FDA — authorised 15 August 2008
- Application: NDA021894
- Marketing authorisation holder: BAUSCH
- Local brand name: XENAZINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Xenazine in United States
FDA authorised Xenazine on 15 August 2008
Marketing authorisations
FDA — authorised 17 August 2015
- Application: ANDA206129
- Marketing authorisation holder: SUN PHARM
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 2016
- Application: ANDA204574
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2017
- Application: ANDA207682
- Marketing authorisation holder: MYLAN
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2017
- Application: ANDA206686
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 December 2017
- Application: ANDA208826
- Marketing authorisation holder: BIONPHARMA
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 January 2018
- Application: ANDA209284
- Marketing authorisation holder: DR REDDYS
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 2018
- Application: ANDA210544
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2019
- Application: ANDA209739
- Marketing authorisation holder: HIKMA
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2020
- Application: ANDA213316
- Marketing authorisation holder: ADAPTIS
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2020
- Application: ANDA206093
- Marketing authorisation holder: APOTEX
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2020
- Application: ANDA213621
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: TETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Xenazine 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 Xenazine approved in United States?
Yes. FDA authorised it on 15 August 2008; FDA authorised it on 17 August 2015; FDA authorised it on 3 February 2016.
Who is the marketing authorisation holder for Xenazine in United States?
BAUSCH holds the US marketing authorisation.