Details for New Drug Application (NDA): 040298

NDA 040298 describes PHENYTEK, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the PHENYTEK profile page.

The generic ingredient in PHENYTEK 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 040298

Tradename:	PHENYTEK
Applicant:	Mylan
Ingredient:	phenytoin sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 040298

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

Suppliers and Packaging for NDA: 040298

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040298	ANDA	Mylan Pharmaceuticals Inc.	0378-2670	0378-2670-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-01)
EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040298	ANDA	Mylan Pharmaceuticals Inc.	0378-2670	0378-2670-93	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-93)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG EXTENDED
Approval Date:	Dec 28, 1998	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG EXTENDED
Approval Date:	Dec 6, 2001	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG EXTENDED
Approval Date:	Dec 6, 2001	TE:	AB	RLD:	No

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