Divalproex Sodium

ANDA 78705, held by Sciegen Pharms. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78705 (Divalproex Sodium), held by Sciegen Pharms, was first approved by FDA on Feb 10, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 10, 2009
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Feb 10, 2009	Original application	Approved	Review

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Nov 8, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Aug 5, 2009	Supplement 4Labeling	Approved	None posted
Aug 4, 2009	Supplement 3Labeling	Approved	None posted
Aug 4, 2009	Supplement 2	Approved	None posted
Aug 4, 2009	Supplement 1	Approved	None posted
Feb 10, 2009	Original application	Approved	Review

Identifiers

Application: ANDA 78705
Drugs@FDA: Overview at FDA
Company: ScieGen 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