FDA — authorised 11 August 1972
- Application: NDA017020
- Marketing authorisation holder: ABBOTT
- Local brand name: PANWARFIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Coumadin in United States
FDA authorised Coumadin on 11 August 1972
Marketing authorisations
FDA — authorised 26 March 1997
- Application: ANDA040145
- Marketing authorisation holder: BARR
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 July 1999
- Application: ANDA040301
- Marketing authorisation holder: TARO
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2004
- Application: ANDA040415
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2006
- Application: ANDA040663
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 July 2006
- Application: ANDA040616
- Marketing authorisation holder: PLIVA
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 May 2011
- Application: ANDA090935
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 2013
- Application: ANDA202202
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 2013
- Application: ANDA200104
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA011771
- Marketing authorisation holder: PHARM RES ASSOC
- Local brand name: ATHROMBIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086119
- Marketing authorisation holder: WATSON LABS
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086118
- Marketing authorisation holder: WATSON LABS
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA086120
- Marketing authorisation holder: WATSON LABS
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086122
- Marketing authorisation holder: WATSON LABS
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086123
- Marketing authorisation holder: WATSON LABS
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088719
- Marketing authorisation holder: USL PHARMA
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088720
- Marketing authorisation holder: USL PHARMA
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088721
- Marketing authorisation holder: USL PHARMA
- Local brand name: WARFARIN SODIUM
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Coumadin approved in United States?
Yes. FDA authorised it on 11 August 1972; FDA authorised it on 26 March 1997; FDA authorised it on 15 July 1999.
Who is the marketing authorisation holder for Coumadin in United States?
ABBOTT holds the US marketing authorisation.