FDA — authorised 14 January 2000
- Application: NDA021014
- Marketing authorisation holder: NOVARTIS
- Local brand name: TRILEPTAL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Trileptal® in United States
FDA authorised Trileptal® on 14 January 2000
Marketing authorisations
FDA — authorised 25 May 2001
- Application: NDA021285
- Marketing authorisation holder: NOVARTIS
- Local brand name: TRILEPTAL
- Indication: SUSPENSION — ORAL
- Status: approved
Other Neurology approved in United States
Frequently asked questions
Is Trileptal® approved in United States?
Yes. FDA authorised it on 14 January 2000; FDA authorised it on 25 May 2001.
Who is the marketing authorisation holder for Trileptal® in United States?
NOVARTIS holds the US marketing authorisation.