FDA — authorised 23 March 1962
- Application: NDA012487
- Marketing authorisation holder: ROCHE
- Local brand name: TARACTAN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Taractan in United States
FDA authorised Taractan on 23 March 1962
Marketing authorisations
FDA — authorised 7 May 1962
- Application: NDA012486
- Marketing authorisation holder: ROCHE
- Local brand name: TARACTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 1967
- Marketing authorisation holder: ROCHE
- Status: approved
FDA — authorised 19 June 1967
- Application: NDA016149
- Marketing authorisation holder: ROCHE
- Local brand name: TARACTAN
- Indication: CONCENTRATE — ORAL
- Status: approved
Taractan 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 Taractan approved in United States?
Yes. FDA authorised it on 23 March 1962; FDA authorised it on 7 May 1962; FDA authorised it on 19 June 1967.
Who is the marketing authorisation holder for Taractan in United States?
ROCHE holds the US marketing authorisation.