Divalproex Sodium

ANDA 77296, held by Chartwell Rx. Divalproex Sodium.

As of Nov 14, 2026, ANDA 77296 (Divalproex Sodium), held by Chartwell Rx, was first approved by FDA on Jul 31, 2008, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 31, 2008
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 31, 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 11 submissions, including labeling and manufacturing supplements


Jul 31, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Mar 8, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Mar 8, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Jan 6, 2014	Supplement 2Manufacturing	Approved	None posted
Jan 21, 2011	Supplement 3Labeling	Approved	None posted
Jul 31, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 77296
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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