FDA.reportPublic FDA data

Application 020593

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPACONVALPROATE SODIUMINJECTABLE;INJECTIONEQ 100MG BASE/MLYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020593-001DEPACONVALPROATE SODIUMEQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-12-30

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020593-001DEPACONEQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-12-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020593-001DEPACONEQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-12-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020593-001DEPACONEQ 100MG BASE/MLINJECTABLE / INJECTIONRLD1996-12-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020593-001DEPACONEQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-12-30a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valproate SodiumVALPROATE SODIUMSagent Pharmaceuticals8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad2026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROATE SODIUM
Valproate SodiumVALPROATE SODIUMFresenius Kabi USA, LLC3dfb6da1-f66a-4618-9f74-d2d6c16c0b582024-12-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROATE SODIUM
Valproate SodiumVALPROATE SODIUMFresenius Kabi USA, LLCc572ece7-03d3-4c2a-aeb5-61f2023b28ea2024-10-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROATE SODIUM
Valproate SodiumVALPROATE SODIUMHikma Pharmaceuticals USA Inc.bcf57b31-4811-4104-82b3-46fb91a53ee02023-12-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROATE SODIUM
Valproate SodiumVALPROATE SODIUMHikma Pharmaceuticals USA Inc.7a687b2f-246d-4736-a20c-92421c2632682023-11-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROATE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-1564DepaconValproate SodiumAbbVie Inc.NDACurrent
0074-1564DepaconValproate SodiumAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63196SUPPL2020-05-20
63161SUPPL2020-05-20
61065SUPPL2019-11-26
61060SUPPL2019-11-26
57784SUPPL2019-02-22
57764SUPPL2019-02-22
54090SUPPL2018-05-10
54069SUPPL2018-05-10
50002SUPPL2017-10-10
49981SUPPL2017-10-06
47505SUPPL2017-03-08
47482SUPPL2017-03-07
45843SUPPL2016-11-08
45814SUPPL2016-11-04
34923SUPPL2016-02-23
25275SUPPL2016-02-23
12808SUPPL2015-10-06
2827SUPPL2015-09-25
34922SUPPL2015-03-17
2826SUPPL2015-03-17
25272SUPPL2015-01-08
12806SUPPL2015-01-08
34920SUPPL2014-12-03
25271SUPPL2014-11-24
34921SUPPL2014-08-22
25274SUPPL2014-08-21
25270SUPPL2014-06-23
12803SUPPL2014-06-23
25273SUPPL2014-06-11
12807SUPPL2014-06-10
34918SUPPL2013-09-17
2825SUPPL2013-09-17
34919SUPPL2013-07-02
34917SUPPL2013-03-04
2824SUPPL2013-03-01
25269SUPPL2011-10-13
2823SUPPL2011-10-13
2822SUPPL2011-10-13
12804SUPPL2011-10-12
34916SUPPL2011-10-07
12805SUPPL2011-10-07
41459SUPPL2008-02-19
44060ORIG2008-02-01
2821SUPPL2006-10-23
12802SUPPL2006-10-18
25268SUPPL2006-01-20
34915SUPPL2006-01-13
2820SUPPL2004-06-02
12801SUPPL2002-01-24
2819SUPPL2002-01-24