FDA — authorised 9 December 1994
- Marketing authorisation holder: MERCK
- Status: approved
🇺🇸 Trusopt in United States
FDA authorised Trusopt on 9 December 1994
Marketing authorisations
FDA — authorised 18 November 2009
- Application: ANDA090604
- Marketing authorisation holder: SANDOZ
- Status: approved
FDA — authorised 24 January 2019
- Application: ANDA205294
- Marketing authorisation holder: FDC LTD
- Status: approved
FDA — authorised 13 June 2019
- Application: ANDA205295
- Marketing authorisation holder: FDC LTD
- Status: approved
FDA — authorised 25 March 2020
- Application: ANDA078981
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 14 May 2021
- Application: ANDA207629
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
Trusopt 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 Trusopt approved in United States?
Yes. FDA authorised it on 9 December 1994; FDA authorised it on 18 November 2009; FDA authorised it on 24 January 2019.
Who is the marketing authorisation holder for Trusopt in United States?
MERCK holds the US marketing authorisation.