Details for New Drug Application (NDA): 213181

NDA 213181 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 213181

Tradename:	DIVALPROEX SODIUM
Applicant:	Ajanta Pharma Ltd
Ingredient:	divalproex sodium
Patents:	0

Pharmacology for NDA: 213181

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 213181

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIVALPROEX SODIUM	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	213181	ANDA	Ajanta Pharma USA Inc.	27241-115	27241-115-01	100 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-01)
DIVALPROEX SODIUM	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	213181	ANDA	Ajanta Pharma USA Inc.	27241-115	27241-115-05	500 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 125MG VALPROIC ACID
Approval Date:	Mar 2, 2020	TE:	AB	RLD:	No

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