FDA — authorised 19 October 2010
- Application: NDA022512
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: PRADAXA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Dabigatranetexilate in United States
FDA authorised Dabigatranetexilate on 19 October 2010
Marketing authorisations
FDA — authorised 21 June 2021
- Application: NDA214358
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: PRADAXA
- Indication: PELLETS — ORAL
- Status: approved
FDA
- Status: approved
Dabigatranetexilate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Dabigatranetexilate approved in United States?
Yes. FDA authorised it on 19 October 2010; FDA authorised it on 21 June 2021; FDA has authorised it.
Who is the marketing authorisation holder for Dabigatranetexilate in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.