FDA — authorised 23 June 1972
- Marketing authorisation holder: RECORDATI RARE
- Status: approved
🇺🇸 Tranxene in United States
FDA authorised Tranxene on 23 June 1972
Marketing authorisations
FDA — authorised 23 June 1972
- Application: NDA017105
- Marketing authorisation holder: AJENAT PHARMS
- Local brand name: TRANXENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 January 2010
- Application: ANDA071858
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 14 June 2022
- Application: ANDA215566
- Marketing authorisation holder: COREPHARMA
- Status: approved
FDA — authorised 28 June 2023
- Application: ANDA213730
- Marketing authorisation holder: NOVITIUM PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 17 October 2024
- Application: ANDA075731
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
TARO's Tranxene, a generic version of the medication, was granted marketing authorisation by the FDA on 17 October 2024. The approval was based on a standard expedited pathway application number ANDA075731. Tranxene is indicated for use in labelling, but the specific local brand name is not reported.
Tranxene 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 Tranxene approved in United States?
Yes. FDA authorised it on 23 June 1972; FDA authorised it on 23 June 1972; FDA authorised it on 14 January 2010.
Who is the marketing authorisation holder for Tranxene in United States?
RECORDATI RARE holds the US marketing authorisation.