Divalproex Sodium

Treats manic or mixed episodes associated with bipolar disorder, with or without…. ANDA 209286, held by Lupin. Divalproex Sodium.

As of Nov 14, 2026, ANDA 209286 (Divalproex Sodium), held by Lupin, was first approved by FDA on Oct 18, 2019, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 18, 2019
Review: Standard
Supplements approved: 8
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 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 9 submissions below

Date	Submission	Status	Documents
Oct 18, 2019	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 9 submissions, including labeling and manufacturing supplements


Jun 11, 2026	Supplement 17Labeling · Standard review	Approved	None posted
Jun 11, 2026	Supplement 19Labeling · Standard review	Approved	None posted
Jun 11, 2026	Supplement 20Labeling · Standard review	Approved	None posted
Jul 10, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Jul 10, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Nov 16, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Nov 16, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Nov 16, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Oct 18, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 209286
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