Divalproex Sodium

ANDA 90210, held by Prinston. Divalproex Sodium.

As of Nov 14, 2026, ANDA 90210 (Divalproex Sodium), held by Prinston, was first approved by FDA on Nov 30, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 30, 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
Nov 30, 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 7 submissions, including labeling and manufacturing supplements


Nov 26, 2014	Supplement 2Labeling	Approved	None posted
Nov 26, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Nov 26, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Nov 30, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90210
Drugs@FDA: Overview at FDA
Company: Prinston Pharmaceutical

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