Arca
Skip to content

Brexpiprazole

Sold as Rexulti. Every branded application for this active ingredient, and 16 generic applications.

  • First approved: Jul 10, 2015
  • Branded applications: 17
  • New uses approved: 5
  • Complete response letters: 0

Applications

NDAs and BLAs for this ingredient, oldest first; each opens its full history
ApprovedApplicationSponsorSupplementsMarketing
Jul 10, 2015RexultiNDA 205422 · New molecular entityOtsuka11Marketed
Aug 11, 2022BrexpiprazoleANDA 213692Teva Pharms USA Inc0Discontinued
Sep 26, 2022BrexpiprazoleANDA 213570Sandoz0Discontinued
Jan 10, 2023BrexpiprazoleANDA 213660Zydus Pharms0Discontinued
Jan 31, 2023BrexpiprazoleANDA 213562Amneal5Discontinued
Feb 3, 2023BrexpiprazoleANDA 213718Ajanta Pharma Ltd0Discontinued
Mar 18, 2023BrexpiprazoleANDA 213512Lupin1Discontinued
Oct 25, 2023BrexpiprazoleANDA 213758Chartwell Rx0Discontinued
Nov 2, 2023BrexpiprazoleANDA 213659Aurobindo Pharma Ltd0Discontinued
Nov 20, 2023BrexpiprazoleANDA 213669Hetero Labs Ltd V0Discontinued
Nov 28, 2023BrexpiprazoleANDA 213782Alkem Labs Ltd0Discontinued
Jan 13, 2025BrexpiprazoleANDA 213683Alembic0Marketed
Feb 24, 2025BrexpiprazoleANDA 213731Apotex0Discontinued
—BrexpiprazoleANDA 213477Zenara0Discontinued
—BrexpiprazoleANDA 213587Prinston Pharma Inc0Discontinued
—BrexpiprazoleANDA 213740Msn Pharms Inc0Discontinued
—BrexpiprazoleANDA 213788Accord Hlthcare Inc0Discontinued

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.