Application 018723

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPAKOTEDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 250MG VALPROIC ACIDYesNo
002DEPAKOTEDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 500MG VALPROIC ACIDYesYes
003DEPAKOTEDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 125MG VALPROIC ACIDYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018723-001DEPAKOTEDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-10
N018723-002DEPAKOTEDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-10
N018723-003DEPAKOTEDIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N018723-001AB
N018723-002AB
N018723-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018723-002DEPAKOTEEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD, RS1983-03-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018723-003DEPAKOTEEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1984-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018723-001DEPAKOTEEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALABRLD1983-03-101e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018723-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018723-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018723-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018723-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018723-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018723-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018723-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018723-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018723-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018723-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018723-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018723-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018723-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018723-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018723-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018723-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018723-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018723-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018723-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018723-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018723-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018723-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018723-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018723-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018723-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018723-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018723-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018723-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018723-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018723-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018723-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018723-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018723-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018723-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018723-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018723-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018723-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018723-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018723-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018723-001AB11e350fbaab3a…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DepakoteDIVALPROEX SODIUMAbbVie Inc.08a65cf4-7749-4ceb-6895-8f4805e2b01f2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018723
application number: NDA018723
ndc (product): 0074-7325
ndc (product): 0074-6212
ndc (product): 0074-6214
ndc (product): 0074-7327
ndc (product): 0074-6215

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-6212DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6212DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6212DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6212DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6212DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6212DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6212DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6212DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6212DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6214DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-6215DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7325DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7325DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7325DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7327DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7327DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
0074-7327DepakoteDivalproex SodiumAbbVie Inc.NDACurrent
70518-1454DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1454DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1454DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1456DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1456DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1456DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1456DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent
70518-1456DepakoteDivalproex SodiumREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85626SUPPL 2026-04-02
85621SUPPL 2026-04-02
85665SUPPL 2026-03-31
82131SUPPL 2025-05-05
82171SUPPL 2025-05-01
81056SUPPL 2025-02-06
81045SUPPL 2025-02-06
77907SUPPL 2024-03-21
77875SUPPL 2024-03-19
73672SUPPL 2023-03-03
73612SUPPL 2023-02-27
69463SUPPL2021-12-03
69462SUPPL2021-12-03
69436SUPPL2021-12-01
66256SUPPL2021-02-17
66255SUPPL2021-02-17
66197SUPPL2021-02-11
63200SUPPL2020-05-20
63199SUPPL2020-05-20
63159SUPPL2020-05-20
61064SUPPL2019-11-26
61063SUPPL2019-11-26
61058SUPPL2019-11-26
57779SUPPL2019-02-22
57762SUPPL2019-02-22
54087SUPPL2018-05-10
54067SUPPL2018-05-10
50000SUPPL2017-10-10
49983SUPPL2017-10-06
47507SUPPL2017-03-08
47478SUPPL2017-03-07
45845SUPPL2016-11-08
45812SUPPL2016-11-04
16014SUPPL2016-02-23
11306SUPPL2016-02-23
33579SUPPL2015-10-06
1051SUPPL2015-09-25
33578SUPPL2015-03-17
1050SUPPL2015-03-17
11304SUPPL2015-01-08
1049SUPPL2015-01-08
11303SUPPL2014-12-03
16011SUPPL2014-11-24
11305SUPPL2014-08-22
16013SUPPL2014-08-21
15121SUPPL2014-06-23
11297SUPPL2014-06-23
16012SUPPL2014-06-11
33577SUPPL2014-06-10
16010SUPPL2013-09-17
11302SUPPL2013-09-17
33576SUPPL2013-07-02
11301SUPPL2013-03-04
1048SUPPL2013-03-01
16009SUPPL2011-10-13
16008SUPPL2011-10-13
15120SUPPL2011-10-13
15118SUPPL2011-10-13
1047SUPPL2011-10-13
11300SUPPL2011-10-12
11299SUPPL2011-10-12
11298SUPPL2011-10-12
11296SUPPL2011-10-12
11295SUPPL2011-10-12
33575SUPPL2009-05-12
15119SUPPL2009-05-01
23543ORIG2008-02-01
15117SUPPL2006-10-23
33574SUPPL2006-10-18
15116SUPPL2006-01-20
33573SUPPL2006-01-13
15115SUPPL2004-06-02