ABBVIE FDA Approval NDA 018082

NDA 018082

ABBVIE

FDA Drug Application

Application #018082

Documents

Letter2004-06-02
Letter2006-01-20
Letter2011-10-13
Letter2014-06-23
Letter2011-10-13
Letter2013-09-17
Letter2015-01-08
Letter2014-06-11
Letter2015-03-17
Letter2015-09-25
Label2011-10-12
Label2011-10-12
Label2013-09-17
Label2014-06-10
Label2014-08-22
Label2015-03-17
Label2015-10-06
Label2016-02-23
Letter2006-10-23
Letter2011-10-13
Letter2009-05-01
Letter2011-10-13
Letter2013-03-01
Letter2014-11-24
Letter2014-08-21
Letter2016-02-23
Label2006-01-13
Label2006-10-18
Label2009-05-12
Label2014-06-23
Label2011-10-12
Label2011-10-12
Label2013-03-04
Label2013-07-02
Label2014-12-03
Label2015-01-08
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
Medication Guide2018-11-08
Letter2019-02-22
Label2019-02-22
Letter2019-11-26
Label2019-11-26
Letter2020-05-20
Label2020-05-29

Application Sponsors

NDA 018082ABBVIE

Marketing Status

Discontinued001

Application Products

001SYRUP;ORAL250MG/5ML1DEPAKENEVALPROIC ACID

FDA Submissions

TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage FormORIG1AP1978-02-28PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1979-12-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1980-09-29PRIORITY
LABELING; LabelingSUPPL4AP1981-12-09
LABELING; LabelingSUPPL6AP1981-11-04
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1982-09-30PRIORITY
LABELING; LabelingSUPPL12AP1985-12-04
LABELING; LabelingSUPPL13AP1986-08-11
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1995-03-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1996-12-02PRIORITY
LABELING; LabelingSUPPL22AP2000-05-16STANDARD
LABELING; LabelingSUPPL23AP2000-06-19STANDARD
LABELING; LabelingSUPPL24AP2002-12-12STANDARD
LABELING; LabelingSUPPL26AP2006-01-11STANDARD
LABELING; LabelingSUPPL27AP2006-10-13STANDARD
LABELING; LabelingSUPPL31AP2011-10-07STANDARD
LABELING; LabelingSUPPL32AP2009-04-23901 REQUIRED
LABELING; LabelingSUPPL33AP2011-10-07STANDARD
LABELING; LabelingSUPPL34AP2014-06-19STANDARD
LABELING; LabelingSUPPL35AP2011-10-07UNKNOWN
LABELING; LabelingSUPPL37AP2011-10-07UNKNOWN
LABELING; LabelingSUPPL38AP2013-02-27STANDARD
LABELING; LabelingSUPPL39AP2013-07-31STANDARD
LABELING; LabelingSUPPL40AP2013-06-14STANDARD
LABELING; LabelingSUPPL41AP2014-11-20STANDARD
LABELING; LabelingSUPPL42AP2015-01-07STANDARD
LABELING; LabelingSUPPL43AP2014-06-09STANDARD
LABELING; LabelingSUPPL44AP2014-08-20STANDARD
LABELING; LabelingSUPPL45AP2015-03-13STANDARD
LABELING; LabelingSUPPL46AP2015-09-23STANDARD
LABELING; LabelingSUPPL47AP2016-02-18STANDARD
LABELING; LabelingSUPPL48AP2016-11-02STANDARD
LABELING; LabelingSUPPL49AP2017-03-06STANDARD
LABELING; LabelingSUPPL50AP2017-10-05STANDARD
LABELING; LabelingSUPPL51AP2018-03-06STANDARD
LABELING; LabelingSUPPL52AP2019-02-21STANDARD
LABELING; LabelingSUPPL53AP2019-11-22STANDARD
LABELING; LabelingSUPPL54AP2020-05-19STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL7Null0
SUPPL18Null0
SUPPL21Null0
SUPPL31Null6
SUPPL33Null6
SUPPL34Null6
SUPPL35Null7
SUPPL37Null7
SUPPL38Null7
SUPPL39Null15
SUPPL40Null6
SUPPL41Null6
SUPPL42Null6
SUPPL43Null7
SUPPL44Null15
SUPPL45Null6
SUPPL46Null6
SUPPL47Null6
SUPPL48Null7
SUPPL49Null7
SUPPL50Null15
SUPPL51Null6
SUPPL52Null6
SUPPL53Null7
SUPPL54Null7

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18082
            [companyName] => ABBVIE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/018081Orig1s068%20018082Orig1s051lbl.pdf#page=38"]
            [products] => [{"drugName":"DEPAKENE","activeIngredients":"VALPROIC ACID","strength":"250MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/19\/2020","submission":"SUPPL-54","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-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018081s070,018082s053lbl.pdf#page=41\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-52","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-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"10\/05\/2017","submission":"SUPPL-50","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-49","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-48","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-47","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-46","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-45","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-42","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-41","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-44","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-34","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-43","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-39","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-40","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-38","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-37","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-35","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-33","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-33","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-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018081s046_18082s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018081s047,018082s032lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2006","submission":"SUPPL-27","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-26","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\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)
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