Divalproex Sodium

ANDA 218793, held by Alembic. Divalproex Sodium.

As of Nov 14, 2026, ANDA 218793 (Divalproex Sodium), held by Alembic, was first approved by FDA on Dec 19, 2024, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 19, 2024
Review: Standard
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Dec 19, 2024	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 4 submissions, including labeling and manufacturing supplements


Oct 5, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Oct 5, 2026	Supplement 2Labeling · Standard review	Approved	None posted
Oct 5, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Dec 19, 2024	Original application	Approved	None posted

Identifiers

Application: ANDA 218793
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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