Divalproex Sodium

ANDA 77615, held by Apotex. Divalproex Sodium.

As of Nov 14, 2026, ANDA 77615 (Divalproex Sodium), held by Apotex, was first approved by FDA on Jul 29, 2008, with 23 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2008
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

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

Products

3 strengths and forms


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

All 24 submissions, including labeling and manufacturing supplements


May 18, 2026	Supplement 25Labeling · Standard review	Approved	None posted
May 18, 2026	Supplement 23Labeling · Standard review	Approved	None posted
May 18, 2026	Supplement 24Labeling · Standard review	Approved	None posted
Jun 3, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 19Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 21Labeling · Standard review	Approved	None posted
Nov 27, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Nov 27, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Nov 27, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Nov 27, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Nov 27, 2019	Supplement 15Labeling · Standard review	Approved	None posted
Nov 27, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Nov 27, 2019	Supplement 17Labeling · Standard review	Approved	None posted
May 22, 2015	Supplement 7Labeling · Standard review	Approved	None posted
May 22, 2015	Supplement 8Labeling · Standard review	Approved	None posted
May 22, 2015	Supplement 9Labeling · Standard review	Approved	None posted
May 22, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Sep 16, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Sep 16, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Sep 16, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Jan 21, 2011	Supplement 3Labeling	Approved	None posted
Jul 29, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 77615
Drugs@FDA: Overview at FDA
Company: Apotex

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