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 4 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Depakote ERDIVALPROEX SODIUMAbbVie Inc.0dc024ce-efc8-4690-7cb5-639c728fccac2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Depakote ER
generic name: DIVALPROEX SODIUM
DepakoteDIVALPROEX SODIUMAbbVie Inc.08a65cf4-7749-4ceb-6895-8f4805e2b01f2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Depakote SprinklesDIVALPROEX SODIUMAbbVie Inc.4619aff4-0f80-444f-858d-42e4137aa8092026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMA-S Medication Solutions3df910c5-b6f0-4a65-9640-b702ecea49f92026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMA-S Medication Solutions94eac383-a89f-4128-b81c-076640b8edcf2026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
DIVALPROEX SODIUMDIVALPROEX SODIUMDirectRxce12c7b1-caa9-4224-bb5f-3e20e0281d662026-03-17WarningsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepackc971b50d-0f78-422f-abee-1c5b4e1d20e72026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMSafecor Health, LLC3aec1944-86a1-490c-a734-d9dd3b52c9d62026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMPreferred Pharmaceuticals Inc.dbd1d178-77a3-46ff-985d-307dffaed1ad2026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMCoupler LLC4834732f-6044-946c-e063-6394a90a5da32026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMAmerican Health Packagingb12b76a0-4b6e-4cd4-9508-10a2c84d8beb2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAvPAKe8cc336b-5191-7f8b-e053-2a95a90a6acb2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMA-S Medication Solutionse5fcf5b1-263e-43e0-9424-e613d5cca3fa2026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMNorthwind Health Company, LLCab6fa448-7485-6644-e053-2a95a90aa1812026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMCoupler LLC46b2e8a9-5d50-d0b2-e063-6294a90a1b472025-12-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepack0669ac77-10df-48af-bc42-55e768b69e4f2025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packaginga8ba3986-1ded-44a8-8d10-d0f252a077942025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMUpsher-Smith Laboratories, LLC02304a23-4a5f-47bc-9687-4044b43f7a202025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMMajor Pharmaceuticalsfb39a94e-93e6-4afe-a300-f80e8f1e0fa62025-11-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMNCS HealthCare of KY, LLC dba Vangard Labsf936b9d0-a58f-4fa5-8db9-752dabb837a62025-11-14Boxed 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