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Zileuton - Generic Drug Details

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Zileuton is the generic ingredient in two branded drugs marketed by Chiesi Usa Inc and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for zileuton. One supplier is listed for this compound.

Summary for Generic Name: zileuton

Tradenames:2
Patents:0
Applicants:1
NDAs:2
Drug Master File Entries: see list6
Suppliers / Packaging: see list1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: zileuton

Clinical Trials for: zileuton

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi Usa Inc
ZYFLO
zileuton
TABLET;ORAL020471-001Dec 9, 1996DISCNNo<disabled><disabled>
Chiesi Usa Inc
ZYFLO CR
zileuton
TABLET, EXTENDED RELEASE;ORAL022052-001May 30, 2007RXYes<disabled><disabled>
Chiesi Usa Inc
ZYFLO
zileuton
TABLET;ORAL020471-003Dec 9, 1996RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: zileuton

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc
ZYFLO
zileuton
TABLET;ORAL020471-001Dec 9, 19964,873,259<disabled>
Chiesi Usa Inc
ZYFLO CR
zileuton
TABLET, EXTENDED RELEASE;ORAL022052-001May 30, 20074,873,259<disabled>
Chiesi Usa Inc
ZYFLO CR
zileuton
TABLET, EXTENDED RELEASE;ORAL022052-001May 30, 20076,183,778<disabled>
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