Divalproex Sodium

ANDA 78445, held by Ph Health. Divalproex Sodium.

As of Nov 14, 2026, ANDA 78445 (Divalproex Sodium), held by Ph Health, was first approved by FDA on Feb 26, 2009, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 26, 2009
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Feb 26, 2009	Original application	Approved	None posted

Products

2 strengths and forms


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

All 11 submissions, including labeling and manufacturing supplements


Feb 28, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Feb 28, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Feb 28, 2016	Supplement 16Labeling · Standard review	Approved	None posted
Oct 26, 2014	Supplement 5Labeling	Approved	None posted
Oct 26, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Oct 26, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Oct 26, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Aug 4, 2009	Supplement 2	Approved	None posted
Aug 4, 2009	Supplement 3	Approved	None posted
Aug 4, 2009	Supplement 4Labeling	Approved	None posted
Feb 26, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78445
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