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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cerilliant
US Department of Justice
McKinsey
Teva
Medtronic
Healthtrust
Cipla
Covington

Generated: April 25, 2018

DrugPatentWatch Database Preview

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 seven 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
Therapeutic Class:Anticonvulsants
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 N 0069-5471-02
CEREBYX fosphenytoin sodium INJECTABLE;INJECTION 020450 NDA Pfizer Laboratories Div Pfizer Inc 0069-5474 N 0069-5474-02

Profile for product number 001

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

Expired US Patents for NDA 020450

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

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Cantor Fitzgerald
Fish and Richardson
Colorcon
Medtronic
Queensland Health
Cipla
Chubb
US Department of Justice

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