Depakote Er

Treats manic or mixed episodes associated with bipolar disorder, with or without…. NDA 21168, held by Abbvie. Divalproex Sodium.

As of Nov 14, 2026, NDA 21168 (Depakote Er), held by Abbvie, was first approved by FDA on Aug 4, 2000, with 41 approved supplements and 0 published complete response letters.

First approved: Aug 4, 2000
Review: Standard
Supplements approved: 41
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Depakote ER is indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures Prophylaxis of migraine headaches 1.1 Mania Depakote ER is a valproate and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 42 submissions below


Mar 24, 2008	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 6, 2005	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 14, 2003	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Aug 4, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

2 strengths and forms


Depakote ErEQ 500MG VALPROIC ACID · tablet, extended release;oral	Divalproex Sodium	RxReference drug
Depakote ErEQ 250MG VALPROIC ACID · tablet, extended release;oral	Divalproex Sodium	RxReference drug

All 42 submissions, including labeling and manufacturing supplements


Mar 31, 2026	Supplement 52Labeling · Standard review	Approved	Letter Label
May 1, 2025	Supplement 49Labeling · Standard review	Approved	Medication Guide Letter Label
Jan 23, 2025	Supplement 48Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 18, 2024	Supplement 46Labeling · Standard review	Approved	Label Letter
Feb 24, 2023	Supplement 44Labeling · Standard review	Approved	Label Letter
Nov 30, 2021	Supplement 43Labeling · Standard review	Approved	Label Letter
Feb 10, 2021	Supplement 42Labeling · Standard review	Approved	Label Letter
May 19, 2020	Supplement 41Labeling · Standard review	Approved	Letter Label
Nov 22, 2019	Supplement 40Labeling · Standard review	Approved	Letter Label
Feb 21, 2019	Supplement 39Labeling · Standard review	Approved	Letter Label
Mar 6, 2018	Supplement 38Labeling · Standard review	Approved	Letter Label
Oct 5, 2017	Supplement 37Labeling · Standard review	Approved	Label Letter
Mar 6, 2017	Supplement 36Labeling · Standard review	Approved	Letter Label
Nov 2, 2016	Supplement 35Labeling · Standard review	Approved	Label Letter
May 12, 2016	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 18, 2016	Supplement 33Labeling · Standard review	Approved	Label Letter
Sep 23, 2015	Supplement 32Labeling · Standard review	Approved	Label Letter
Mar 20, 2015	Supplement 30Labeling · Standard review	Approved	Label Letter
Mar 13, 2015	Supplement 31Labeling · Standard review	Approved	Letter Label
Jan 7, 2015	Supplement 27Labeling · Standard review	Approved	Letter Label
Nov 20, 2014	Supplement 26Labeling · Standard review	Approved	Label Letter
Aug 20, 2014	Supplement 29Labeling · Standard review	Approved	Label Letter
Jun 19, 2014	Supplement 19Labeling · Standard review	Approved	Letter Label
Jun 9, 2014	Supplement 28Labeling · Standard review	Approved	Letter Label
Jul 31, 2013	Supplement 24Labeling · Standard review	Approved	Letter Label
Jun 14, 2013	Supplement 25Labeling · Standard review	Approved	Label
Feb 27, 2013	Supplement 23Labeling · Standard review	Approved	Letter Label
Oct 7, 2011	Supplement 22Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 20Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 17Labeling · Standard review	Approved	Letter Label
Oct 7, 2011	Supplement 16Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 18Labeling	Approved	Label Letter
Mar 24, 2008	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 13, 2006	Supplement 14Labeling · Standard review	Approved	Letter Label
Jan 11, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 6, 2005	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 14, 2003	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Apr 20, 2003	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 20, 2002	Supplement 4Labeling · Standard review	Approved	Review Letter Label
Dec 12, 2002	Supplement 3Labeling · Standard review	Approved	Letter
May 31, 2002	Supplement 1Manufacturing · Standard review	Approved	Label Letter
Aug 4, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 21168
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters