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FDA NDA · NDA021158

FACTIVE

Sponsor: LG CHEM LTD

APPLICATION
NDA021158
TYPE
NDA
ORIGINAL APPROVAL
2003-04-04
LATEST ACTION
2019-05-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FACTIVE · ReferenceDiscontinued
GEMIFLOXACIN MESYLATE EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2019-05-03Labeling · Supplement 26 · standard — Letter ↗AP
2018-12-13Labeling · Supplement 24 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 25 · standard — Label ↗AP
2016-07-26Labeling · Supplement 23 · standard — Letter ↗AP
2013-08-14Labeling · Supplement 22 · standard — Letter ↗AP
2011-10-18Labeling · Supplement 21 · standard — Label ↗AP
2011-08-04Labeling · Supplement 19 · unknownAP
2011-02-25Labeling · Supplement 18 · 901 required — Label ↗AP
2009-04-27Labeling · Supplement 14 · standard — Label ↗AP
2008-10-29Labeling · Supplement 13 · standard — Label ↗AP
2008-10-03Labeling · Supplement 12 · standard — Letter ↗AP
2007-12-19Labeling · Supplement 11 · standard — Letter ↗AP
2007-05-01Efficacy · Supplement 7 · standard — Label ↗AP
2006-10-26Labeling · Supplement 5 · standard — Letter ↗AP
2004-09-07Labeling · Supplement 3 · standard — Letter ↗AP
2004-07-28Labeling · Supplement 2 · standard — Letter ↗AP
2003-07-25Efficacy · Supplement 1 · standard — Letter ↗AP
2003-04-04Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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