Details for New Drug Application (NDA): 217358

NDA 217358 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, Reddys, Sciegen Pharms, Unichem, and Yichang Humanwell, and is included in thirty-eight NDAs. It is available from forty-three 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-four suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for 217358

Tradename:	DIVALPROEX SODIUM
Applicant:	Mankind Pharma
Ingredient:	divalproex sodium
Patents:	0

Pharmacology for NDA: 217358

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 217358

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIVALPROEX SODIUM	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	217358	ANDA	Lifestar Pharma LLC	70756-447	70756-447-11	100 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-11)
DIVALPROEX SODIUM	divalproex sodium	CAPSULE, DELAYED REL PELLETS;ORAL	217358	ANDA	Lifestar Pharma LLC	70756-447	70756-447-12	1000 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 125MG VALPROIC ACID
Approval Date:	Aug 12, 2025	TE:	AB	RLD:	No

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