Divalproex Sodium

ANDA 79080, held by Actavis Labs Fl Inc. Divalproex Sodium.

As of Nov 14, 2026, ANDA 79080 (Divalproex Sodium), held by Actavis Labs Fl Inc, was first approved by FDA on Feb 25, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 25, 2011
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Feb 25, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Oct 14, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Oct 14, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Feb 25, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 79080
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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