Depakote

Treats manic episodes associated with bipolar disorder Monotherapy and adjunctive therapy…. NDA 18723, held by Abbvie. Divalproex Sodium.

As of Nov 14, 2026, NDA 18723 (Depakote), held by Abbvie, was first approved by FDA on Mar 10, 1983, with 56 approved supplements and 0 published complete response letters.

First approved: Mar 10, 1983
Review: Standard
Supplements approved: 56
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Depakote is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder 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 (divalproex sodium) is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. 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 57 submissions below


Jun 20, 1996	Supplement 20Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 18, 1996	Supplement 17Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 10, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


DepakoteEQ 250MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	RxReference drug
DepakoteEQ 500MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	RxReference drug
DepakoteEQ 125MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	RxReference drug

All 57 submissions, including labeling and manufacturing supplements


Mar 31, 2026	Supplement 73Labeling · Standard review	Approved	Letter Label Medication Guide
May 1, 2025	Supplement 70Labeling · Standard review	Approved	Letter Label
Jan 23, 2025	Supplement 69Labeling · Standard review	Approved	Label Letter
Mar 18, 2024	Supplement 68Labeling · Standard review	Approved	Label Letter
Feb 24, 2023	Supplement 66Labeling · Standard review	Approved	Label Letter
Nov 30, 2021	Supplement 65Labeling · Standard review	Approved	Label Letter
Feb 10, 2021	Supplement 64Labeling · Standard review	Approved	Label Letter
May 19, 2020	Supplement 63Labeling · Standard review	Approved	Letter Label
Nov 22, 2019	Supplement 62Labeling · Standard review	Approved	Letter Label
Feb 21, 2019	Supplement 61Labeling · Standard review	Approved	Letter Label
Mar 6, 2018	Supplement 60Labeling · Standard review	Approved	Letter Label
Oct 5, 2017	Supplement 59Labeling · Standard review	Approved	Label Letter
Mar 6, 2017	Supplement 58Labeling · Standard review	Approved	Letter Label
Nov 2, 2016	Supplement 57Labeling · Standard review	Approved	Label Letter
Feb 18, 2016	Supplement 56Labeling · Standard review	Approved	Label Letter
Sep 23, 2015	Supplement 55Labeling · Standard review	Approved	Label Letter
Mar 13, 2015	Supplement 54Labeling · Standard review	Approved	Letter Label
Jan 7, 2015	Supplement 51Labeling · Standard review	Approved	Letter Label
Nov 20, 2014	Supplement 50Labeling · Standard review	Approved	Label Letter
Aug 20, 2014	Supplement 53Labeling · Standard review	Approved	Label Letter
Jun 19, 2014	Supplement 41Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 52Labeling · Standard review	Approved	Letter Label
Jul 31, 2013	Supplement 48Labeling · Standard review	Approved	Label Letter
Jun 14, 2013	Supplement 49Labeling · Standard review	Approved	Label
Feb 27, 2013	Supplement 47Labeling · Standard review	Approved	Label Letter
Oct 7, 2011	Supplement 43Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 45Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 46Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 40Labeling · Standard review	Approved	Letter Label
Oct 7, 2011	Supplement 37Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 39Labeling	Approved	Label Letter
Oct 13, 2006	Supplement 33Labeling · Standard review	Approved	Letter Label
Jan 11, 2006	Supplement 32Labeling · Standard review	Approved	Letter Label
Dec 12, 2002	Supplement 29Labeling · Standard review	Approved	Letter
Dec 9, 2002	Supplement 31Manufacturing · Standard review	Approved	None posted
Nov 5, 2002	Supplement 30Manufacturing · Standard review	Approved	None posted
Jun 19, 2000	Supplement 28Labeling · Standard review	Approved	None posted
Sep 22, 1998	Supplement 27Manufacturing · Standard review	Approved	None posted
May 8, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 2, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 24, 1997	Supplement 24Manufacturing · Standard review	Approved	None posted
Dec 2, 1996	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 20, 1996	Supplement 20Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 18, 1996	Supplement 17Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 23, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 22, 1994	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 18, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 16, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 21, 1989	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 17, 1988	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 24, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 11, 1986	Supplement 4Labeling	Approved	None posted
Aug 11, 1986	Supplement 2Labeling	Approved	None posted
Dec 23, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 6, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 26, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 10, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Show all 57

Identifiers

Application: NDA 18723
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