Depakote

NDA 19680, held by Abbvie. Divalproex Sodium.

As of Nov 13, 2026, NDA 19680 (Depakote), held by Abbvie, was first approved by FDA on Sep 12, 1989, with 44 approved supplements and 0 published complete response letters.

First approved: Sep 12, 1989
Review: Standard
Supplements approved: 44
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Depakote Sprinkle Capsules are an anti-epileptic drug indicated for: 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 1.1 Epilepsy Depakote Sprinkle Capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 45 submissions below


Mar 24, 2008	Supplement 24Efficacy (new indication or use) · Priority review	Approved	None posted
Jun 20, 1996	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 12, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
DepakoteEQ 125MG VALPROIC ACID · capsule, delayed rel pellets;oral	Divalproex Sodium	RxReference drug

All 45 submissions, including labeling and manufacturing supplements


Mar 31, 2026	Supplement 60Labeling · Standard review	Approved	Letter Label
May 1, 2025	Supplement 57Labeling · Standard review	Approved	Letter Label
Jan 23, 2025	Supplement 56Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 18, 2024	Supplement 55Labeling · Standard review	Approved	Label Letter
Feb 24, 2023	Supplement 53Labeling · Standard review	Approved	Label Letter
Nov 30, 2021	Supplement 52Labeling · Standard review	Approved	Label Letter
Feb 10, 2021	Supplement 51Labeling · Standard review	Approved	Label Letter
May 19, 2020	Supplement 50Labeling · Standard review	Approved	Letter Label
Nov 22, 2019	Supplement 49Labeling · Standard review	Approved	Label Letter
Feb 21, 2019	Supplement 48Labeling · Standard review	Approved	Letter Label
Mar 6, 2018	Supplement 47Labeling · Standard review	Approved	Letter Label
Oct 5, 2017	Supplement 46Labeling · Standard review	Approved	Label Letter
Mar 6, 2017	Supplement 45Labeling · Standard review	Approved	Letter Label
Nov 2, 2016	Supplement 44Labeling · Standard review	Approved	Label Letter
Feb 18, 2016	Supplement 43Labeling · Standard review	Approved	Letter Label
Sep 23, 2015	Supplement 42Labeling · Standard review	Approved	Label Letter
Mar 13, 2015	Supplement 41Labeling · Standard review	Approved	Letter Label
Jan 7, 2015	Supplement 38Labeling · Standard review	Approved	Letter Label
Nov 20, 2014	Supplement 37Labeling · Standard review	Approved	Label Letter
Aug 20, 2014	Supplement 40Labeling · Standard review	Approved	Label Letter
Jun 20, 2014	Supplement 33Labeling	Approved	Letter Label
Jun 19, 2014	Supplement 28Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 39Labeling · Standard review	Approved	Letter Label
Jul 31, 2013	Supplement 35Labeling · Standard review	Approved	Letter Label
Jun 14, 2013	Supplement 36Labeling · Standard review	Approved	Label
Feb 27, 2013	Supplement 34Labeling · Standard review	Approved	Label Letter
Oct 7, 2011	Supplement 31Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 29Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 7, 2011	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 26Labeling	Approved	Label Letter
Mar 24, 2008	Supplement 24Efficacy (new indication or use) · Priority review	Approved	None posted
Dec 19, 2006	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 13, 2006	Supplement 22Labeling · Standard review	Approved	Letter Label
Jan 11, 2006	Supplement 19Labeling · Standard review	Approved	Letter Label
Dec 12, 2002	Supplement 15Labeling · Standard review	Approved	Letter
Nov 5, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 19, 2000	Supplement 14Labeling · Standard review	Approved	None posted
May 8, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 2, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 20, 1996	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 26, 1996	Supplement 10Labeling · Standard review	Approved	None posted
Mar 23, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 14, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 12, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19680
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