FDA — authorised 4 August 2000
- Application: NDA021168
- Marketing authorisation holder: ABBVIE
- Local brand name: DEPAKOTE ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Divalproex (DIV) ER on 4 August 2000
Yes. FDA authorised it on 4 August 2000; FDA authorised it on 20 December 2002; FDA authorised it on 24 March 2008.
ABBVIE holds the US marketing authorisation.