← FDA DRUG APPROVALS

FDA NDA · NDA020471

ZYFLO

zileuton

Sponsor: CHIESI

APPLICATION
NDA020471
TYPE
NDA
ORIGINAL APPROVAL
1996-12-09
LATEST ACTION
2012-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZYFLO · ReferenceDiscontinued
ZILEUTON 600MG · TABLET · ORAL
ZYFLO · ReferenceDiscontinued
ZILEUTON 300MG · TABLET · ORAL

Approval history

2012-06-08Labeling · Supplement 17 · unknown — Label ↗AP
2009-08-21Labeling · Supplement 14 · standard — Letter ↗AP
2005-09-28Manufacturing (CMC) · Supplement 11 · standard — Label ↗AP
2002-12-16Labeling · Supplement 9 · standard — Review ↗AP
2001-04-23Labeling · Supplement 8 · standardAP
1998-09-24Manufacturing (CMC) · Supplement 6 · standardAP
1998-09-04Labeling · Supplement 7 · standard — Review ↗AP
1997-09-08Manufacturing (CMC) · Supplement 5 · standardAP
1997-05-30Manufacturing (CMC) · Supplement 3 · standardAP
1997-05-21Manufacturing (CMC) · Supplement 1 · standardAP
1997-05-06Manufacturing (CMC) · Supplement 4 · standardAP
1996-12-09Type 1 - New Molecular Entity · 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.

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