FDA — authorised 2 July 2020
- Application: NDA209376
- Marketing authorisation holder: AM REGENT
- Local brand name: TRALEMENT
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Tralement in United States
FDA authorised Tralement on 2 July 2020
Marketing authorisations
FDA
- Status: approved
Tralement 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 Tralement approved in United States?
Yes. FDA authorised it on 2 July 2020; FDA has authorised it.
Who is the marketing authorisation holder for Tralement in United States?
AM REGENT holds the US marketing authorisation.