Details for New Drug Application (NDA): 084427

NDA 084427 describes DILANTIN, which is a drug marketed by Viatris, Parke Davis, and Pharmacia, and is included in four NDAs. It is available from five suppliers. Additional details are available on the DILANTIN profile page.

The generic ingredient in DILANTIN is phenytoin. There are two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phenytoin profile page.

Summary for 084427

Tradename:	DILANTIN
Applicant:	Pharmacia
Ingredient:	phenytoin
Patents:	0

Pharmacology for NDA: 084427

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 084427

Anticonvulsants

Cytochrome P-450 CYP1A2 Inducers

Voltage-Gated Sodium Channel Blockers

Suppliers and Packaging for NDA: 084427

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DILANTIN	phenytoin	TABLET, CHEWABLE;ORAL	084427	ANDA	Parke-Davis Div of Pfizer Inc	0071-0007	0071-0007-24	100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24)
DILANTIN	phenytoin	TABLET, CHEWABLE;ORAL	084427	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8424	0615-8424-39	30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8424-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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