NDA 018723

ABBVIE

FDA Drug Application

Application #018723

Documents

• Letter: 2011-10-13
• Letter: 2013-03-01
• Letter: 2015-01-08
• Letter: 2015-03-17
• Letter: 2015-09-25
• Label: 2011-10-12
• Label: 2011-10-12
• Label: 2014-06-23
• Label: 2011-10-12
• Label: 2011-10-12
• Label: 2011-10-12
• Label: 2013-03-04
• Label: 2013-09-17
• Label: 2014-12-03
• Label: 2015-01-08
• Label: 2014-08-22
• Label: 2016-02-23
• Letter: 2004-06-02
• Letter: 2006-01-20
• Letter: 2006-10-23
• Letter: 2011-10-13
• Letter: 2009-05-01
• Letter: 2011-10-13
• Letter: 2014-06-23
• Letter: 2011-10-13
• Letter: 2011-10-13
• Letter: 2013-09-17
• Letter: 2014-11-24
• Letter: 2014-06-11
• Letter: 2014-08-21
• Letter: 2016-02-23
• Other Important Information from FDA: 2008-02-01
• Label: 2006-01-13
• Label: 2006-10-18
• Label: 2009-05-12
• Label: 2013-07-02
• Label: 2014-06-10
• Label: 2015-03-17
• Label: 2015-10-06
• 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
• Letter: 2020-05-20
• Label: 2020-05-20
• Medication Guide: 2020-05-20
• Letter: 2021-02-11
• Label: 2021-02-17
• Medication Guide: 2021-02-17
• Letter: 2021-12-01
• Label: 2021-12-03
• Medication Guide: 2021-12-03

Application Sponsors

NDA 018723

ABBVIE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, DELAYED RELEASE;ORAL	EQ 250MG VALPROIC ACID	1	DEPAKOTE	DIVALPROEX SODIUM
002	TABLET, DELAYED RELEASE;ORAL	EQ 500MG VALPROIC ACID	1	DEPAKOTE	DIVALPROEX SODIUM
003	TABLET, DELAYED RELEASE;ORAL	EQ 125MG VALPROIC ACID	1	DEPAKOTE	DIVALPROEX SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1983-03-10	STANDARD
LABELING; Labeling	SUPPL	2	AP	1986-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-12-06	STANDARD
LABELING; Labeling	SUPPL	4	AP	1986-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1985-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-11-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-08-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1994-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1994-06-22	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	1996-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-03-23	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	1996-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1996-12-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1997-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1998-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-09-22	STANDARD
LABELING; Labeling	SUPPL	28	AP	2000-06-19	STANDARD
LABELING; Labeling	SUPPL	29	AP	2002-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2002-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2002-12-09	STANDARD
LABELING; Labeling	SUPPL	32	AP	2006-01-11	STANDARD
LABELING; Labeling	SUPPL	33	AP	2006-10-13	STANDARD
LABELING; Labeling	SUPPL	37	AP	2011-10-07	STANDARD
LABELING; Labeling	SUPPL	39	AP	2009-04-23	901 REQUIRED
LABELING; Labeling	SUPPL	40	AP	2011-10-07	STANDARD
LABELING; Labeling	SUPPL	41	AP	2014-06-19	STANDARD
LABELING; Labeling	SUPPL	43	AP	2011-10-07	UNKNOWN
LABELING; Labeling	SUPPL	45	AP	2011-10-07	UNKNOWN
LABELING; Labeling	SUPPL	46	AP	2011-10-07	UNKNOWN
LABELING; Labeling	SUPPL	47	AP	2013-02-27	STANDARD
LABELING; Labeling	SUPPL	48	AP	2013-07-31	STANDARD
LABELING; Labeling	SUPPL	49	AP	2013-06-14	STANDARD
LABELING; Labeling	SUPPL	50	AP	2014-11-20	STANDARD
LABELING; Labeling	SUPPL	51	AP	2015-01-07	STANDARD
LABELING; Labeling	SUPPL	52	AP	2014-06-09	STANDARD
LABELING; Labeling	SUPPL	53	AP	2014-08-20	STANDARD
LABELING; Labeling	SUPPL	54	AP	2015-03-13	STANDARD
LABELING; Labeling	SUPPL	55	AP	2015-09-23	STANDARD
LABELING; Labeling	SUPPL	56	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	57	AP	2016-11-02	STANDARD
LABELING; Labeling	SUPPL	58	AP	2017-03-06	STANDARD
LABELING; Labeling	SUPPL	59	AP	2017-10-05	STANDARD
LABELING; Labeling	SUPPL	60	AP	2018-03-06	STANDARD
LABELING; Labeling	SUPPL	61	AP	2019-02-21	STANDARD
LABELING; Labeling	SUPPL	62	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	63	AP	2020-05-19	STANDARD
LABELING; Labeling	SUPPL	64	AP	2021-02-10	STANDARD
LABELING; Labeling	SUPPL	65	AP	2021-11-30	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	37	Null	7
SUPPL	40	Null	15
SUPPL	41	Null	6
SUPPL	43	Null	15
SUPPL	45	Null	15
SUPPL	46	Null	6
SUPPL	47	Null	6
SUPPL	48	Null	6
SUPPL	49	Null	7
SUPPL	50	Null	7
SUPPL	51	Null	15
SUPPL	52	Null	15
SUPPL	53	Null	6
SUPPL	54	Null	7
SUPPL	55	Null	7
SUPPL	56	Null	15
SUPPL	57	Null	6
SUPPL	58	Null	6
SUPPL	59	Null	7
SUPPL	60	Null	7
SUPPL	61	Null	33
SUPPL	62	Null	6
SUPPL	63	Null	6
SUPPL	64	Null	6
SUPPL	65	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18723
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/018723s063lbl.pdf#page=48"]
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            [labels] => [{"actionDate":"05\/19\/2020","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/018723s063lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2019","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018723s062lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018723s061lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2018","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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            [originalApprovals] => [{"actionDate":"DEPAKOTE","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DEPAKOTE","submission":"DIVALPROEX SODIUM","actionType":"EQ 500MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DEPAKOTE","submission":"DIVALPROEX SODIUM","actionType":"EQ 125MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)