Sodium Iodide I 131

NDA 16515, held by Curium. Sodium Iodide I-131.

As of Nov 13, 2026, NDA 16515 (Sodium Iodide I 131), held by Curium, was first approved by FDA on Aug 18, 1971, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 18, 1971
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 18, 1971	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Sodium Iodide I 1313.5-150mCi/VIAL · solution;oral	Sodium Iodide I-131	DiscontinuedReference drug
Sodium Iodide I 1310.8-100mCi · capsule;oral	Sodium Iodide I-131	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Feb 6, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label
Oct 20, 2015	Supplement 13Labeling · Standard review	Approved	Label Letter
Mar 20, 2014	Supplement 12Labeling · Standard review	Approved	Label Letter
Feb 3, 2012	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 7, 1988	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 11, 1983	Supplement 7Labeling	Approved	None posted
Oct 27, 1977	Supplement 3Labeling	Approved	None posted
Oct 27, 1977	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 27, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 2, 1976	Supplement 1Labeling	Approved	None posted
Aug 18, 1971	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16515
Drugs@FDA: Overview at FDA
Company: Curium

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters