ABBVIE FDA Approval NDA 019680

NDA 019680

ABBVIE

FDA Drug Application

Application #019680

Documents

Letter2004-06-02
Letter2006-01-20
Letter2006-12-28
Letter2006-10-23
Letter2009-05-01
Letter2011-10-13
Letter2011-10-13
Letter2013-09-17
Letter2014-06-11
Letter2015-03-17
Letter2015-09-25
Label2006-01-13
Label2006-10-18
Label2009-05-07
Label2011-10-12
Label2014-06-23
Label2011-10-12
Label2013-03-04
Label2013-07-02
Label2014-06-10
Letter2011-10-13
Letter2014-06-23
Letter2011-10-13
Letter2014-06-23
Letter2013-03-01
Letter2014-11-24
Letter2015-01-08
Letter2014-08-21
Letter2016-02-23
Other Important Information from FDA2008-02-01
Label2006-12-26
Label2011-10-12
Label2011-10-12
Label2014-06-23
Label2013-09-17
Label2014-12-03
Label2015-01-08
Label2014-08-22
Label2015-03-17
Label2015-10-06
Label2016-02-23
Letter2016-11-04
Label2016-11-08
Label2017-03-07
Letter2017-03-08
Letter2017-10-06
Label2017-10-10
Letter2018-05-10
Label2018-05-10
Letter2019-02-22
Label2019-02-22
Letter2019-11-26
Label2019-12-10
Medication Guide2019-12-10
Letter2020-05-20
Label2020-05-20
Medication Guide2020-05-20
Letter2021-02-11
Label2021-02-17
Medication Guide2021-02-17
Letter2021-12-01
Label2021-12-03
Medication Guide2021-12-03

Application Sponsors

NDA 019680ABBVIE

Marketing Status

Prescription001

Application Products

001CAPSULE, DELAYED REL PELLETS;ORALEQ 125MG VALPROIC ACID1DEPAKOTEDIVALPROEX SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1989-09-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1993-01-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1995-03-23STANDARD
EFFICACY; EfficacySUPPL8AP1996-06-20STANDARD
LABELING; LabelingSUPPL10AP1996-04-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1996-12-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1998-05-08STANDARD
LABELING; LabelingSUPPL14AP2000-06-19STANDARD
LABELING; LabelingSUPPL15AP2002-12-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2002-11-05STANDARD
LABELING; LabelingSUPPL19AP2006-01-11STANDARD
LABELING; LabelingSUPPL21AP2006-12-19STANDARD
LABELING; LabelingSUPPL22AP2006-10-13STANDARD
EFFICACY; EfficacySUPPL24AP2008-03-24PRIORITY
LABELING; LabelingSUPPL25AP2011-10-07STANDARD
LABELING; LabelingSUPPL26AP2009-04-23901 REQUIRED
LABELING; LabelingSUPPL27AP2011-10-07STANDARD
LABELING; LabelingSUPPL28AP2014-06-19STANDARD
LABELING; LabelingSUPPL29AP2011-10-07UNKNOWN
LABELING; LabelingSUPPL31AP2011-10-07UNKNOWN
LABELING; LabelingSUPPL33AP2014-06-20UNKNOWN
LABELING; LabelingSUPPL34AP2013-02-27STANDARD
LABELING; LabelingSUPPL35AP2013-07-31STANDARD
LABELING; LabelingSUPPL36AP2013-06-14STANDARD
LABELING; LabelingSUPPL37AP2014-11-20STANDARD
LABELING; LabelingSUPPL38AP2015-01-07STANDARD
LABELING; LabelingSUPPL39AP2014-06-09STANDARD
LABELING; LabelingSUPPL40AP2014-08-20STANDARD
LABELING; LabelingSUPPL41AP2015-03-13STANDARD
LABELING; LabelingSUPPL42AP2015-09-23STANDARD
LABELING; LabelingSUPPL43AP2016-02-18STANDARD
LABELING; LabelingSUPPL44AP2016-11-02STANDARD
LABELING; LabelingSUPPL45AP2017-03-06STANDARD
LABELING; LabelingSUPPL46AP2017-10-05STANDARD
LABELING; LabelingSUPPL47AP2018-03-06STANDARD
LABELING; LabelingSUPPL48AP2019-02-21STANDARD
LABELING; LabelingSUPPL49AP2019-11-22STANDARD
LABELING; LabelingSUPPL50AP2020-05-19STANDARD
LABELING; LabelingSUPPL51AP2021-02-10STANDARD
LABELING; LabelingSUPPL52AP2021-11-30STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL7Null0
SUPPL11Null0
SUPPL13Null0
SUPPL16Null0
SUPPL24Null8
SUPPL25Null6
SUPPL27Null15
SUPPL28Null6
SUPPL29Null6
SUPPL31Null6
SUPPL33Null15
SUPPL34Null6
SUPPL35Null6
SUPPL36Null7
SUPPL37Null15
SUPPL38Null6
SUPPL39Null6
SUPPL40Null6
SUPPL41Null7
SUPPL42Null7
SUPPL43Null15
SUPPL44Null15
SUPPL45Null6
SUPPL46Null7
SUPPL47Null7
SUPPL48Null15
SUPPL49Null6
SUPPL50Null6
SUPPL51Null7
SUPPL52Null7

TE Codes

001PrescriptionAB

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19680
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/019680s050lbl.pdf#page=42"]
            [products] => [{"drugName":"DEPAKOTE","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 125MG VALPROIC ACID","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/19\/2020","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/019680s050lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2019","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019680s049lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019680s048lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2018","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019680s047lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2017","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019680s046lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2017","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019680s045lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2016","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019680s044lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2016","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019680s043lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2015","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019680s042lbledt.pdf\"}]","notes":""},{"actionDate":"03\/13\/2015","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018723s054,019680s041lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2015","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019680s038lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2014","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019680s037lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2014","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019680s040lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2014","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019680s033lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019680s028lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2014","submission":"SUPPL-39","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-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019680s035lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2013","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019680s036lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2013","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019680s034lblupdated.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019680s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019680s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019680s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-27","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019680s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019680s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019680s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2006","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019680s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2006","submission":"SUPPL-22","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-19","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":"DEPAKOTE","submission":"DIVALPROEX SODIUM","actionType":"EQ 125MG VALPROIC ACID","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)
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