FDA — authorised 4 August 2000
- Application: NDA021168
- Marketing authorisation holder: ABBVIE
- Local brand name: DEPAKOTE ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Depakote ER in United States
FDA authorised Depakote ER on 4 August 2000
Marketing authorisations
FDA — authorised 20 December 2002
- Application: NDA020782
- Marketing authorisation holder: ABBOTT
- Local brand name: DEPAKOTE ER
- Indication: Tablet, Extended Release — Oral
- Status: approved
FDA — authorised 24 March 2008
- Application: NDA022267
- Marketing authorisation holder: ABBVIE INC
- Local brand name: DEPAKOTE ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 July 2008
- Application: ANDA078290
- Marketing authorisation holder: INVATECH
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 29 July 2008
- Application: ANDA078597
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 25 November 2008
- Application: ANDA078853
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 23 January 2009
- Application: ANDA078979
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: DIVALPROEX SODIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA078919
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: DIVALPROEX SODIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 27 February 2009
- Application: ANDA078239
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 March 2009
- Application: ANDA077100
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 30 November 2009
- Application: ANDA090210
- Marketing authorisation holder: PRINSTON INC
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 5 April 2011
- Application: ANDA079163
- Marketing authorisation holder: UNICHEM LABS LTD
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 21 April 2011
- Application: ANDA090554
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 15 March 2012
- Application: ANDA090161
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 May 2015
- Application: ANDA203730
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 October 2019
- Application: ANDA209286
- Marketing authorisation holder: LUPIN
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 February 2020
- Application: ANDA213181
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: DIVALPROEX SODIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 17 November 2020
- Application: ANDA211505
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: DIVALPROEX SODIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 15 March 2021
- Application: ANDA214462
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: DIVALPROEX SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 December 2024
- Application: ANDA218793
- Marketing authorisation holder: ALEMBIC
- Local brand name: DIVALPROEX SODIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 12 August 2025
- Application: ANDA217358
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: DIVALPROEX SODIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA
- Status: approved
Depakote ER in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Depakote ER approved in United States?
Yes. FDA authorised it on 4 August 2000; FDA authorised it on 20 December 2002; FDA authorised it on 24 March 2008.
Who is the marketing authorisation holder for Depakote ER in United States?
ABBVIE holds the US marketing authorisation.