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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 six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the zileuton profile page.

Summary for NDA: 022052

Tradename:
ZYFLO CR
Applicant:
Chiesi Usa Inc
Ingredient:
zileuton
Patents:0
Therapeutic Class:Respiratory Tract Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:May 30, 2007TE:RLD:Yes

Expired Orange Book 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;ORAL022052-001May 30, 20074,873,259► subscribe
Chiesi Usa Inc
ZYFLO CR
zileuton
TABLET, EXTENDED RELEASE;ORAL022052-001May 30, 20076,183,778► subscribe
Chiesi Usa Inc
ZYFLO CR
zileuton
TABLET, EXTENDED RELEASE;ORAL022052-001May 30, 20075,422,123► subscribe
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