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Last Updated: April 17, 2024

Details for New Drug Application (NDA): 020450

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NDA 020450 describes CEREBYX, which is a drug marketed by Parke Davis and is included in one NDA. It is available from one supplier. Additional details are available on the CEREBYX profile page.

The generic ingredient in CEREBYX is fosphenytoin sodium. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

Summary for 020450

Tradename:	CEREBYX
Applicant:	Parke Davis
Ingredient:	fosphenytoin sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020450

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: 020450

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEREBYX	fosphenytoin sodium	INJECTABLE;INJECTION	020450	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5471	0069-5471-02	25 VIAL, SINGLE-DOSE in 1 CARTON (0069-5471-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0069-5471-01)
CEREBYX	fosphenytoin sodium	INJECTABLE;INJECTION	020450	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5474	0069-5474-02	10 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-5474-02) / 10 mL in 1 VIAL, SINGLE-DOSE (0069-5474-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG PHENYTOIN NA/ML
Approval Date:	Aug 5, 1996	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020450

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Parke Davis	CEREBYX	fosphenytoin sodium	INJECTABLE;INJECTION	020450-001	Aug 5, 1996	⤷ Try a Trial	⤷ Try a Trial
Parke Davis	CEREBYX	fosphenytoin sodium	INJECTABLE;INJECTION	020450-001	Aug 5, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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