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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078290


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NDA 078290 describes DIVALPROEX SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Dr Reddys Labs Ltd, Mankind Pharma, Rising, Teva Pharms Usa, Zydus Pharms Usa Inc, Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Invatech, Lupin, Mylan, Orbion Pharms, Ph Health, Pharmobedient, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Annora Pharma, Cosette, Impax Labs, Lupin Ltd, Reddys, Sciegen Pharms Inc, Unichem, and Yichang Humanwell, and is included in thirty-eight NDAs. It is available from forty-one suppliers. Additional details are available on the DIVALPROEX SODIUM profile page.

The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 078290
Tradename:DIVALPROEX SODIUM
Applicant:Invatech
Ingredient:divalproex sodium
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Jul 29, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Jul 29, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Jul 29, 2008TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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