Details for New Drug Application (NDA): 090070

NDA 090070 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 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 suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for 090070

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

Pharmacology for NDA: 090070

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 090070

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIVALPROEX SODIUM	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	090070	ANDA	Dr. Reddy's Laboratories Ltd	55111-534	55111-534-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-01)
DIVALPROEX SODIUM	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	090070	ANDA	Dr. Reddy's Laboratories Ltd	55111-534	55111-534-05	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 500MG VALPROIC ACID
Approval Date:	Mar 12, 2012	TE:	AB	RLD:	No

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