FDA — authorised 6 November 1964
- Application: NDA014685
- Marketing authorisation holder: RANBAXY
- Local brand name: AVENTYL
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Aventyl in United States
FDA authorised Aventyl on 6 November 1964
Marketing authorisations
FDA — authorised 6 November 1964
- Status: approved
FDA — authorised 15 April 1994
- Application: NDA018013
- Marketing authorisation holder: SPECGX LLC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 20 February 2002
- Application: ANDA074132
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
FDA — authorised 3 August 2007
- Application: ANDA075520
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
FDA — authorised 24 February 2021
- Application: ANDA213441
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
FDA — authorised 15 August 2023
- Application: ANDA217731
- Marketing authorisation holder: RUBICON RESEARCH
- Status: approved
Aventyl 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 Aventyl approved in United States?
Yes. FDA authorised it on 6 November 1964; FDA authorised it on 6 November 1964; FDA authorised it on 15 April 1994.
Who is the marketing authorisation holder for Aventyl in United States?
RANBAXY holds the US marketing authorisation.