FDA — authorised 6 August 1959
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Status: approved
🇺🇸 Tenuate in United States
FDA authorised Tenuate on 6 August 1959
Marketing authorisations
FDA — authorised 6 August 1959
- Application: NDA011722
- Marketing authorisation holder: MPP PHARMA
- Local brand name: TENUATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 1975
- Application: NDA017669
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: TENUATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 1975
- Application: NDA017668
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: TENUATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2010
- Application: ANDA201212
- Marketing authorisation holder: AVANTHI INC
- Status: approved
FDA — authorised 18 July 2011
- Application: ANDA200177
- Marketing authorisation holder: LANNETT CO INC
- Status: approved
FDA — authorised 24 October 2011
- Application: ANDA091680
- Marketing authorisation holder: LANNETT CO INC
- Indication: Not Applicable
- Status: approved
Tenuate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Tenuate approved in United States?
Yes. FDA authorised it on 6 August 1959; FDA authorised it on 6 August 1959; FDA authorised it on 20 March 1975.
Who is the marketing authorisation holder for Tenuate in United States?
ACTAVIS LABS UT INC holds the US marketing authorisation.