FDA — authorised 26 December 2002
- Marketing authorisation holder: PFIZER IRELAND
- Status: approved
🇺🇸 Relpax in United States
FDA authorised Relpax on 26 December 2002
Marketing authorisations
FDA — authorised 26 December 2002
- Application: NDA021016
- Marketing authorisation holder: UPJOHN
- Local brand name: RELPAX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 2020
- Application: ANDA205152
- Marketing authorisation holder: MYLAN
- Indication: Labeling
- Status: approved
FDA — authorised 24 November 2020
- Application: ANDA210708
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 13 February 2024
- Application: ANDA202040
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
Teva Pharms USA was granted marketing authorisation by the FDA for Relpax on 13 February 2024. The application number for this approval is ANDA202040. The approved indication for Relpax is listed in the labelling.
FDA — authorised 7 July 2025
- Application: ANDA219143
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
Relpax 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 Relpax approved in United States?
Yes. FDA authorised it on 26 December 2002; FDA authorised it on 26 December 2002; FDA authorised it on 30 September 2020.
Who is the marketing authorisation holder for Relpax in United States?
PFIZER IRELAND holds the US marketing authorisation.