FDA — authorised 2 May 2025
- Application: ANDA217810
- Marketing authorisation holder: APOTEX
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 DOACs in United States
FDA authorised DOACs on 2 May 2025
Marketing authorisations
FDA — authorised 14 May 2025
- Application: ANDA210301
- Marketing authorisation holder: ALEMBIC
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA213114
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA213348
- Marketing authorisation holder: SUNSHINE
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA219332
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA216995
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2025
- Application: ANDA208220
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 2025
- Application: ANDA218502
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: RIVAROXABAN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 August 2025
- Application: ANDA218445
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 2025
- Application: ANDA218195
- Marketing authorisation holder: LUPIN
- Local brand name: RIVAROXABAN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 November 2025
- Application: ANDA208579
- Marketing authorisation holder: APOTEX
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 February 2026
- Application: ANDA218768
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 2026
- Application: ANDA218427
- Marketing authorisation holder: APOTEX
- Local brand name: RIVAROXABAN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA212220
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is DOACs approved in United States?
Yes. FDA authorised it on 2 May 2025; FDA authorised it on 14 May 2025; FDA authorised it on 14 May 2025.
Who is the marketing authorisation holder for DOACs in United States?
APOTEX holds the US marketing authorisation.