FDA — authorised 21 October 2011
- Marketing authorisation holder: LUNDBECK LLC
- Status: approved
🇺🇸 Onfi in United States
FDA authorised Onfi on 21 October 2011
Marketing authorisations
FDA — authorised 14 December 2012
- Application: NDA203993
- Marketing authorisation holder: LUNDBECK PHARMS LLC
- Local brand name: ONFI
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209808
- Marketing authorisation holder: PIRAMAL
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209308
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209687
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA210039
- Marketing authorisation holder: AMNEAL
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209715
- Marketing authorisation holder: HIKMA
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209718
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA211449
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209440
- Marketing authorisation holder: TARO
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2018
- Application: ANDA209795
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 2019
- Application: ANDA212398
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 July 2019
- Application: ANDA210746
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 September 2019
- Application: ANDA212714
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2019
- Application: ANDA212092
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CLOBAZAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2020
- Application: ANDA211032
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 February 2020
- Application: ANDA209796
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 April 2020
- Application: ANDA213110
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 February 2021
- Application: NDA202067
- Marketing authorisation holder: LUNDBECK PHARMS LLC
- Indication: Labeling
- Status: approved
FDA — authorised 16 March 2021
- Application: NDA210833
- Marketing authorisation holder: ASSERTIO SPECLTY
- Indication: Labeling
- Status: approved
FDA — authorised 12 November 2021
- Application: ANDA208819
- Marketing authorisation holder: BIONPHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 24 March 2022
- Application: ANDA214404
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 September 2022
- Application: ANDA216008
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CLOBAZAM
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 April 2023
- Application: ANDA213039
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 15 July 2024
- Application: ANDA213404
- Marketing authorisation holder: MSN
- Indication: Labeling
- Status: approved
Onfi, a medication, was granted marketing authorisation by the FDA in the United States on 15 July 2024. The application number for this approval is ANDA213404. The marketing authorisation holder is MSN, but the local brand name for Onfi is not reported.
Onfi 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 Onfi approved in United States?
Yes. FDA authorised it on 21 October 2011; FDA authorised it on 14 December 2012; FDA authorised it on 22 October 2018.
Who is the marketing authorisation holder for Onfi in United States?
LUNDBECK LLC holds the US marketing authorisation.