Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG VALPROIC ACID | 1 | DEPAKOTE ER | DIVALPROEX SODIUM |
| 002 | TABLET, EXTENDED RELEASE;ORAL | EQ 250MG VALPROIC ACID | 1 | DEPAKOTE ER | DIVALPROEX SODIUM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2002-12-12 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2002-12-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2003-08-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2003-04-20 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2006-01-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2005-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2006-10-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2008-03-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2011-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 19 | AP | 2014-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2011-10-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 22 | AP | 2011-10-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 23 | AP | 2013-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2013-07-31 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2013-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2014-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2015-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2014-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2014-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2015-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2015-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2015-09-23 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2016-02-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2016-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2016-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2017-03-06 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2017-10-05 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2018-03-06 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2019-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2019-11-22 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2020-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2021-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2021-11-30 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 22 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Null | 15 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 38 | Null | 15 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 43 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 21168
[companyName] => ABBVIE
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/021168s042lbl.pdf#page=48"]
[products] => [{"drugName":"DEPAKOTE ER","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 500MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DEPAKOTE ER","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 250MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/10\/2021","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021168s042lbl.pdf\"}]","notes":""},{"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\\\/021168s041lbl.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\\\/021168s040lbl.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\\\/021168s039lbl.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\\\/021168s038lbl.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\\\/021168s037lbl.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\\\/021168s036lbl.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\\\/021168s035lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2016","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021168s033lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2015","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021168s032lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2015","submission":"SUPPL-30","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021168Orig1s030lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2015","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021168s031lbl.pdf\"}]","notes":""},{"actionDate":"01\/07\/2015","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021168s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021168s026lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2014","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021168s029lbl.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\\\/021168s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2014","submission":"SUPPL-28","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-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021168s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2013","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021168s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2013","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021168s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021168s016lbl.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\\\/021168s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-17","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021168s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021168s016lbl.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\\\/021168s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021168s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2008","submission":"SUPPL-15","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021168s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2006","submission":"SUPPL-14","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-9","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":"12\/06\/2005","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021168s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2003","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21168se5-007_depakote_lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2002","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20782_depakote_lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2002","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21168s1lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/04\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21168lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DEPAKOTE ER","submission":"DIVALPROEX SODIUM","actionType":"EQ 500MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DEPAKOTE ER","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-02-10
)
)