Divalproex Sodium

ANDA 76941, held by Teva. Divalproex Sodium.

As of Nov 14, 2026, ANDA 76941 (Divalproex Sodium), held by Teva, was first approved by FDA on Jul 29, 2008, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2008
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jul 29, 2008	Original application	Approved	Label Letter

Products

3 strengths and forms


Divalproex SodiumEQ 125MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Discontinued
Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Discontinued
Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Oct 13, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 21Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 23Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Feb 20, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Feb 20, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Feb 20, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Feb 20, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Feb 20, 2016	Supplement 16Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 5Labeling	Approved	None posted
Sep 13, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Jan 20, 2010	Supplement 3Labeling	Approved	None posted
Jul 29, 2008	Original application	Approved	Label Letter

Identifiers

Application: ANDA 76941
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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