FDA — authorised 26 March 2015
- Application: ANDA204584
- Marketing authorisation holder: PH HEALTH
- Local brand name: TOLCAPONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Anti-Parkinson medication in United States
FDA authorised Anti-Parkinson medication on 26 March 2015
Marketing authorisations
FDA — authorised 7 August 2018
- Application: ANDA208937
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: TOLCAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 2019
- Application: ANDA210095
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: TOLCAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2020
- Application: ANDA207729
- Marketing authorisation holder: ALVOGEN
- Local brand name: TOLCAPONE
- Indication: TABLET — ORAL
- Status: approved
Anti-Parkinson medication in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neurology approved in United States
Frequently asked questions
Is Anti-Parkinson medication approved in United States?
Yes. FDA authorised it on 26 March 2015; FDA authorised it on 7 August 2018; FDA authorised it on 1 August 2019.
Who is the marketing authorisation holder for Anti-Parkinson medication in United States?
PH HEALTH holds the US marketing authorisation.