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 3 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMRising Pharma Holdings, Inc.6316061c-9758-4f38-9cb2-7ca833dd20bf2026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMLupin Pharmaceuticals, Inc.33798a7c-c5a9-49a5-be5d-1312910ef4682026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMLupin Pharmaceuticals, Inc.1f081c74-9f73-4ed9-9157-8d73d586a4092026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.cf15569c-5010-4e9b-aef0-7df4de5ed04e2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.ab8616a5-ea72-4df7-b095-54ea19ef6fba2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.ed24bb3a-bba1-4b27-8733-96619793fc152026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMBionpharma Inc.19064624-81d1-4ce3-bfe4-955bad6af6a22026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMFirst Nation Group, LLCa76f9909-28c9-4eb7-8ffd-ff6222fea0792026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC283af6d2-8ea2-4225-b2e7-a2057dbdb7932026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMSun Pharmaceutical Industries, Inc.64797788-fdcb-4d12-a1a4-743ad71bd17b2026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMUnichem Pharmaceuticals (USA), Inc.1ec1a441-218a-4c80-a0cb-69bcc327f4722026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMPreferred Pharmaceuticals Inc.dc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c2026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMLifestar Pharma LLCb2388bfd-7455-48ae-b396-463df0c278f02026-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMDr. Reddy's Laboratories Ltdf911748c-fb3a-fe1a-ab2a-4b40455e05ef2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMAlembic Pharmaceuticals Inc.fea19b14-d8ed-4954-bc54-b9240f78b3c32026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMPreferred Pharmaceuticals, Inc.83a77f60-ed58-4fa0-a584-e6a0c767d19d2026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMPreferred Pharmaceuticals Inc.d1d4d790-73d5-4a3b-a786-99f2c98125462026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
divalproex sodiumDIVALPROEX SODIUMZydus Pharmaceuticals USA Inc.ed710c62-8ba6-4f19-b240-3ee73cd03d672026-04-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAurobindo Pharma Limiteddbd47222-14f1-4588-a009-9b81b55ca60d2026-04-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAmneal Pharmaceuticals LLC7d3352ee-a240-43ff-a243-29ad2bc989c72026-04-04Boxed 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