FDA.reportPublic FDA data

Application 019680

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPAKOTEDIVALPROEX SODIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 125MG VALPROIC ACIDYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-6114DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6114DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6114DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6114DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6114DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6114DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6114DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6114DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6114DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0781-2243Divalproex SodiumDivalproex SodiumSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2243Divalproex SodiumDivalproex SodiumSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2243Divalproex SodiumDivalproex SodiumSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2243Divalproex SodiumDivalproex SodiumSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2243Divalproex SodiumDivalproex SodiumSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2243Divalproex SodiumDivalproex SodiumSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2243Divalproex SodiumDivalproex SodiumSandoz Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85627SUPPL 2026-04-02
85622SUPPL 2026-04-02
82132SUPPL 2025-05-05
82173SUPPL 2025-05-01
81057SUPPL 2025-02-06
81044SUPPL 2025-02-06
81043SUPPL 2025-02-06
77903SUPPL 2024-03-21
77876SUPPL 2024-03-19
73629SUPPL 2023-02-28
73613SUPPL 2023-02-27
69461SUPPL2021-12-03
69460SUPPL2021-12-03
69437SUPPL2021-12-01
66258SUPPL2021-02-17
66257SUPPL2021-02-17
66198SUPPL2021-02-11
63198SUPPL2020-05-20
63197SUPPL2020-05-20
63160SUPPL2020-05-20
61222SUPPL2019-12-10
61221SUPPL2019-12-10
61059SUPPL2019-11-26
57780SUPPL2019-02-22
57763SUPPL2019-02-22
54088SUPPL2018-05-10
54068SUPPL2018-05-10
50001SUPPL2017-10-10
49982SUPPL2017-10-06
47506SUPPL2017-03-08
47481SUPPL2017-03-07
45842SUPPL2016-11-08
45813SUPPL2016-11-04
33867SUPPL2016-02-23
19096SUPPL2016-02-23
33866SUPPL2015-10-06
1503SUPPL2015-09-25
33865SUPPL2015-03-17
1502SUPPL2015-03-17
33863SUPPL2015-01-08
19094SUPPL2015-01-08
33862SUPPL2014-12-03
19093SUPPL2014-11-24
33864SUPPL2014-08-22
19095SUPPL2014-08-21
33860SUPPL2014-06-23
19091SUPPL2014-06-23
19089SUPPL2014-06-23
11630SUPPL2014-06-23
1501SUPPL2014-06-11
11634SUPPL2014-06-10
33861SUPPL2013-09-17
1500SUPPL2013-09-17
11633SUPPL2013-07-02
11632SUPPL2013-03-04
19092SUPPL2013-03-01
19090SUPPL2011-10-13
19088SUPPL2011-10-13
1499SUPPL2011-10-13
1498SUPPL2011-10-13
33859SUPPL2011-10-12
33858SUPPL2011-10-12
11631SUPPL2011-10-12
11629SUPPL2011-10-12
11628SUPPL2009-05-07
1497SUPPL2009-05-01
23550ORIG2008-02-01
1495SUPPL2006-12-28
33857SUPPL2006-12-26
1496SUPPL2006-10-23
11627SUPPL2006-10-18
1494SUPPL2006-01-20
11626SUPPL2006-01-13
1493SUPPL2004-06-02