FDA — authorised 29 July 2008
- Application: ANDA078755
- Marketing authorisation holder: DR REDDYS LABS LTD
- Status: approved
🇺🇸 Divalproex in United States
FDA authorised Divalproex on 29 July 2008
Marketing authorisations
FDA — authorised 23 January 2009
- Application: ANDA078979
- Marketing authorisation holder: DR REDDYS LABS LTD
- Status: supplemented
FDA — authorised 29 January 2009
- Application: ANDA077567
- Marketing authorisation holder: MYLAN
- Status: supplemented
FDA — authorised 25 February 2022
- Application: ANDA214643
- Marketing authorisation holder: UNICHEM
- Status: supplemented
FDA — authorised 26 September 2023
- Application: ANDA215527
- Marketing authorisation holder: ANNORA PHARMA
- Status: supplemented
FDA
- Status: approved
Other Neuroscience approved in United States
Frequently asked questions
Is Divalproex approved in United States?
Yes. FDA authorised it on 29 July 2008; FDA authorised it on 23 January 2009; FDA authorised it on 29 January 2009.
Who is the marketing authorisation holder for Divalproex in United States?
DR REDDYS LABS LTD holds the US marketing authorisation.