Depakote Cp

NDA 19794, held by Abbott. Divalproex Sodium.

As of Nov 13, 2026, NDA 19794 (Depakote Cp), held by Abbott, was first approved by FDA on Jul 11, 1990, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 11, 1990
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 11, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Depakote CpEQ 250MG BASE · tablet, delayed release;oral	Divalproex Sodium	Discontinued
Depakote CpEQ 500MG BASE · tablet, delayed release;oral	Divalproex Sodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 2, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 23, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 11, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19794
Drugs@FDA: Overview at FDA
Company: Abbott

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