Depakene

NDA 18081, held by Abbvie. Valproic Acid.

As of Nov 13, 2026, NDA 18081 (Depakene), held by Abbvie, was first approved by FDA on Feb 28, 1978, with 51 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1978
Review: Priority
Supplements approved: 51
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 52 submissions below

Date	Submission	Status	Documents
Feb 28, 1978	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Depakene250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Valproic Acid	DiscontinuedReference drug

All 52 submissions, including labeling and manufacturing supplements


May 19, 2020	Supplement 71Labeling · Standard review	Approved	Label
Nov 22, 2019	Supplement 70Labeling · Standard review	Approved	Letter Label Medication Guide
Feb 21, 2019	Supplement 69Labeling · Standard review	Approved	Letter Label
Mar 6, 2018	Supplement 68Labeling · Standard review	Approved	Letter Label
Oct 5, 2017	Supplement 67Labeling · Standard review	Approved	Label Letter
Mar 6, 2017	Supplement 66Labeling · Standard review	Approved	Letter Label
Nov 2, 2016	Supplement 65Labeling · Standard review	Approved	Label Letter
Feb 18, 2016	Supplement 64Labeling · Standard review	Approved	Letter Label
Sep 23, 2015	Supplement 63Labeling · Standard review	Approved	Label Letter
Mar 13, 2015	Supplement 62Labeling · Standard review	Approved	Letter Label
Jan 7, 2015	Supplement 59Labeling · Standard review	Approved	Label Letter
Nov 20, 2014	Supplement 58Labeling · Standard review	Approved	Label Letter
Aug 20, 2014	Supplement 61Labeling · Standard review	Approved	Label Letter
Jun 19, 2014	Supplement 49Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 60Labeling · Standard review	Approved	Letter Label
Jul 31, 2013	Supplement 56Labeling · Standard review	Approved	Label Letter
Jun 14, 2013	Supplement 57Labeling · Standard review	Approved	Label
Feb 27, 2013	Supplement 54Labeling · Standard review	Approved	Label Letter
Oct 7, 2011	Supplement 46Labeling · Standard review	Approved	Letter Label
Oct 7, 2011	Supplement 48Labeling · Standard review	Approved	Letter Label
Oct 7, 2011	Supplement 50Labeling	Approved	Letter Label
Oct 7, 2011	Supplement 52Labeling	Approved	Letter Label
Apr 23, 2009	Supplement 47Labeling	Approved	Letter
Oct 13, 2006	Supplement 44Labeling · Standard review	Approved	Letter Label
Jan 11, 2006	Supplement 42Labeling · Standard review	Approved	Letter Label
Dec 12, 2002	Supplement 38Labeling · Standard review	Approved	Letter
Dec 20, 2000	Supplement 35Manufacturing · Priority review	Approved	None posted
Jun 20, 2000	Supplement 34Manufacturing · Priority review	Approved	None posted
Jun 20, 2000	Supplement 36Manufacturing · Priority review	Approved	None posted
Jun 19, 2000	Supplement 32Labeling · Standard review	Approved	None posted
May 16, 2000	Supplement 29Labeling · Standard review	Approved	None posted
Dec 6, 1999	Supplement 33Manufacturing · Priority review	Approved	None posted
Sep 22, 1998	Supplement 31Manufacturing · Priority review	Approved	None posted
May 8, 1998	Supplement 30Manufacturing · Priority review	Approved	None posted
Dec 2, 1996	Supplement 28Manufacturing · Priority review	Approved	None posted
Mar 23, 1995	Supplement 25Manufacturing · Priority review	Approved	None posted
Mar 21, 1989	Supplement 21Manufacturing · Priority review	Approved	None posted
Dec 2, 1987	Supplement 20Manufacturing · Priority review	Approved	None posted
Aug 11, 1986	Supplement 18Labeling	Approved	None posted
May 30, 1986	Supplement 15Labeling	Approved	None posted
May 30, 1986	Supplement 17Labeling	Approved	None posted
Dec 4, 1985	Supplement 16Labeling	Approved	None posted
Oct 28, 1983	Supplement 14Manufacturing · Priority review	Approved	None posted
Sep 30, 1982	Supplement 12Manufacturing · Priority review	Approved	None posted
Dec 9, 1981	Supplement 5Labeling	Approved	None posted
Dec 9, 1981	Supplement 8Labeling	Approved	None posted
Nov 4, 1981	Supplement 7Labeling	Approved	None posted
Jun 16, 1980	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 20, 1979	Supplement 2Manufacturing · Priority review	Approved	None posted
Dec 20, 1979	Supplement 3Manufacturing · Priority review	Approved	None posted
May 3, 1979	Supplement 1Labeling	Approved	None posted
Feb 28, 1978	Original applicationNew molecular entity · Priority review	Approved	None posted

Show all 52

Identifiers

Application: NDA 18081
Drugs@FDA: Overview at FDA
Company: AbbVie

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