Depacon

NDA 20593, held by Abbvie. Valproate Sodium.

First approved: Dec 30, 1996
Review: Standard
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Jan 24, 2002	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 30, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
DepaconEQ 100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Valproate Sodium	Discontinued · reference drug

All 33 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 19, 2020	Supplement 41Labeling · Standard review	Approved	Letter Label
Nov 22, 2019	Supplement 40Labeling · Standard review	Approved	Letter Label
Feb 21, 2019	Supplement 39Labeling · Standard review	Approved	Letter Label
Mar 6, 2018	Supplement 38Labeling · Standard review	Approved	Letter Label
Oct 5, 2017	Supplement 37Labeling · Standard review	Approved	Label Letter
Mar 6, 2017	Supplement 36Labeling · Standard review	Approved	Letter Label
Nov 2, 2016	Supplement 35Labeling · Standard review	Approved	Label Letter
Feb 18, 2016	Supplement 34Labeling · Standard review	Approved	Letter Label
Sep 23, 2015	Supplement 33Labeling · Standard review	Approved	Label Letter
Mar 13, 2015	Supplement 32Labeling · Standard review	Approved	Letter Label
Jan 7, 2015	Supplement 29Labeling · Standard review	Approved	Label Letter
Nov 20, 2014	Supplement 28Labeling · Standard review	Approved	Label Letter
Aug 20, 2014	Supplement 31Labeling · Standard review	Approved	Label Letter
Jun 19, 2014	Supplement 19Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 30Labeling · Standard review	Approved	Letter Label
Jul 31, 2013	Supplement 26Labeling · Standard review	Approved	Letter Label
Jun 14, 2013	Supplement 27Labeling · Standard review	Approved	Label
Feb 27, 2013	Supplement 25Labeling · Standard review	Approved	Label Letter
Oct 7, 2011	Supplement 23Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 20Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 16Labeling · Standard review	Approved	Letter Label
Oct 13, 2006	Supplement 15Labeling · Standard review	Approved	Letter Label
Jan 11, 2006	Supplement 11Labeling · Standard review	Approved	Letter Label
Dec 12, 2002	Supplement 9Labeling · Standard review	Approved	Letter
Aug 12, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 26, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 24, 2002	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jun 20, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 19, 2000	Supplement 2Labeling · Standard review	Approved	None posted
May 15, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 8, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 16, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 30, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20593
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters