FDA — authorised 31 January 2011
- Application: ANDA200272
- Marketing authorisation holder: ELITE LABS
- Indication: Labeling
- Status: approved
🇺🇸 Tesomet "High dose" in fasted condition in United States
FDA authorised Tesomet "High dose" in fasted condition on 31 January 2011
Marketing authorisations
FDA — authorised 20 June 2013
- Application: NDA021998
- Marketing authorisation holder: FDN CONSUMER
- Indication: Efficacy
- Status: approved
FDA — authorised 31 July 2015
- Application: ANDA202765
- Marketing authorisation holder: CSPC-NBP PHARM
- Status: approved
FDA — authorised 31 January 2017
- Application: ANDA207682
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 1 September 2017
- Application: BLA761060
- Marketing authorisation holder: WYETH PHARMS INC
- Indication: Efficacy
- Status: approved
FDA — authorised 13 June 2019
- Application: BLA761073
- Marketing authorisation holder: AMGEN INC
- Status: approved
FDA — authorised 9 March 2021
- Application: ANDA209597
- Marketing authorisation holder: PHARMOBEDIENT
- Status: approved
FDA — authorised 3 May 2021
- Application: BLA761080
- Marketing authorisation holder: HOSPIRA INC
- Indication: Labeling
- Status: approved
FDA — authorised 3 June 2025
- Application: ANDA217187
- Marketing authorisation holder: PRECISION DOSE INC
- Status: approved
Tesomet "High dose" in fasted condition in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Tesomet "High dose" in fasted condition approved in United States?
Yes. FDA authorised it on 31 January 2011; FDA authorised it on 20 June 2013; FDA authorised it on 31 July 2015.
Who is the marketing authorisation holder for Tesomet "High dose" in fasted condition in United States?
ELITE LABS holds the US marketing authorisation.