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 5 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
divalproex sodiumDIVALPROEX SODIUMA-S Medication Solutionsea5c5e3c-c23f-4ec0-b1ab-6b317f3d2f912025-11-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMMylan Institutional Inc.b367d81d-4eca-4e28-b490-34be4c0035612025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack1107f190-bef1-41cb-9393-8479b0a560402025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack71296464-0c09-4ff2-beb3-377af77dc4cf2025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepackfbaff0ae-431e-4e83-81c2-41eb4b18ee872025-10-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack79e6dc26-a38b-4642-a216-1fa1213b919a2025-10-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepackdf8f3825-a037-4343-859d-e59bca5f1e432025-09-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMCoupler LLC3eee54a6-5b4c-330d-e063-6394a90a9f182025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepackd67af03a-5261-4358-8787-2e729267ff7e2025-09-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack47412563-ec3e-44fd-9f3f-c00b9b09033a2025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepackcd6fe37a-d26d-4ae8-a894-b44878e6bf8e2025-08-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepack0822300b-68c0-4e70-b1ba-8eb42cf373f72025-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepacke4a815eb-ea20-482a-bb67-06ab342645152025-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMProficient Rx LP15ffe3d8-d483-4c45-adc4-1cc8a5b68d192025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packagingca6bbec6-5631-4436-957e-fb8707e1683d2025-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMCoupler LLC38f4f2fd-400b-ccc4-e063-6294a90a5f412025-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMATLANTIC BIOLOGICALS CORP.699a9722-27bd-4e90-819b-d4ecb99466c82025-06-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMATLANTIC BIOLOGICALS CORP.57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc2025-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepack8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf2025-06-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packaging2e4778d8-8798-4da1-bb33-1aa1414b58092025-04-23Boxed 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