FDA — authorised 31 July 1984
- Marketing authorisation holder: TEVA
- Status: approved
🇺🇸 Orap in United States
FDA authorised Orap on 31 July 1984
Marketing authorisations
FDA — authorised 31 July 1984
- Application: NDA017473
- Marketing authorisation holder: TEVA
- Local brand name: ORAP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 2015
- Application: ANDA204521
- Marketing authorisation holder: PH HEALTH
- Local brand name: PIMOZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 2026
- Application: ANDA219897
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: PIMOZIDE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Orap (Pimozide) tablets for the treatment of various psychiatric disorders. The approval was granted to Novitium Pharma, the marketing authorisation holder. The approval date was 13 April 2026, and the application number was ANDA219897.
Orap 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 Orap approved in United States?
Yes. FDA authorised it on 31 July 1984; FDA authorised it on 31 July 1984; FDA authorised it on 28 September 2015.
Who is the marketing authorisation holder for Orap in United States?
TEVA holds the US marketing authorisation.