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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040342

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NDA 040342 describes PHENYTOIN, which is a drug marketed by Actavis Mid Atlantic, Pai Holdings Pharm, Taro, Vistapharm Llc, Epic Pharma Llc, Rising, Aurobindo Pharma, Pharmeral, Watson Labs, Acella, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott, and is included in twenty-three NDAs. It is available from eight suppliers. Additional details are available on the PHENYTOIN profile page.

The generic ingredient in PHENYTOIN is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Summary for 040342

Tradename:	PHENYTOIN
Applicant:	Vistapharm Llc
Ingredient:	phenytoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 040342

Anticonvulsants
Cytochrome P-450 CYP1A2 Inducers
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Jan 31, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Aug 18, 2005	TE:		RLD:	No

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