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. Six 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 30, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 022052

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

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