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Last Updated: March 29, 2024

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. 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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 30, 2007TE:RLD: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 ⤷  Try a Trial ⤷  Try a Trial
Chiesi ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
Chiesi ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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