FDA — authorised 27 October 1986
- Application: NDA019032
- Marketing authorisation holder: PROMIUS PHARMA
- Local brand name: TENEX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Tenex in United States
FDA authorised Tenex on 27 October 1986
Marketing authorisations
FDA — authorised 27 October 1986
- Marketing authorisation holder: PROMIUS PHARMA
- Status: approved
FDA — authorised 17 October 1995
- Application: ANDA074145
- Marketing authorisation holder: WATSON LABS
- Status: approved
FDA — authorised 2 September 2009
- Application: NDA022037
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 22 August 2016
- Application: ANDA074796
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Indication: Labeling
- Status: approved
FDA — authorised 19 November 2024
- Application: ANDA219033
- Marketing authorisation holder: UNICHEM
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA219689
- Marketing authorisation holder: RUBICON RESEARCH
- Status: approved
Tenex 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 Tenex approved in United States?
Yes. FDA authorised it on 27 October 1986; FDA authorised it on 27 October 1986; FDA authorised it on 17 October 1995.
Who is the marketing authorisation holder for Tenex in United States?
PROMIUS PHARMA holds the US marketing authorisation.