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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022052

ZYFLO CR (ZILEUTON)
600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
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Strength: 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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