Ranitidine Bismuth Citrate

Sold as Tritec. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Ranitidine Bismuth Citrate (sold as Tritec), with 1 new use approved and 0 published complete response letters.

First approved: not available
Applications: 1
New uses approved: 1
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
: Vascular Function in Health and DiseaseChronic Obstructive Pulmonary Disease, Pulmonary Artery Hypertension · D. Walter Wray	Phase 1	Recruiting	Nov 17, 2016

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
—	TritecNDA 20559	Glaxosmithkline	1	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