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As of Nov 15, 2026, NDA 22052 (Zyflo Cr), held by Chiesi, was first approved by FDA on May 30, 2007, with 4 approved supplements and 0 published complete response letters.
First approved: May 30, 2007
Review: Standard
Supplements approved: 4
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 5 submissions below
Date
Submission
Status
Documents
May 30, 2007
Original applicationNew dosage form · Standard review
Zyflo Cr600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
