FDA — authorised 24 April 2020
- Application: NDA212489
- Marketing authorisation holder: AMNEAL
- Local brand name: ONGENTYS
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Ongentys in United States
FDA authorised Ongentys on 24 April 2020
Marketing authorisations
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 Neuroscience approved in United States
Frequently asked questions
Is Ongentys approved in United States?
Yes. FDA authorised it on 24 April 2020; FDA has authorised it.
Who is the marketing authorisation holder for Ongentys in United States?
AMNEAL holds the US marketing authorisation.