Divalproex Sodium

Treats manic or mixed episodes associated with bipolar disorder, with or without…. ANDA 78239, held by Zydus Pharms USA Inc. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78239 (Divalproex Sodium), held by Zydus Pharms USA Inc, was first approved by FDA on Feb 27, 2009, with 24 approved supplements and 0 published complete response letters.

First approved: Feb 27, 2009
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Divalproex sodium extended-release tablets are 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 Divalproex sodium extended-release tablets are valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Feb 27, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, extended release;oral	Divalproex Sodium	Rx
Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, extended release;oral	Divalproex Sodium	Rx

All 25 submissions, including labeling and manufacturing supplements


Jun 3, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Jul 28, 2023	Supplement 32Labeling · Standard review	Approved	None posted
Jul 28, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Jul 28, 2023	Supplement 27Labeling · Standard review	Approved	None posted
Jul 28, 2023	Supplement 26Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 24Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 23Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 21Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 15Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Sep 19, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Sep 19, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Sep 19, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Sep 19, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Sep 19, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Sep 19, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Aug 4, 2009	Supplement 2	Approved	None posted
Aug 4, 2009	Supplement 1Labeling	Approved	None posted
Feb 27, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78239
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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