Details for New Drug Application (NDA): 040521

NDA 040521 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.

Summary for 040521

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

Pharmacology for NDA: 040521

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 040521

Anticonvulsants

Cytochrome P-450 CYP1A2 Inducers

Voltage-Gated Sodium Channel Blockers

Suppliers and Packaging for NDA: 040521

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHENYTOIN	phenytoin	SUSPENSION;ORAL	040521	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0892	0121-0892-63	4 mL in 1 CUP, UNIT-DOSE (0121-0892-63)
PHENYTOIN	phenytoin	SUSPENSION;ORAL	040521	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-4070	17856-4070-1	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-4070-1) / 4 mL in 1 CUP, UNIT-DOSE (17856-4070-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Mar 8, 2004	TE:	AB	RLD:	No

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