Details for New Drug Application (NDA): 020471

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NDA 020471 describes ZYFLO, which is a drug marketed by Chiesi and is included in two NDAs. It is available from one supplier. Additional details are available on the ZYFLO profile page.

The generic ingredient in ZYFLO 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 020471

Tradename:	ZYFLO
Applicant:	Chiesi
Ingredient:	zileuton
Patents:	0

Pharmacology for NDA: 020471

Mechanism of Action	5-Lipoxygenase Inhibitors
Physiological Effect	Decreased Leukotriene Production

Suppliers and Packaging for NDA: 020471

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYFLO	zileuton	TABLET;ORAL	020471	NDA	Chiesi USA, Inc.	10122-901	10122-901-12	120 TABLET in 1 BOTTLE (10122-901-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Dec 9, 1996	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Dec 9, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020471

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-001	Dec 9, 1996	⤷ Sign Up	⤷ Sign Up
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-003	Dec 9, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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