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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 090517

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NDA 090517 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, Nostrum Labs Inc, Pharm Assoc, Pharmobedient Cnsltg, and Quagen, and is included in fifteen NDAs. It is available from seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the valproic acid profile page.

Summary for 090517

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

Pharmacology for NDA: 090517

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 090517

Anticonvulsants
Antimanic Agents
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 090517

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VALPROIC ACID	valproic acid	SYRUP;ORAL	090517	ANDA	QUAGEN PHARMACEUTICALS LLC	70752-202	70752-202-12	12 BOTTLE in 1 CASE (70752-202-12) / 473 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	250MG/5ML
Approval Date:	May 28, 2010	TE:	AA	RLD:	No

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