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 2 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex sodiumDIVALPROEX SODIUMCamber Pharmaceuticals, Inc.e8e954d4-54e3-491c-867c-b3b656b70f232026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.74a9f020-f7a1-44e2-a452-f0e37bd3e0772026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMSt. Mary's Medical Park Pharmacy35a91dd3-19d0-09cb-e063-6394a90af01b2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMSt. Mary's Medical Park Pharmacy35a95333-9fc1-7a9f-e063-6294a90a9f302026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMMajor Pharmaceuticals4a0fa934-ec8c-460e-86eb-11281728fe852026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMUnichem Pharmaceuticals (USA), Inc.1d4129ae-0ce8-4a04-9f9d-c770508de8ed2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMUnit Dose Solutions, Inc.547d8305-bfc5-f4da-e063-6294a90a61062026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC4fc50afb-67f3-4bf3-9ec3-cc12734f47fd2026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMNorthStar Rx LLCaab6b411-11e9-4a16-afb6-d471ba4756e92026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC41e32cd5-1393-4ef1-81cb-8e3795e306822026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.a999f402-be1d-4153-b743-cfdb95ed15622026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.7ead614c-a68d-4a2f-94d0-e6404a8f87602026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.6af40b06-0a92-454c-9277-80e89de272312026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMCoupler LLC533245ba-7088-c929-e063-6294a90abe1d2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC8e86a610-45ef-4be7-a3ab-f656f5b327062026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutions79132bea-04d8-4dd9-bd31-07f0ba805c212026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.beba3da1-e80d-45b4-9bd6-3ed85c9482f32026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMBluePoint Laboratoriesb95494e2-ee7a-7415-e053-2995a90ae8522026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMAjanta Pharma USA Inc.773a289b-65ed-4045-80c5-f00e28c1c0792026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMNorthStar Rx LLC589ae3a6-8b2e-d931-d36b-1937287ab5c02026-05-20Boxed 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