Factive

NDA 21158, held by Lg Chem Ltd. Gemifloxacin Mesylate.

As of Nov 14, 2026, NDA 21158 (Factive), held by Lg Chem Ltd, was first approved by FDA on Apr 4, 2003, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 4, 2003
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


May 1, 2007	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 25, 2003	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 4, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
FactiveEQ 320MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Gemifloxacin Mesylate	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


May 3, 2019	Supplement 26Labeling · Standard review	Approved	Label Medication Guide Letter
Dec 13, 2018	Supplement 24Labeling · Standard review	Approved	Label Letter
Oct 18, 2018	Supplement 25Labeling · Standard review	Approved	Letter Label
Jul 26, 2016	Supplement 23Labeling · Standard review	Approved	Letter Label
Aug 14, 2013	Supplement 22Labeling · Standard review	Approved	Letter Label
Oct 18, 2011	Supplement 21Labeling · Standard review	Approved	Label Letter
Aug 4, 2011	Supplement 19Labeling	Approved	None posted
Feb 25, 2011	Supplement 18Labeling	Approved	Label Letter
Apr 27, 2009	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 29, 2008	Supplement 13Labeling · Standard review	Approved	Label
Oct 3, 2008	Supplement 12Labeling · Standard review	Approved	Label Letter
Dec 19, 2007	Supplement 11Labeling · Standard review	Approved	Letter
May 1, 2007	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 26, 2006	Supplement 5Labeling · Standard review	Approved	Letter Label
Sep 7, 2004	Supplement 3Labeling · Standard review	Approved	Letter Label
Jul 28, 2004	Supplement 2Labeling · Standard review	Approved	Letter Label
Jul 25, 2003	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 4, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21158
Drugs@FDA: Overview at FDA
Company: LG Chem

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