Divalproex Sodium

ANDA 78791, held by Impax Labs. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78791 (Divalproex Sodium), held by Impax Labs, was first approved by FDA on May 6, 2009, with 14 approved supplements and 0 published complete response letters.

First approved: May 6, 2009
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 6, 2009	Original application	Approved	None posted

Products

2 strengths and forms


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

All 15 submissions, including labeling and manufacturing supplements


Sep 23, 2026	Supplement 21Labeling · Standard review	Approved	None posted
Sep 23, 2026	Supplement 22Labeling · Standard review	Approved	None posted
Sep 23, 2026	Supplement 23Labeling · Standard review	Approved	None posted
Sep 23, 2026	Supplement 24Labeling · Standard review	Approved	None posted
Sep 23, 2026	Supplement 25Labeling · Standard review	Approved	None posted
Sep 23, 2026	Supplement 26Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Feb 16, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Aug 4, 2009	Supplement 1	Approved	None posted
Aug 4, 2009	Supplement 2Labeling	Approved	None posted
May 6, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78791
Drugs@FDA: Overview at FDA
Company: Impax 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