FDA.reportPublic FDA data

Application 022267

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPAKOTE ERDIVALPROEX SODIUMTABLET, EXTENDED RELEASE; ORAL250MGNoNo
002DEPAKOTE ERDIVALPROEX SODIUMTABLET, EXTENDED RELEASE; ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 6 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack48a6e47a-3697-492d-9086-56e4ca0151e52025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepackc8d9cd69-ceca-3057-9d1c-12c44b19f7672025-03-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBluePoint Laboratories1b12c694-e120-45f6-ad28-36373e2c53782025-03-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack0fb57229-08ef-44d6-b40a-92b2f96ff7952025-02-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packaging64b509bc-f398-48ad-bdcb-9904e61d92252025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMAlembic Pharmaceuticals Limitedf34c4504-5409-406e-995b-138e5f7002422025-01-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMNuCare Pharmaceuticals,Inc.0bef10ed-e4b5-95ae-e063-6294a90a86eb2025-01-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMZydus Lifesciences Limitedb0f33792-dd96-40cc-a28e-acdcdca2f4b82024-11-28Name fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutionsc8f72850-92d5-4f64-b9f1-657f72bfa15a2024-11-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMNCS HealthCare of KY, LLC dba Vangard Labs388fd4bc-f12f-4e55-a1e7-72aa585519fa2024-09-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMNCS HealthCare of KY, LLC dba Vangard Labs319bbead-bec8-4bb7-9ecb-b2e161c44b8d2024-09-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC9a9f5f24-e421-406f-ac91-d1f964245f542024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutions8ecfe765-d743-4308-9cd9-4a7b1a229ea92024-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutions63d61062-2700-47f4-8ab4-3bd641b81fe12024-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLCbf34dd25-abe3-4587-b481-df052f0854292023-08-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC0f5bb45e-836b-48ce-9764-2d50edcb202c2023-05-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMHahnemann Laboratories, INC.f7fec516-ec6f-6248-e053-6294a90a33422023-03-28Name fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMProficient Rx LPabac11e6-7ce1-491c-9ac3-61f3df54c4a42022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMHahnemann Laboratories, INC.e3281609-460a-4982-e053-2995a90a01c52022-07-06Name fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC177e34e9-f74d-42aa-8e3c-5fb4f41c23222018-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23704ORIG2011-12-20
29498SUPPL2009-11-24
17172SUPPL2009-10-21
42475ORIG2009-09-03
24269ORIG2009-09-03
38470ORIG2008-03-27
53237ORIG1900-01-01