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Last Updated: July 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022052


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NDA 022052 describes ZYFLO CR, which is a drug marketed by Chiesi and is included in one NDA. It is available from one supplier. Additional details are available on the ZYFLO CR profile page.

The generic ingredient in ZYFLO CR is zileuton. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the zileuton profile page.
Summary for 022052
Tradename:ZYFLO CR
Applicant:Chiesi
Ingredient:zileuton
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022052
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052 NDA AUTHORIZED GENERIC Prasco, LLC 66993-485 66993-485-32 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-485-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:May 30, 2007TE:ABRLD:Yes

Expired US Patents for NDA 022052

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007   Start Trial   Start Trial
Chiesi ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007   Start Trial   Start Trial
Chiesi ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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