Divalproex Sodium

ANDA 78979, held by Dr Reddys Labs Ltd. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78979 (Divalproex Sodium), held by Dr Reddys Labs Ltd, was first approved by FDA on Jan 23, 2009, with 25 approved supplements and 0 published complete response letters.

First approved: Jan 23, 2009
Supplements approved: 25
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 26 submissions below

Date	Submission	Status	Documents
Jan 23, 2009	Original application	Approved	Letter

Products

1 strengths and forms

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

All 26 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 32Labeling · Standard review	Approved	None posted
Oct 14, 2026	Supplement 30Labeling · Standard review	Approved	None posted
Oct 14, 2026	Supplement 29Labeling · Standard review	Approved	None posted
Oct 14, 2026	Supplement 28Labeling · Standard review	Approved	None posted
Oct 11, 2023	Supplement 27Labeling · Standard review	Approved	None posted
Jan 11, 2023	Supplement 26Labeling · Standard review	Approved	None posted
Jan 11, 2023	Supplement 24Labeling · Standard review	Approved	None posted
Jul 6, 2020	Supplement 23Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 21Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 18Labeling · Standard review	Approved	None posted
May 19, 2016	Supplement 16Labeling · Standard review	Approved	None posted
May 19, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Aug 18, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Aug 18, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Aug 18, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Feb 5, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Feb 5, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Feb 5, 2014	Supplement 6Labeling	Approved	None posted
Jan 21, 2011	Supplement 4Labeling	Approved	None posted
Jan 7, 2010	Supplement 3Labeling	Approved	None posted
Jan 23, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 78979
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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