2029-10-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-002 7094781 2025-12-05 Drug substance, Drug product 2024-04-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-002 7094781*PED 2026-06-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-002 10946015 2026-09-11 U-3881 Drug product 2024-04-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-002 10946015*PED 2027-03-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-002 8268847 2029-04-18 U-3882 Drug product 2024-04-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N218490-002 8268847*PED 2029-10-18 Pediatric extension a50c72e98297…
Observed Orange Book exclusivity history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OPSYNVI MACITENTAN AND TADALAFIL Actelion Pharmaceuticals US, Inc. 6945b183-18d3-40de-afd1-c88e33cc1a63 2025-04-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 218490 application number: NDA218490
Documents# Document, Submission type, Date table Document Submission type Date 81891 SUPPL 2025-04-08 81822 SUPPL 2025-04-03 80567 SUPPL 2024-12-13 79983 ORIG 2024-10-25 77958 ORIG 2024-03-25 77957 ORIG 2024-03-25 77953 ORIG 2024-03-25