FDA — authorised 2 October 2003
- Application: ANDA040416
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: JANTOVEN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Coumadin in United States
FDA authorised Coumadin on 2 October 2003
Marketing authorisations
FDA — authorised 25 May 2011
- Application: ANDA090935
- Marketing authorisation holder: INVAGEN PHARMS
- Status: approved
FDA — authorised 5 September 2018
- Application: ANDA040616
- Marketing authorisation holder: PLIVA
- Indication: Labeling
- Status: approved
FDA — authorised 27 September 2019
- Application: ANDA040301
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
FDA — authorised 31 October 2019
- Application: ANDA202202
- Marketing authorisation holder: AMNEAL PHARMS
- Indication: Labeling
- Status: approved
Coumadin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Coumadin approved in United States?
Yes. FDA authorised it on 2 October 2003; FDA authorised it on 25 May 2011; FDA authorised it on 5 September 2018.
Who is the marketing authorisation holder for Coumadin in United States?
UPSHER SMITH LABS holds the US marketing authorisation.