FDA — authorised 27 August 2015
- Application: NDA022416
- Marketing authorisation holder: SUMITOMO PHARMA AM
- Indication: Efficacy
- Status: approved
🇺🇸 Eslicarbazepine Acetate in United States
FDA authorised Eslicarbazepine Acetate on 27 August 2015
Marketing authorisations
FDA — authorised 3 August 2023
- Application: ANDA211186
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
FDA — authorised 6 October 2023
- Application: ANDA211199
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 7 December 2023
- Application: ANDA211236
- Marketing authorisation holder: APOTEX
- Status: approved
FDA — authorised 27 February 2024
- Application: ANDA211227
- Marketing authorisation holder: TORRENT
- Status: approved
FDA
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
Eslicarbazepine Acetate 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 Eslicarbazepine Acetate approved in United States?
Yes. FDA authorised it on 27 August 2015; FDA authorised it on 3 August 2023; FDA authorised it on 6 October 2023.
Who is the marketing authorisation holder for Eslicarbazepine Acetate in United States?
SUMITOMO PHARMA AM holds the US marketing authorisation.