FDA — authorised 16 August 2012
- Application: ANDA078941
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ongentys in United States
FDA authorised Ongentys on 16 August 2012
Marketing authorisations
FDA — authorised 5 June 2017
- Application: ANDA207210
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2018
- Application: ANDA206669
- Marketing authorisation holder: SUNSHINE
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2020
- Application: NDA212489
- Marketing authorisation holder: AMNEAL
- Local brand name: ONGENTYS
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Ongentys 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 Ongentys approved in United States?
Yes. FDA authorised it on 16 August 2012; FDA authorised it on 5 June 2017; FDA authorised it on 3 October 2018.
Who is the marketing authorisation holder for Ongentys in United States?
WOCKHARDT BIO AG holds the US marketing authorisation.