Sodium Iodide I-131

Sold as Iodotope, Sodium Iodide I 131, Hicon. Every FDA application for this active ingredient: 6 branded and 2 generic.

As of Nov 15, 2026, FDA lists 8 applications for Sodium Iodide I-131 (sold as Iodotope, Sodium Iodide I 131, Hicon), first approved May 2, 1957, with 1 new use approved and 0 published complete response letters.

First approved: May 2, 1957
Applications: 8
New uses approved: 1
Complete response letters: 0

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Aldosterone & Sodium Regulation in Postural Tachycardia Syndrome - ScreeningPostural Tachycardia Syndrome · Vanderbilt University	Not applicable	Active, not recruiting	Feb 4, 2013
IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer PatientsThyroid Cancer, Thyroid Neoplasms · University College, London	Phase 2 / Phase 3	Active, not recruiting	Jul 20, 2011

Applications

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


May 2, 1957	IodotopeNDA 10929 · New formulation or manufacturer	Bracco	19	Discontinued
Aug 18, 1971	Sodium Iodide I 131NDA 16515 · New formulation or manufacturer	Curium	10	Discontinued
Aug 20, 1971	Sodium Iodide I 131NDA 16517 · New formulation or manufacturer	Curium	10	Discontinued
Nov 9, 1976	Sodium Iodide I 131NDA 17316 · New formulation or manufacturer	Cis	1	Discontinued
Nov 16, 1976	Sodium Iodide I 131NDA 17315 · New formulation or manufacturer	Sun Pharm Inds Inc	2	Discontinued
Jan 24, 2003	Hicon, Sodium Iodide I 131NDA 21305 · New dosage form	Jubilant	20	Marketed
Feb 5, 2020	Sodium Iodide I 131ANDA 209166	Intl Isotopes	0	Marketed
Jun 12, 2025	Sodium Iodide I 131ANDA 213615	Cardinal Hlth 414	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