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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 208120

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NDA 208120 describes VALPROATE SODIUM, which is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Norvium Bioscience, 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 208120

Tradename:	VALPROATE SODIUM
Applicant:	Norvium Bioscience
Ingredient:	valproate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/ML
Approval Date:	Dec 22, 2021	TE:		RLD:	No

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