FDA.reportPublic FDA data

Application 018082

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPAKENEVALPROIC ACIDSYRUP;ORAL250MG/5MLYesNo

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

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
N018082-001DEPAKENEVALPROIC ACID250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N018082-001DEPAKENE250MG/5MLSYRUP / ORALRLD, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N018082-001DEPAKENE250MG/5MLSYRUP / ORALAARLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018082-001DEPAKENE250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD, Approved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N018082-001AA1ea99ee380514…

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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 ACIDREMEDYREPACK INC.ec41025a-ed7d-48c8-9005-08e3a9417f302026-04-23Boxed 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 ACIDREMEDYREPACK INC.1edd220d-d151-4177-9a29-9fee36489fb72025-10-01Boxed 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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-5682DepakeneValproic AcidAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63337SUPPL2020-05-29
63158SUPPL2020-05-20
61068SUPPL2019-11-26
61057SUPPL2019-11-26
57783SUPPL2019-02-22
57761SUPPL2019-02-22
56338SUPPL2018-11-08
54086SUPPL2018-05-10
54066SUPPL2018-05-10
49999SUPPL2017-10-10
49984SUPPL2017-10-06
47508SUPPL2017-03-08
47480SUPPL2017-03-07
45841SUPPL2016-11-08
45811SUPPL2016-11-04
14030SUPPL2016-02-23
11155SUPPL2016-02-23
11154SUPPL2015-10-06
835SUPPL2015-09-25
11153SUPPL2015-03-17
834SUPPL2015-03-17
33431SUPPL2015-01-08
832SUPPL2015-01-08
33430SUPPL2014-12-03
14028SUPPL2014-11-24
11152SUPPL2014-08-22
14029SUPPL2014-08-21
33425SUPPL2014-06-23
829SUPPL2014-06-23
833SUPPL2014-06-11
11151SUPPL2014-06-10
11150SUPPL2013-09-17
831SUPPL2013-09-17
33429SUPPL2013-07-02
33428SUPPL2013-03-04
14027SUPPL2013-03-01
14026SUPPL2011-10-13
14024SUPPL2011-10-13
830SUPPL2011-10-13
828SUPPL2011-10-13
33427SUPPL2011-10-12
33426SUPPL2011-10-12
11149SUPPL2011-10-12
11148SUPPL2011-10-12
33424SUPPL2009-05-12
14025SUPPL2009-05-01
44019ORIG2008-02-01
14023SUPPL2006-10-23
33423SUPPL2006-10-18
827SUPPL2006-01-20
33422SUPPL2006-01-13
826SUPPL2004-06-02