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Generated: April 22, 2019

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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
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 in 1 CARTON (0069-5471-02) > 2 mL in 1 VIAL (0069-5471-01)
CEREBYX fosphenytoin sodium INJECTABLE;INJECTION 020450 NDA Pfizer Laboratories Div Pfizer Inc 0069-5474 0069-5474-02 10 VIAL in 1 PACKAGE (0069-5474-02) > 10 mL in 1 VIAL (0069-5474-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG PHENYTOIN NA/ML
Approval Date:Aug 5, 1996TE:APRLD:Yes

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