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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 089892

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NDA 089892 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 089892

Tradename:	PHENYTOIN
Applicant:	Actavis Mid Atlantic
Ingredient:	phenytoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 089892

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:	Sep 25, 1992	TE:		RLD:	No

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