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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 073178

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NDA 073178 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 073178

Tradename:	VALPROIC ACID
Applicant:	Ani Pharms
Ingredient:	valproic acid
Patents:	0

Pharmacology for NDA: 073178

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 073178

Anticonvulsants
Antimanic Agents
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 073178

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VALPROIC ACID	valproic acid	SYRUP;ORAL	073178	ANDA	ANI Pharmaceuticals, Inc.	62559-266	62559-266-16	473 mL in 1 BOTTLE (62559-266-16)
VALPROIC ACID	valproic acid	SYRUP;ORAL	073178	ANDA	REMEDYREPACK INC.	70518-4298	70518-4298-0	10 CUP in 1 BOX (70518-4298-0) / 20 mL in 1 CUP (70518-4298-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	250MG/5ML
Approval Date:	Aug 25, 1992	TE:	AA	RLD:	No

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