FDA.reportPublic FDA data

Application 018081

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPAKENEVALPROIC ACIDCAPSULE;ORAL250MGYesNo

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
N018081-001DEPAKENEVALPROIC ACID250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982

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 UTC2022-10N018081-001DEPAKENE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018081-001DEPAKENE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018081-001DEPAKENE250MGCAPSULE / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018081-001DEPAKENE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09N018081-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018081-001AB1ea99ee380514…

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valproic AcidVALPROIC ACIDREMEDYREPACK INC.1edd220d-d151-4177-9a29-9fee36489fb72026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
VALPROIC ACIDVALPROIC ACIDAmerican Health Packaging4b619f73-44e5-4a99-b425-a96cb2228c872026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
VALPROIC ACIDVALPROIC ACIDREMEDYREPACK INC.65c1589e-c591-4b79-b75e-884c0d609ae82026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
ValproicVALPROIC ACIDActavis Pharma, Inc.cef3e335-5891-412f-89c4-79fcd2f145b72026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDBionpharma Inc.ceb52870-76d0-4108-a1d4-ba7096fbacdd2026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDChartwell RX, LLC8051ad62-3b6e-461e-8090-60f5c0a904f42026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDXttrium Laboratories Inc.3b124a29-30bd-d30e-e063-6294a90ac4ca2026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDANI Pharmaceuticals, Inc.2314af65-b928-42a9-91eb-6372909ab4f52026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDChartwell Governmental & Specialty RX, LLC.5d19f389-7180-4e01-845f-519b7ea60ba02025-11-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
VALPROIC ACIDVALPROIC ACIDMajor Pharmaceuticalsa33f7657-ad0f-43e9-ba48-024746e6d08e2025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDKesin Pharma Corporation3a2155d0-e79d-3e11-e063-6294a90a4aae2025-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
valproic acidVALPROIC ACIDUpsher-Smith Laboratories, LLC7d4df6ad-3d53-4664-9200-749487bf36892025-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDATLANTIC BIOLOGICALS CORP.453444b6-1f50-49de-ab3c-1e429c83bffa2025-06-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDNCS HealthCare of KY, LLC dba Vangard Labs8785a152-3010-4370-aaf5-11315a1a56e12025-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
ValproicVALPROIC ACIDAphena Pharma Solutions - Tennessee, LLC34a0d45a-4388-7d8b-e063-6394a90a6c3f2025-05-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
VALPROIC ACIDVALPROIC ACIDPAI Holdings, LLC dba PAI Pharma7d5cb52e-37dd-4dfa-a6f4-09f9548846c62025-01-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDBryant Ranch Prepacka9cef1ec-ba52-4849-8889-87898d6f41992025-01-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDDirect_Rx8bdbacb1-b38a-3282-e053-2a95a90af0222025-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
VALPROIC ACIDVALPROIC ACIDBryant Ranch Prepackdb53c5aa-d7a5-49ba-8227-c2d67ced23e22024-10-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID
Valproic AcidVALPROIC ACIDNorthStar Rx LLC1286ab49-fa34-488e-e063-6394a90ad5822024-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VALPROIC ACID

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-5681DepakeneValproic AcidAbbVie Inc.NDACurrent
70518-1459DepakeneValproic AcidREMEDYREPACK INC.NDACurrent
70518-1459DepakeneValproic AcidREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63202SUPPL2020-05-20
61067SUPPL2019-11-26
61066SUPPL2019-11-26
61056SUPPL2019-11-26
57782SUPPL2019-02-22
57760SUPPL2019-02-22
54085SUPPL2018-05-10
54065SUPPL2018-05-10
49998SUPPL2017-10-10
49985SUPPL2017-10-06
47509SUPPL2017-03-08
47479SUPPL2017-03-07
45840SUPPL2016-11-08
45810SUPPL2016-11-04
33421SUPPL2016-02-23
825SUPPL2016-02-23
33420SUPPL2015-10-06
14022SUPPL2015-09-25
33419SUPPL2015-03-17
14021SUPPL2015-03-17
14019SUPPL2015-01-08
11146SUPPL2015-01-08
11145SUPPL2014-12-03
14018SUPPL2014-11-24
33418SUPPL2014-08-22
14020SUPPL2014-08-21
14014SUPPL2014-06-23
11141SUPPL2014-06-23
824SUPPL2014-06-11
11147SUPPL2014-06-10
14017SUPPL2013-09-17
11144SUPPL2013-09-17
33417SUPPL2013-07-02
33416SUPPL2013-03-04
14016SUPPL2013-03-01
14015SUPPL2011-10-13
14013SUPPL2011-10-13
823SUPPL2011-10-13
821SUPPL2011-10-13
33415SUPPL2011-10-12
33414SUPPL2011-10-12
11143SUPPL2011-10-12
11142SUPPL2011-10-12
822SUPPL2009-05-01
23540ORIG2008-02-01
14012SUPPL2006-10-23
33413SUPPL2006-10-18
14011SUPPL2006-01-20
33412SUPPL2006-01-13
820SUPPL2004-06-02