Details for New Drug Application (NDA): 077100

NDA 077100 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 077100

Tradename:	DIVALPROEX SODIUM
Applicant:	Zydus Pharms Usa Inc
Ingredient:	divalproex sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 125MG VALPROIC ACID
Approval Date:	Mar 5, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 250MG VALPROIC ACID
Approval Date:	Mar 5, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 500MG VALPROIC ACID
Approval Date:	Mar 5, 2009	TE:	AB	RLD:	No

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