Divalproex Sodium

ANDA 78700, held by Cosette Pharms Nc. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78700 (Divalproex Sodium), held by Cosette Pharms Nc, was first approved by FDA on Aug 3, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2009
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 3, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Oct 2, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Oct 2, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Oct 2, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Sep 27, 2011	Supplement 1Labeling	Approved	None posted
Aug 3, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78700
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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