Divalproex Sodium

ANDA 78411, held by Ph Health. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78411 (Divalproex Sodium), held by Ph Health, was first approved by FDA on Nov 3, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 3, 2008
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 3, 2008	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Mar 3, 2010	Supplement 1Labeling	Approved	None posted
Nov 3, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78411
Drugs@FDA: Overview at FDA
Company: PH Health

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