Iosat

NDA 18664, held by Anbex. Potassium Iodide.

As of Nov 13, 2026, NDA 18664 (Iosat), held by Anbex, was first approved by FDA on Oct 14, 1982, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 14, 1982
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses Helps prevent radioactive iodine from getting into the thyroid gland during a nuclear radiation emergency. Use along with other emergency measures recommended by public officials.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Oct 14, 1982	Original application	Approved	None posted

Products

2 strengths and forms


Iosat130MG · tablet;oral	Potassium Iodide	OTCReference drug
Iosat65MG · tablet;oral	Potassium Iodide	OTCReference drug

All 9 submissions, including labeling and manufacturing supplements


Dec 20, 2016	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 6, 2016	Supplement 17Manufacturing	Approved	None posted
Jun 17, 2015	Supplement 16Manufacturing	Approved	None posted
Mar 3, 2015	Supplement 15Manufacturing	Approved	None posted
May 12, 2011	Supplement 13Manufacturing	Approved	None posted
Jan 14, 2005	Supplement 7Labeling	Approved	None posted
Sep 13, 2000	Supplement 2Manufacturing	Approved	None posted
Nov 4, 1985	Supplement 1Manufacturing	Approved	None posted
Oct 14, 1982	Original application	Approved	None posted

Identifiers

Application: NDA 18664
Drugs@FDA: Overview at FDA
Company: ANBEX

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