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Last Updated: May 15, 2021

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Details for New Drug Application (NDA): 078853

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NDA 078853 describes DIVALPROEX SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan, Teva Pharms Usa, Zydus Pharms Usa Inc, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Celltrion, Invatech, Lupin, Orchid Hlthcare, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Amta, Cosette, Impax Labs, Lupin Ltd, Reddys, and Wockhardt, and is included in thirty-four NDAs. It is available from thirty-nine 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-one suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 078853
Tradename:DIVALPROEX SODIUM
Applicant:Orchid Hlthcare
Ingredient:divalproex sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Nov 25, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Nov 25, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Nov 25, 2008TE:ABRLD:No

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