Details for New Drug Application (NDA): 040342

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NDA 040342 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.

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

Anticonvulsants
Cytochrome P-450 CYP1A2 Inducers
Voltage-Gated Sodium Channel Blockers

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENYTOIN	phenytoin	SUSPENSION;ORAL	040342	ANDA	VistaPharm, LLC	66689-036	66689-036-50	5 TRAY in 1 CASE (66689-036-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 4 mL in 1 CUP, UNIT-DOSE (66689-036-01)
PHENYTOIN	phenytoin	SUSPENSION;ORAL	040342	ANDA	VistaPharm, LLC	66689-775	66689-775-08	237 mL in 1 BOTTLE (66689-775-08)

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Jan 31, 2001	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Aug 18, 2005	TE:		RLD:	No

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