Gatifloxacin

Sold as Zymar, Zymaxid. Every FDA application for this active ingredient: 2 branded and 7 generic.

As of Nov 15, 2026, FDA lists 9 applications for Gatifloxacin (sold as Zymar, Zymaxid), first approved Mar 28, 2003, with 1 new use approved and 0 published complete response letters.

First approved: Mar 28, 2003
Applications: 9
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $1.2M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Gatifloxacin	Part D	$1.2M	-11%	18,365

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

GATIFLOXACIN 0.5% EYE DROPS: $9.47 per MLGeneric · -14% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With TuberculosisTuberculosis · Beijing Children's Hospital	—	Recruiting	Aug 10, 2018

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Mar 28, 2003	ZymarNDA 21493 · New dosage form	Allergan	6	Discontinued
May 18, 2010	ZymaxidNDA 22548 · New formulation or manufacturer	Abbvie	2	Marketed
Aug 19, 2011	GatifloxacinANDA 79084	Apotex Inc	1	Discontinued
Aug 28, 2013	GatifloxacinANDA 202653	Lupin	1	Discontinued
Sep 3, 2014	GatifloxacinANDA 203189	Hikma	1	Discontinued
Jul 11, 2016	GatifloxacinANDA 204227	Sandoz	1	Marketed
Jun 8, 2018	GatifloxacinANDA 206446	Rising	0	Discontinued
Nov 3, 2021	GatifloxacinANDA 213542	Caplin	0	Marketed
—	GatifloxacinANDA 203190	Hi-Tech Pharmacal	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA