FDA — authorised 2 May 2011
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
🇺🇸 Tradjenta in United States
FDA authorised Tradjenta on 2 May 2011
Marketing authorisations
FDA — authorised 11 February 2016
- Application: NDA201281
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 14 March 2017
- Application: NDA208026
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
FDA — authorised 13 December 2017
- Application: NDA206073
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
FDA — authorised 30 October 2023
- Application: NDA212614
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
FDA — authorised 3 November 2025
- Application: ANDA208459
- Marketing authorisation holder: MSN
- Status: approved
Tradjenta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Tradjenta approved in United States?
Yes. FDA authorised it on 2 May 2011; FDA authorised it on 11 February 2016; FDA authorised it on 14 March 2017.
Who is the marketing authorisation holder for Tradjenta in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.