FDA — authorised 3 April 2017
- Marketing authorisation holder: TEVA PHARMS USA INC
- Status: approved
🇺🇸 Austedo in United States
FDA authorised Austedo on 3 April 2017
Marketing authorisations
FDA — authorised 3 April 2017
- Application: NDA208082
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: AUSTEDO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 August 2017
- Application: NDA209885
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: AUSTEDO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 July 2024
- Application: NDA216354
- Marketing authorisation holder: TEVA
- Indication: Manufacturing (CMC)
- Status: approved
Teva Pharmaceuticals has been granted marketing authorisation by the FDA for Austedo, a pharmaceutical product. This authorisation was awarded on 1 July 2024, following a standard review process. The approval is for manufacturing (CMC) purposes, as indicated by the application number NDA216354.
FDA — authorised 26 December 2024
- Application: ANDA215971
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DEUTETRABENAZINE
- Indication: TABLET — ORAL
- Status: approved
Austedo 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 Austedo approved in United States?
Yes. FDA authorised it on 3 April 2017; FDA authorised it on 3 April 2017; FDA authorised it on 30 August 2017.
Who is the marketing authorisation holder for Austedo in United States?
TEVA PHARMS USA INC holds the US marketing authorisation.