Phenindione

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

As of Nov 14, 2026, FDA lists 1 application for Phenindione (sold as Hedulin), with 0 new uses approved and 0 published complete response letters.

First approved: not available
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
Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APSAntiphospholipid Syndrome, Arterial Thrombosis · McMaster University	—	Recruiting	Dec 12, 2022

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
—	HedulinNDA 8767	Sanofi Aventis US	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