FDA — authorised 29 July 1993
- Marketing authorisation holder: MEDA PHARMS
- Status: approved
🇺🇸 Felbatol in United States
FDA authorised Felbatol on 29 July 1993
Marketing authorisations
FDA — authorised 29 July 1993
- Application: NDA020189
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Local brand name: FELBATOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2011
- Application: ANDA201680
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: FELBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 2011
- Application: ANDA202385
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: FELBAMATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 4 November 2015
- Application: ANDA202284
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FELBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2016
- Application: ANDA204595
- Marketing authorisation holder: ALVOGEN
- Local brand name: FELBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 2017
- Application: ANDA207093
- Marketing authorisation holder: TARO
- Local brand name: FELBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2017
- Application: ANDA208970
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: FELBAMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 2017
- Application: ANDA206314
- Marketing authorisation holder: TARO
- Local brand name: FELBAMATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 May 2019
- Application: ANDA211333
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: FELBAMATE
- Indication: SUSPENSION — ORAL
- Status: approved
Felbatol 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 Felbatol approved in United States?
Yes. FDA authorised it on 29 July 1993; FDA authorised it on 29 July 1993; FDA authorised it on 13 September 2011.
Who is the marketing authorisation holder for Felbatol in United States?
MEDA PHARMS holds the US marketing authorisation.