← FDA DRUG APPROVALS

FDA NDA · NDA022052

ZYFLO CR

Sponsor: CHIESI

APPLICATION
NDA022052
TYPE
NDA
ORIGINAL APPROVAL
2007-05-30
LATEST ACTION
2018-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ZYFLO CR · ReferenceDiscontinued
ZILEUTON 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-12-31Labeling · Supplement 14 · standard — Label ↗AP
2014-10-27Manufacturing (CMC) · Supplement 10 · standardAP
2011-11-30Labeling · Supplement 9 · unknown — Letter ↗AP
2009-09-04Labeling · Supplement 5 · standard — Letter ↗AP
2007-05-30Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →