Divalproex Sodium

ANDA 90407, held by Rising. Divalproex Sodium.

As of Nov 14, 2026, ANDA 90407 (Divalproex Sodium), held by Rising, was first approved by FDA on Mar 28, 2011, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 28, 2011
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Mar 28, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Divalproex SodiumEQ 125MG VALPROIC ACID · capsule, delayed rel pellets;oral	Divalproex Sodium	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Jan 24, 2026	Supplement 18Labeling · Standard review	Approved	None posted
Jan 24, 2026	Supplement 17Labeling · Standard review	Approved	None posted
Jan 24, 2026	Supplement 15Labeling · Standard review	Approved	None posted
Jun 25, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Jun 25, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Jun 25, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Jun 25, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Jun 25, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Jun 25, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Jun 25, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Dec 8, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Dec 30, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Dec 30, 2013	Supplement 2Labeling	Approved	None posted
Mar 28, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90407
Drugs@FDA: Overview at FDA
Company: Rising 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