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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 075379

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NDA 075379 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 075379

Tradename:	VALPROIC ACID
Applicant:	Pharm Assoc
Ingredient:	valproic acid
Patents:	0

Pharmacology for NDA: 075379

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 075379

Anticonvulsants
Antimanic Agents
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 075379

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VALPROIC ACID	valproic acid	SYRUP;ORAL	075379	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0675	0121-0675-85	473 mL in 1 BOTTLE (0121-0675-85)
VALPROIC ACID	valproic acid	SYRUP;ORAL	075379	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1350	0121-1350-00	10 TRAY in 1 CASE (0121-1350-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1350-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	250MG/5ML
Approval Date:	Dec 15, 2000	TE:	AA	RLD:	No

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