Divalproex Sodium

ANDA 77100, held by Zydus Pharms USA Inc. Divalproex Sodium.

As of Nov 14, 2026, ANDA 77100 (Divalproex Sodium), held by Zydus Pharms USA Inc, was first approved by FDA on Mar 5, 2009, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 5, 2009
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Mar 5, 2009	Original application	Approved	None posted

Products

3 strengths and forms


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

All 17 submissions, including labeling and manufacturing supplements


Jan 9, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 28Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 29Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 30Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 20Labeling · Standard review	Approved	None posted
Feb 17, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Feb 17, 2015	Supplement 16Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Sep 13, 2014	Supplement 13Labeling · Standard review	Approved	None posted
Jan 14, 2010	Supplement 1Labeling	Approved	None posted
Mar 5, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 77100
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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