FDA NDA · NDA021144

KETEK

Sponsor: SANOFI AVENTIS US

APPLICATION

NDA021144

TYPE

NDA

ORIGINAL APPROVAL

2004-04-01

LATEST ACTION

2015-11-04

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

KETEKDiscontinued

TELITHROMYCIN 300MG · TABLET · ORAL

KETEKDiscontinued

TELITHROMYCIN 400MG · TABLET · ORAL

2015-11-04Labeling · Supplement 19 · standard — Letter ↗AP

2015-03-09Labeling · Supplement 18 · standard — Letter ↗AP

2014-02-26Manufacturing (CMC) · Supplement 17 · standardAP

2013-07-11Manufacturing (CMC) · Supplement 16 · standardAP

2011-06-20REMS · Supplement 15 — Letter ↗AP

2010-12-08Labeling · Supplement 13 · standard — Label ↗AP

2010-12-08Labeling · Supplement 14 · standard — Letter ↗AP

2007-02-12Labeling · Supplement 12 · standard — Letter ↗AP

2006-06-29Labeling · Supplement 11 · standard — Letter ↗AP

2005-11-02Labeling · Supplement 4 · standard — Letter ↗AP

2005-04-08Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP

2005-02-09Labeling · Supplement 3 · standard — Letter ↗AP

2005-02-09Efficacy · Supplement 1 · unknown — Letter ↗AP

2004-04-01Type 1 - New Molecular Entity · Original · standard — Review ↗AP

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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