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 7 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
divalproex sodiumDIVALPROEX SODIUMDr.Reddy's Laboratories Limited15f8a5be-e269-2e07-60d9-1dd7bf5f52812018-12-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex sodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLCad5e8bd8-c923-40f0-a106-55620c4247d72018-10-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLCb74adc5e-e92d-46a7-afdc-a6464a440bde2018-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIVALPROEX SODIUM
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC9cfdcb58-d6d7-43bb-b6e1-17172b1432962018-02-16Boxed 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