FDA.reportPublic FDA data

Application 021168

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPAKOTE ERDIVALPROEX SODIUMTABLET, EXTENDED RELEASE;ORALEQ 500MG VALPROIC ACIDYesYes
002DEPAKOTE ERDIVALPROEX SODIUMTABLET, EXTENDED RELEASE;ORALEQ 250MG VALPROIC ACIDYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-3826DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7126DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7401DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7401DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7401DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7402DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7402DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7402DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7402DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
21695-163DepakoteDivalproex sodiumRebel Distributors CorpNDACurrent
21695-359DepakoteDivalproex sodiumRebel Distributors CorpNDACurrent
43353-310DepakoteDivalproex SodiumAphena Pharma Solutions - Tennessee, LLCNDACurrent
53808-1061Divalproex Sodium Extended-ReleaseDivalproex SodiumState of Florida DOH Central PharmacyNDA AUTHORIZED GENERICCurrent
63629-3370DepakoteDivalproex SodiumBryant Ranch PrepackNDACurrent
63629-3370DepakoteDivalproex SodiumBryant Ranch PrepackNDACurrent
64725-0314Divalproex Sodium Extended-ReleaseDivalproex SodiumTYA PharmaceuticalsNDA AUTHORIZED GENERICCurrent
64725-0315Divalproex Sodium Extended-ReleaseDivalproex SodiumTYA PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68382-314Divalproex SodiumDivalproex SodiumZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-314Divalproex SodiumDivalproex SodiumZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-314Divalproex SodiumDivalproex SodiumZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-315Divalproex SodiumDivalproex SodiumZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-315Divalproex SodiumDivalproex SodiumZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-315Divalproex SodiumDivalproex SodiumZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
70518-1758DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1758DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1758DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1758DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1758DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1759DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1759DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1759DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1759DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85628SUPPL 2026-04-02
85623SUPPL 2026-04-02
82559SUPPL 2025-06-12
82133SUPPL 2025-05-05
82172SUPPL 2025-05-01
81058SUPPL 2025-02-06
81042SUPPL 2025-02-06
81041SUPPL 2025-02-06
77905SUPPL 2024-03-21
77877SUPPL 2024-03-19
73630SUPPL 2023-02-28
73614SUPPL 2023-02-27
69459SUPPL2021-12-03
69458SUPPL2021-12-03
69438SUPPL2021-12-01
66260SUPPL2021-02-17
66259SUPPL2021-02-17
66199SUPPL2021-02-11
63201SUPPL2020-05-20
63162SUPPL2020-05-20
61070SUPPL2019-11-26
61069SUPPL2019-11-26
61061SUPPL2019-11-26
57781SUPPL2019-02-22
57765SUPPL2019-02-22
54092SUPPL2018-05-10
54091SUPPL2018-05-10
54070SUPPL2018-05-10
50003SUPPL2017-10-10
49980SUPPL2017-10-06
47504SUPPL2017-03-08
47483SUPPL2017-03-07
45844SUPPL2016-11-08
45815SUPPL2016-11-04
14558SUPPL2016-02-24
26967SUPPL2016-02-23
36267SUPPL2015-10-06
4534SUPPL2015-09-25
14557SUPPL2015-04-21
4532SUPPL2015-04-16
36266SUPPL2015-03-17
4533SUPPL2015-03-17
36264SUPPL2015-01-08
26964SUPPL2015-01-08
14555SUPPL2014-12-03
26963SUPPL2014-11-24
14556SUPPL2014-08-22
26966SUPPL2014-08-21
36260SUPPL2014-06-23
4527SUPPL2014-06-23
26965SUPPL2014-06-11
36265SUPPL2014-06-10
36263SUPPL2013-09-17
4531SUPPL2013-09-17
14554SUPPL2013-07-02
36262SUPPL2013-03-01
4530SUPPL2013-03-01
26962SUPPL2011-10-19
4529SUPPL2011-10-19
4528SUPPL2011-10-19
4525SUPPL2011-10-19
36261SUPPL2011-10-12
36258SUPPL2011-10-12
14553SUPPL2011-10-12
14552SUPPL2011-10-12
36259SUPPL2009-05-07
4526SUPPL2009-05-04
14551SUPPL2008-03-27
26961SUPPL2008-03-26
23631ORIG2008-02-01
4524SUPPL2006-10-23
14550SUPPL2006-10-18
21487SUPPL2006-07-10
21486SUPPL2006-07-10
26960SUPPL2006-01-20
36256SUPPL2006-01-13
36257SUPPL2005-12-13
4523SUPPL2005-12-13
14549SUPPL2004-06-15
4522SUPPL2004-06-15
26959SUPPL2004-06-02
4521SUPPL2004-06-02
21485ORIG2003-12-15
36255SUPPL2003-04-04
26958SUPPL2002-05-31
14548SUPPL2002-05-31
14547ORIG2000-08-04
4520ORIG2000-08-04
54052ORIG1900-01-01
54051ORIG1900-01-01
53235ORIG1900-01-01
53234ORIG1900-01-01
53233ORIG1900-01-01
53232ORIG1900-01-01