ABBVIE FDA Approval NDA 020593

NDA 020593

ABBVIE

FDA Drug Application

Application #020593

Documents

Letter2002-01-24
Letter2004-06-02
Letter2006-10-23
Letter2011-10-13
Letter2011-10-13
Letter2013-03-01
Letter2013-09-17
Letter2015-03-17
Letter2015-09-25
Label2002-01-24
Label2006-10-18
Label2014-06-23
Label2011-10-12
Label2011-10-07
Label2015-01-08
Label2014-06-10
Label2015-10-06
Letter2006-01-20
Letter2011-10-13
Letter2014-06-23
Letter2014-11-24
Letter2015-01-08
Letter2014-06-11
Letter2014-08-21
Letter2016-02-23
Label2006-01-13
Label2011-10-07
Label2013-03-04
Label2013-09-17
Label2013-07-02
Label2014-12-03
Label2014-08-22
Label2015-03-17
Label2016-02-23
Review2008-02-19
Other Important Information from FDA2008-02-01
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
Label2019-11-26
Letter2020-05-20
Label2020-05-20

Application Sponsors

NDA 020593ABBVIE

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 100MG BASE/ML1DEPACONVALPROATE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1996-12-30STANDARD
LABELING; LabelingSUPPL2AP2000-06-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1999-12-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-05-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-06-20STANDARD
EFFICACY; EfficacySUPPL6AP2002-01-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-06-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2002-08-12STANDARD
LABELING; LabelingSUPPL9AP2002-12-12STANDARD
LABELING; LabelingSUPPL11AP2006-01-11STANDARD
LABELING; LabelingSUPPL15AP2006-10-13STANDARD
LABELING; LabelingSUPPL16AP2011-10-07STANDARD
LABELING; LabelingSUPPL19AP2014-06-19STANDARD
LABELING; LabelingSUPPL20AP2011-10-07UNKNOWN
LABELING; LabelingSUPPL23AP2011-10-07UNKNOWN
LABELING; LabelingSUPPL25AP2013-02-27STANDARD
LABELING; LabelingSUPPL26AP2013-07-31STANDARD
LABELING; LabelingSUPPL27AP2013-06-14STANDARD
LABELING; LabelingSUPPL28AP2014-11-20STANDARD
LABELING; LabelingSUPPL29AP2015-01-07STANDARD
LABELING; LabelingSUPPL30AP2014-06-09STANDARD
LABELING; LabelingSUPPL31AP2014-08-20STANDARD
LABELING; LabelingSUPPL32AP2015-03-13STANDARD
LABELING; LabelingSUPPL33AP2015-09-23STANDARD
LABELING; LabelingSUPPL34AP2016-02-18STANDARD
LABELING; LabelingSUPPL35AP2016-11-02STANDARD
LABELING; LabelingSUPPL36AP2017-03-06STANDARD
LABELING; LabelingSUPPL37AP2017-10-05STANDARD
LABELING; LabelingSUPPL38AP2018-03-06STANDARD
LABELING; LabelingSUPPL39AP2019-02-21STANDARD
LABELING; LabelingSUPPL40AP2019-11-22STANDARD
LABELING; LabelingSUPPL41AP2020-05-19STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL8Null0
SUPPL16Null15
SUPPL19Null6
SUPPL20Null7
SUPPL23Null15
SUPPL25Null6
SUPPL26Null6
SUPPL27Null6
SUPPL28Null7
SUPPL29Null7
SUPPL30Null15
SUPPL31Null6
SUPPL32Null6
SUPPL33Null7
SUPPL34Null7
SUPPL35Null15
SUPPL36Null6
SUPPL37Null6
SUPPL38Null6
SUPPL39Null7
SUPPL40Null15
SUPPL41Null6

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20593
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEPACON","activeIngredients":"VALPROATE SODIUM","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/19\/2020","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020593s041lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2019","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020593s040lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020593s039lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2018","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020593s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2017","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020593s037lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2017","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020593s036lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2016","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020593s035lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020593s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2015","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020593s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2015","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020593s032lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020593s029lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2014","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020593s028lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2014","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020593s031lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2014","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020593s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2014","submission":"SUPPL-30","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-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020593s026lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2013","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020593s027lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2013","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020593s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020593s016s020s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020593s016s020s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020593s016s020s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2006","submission":"SUPPL-15","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-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2002","submission":"SUPPL-6","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20593s006lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEPACON","submission":"VALPROATE SODIUM","actionType":"EQ 100MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)
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