FDA — authorised 28 July 1995
- Application: ANDA072489
- Marketing authorisation holder: AM REGENT
- Status: approved
🇺🇸 Acetadote in United States
FDA authorised Acetadote on 28 July 1995
Marketing authorisations
FDA — authorised 21 June 2012
- Application: ANDA203853
- Marketing authorisation holder: ALVOGEN
- Status: approved
FDA — authorised 3 February 2022
- Application: ANDA213693
- Marketing authorisation holder: GLENMARK PHARMS
- Status: approved
FDA — authorised 19 April 2023
- Application: ANDA217182
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Status: approved
FDA — authorised 14 March 2025
- Application: ANDA214177
- Marketing authorisation holder: CONBA USA
- Status: approved
Acetadote 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 Acetadote approved in United States?
Yes. FDA authorised it on 28 July 1995; FDA authorised it on 21 June 2012; FDA authorised it on 3 February 2022.
Who is the marketing authorisation holder for Acetadote in United States?
AM REGENT holds the US marketing authorisation.