Divalproex Sodium

Treats manic or mixed episodes associated with bipolar disorder, with or without…. ANDA 77567, held by Mylan. Divalproex Sodium.

As of Nov 14, 2026, ANDA 77567 (Divalproex Sodium), held by Mylan, was first approved by FDA on Jan 29, 2009, with 21 approved supplements and 0 published complete response letters.

First approved: Jan 29, 2009
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (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 a 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 22 submissions below

Date	Submission	Status	Documents
Jan 29, 2009	Original application	Approved	Label Letter

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 22 submissions, including labeling and manufacturing supplements


Jun 12, 2026	Supplement 39Labeling · Standard review	Approved	None posted
Sep 2, 2025	Supplement 36Labeling · Standard review	Approved	None posted
Sep 2, 2025	Supplement 37Labeling · Standard review	Approved	None posted
Sep 2, 2025	Supplement 38Labeling · Standard review	Approved	None posted
Oct 23, 2023	Supplement 28Labeling · Standard review	Approved	None posted
Oct 23, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Oct 23, 2023	Supplement 32Labeling · Standard review	Approved	None posted
Oct 23, 2023	Supplement 34Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 24Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Sep 22, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Sep 22, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Sep 22, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Sep 10, 2010	Supplement 5Labeling	Approved	None posted
Jan 29, 2009	Original application	Approved	Label Letter

Identifiers

Application: ANDA 77567
Drugs@FDA: Overview at FDA
Company: Mylan

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