FDA — authorised 18 January 2008
- Marketing authorisation holder: JANSSEN R AND D
- Status: approved
🇺🇸 Intelence in United States
FDA authorised Intelence on 18 January 2008
Marketing authorisations
FDA — authorised 18 January 2008
- Application: NDA022187
- Marketing authorisation holder: JANSSEN R AND D
- Local brand name: INTELENCE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 June 2021
- Application: ANDA214196
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 13 April 2022
- Application: ANDA215402
- Marketing authorisation holder: CARNEGIE
- Status: approved
FDA — authorised 2 October 2025
- Application: ANDA219152
- Marketing authorisation holder: BIONPHARMA
- Status: approved
Intelence in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Intelence approved in United States?
Yes. FDA authorised it on 18 January 2008; FDA authorised it on 18 January 2008; FDA authorised it on 14 June 2021.
Who is the marketing authorisation holder for Intelence in United States?
JANSSEN R AND D holds the US marketing authorisation.