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 1 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.7e96b724-5f5f-43cb-8d8b-adff3e1fc7792026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepackd524db34-99c4-4837-a532-a619f82c21ba2026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.bbe7d9b9-70e4-4531-a24f-5918966d94f52026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.66b0a3e0-70df-469e-845f-17769482304b2026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC5e59609f-d79d-414b-a6fc-7efb1ba5b2002026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMBluePoint Laboratories352b4c3c-e419-4827-9e00-febb0164e0f52026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMCardinal Health 107, LLC0816a066-9ee3-4c23-944d-3539fc2c12bf2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.bb94bbb1-07c1-49be-8c2c-f5635c65366d2026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.aa386ae3-ceac-4e3b-8fb1-ced3107a4c542026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.0339e27d-3dbf-4c37-a14e-f53557c08e192026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMMajor Pharmaceuticals4ef6c5fd-42b2-4419-9b5a-e6d63571e3a02026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.5926c3ff-c995-4789-941c-d38aa7db94dc2026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.90225548-85a8-4ea7-95d3-e8231c36fe5a2026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.a67855ff-a879-43f0-bca3-94c304348bf52026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.392df14f-4d65-4be9-973b-1f0ce1013d8f2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.33f07aac-4dc5-4f97-976a-a84f93497bc62026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.3b41cd15-9981-4d44-9c4b-e84168d864532026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMDr. Reddy's Laboratories Ltdfa823ee0-0c69-6b85-da1e-9bb2e2150ea52026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMDr. Reddy's Laboratories Ltd2e35f833-1cf7-12eb-9567-7a191e32e1382026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMCoupler LLC55f1614b-aadc-34ca-e063-6394a90ae2a72026-07-06Boxed 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