FDA — authorised 15 December 2023
- Application: ANDA208070
- Marketing authorisation holder: APOTEX
- Status: approved
🇺🇸 DABIGATRAN ETEXILATE in United States
FDA authorised DABIGATRAN ETEXILATE on 15 December 2023
Marketing authorisations
FDA — authorised 11 September 2024
- Application: ANDA208040
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 28 January 2025
- Application: ANDA208048
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 3 February 2025
- Application: ANDA208067
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA208039
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
DABIGATRAN ETEXILATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DABIGATRAN ETEXILATE approved in United States?
Yes. FDA authorised it on 15 December 2023; FDA authorised it on 11 September 2024; FDA authorised it on 28 January 2025.
Who is the marketing authorisation holder for DABIGATRAN ETEXILATE in United States?
APOTEX holds the US marketing authorisation.