Last Updated: June 24, 2026

Details for New Drug Application (NDA): 076295

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NDA 076295 describes VALPROATE SODIUM, which is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Pharmobedient, and Sagent, and is included in four NDAs. It is available from three suppliers. Additional details are available on the VALPROATE SODIUM profile page.

The generic ingredient in VALPROATE SODIUM is valproate sodium. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the valproate sodium profile page.

Summary for 076295

Tradename:	VALPROATE SODIUM
Applicant:	Sagent
Ingredient:	valproate sodium
Patents:	0

Pharmacology for NDA: 076295

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 076295

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	076295	ANDA	Sagent Pharmaceuticals	25021-797	25021-797-05	10 VIAL in 1 CARTON (25021-797-05) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/ML
Approval Date:	Nov 14, 2002	TE:	AP	RLD:	No

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