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Rivaroxaban

Sold as Xarelto, Yulzety. Every FDA application for this active ingredient: 4 branded and 27 generic.

  • First approved: Jul 1, 2011
  • Applications: 31
  • New uses approved: 10
  • Complete response letters: 0

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
ApprovedApplicationSponsorSupplementsMarketing
Jul 1, 2011XareltoNDA 22406 · New molecular entityJanssen Pharms34Marketed
Nov 4, 2011XareltoNDA 202439 · New indicationJanssen Pharms25Marketed
Dec 20, 2021XareltoNDA 215859 · New dosage formJanssen Pharms3Discontinued
May 2, 2025RivaroxabanANDA 217810Apotex0Marketed
May 14, 2025RivaroxabanANDA 208534Dr Reddys0Marketed
May 14, 2025RivaroxabanANDA 208543Invagen Pharms0Discontinued
May 14, 2025RivaroxabanANDA 208555Lupin0Marketed
May 14, 2025RivaroxabanANDA 210301Alembic0Marketed
May 14, 2025RivaroxabanANDA 213114Macleods Pharms0Marketed
May 14, 2025RivaroxabanANDA 213348Sunshine0Marketed
May 14, 2025RivaroxabanANDA 216995Aiping Pharm Inc0Marketed
May 14, 2025RivaroxabanANDA 218107Biocon Pharma0Marketed
May 14, 2025RivaroxabanANDA 219332Ascent Pharms Inc0Marketed
May 15, 2025RivaroxabanANDA 208220Breckenridge0Marketed
May 15, 2025RivaroxabanANDA 208544Aurobindo Pharma Ltd0Marketed
Jun 26, 2025RivaroxabanANDA 218502Alkem Labs Ltd0Marketed
Jul 31, 2025RivaroxabanANDA 218117Sciegen Pharms0Marketed
Aug 11, 2025RivaroxabanANDA 218445Regcon Holdings0Marketed
Sep 25, 2025RivaroxabanANDA 218195Lupin0Marketed
Oct 7, 2025RivaroxabanANDA 208557Taro0Marketed
Oct 24, 2025RivaroxabanANDA 208546Msn0Marketed
Nov 14, 2025RivaroxabanANDA 208579Apotex0Discontinued
Feb 20, 2026RivaroxabanANDA 218768Invagen Pharms0Marketed
Mar 2, 2026RivaroxabanANDA 218427Apotex0Discontinued
Jun 30, 2026RivaroxabanANDA 208334Micro Labs0Marketed
Jul 1, 2026RivaroxabanANDA 220874Mankind Pharma0Marketed
Aug 19, 2026RivaroxabanANDA 216255Epic Pharma LLC0Marketed
Oct 16, 2026YulzetyNDA 221033 · New dosage formRosemont Pharms0Marketed
Oct 27, 2026RivaroxabanANDA 212247Teva Pharms USA0Marketed
—RivaroxabanANDA 208549Prinston Inc0Discontinued
—RivaroxabanANDA 212220Mylan Pharms 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.