Sodium Iodide I 131

NDA 17316, held by Cis. Sodium Iodide I-131.

As of Nov 15, 2026, NDA 17316 (Sodium Iodide I 131), held by Cis, was first approved by FDA on Nov 9, 1976, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 9, 1976
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 9, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Sodium Iodide I 13150uCi · capsule;oral	Sodium Iodide I-131	Discontinued
Sodium Iodide I 131100uCi · capsule;oral	Sodium Iodide I-131	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 5, 1985	Supplement 3Labeling	Approved	None posted
Nov 9, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17316
Drugs@FDA: Overview at FDA
Company: C.I.S

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