Divalproex Sodium

Treats manic episodes associated with bipolar disorder Monotherapy and adjunctive therapy…. ANDA 78597, held by Sun Pharm Inds. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78597 (Divalproex Sodium), held by Sun Pharm Inds, was first approved by FDA on Jul 29, 2008, with 20 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2008
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Divalproex sodium 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 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 21 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	Rx
Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Rx
Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Rx

All 21 submissions, including labeling and manufacturing supplements


Sep 19, 2025	Supplement 44Labeling · Standard review	Approved	None posted
Sep 19, 2025	Supplement 43Labeling · Standard review	Approved	None posted
Jul 15, 2024	Supplement 40Labeling · Standard review	Approved	None posted
Oct 6, 2023	Supplement 38Labeling · Standard review	Approved	None posted
Oct 6, 2023	Supplement 35Labeling · Standard review	Approved	None posted
Oct 6, 2023	Supplement 33Labeling · Standard review	Approved	None posted
Jan 30, 2020	Supplement 28Labeling · Standard review	Approved	None posted
Jan 30, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Jan 30, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Jan 30, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Jan 30, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Jan 30, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Jan 30, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Jan 30, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Jan 30, 2020	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
Mar 20, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Mar 20, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Jan 12, 2010	Supplement 3Labeling	Approved	None posted
Jul 29, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 78597
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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