FDA — authorised 11 March 1968
- Application: NDA016608
- Marketing authorisation holder: NOVARTIS
- Local brand name: TEGRETOL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Carbamazepine-Containing Product in Oral Dose Form in United States
FDA authorised Carbamazepine-Containing Product in Oral Dose Form on 11 March 1968
Marketing authorisations
FDA — authorised 14 December 1981
- Application: NDA018281
- Marketing authorisation holder: NOVARTIS
- Local brand name: TEGRETOL
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA
- Status: approved
Carbamazepine-Containing Product in Oral Dose Form in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Carbamazepine-Containing Product in Oral Dose Form approved in United States?
Yes. FDA authorised it on 11 March 1968; FDA authorised it on 14 December 1981; FDA has authorised it.
Who is the marketing authorisation holder for Carbamazepine-Containing Product in Oral Dose Form in United States?
NOVARTIS holds the US marketing authorisation.