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Generated: November 21, 2018

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Details for New Drug Application (NDA): 022052

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NDA 022052 describes ZYFLO CR, which is a drug marketed by Chiesi Usa Inc and is included in one NDA. It is available from two suppliers. 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. Three suppliers are listed for this compound. Additional details are available on the zileuton profile page.
Summary for 022052
Tradename:ZYFLO CR
Applicant:Chiesi Usa Inc
Ingredient:zileuton
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022052
Mechanism of Action5-Lipoxygenase Inhibitors
Physiological EffectDecreased Leukotriene Production
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 Chiesi USA, Inc. 10122-902 10122-902-12 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (10122-902-12)
ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052 NDA Chiesi USA, Inc. 10122-902 10122-902-20 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (10122-902-20)

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 Usa Inc ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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