Divalproex Sodium

Treats manic episodes associated with bipolar disorder Monotherapy and adjunctive therapy…. ANDA 78790, held by Lupin. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78790 (Divalproex Sodium), held by Lupin, was first approved by FDA on Jul 29, 2008, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2008
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Divalproex sodium delayed-release tablet 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 Divalproex sodium delayed-release tablet 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 23 submissions below

Date	Submission	Status	Documents
Jul 29, 2008	Original application	Approved	Letter

Products

3 strengths and forms


Divalproex SodiumEQ 125MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Discontinued
Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Discontinued
Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Discontinued

All 23 submissions, including labeling and manufacturing supplements


May 28, 2026	Supplement 32Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 31Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 30Labeling · Standard review	Approved	None posted
Aug 13, 2024	Supplement 29Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 28Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 27Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 26Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 25Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 24Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 23Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 21Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Jan 14, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 14Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 13Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Jan 20, 2010	Supplement 2Labeling	Approved	None posted
Jul 29, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 78790
Drugs@FDA: Overview at FDA
Company: Lupin

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