FDA — authorised 17 September 1986
- Application: ANDA070541
- Marketing authorisation holder: TEVA
- Local brand name: EPITOL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Tegretol in United States
FDA authorised Tegretol on 17 September 1986
Marketing authorisations
FDA — authorised 29 July 1992
- Application: ANDA073524
- Marketing authorisation holder: TEVA
- Local brand name: EPITOL
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 30 September 1997
- Application: NDA020712
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: CARBATROL
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 November 2011
- Application: ANDA075948
- Marketing authorisation holder: APOTEX
- Indication: REMS
- Status: approved
FDA — authorised 8 November 2022
- Application: ANDA078986
- Marketing authorisation holder: APOTEX INC
- Indication: Labeling
- Status: approved
FDA — authorised 2 March 2023
- Application: ANDA216235
- Marketing authorisation holder: SCIECURE PHARMA INC
- Status: approved
FDA — authorised 9 January 2024
- Application: ANDA213311
- Marketing authorisation holder: CSPC OUYI
- Indication: Labeling
- Status: approved
The FDA approved the marketing authorisation for Tegretol on 9 January 2024. The approval was granted to CSPC OUYI under the standard expedited pathway. The application number for this approval is ANDA213311.
Tegretol 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 Tegretol approved in United States?
Yes. FDA authorised it on 17 September 1986; FDA authorised it on 29 July 1992; FDA authorised it on 30 September 1997.
Who is the marketing authorisation holder for Tegretol in United States?
TEVA holds the US marketing authorisation.