Norfloxacin

Sold as Noroxin, Chibroxin. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 2 applications for Norfloxacin (sold as Noroxin, Chibroxin), first approved Oct 31, 1986, with 4 new uses approved and 0 published complete response letters.

First approved: Oct 31, 1986
Applications: 2
New uses approved: 4
Complete response letters: 0

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
Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial PeritonitisSpontaneous Bacterial Peritonitis · Tanta University	Phase 3	Recruiting	Nov 13, 2019

Applications

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


Oct 31, 1986	NoroxinNDA 19384 · New molecular entity	Merck	54	Discontinued
Jun 17, 1991	ChibroxinNDA 19757 · New dosage form	Merck	10	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