Details for New Drug Application (NDA): 090161

NDA 090161 describes DIVALPROEX SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Rising, Teva Pharms Usa, Zydus Pharms Usa Inc, Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Invatech, Lupin, Mylan, Norvium Bioscience, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Annora Pharma, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, Utopic Pharms, and Wockhardt, and is included in thirty-six NDAs. It is available from forty 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 090161

Tradename:	DIVALPROEX SODIUM
Applicant:	Dr Reddys Labs Ltd
Ingredient:	divalproex sodium
Patents:	0

Pharmacology for NDA: 090161

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 090161

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIVALPROEX SODIUM	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	090161	ANDA	Major Pharmaceuticals	0904-6363	0904-6363-45	80 BLISTER PACK in 1 CARTON (0904-6363-45) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
DIVALPROEX SODIUM	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	090161	ANDA	Major Pharmaceuticals	0904-6363	0904-6363-61	100 BLISTER PACK in 1 CARTON (0904-6363-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 250MG VALPROIC ACID
Approval Date:	Mar 15, 2012	TE:	AB	RLD:	No

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