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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 040884

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NDA 040884 describes PHENYTOIN, which is a drug marketed by Actavis Mid Atlantic, Pai Holdings Pharm, Taro, Vistapharm, 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 nine 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-four suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Summary for 040884

Tradename:	PHENYTOIN
Applicant:	Epic Pharma Llc
Ingredient:	phenytoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 040884

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	50MG
Approval Date:	Nov 28, 2014	TE:	AB	RLD:	No

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