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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 090407

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NDA 090407 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 090407

Tradename:	DIVALPROEX SODIUM
Applicant:	Rising
Ingredient:	divalproex sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 125MG VALPROIC ACID
Approval Date:	Mar 28, 2011	TE:		RLD:	No

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