FDA — authorised 8 May 1956
- Marketing authorisation holder: KING PHARMS R AND D
- Status: approved
🇺🇸 Triostat in United States
FDA authorised Triostat on 8 May 1956
Marketing authorisations
FDA — authorised 17 August 2005
- Application: ANDA076923
- Marketing authorisation holder: XGEN PHARMS
- Status: approved
FDA — authorised 20 March 2009
- Application: ANDA090097
- Marketing authorisation holder: DR REDDYS LABS SA
- Status: approved
FDA — authorised 20 April 2016
- Application: ANDA091382
- Marketing authorisation holder: SUN PHARM
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA211510
- Marketing authorisation holder: TEVA PHARMS USA
- Status: approved
FDA — authorised 6 February 2024
- Application: ANDA218070
- Marketing authorisation holder: BIOCON PHARMA
- Status: approved
Triostat in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Triostat approved in United States?
Yes. FDA authorised it on 8 May 1956; FDA authorised it on 17 August 2005; FDA authorised it on 20 March 2009.
Who is the marketing authorisation holder for Triostat in United States?
KING PHARMS R AND D holds the US marketing authorisation.