ZYFLO CR - 10122-902-12 - (zileuton)

Alphabetical Index


Drug Information of ZYFLO CR

Product NDC: 10122-902
Proprietary Name: ZYFLO CR
Non Proprietary Name: zileuton
Active Ingredient(s): 600    mg/1 & nbsp;   zileuton
Administration Route(s): ORAL
Dosage Form(s): TABLET, MULTILAYER, EXTENDED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of ZYFLO CR

Product NDC: 10122-902
Labeler Name: Cornerstone Therapeutics Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022052
Marketing Category: NDA
Start Marketing Date: 20070530

Package Information of ZYFLO CR

Package NDC: 10122-902-12
Package Description: 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (10122-902-12)

NDC Information of ZYFLO CR

NDC Code 10122-902-12
Proprietary Name ZYFLO CR
Package Description 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (10122-902-12)
Product NDC 10122-902
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name zileuton
Dosage Form Name TABLET, MULTILAYER, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20070530
Marketing Category Name NDA
Labeler Name Cornerstone Therapeutics Inc.
Substance Name ZILEUTON
Strength Number 600
Strength Unit mg/1
Pharmaceutical Classes 5-Lipoxygenase Inhibitor [EPC],5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE]

Complete Information of ZYFLO CR


General Information