Active Ingredient: ZILEUTON
Proprietary Name: ZYFLO CR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022052
Product Number: 001
Approval Date: May 30, 2007
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:
Discontinued
Patent and Exclusivity Information