Details for New Drug Application (NDA): 200565

NDA 200565 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 200565

Tradename:	PHENYTOIN
Applicant:	Taro
Ingredient:	phenytoin
Patents:	0

Pharmacology for NDA: 200565

Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inducers Cytochrome P450 3A Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 200565

Anticonvulsants

Cytochrome P-450 CYP1A2 Inducers

Voltage-Gated Sodium Channel Blockers

Suppliers and Packaging for NDA: 200565

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENYTOIN	phenytoin	TABLET, CHEWABLE;ORAL	200565	ANDA	Major Pharmaceuticals	0904-7199	0904-7199-07	30 BLISTER PACK in 1 CARTON (0904-7199-07) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
PHENYTOIN	phenytoin	TABLET, CHEWABLE;ORAL	200565	ANDA	Taro Pharmaceuticals U.S.A., Inc	51672-4146	51672-4146-1	100 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	50MG
Approval Date:	Apr 17, 2014	TE:	AB	RLD:	No

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