Emedastine Difumarate

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

As of Nov 15, 2026, FDA lists 1 application for Emedastine Difumarate (sold as Emadine), first approved Dec 29, 1997, with 0 new uses approved and 0 published complete response letters.

First approved: Dec 29, 1997
Applications: 1
New uses approved: 0
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
This Phase 1a Study Will Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Relative Bioavailability of Single-dose DMI019 Nasal Spray in Healthy Participants.Healthy Volunteers · The Third Xiangya Hospital of Central South University	Phase 1	Not yet recruiting	Sep 22, 2026

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Dec 29, 1997	EmadineNDA 20706 · New molecular entity	Novartis	11	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