Divalproex Sodium

Treats manic episodes associated with bipolar disorder. ANDA 78853, held by Orbion Pharms. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78853 (Divalproex Sodium), held by Orbion Pharms, was first approved by FDA on Nov 25, 2008, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 25, 2008
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Divalproex sodium delayed-release tablets are 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 14 submissions below

Date	Submission	Status	Documents
Nov 25, 2008	Original application	Approved	None posted

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 14 submissions, including labeling and manufacturing supplements


Nov 22, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Nov 22, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Jan 11, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 13Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Jan 7, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Mar 18, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Mar 18, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Mar 18, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Jan 20, 2010	Supplement 1Labeling	Approved	None posted
Nov 25, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78853
Drugs@FDA: Overview at FDA
Company: Orbion Pharmaceuticals

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