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Macitentan

Sold as Opsumit. Every branded application for this active ingredient, and 13 generic applications.

  • First approved: Oct 18, 2013
  • Branded applications: 14
  • New uses approved: 1
  • Complete response letters: 0

Applications

NDAs and BLAs for this ingredient, oldest first; each opens its full history
ApprovedApplicationSponsorSupplementsMarketing
Oct 18, 2013OpsumitNDA 204410 · New molecular entityActelion23Marketed
Apr 6, 2021MacitentanANDA 211224Zydus Lifesciences4Marketed
Apr 18, 2023MacitentanANDA 211198Aurobindo Pharma Ltd6Marketed
Jan 9, 2024MacitentanANDA 211195Apotex3Marketed
Aug 5, 2024MacitentanANDA 211107Torrent2Marketed
Aug 18, 2025MacitentanANDA 211128Alembic0Marketed
Aug 20, 2025MacitentanANDA 211136Msn0Marketed
Aug 26, 2025MacitentanANDA 211123Sun Pharm0Marketed
Nov 5, 2025MacitentanANDA 211120Laurus0Marketed
Dec 3, 2025MacitentanANDA 211026Lepu Pharm1Marketed
Dec 3, 2025MacitentanANDA 211161Mylan0Marketed
Jun 8, 2026MacitentanANDA 211000Amneal0Marketed
Jun 8, 2026MacitentanANDA 211187Teva Pharms USA Inc0Marketed
—MacitentanANDA 214112Rhodes Pharms0Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Drugs@FDA

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.