NDA 018081

ABBVIE

FDA Drug Application

Application #018081

Documents

• Letter: 2004-06-02
• Letter: 2011-10-13
• Letter: 2009-05-01
• Letter: 2011-10-13
• Letter: 2014-06-11
• Letter: 2016-02-23
• Label: 2014-06-23
• Label: 2011-10-12
• Label: 2011-10-12
• Label: 2013-09-17
• Label: 2014-12-03
• Label: 2015-01-08
• Label: 2014-06-10
• Letter: 2006-01-20
• Letter: 2006-10-23
• Letter: 2011-10-13
• Letter: 2014-06-23
• Letter: 2011-10-13
• Letter: 2013-03-01
• Letter: 2013-09-17
• Letter: 2014-11-24
• Letter: 2015-01-08
• Letter: 2014-08-21
• Letter: 2015-03-17
• Letter: 2015-09-25
• Other Important Information from FDA: 2008-02-01
• Label: 2006-01-13
• Label: 2006-10-18
• Label: 2011-10-12
• Label: 2011-10-12
• Label: 2013-03-04
• Label: 2013-07-02
• Label: 2014-08-22
• Label: 2015-03-17
• Label: 2015-10-06
• Label: 2016-02-23
• Letter: 2016-11-04
• Label: 2016-11-08
• Label: 2017-03-07
• Letter: 2017-03-08
• Letter: 2017-10-06
• Label: 2017-10-10
• Letter: 2018-05-10
• Label: 2018-05-10
• Letter: 2019-02-22
• Label: 2019-02-22
• Letter: 2019-11-26
• Label: 2019-11-26
• Medication Guide: 2019-11-26
• Label: 2020-05-20

Application Sponsors

NDA 018081

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

250MG

1

DEPAKENE

VALPROIC ACID

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1978-02-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1979-12-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-12-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-06-16	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1981-12-09
LABELING; Labeling	SUPPL	7	AP	1981-11-04
LABELING; Labeling	SUPPL	8	AP	1981-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-09-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1983-10-28	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1986-05-30
LABELING; Labeling	SUPPL	16	AP	1985-12-04
LABELING; Labeling	SUPPL	17	AP	1986-05-30
LABELING; Labeling	SUPPL	18	AP	1986-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1987-12-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1989-03-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1995-03-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1996-12-02	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2000-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1998-05-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1998-09-22	PRIORITY
LABELING; Labeling	SUPPL	32	AP	2000-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1999-12-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2000-06-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2000-12-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2000-06-20	PRIORITY
LABELING; Labeling	SUPPL	38	AP	2002-12-12	STANDARD
LABELING; Labeling	SUPPL	42	AP	2006-01-11	STANDARD
LABELING; Labeling	SUPPL	44	AP	2006-10-13	STANDARD
LABELING; Labeling	SUPPL	46	AP	2011-10-07	STANDARD
LABELING; Labeling	SUPPL	47	AP	2009-04-23	901 REQUIRED
LABELING; Labeling	SUPPL	48	AP	2011-10-07	STANDARD
LABELING; Labeling	SUPPL	49	AP	2014-06-19	STANDARD
LABELING; Labeling	SUPPL	50	AP	2011-10-07	UNKNOWN
LABELING; Labeling	SUPPL	52	AP	2011-10-07	UNKNOWN
LABELING; Labeling	SUPPL	54	AP	2013-02-27	STANDARD
LABELING; Labeling	SUPPL	56	AP	2013-07-31	STANDARD
LABELING; Labeling	SUPPL	57	AP	2013-06-14	STANDARD
LABELING; Labeling	SUPPL	58	AP	2014-11-20	STANDARD
LABELING; Labeling	SUPPL	59	AP	2015-01-07	STANDARD
LABELING; Labeling	SUPPL	60	AP	2014-06-09	STANDARD
LABELING; Labeling	SUPPL	61	AP	2014-08-20	STANDARD
LABELING; Labeling	SUPPL	62	AP	2015-03-13	STANDARD
LABELING; Labeling	SUPPL	63	AP	2015-09-23	STANDARD
LABELING; Labeling	SUPPL	64	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	65	AP	2016-11-02	STANDARD
LABELING; Labeling	SUPPL	66	AP	2017-03-06	STANDARD
LABELING; Labeling	SUPPL	67	AP	2017-10-05	STANDARD
LABELING; Labeling	SUPPL	68	AP	2018-03-06	STANDARD
LABELING; Labeling	SUPPL	69	AP	2019-02-21	STANDARD
LABELING; Labeling	SUPPL	70	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	71	AP	2020-05-19	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	25	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	46	Null	6
SUPPL	48	Null	6
SUPPL	49	Null	6
SUPPL	50	Null	6
SUPPL	52	Null	6
SUPPL	54	Null	15
SUPPL	56	Null	6
SUPPL	57	Null	6
SUPPL	58	Null	6
SUPPL	59	Null	7
SUPPL	60	Null	7
SUPPL	61	Null	15
SUPPL	62	Null	15
SUPPL	63	Null	6
SUPPL	64	Null	7
SUPPL	65	Null	7
SUPPL	66	Null	15
SUPPL	67	Null	6
SUPPL	68	Null	6
SUPPL	69	Null	7
SUPPL	70	Null	7
SUPPL	71	Null	15

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18081
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/018081s070,018082s053lbl.pdf#page=41"]
            [products] => [{"drugName":"DEPAKENE","activeIngredients":"VALPROIC ACID","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/19\/2020","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/018081s071,018082s054lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2019","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018081s070,018082s053lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018081s069,018082s052lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2018","submission":"SUPPL-68","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"10\/05\/2017","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018081s067,018082s050lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2017","submission":"SUPPL-66","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018081s066,018082s049lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2016","submission":"SUPPL-65","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018081s065_018082s048lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2016","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018081s064,018082s047lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2015","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018081s063,018082s046lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2015","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018081s062,018082s045lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2015","submission":"SUPPL-59","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018081s059,018082s042lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2014","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018081s058,018082s041lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2014","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018081s061,018082s044lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018081s049,018082s034lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2014","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2013","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018081s056lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2013","submission":"SUPPL-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018081s057,018082s040lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2013","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018081s054,018082s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018081s046_18082s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018081s046_18082s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-48","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018081s046_18082s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-48","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018081s046_18082s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018081s046_18082s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2006","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2006","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEPAKENE","submission":"VALPROIC ACID","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)