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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 074060

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NDA 074060 describes VALPROIC ACID, which is a drug marketed by Bionpharma, Catalent, Hibrow Hlthcare, Par Pharm, Scherer Rp, Sun Pharm Inds Ltd, Upsher Smith Labs, Ani Pharms, Chartwell Rx, Hikma, Lannett Co Inc, Pai Holdings, Pharm Assoc, Pharmobedient Cnsltg, and Quagen, and is included in fifteen NDAs. It is available from nineteen suppliers. Additional details are available on the VALPROIC ACID profile page.

The generic ingredient in VALPROIC ACID is valproic acid. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the valproic acid profile page.

Summary for 074060

Tradename:	VALPROIC ACID
Applicant:	Hikma
Ingredient:	valproic acid
Patents:	0

Pharmacology for NDA: 074060

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 074060

Anticonvulsants
Antimanic Agents
Enzyme Inhibitors
GABA Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	250MG/5ML
Approval Date:	Jan 13, 1995	TE:		RLD:	No

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