Details for New Drug Application (NDA): 040731

NDA 040731 describes EXTENDED PHENYTOIN SODIUM, which is a drug marketed by Amneal Pharms Ny, Ani Pharms, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Unichem, Wockhardt, and Wockhardt Usa, and is included in eleven NDAs. It is available from seventeen suppliers. Additional details are available on the EXTENDED PHENYTOIN SODIUM profile page.

The generic ingredient in EXTENDED PHENYTOIN SODIUM 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 040731

Tradename:	EXTENDED PHENYTOIN SODIUM
Applicant:	Sun Pharm Inds
Ingredient:	phenytoin sodium
Patents:	0

Pharmacology for NDA: 040731

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: 040731

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040731	ANDA	Sun Pharmaceutical Industries, Inc.	62756-299	62756-299-08	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-08)
EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040731	ANDA	Sun Pharmaceutical Industries, Inc.	62756-299	62756-299-13	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG EXTENDED
Approval Date:	Jun 30, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG EXTENDED
Approval Date:	Jun 30, 2008	TE:	AB	RLD:	No

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