Divalproex Sodium

ANDA 78919, held by Zydus Pharms USA Inc. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78919 (Divalproex Sodium), held by Zydus Pharms USA Inc, was first approved by FDA on Jan 27, 2009, with 19 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2009
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Divalproex sodium delayed-release capsules are an anti-epileptic drug indicated for: 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 1.1 Epilepsy Divalproex sodium delayed-release capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Divalproex SodiumEQ 125MG VALPROIC ACID · capsule, delayed rel pellets;oral	Divalproex Sodium	Rx

All 20 submissions, including labeling and manufacturing supplements


Jul 6, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Jul 6, 2020	Supplement 24Labeling · 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
Jan 9, 2020	Supplement 17Labeling · 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 20Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 16Labeling · Standard review	Approved	None posted
May 11, 2015	Supplement 15Labeling · Standard review	Approved	None posted
May 11, 2015	Supplement 13Labeling · Standard review	Approved	None posted
May 11, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Feb 11, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Feb 11, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Feb 11, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Apr 2, 2010	Supplement 4Labeling	Approved	None posted
Jan 7, 2010	Supplement 3Labeling	Approved	None posted
Jan 27, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78919
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