Iodotope

NDA 10929, held by Bracco. Sodium Iodide I-131.

As of Nov 14, 2026, NDA 10929 (Iodotope), held by Bracco, was first approved by FDA on May 2, 1957, with 19 approved supplements and 0 published complete response letters.

First approved: May 2, 1957
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
May 2, 1957	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Iodotope1-130mCi · capsule;oral	Sodium Iodide I-131	Discontinued
Iodotope7-106mCi/BOT · solution;oral	Sodium Iodide I-131	Discontinued
Iodotope1-150mCi · capsule;oral	Sodium Iodide I-131	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Aug 14, 2001	Supplement 36Manufacturing · Standard review	Approved	None posted
Mar 24, 1998	Supplement 35Manufacturing · Standard review	Approved	None posted
Sep 5, 1995	Supplement 34Manufacturing · Standard review	Approved	None posted
May 9, 1995	Supplement 33Manufacturing · Standard review	Approved	None posted
Apr 22, 1986	Supplement 30Labeling	Approved	None posted
Sep 30, 1985	Supplement 32Manufacturing · Standard review	Approved	None posted
Feb 23, 1981	Supplement 19Labeling	Approved	None posted
Aug 8, 1980	Supplement 28Manufacturing · Standard review	Approved	None posted
Aug 7, 1980	Supplement 27Labeling	Approved	None posted
Nov 6, 1979	Supplement 26Labeling	Approved	None posted
May 1, 1979	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 22, 1979	Supplement 20Labeling	Approved	None posted
Sep 14, 1978	Supplement 23Labeling	Approved	None posted
Sep 14, 1978	Supplement 22Labeling	Approved	None posted
Sep 14, 1978	Supplement 21Labeling	Approved	None posted
May 30, 1978	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 30, 1977	Supplement 17Labeling	Approved	None posted
Mar 7, 1977	Supplement 16Labeling	Approved	None posted
Dec 14, 1976	Supplement 18Manufacturing · Standard review	Approved	None posted
May 2, 1957	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 10929
Drugs@FDA: Overview at FDA
Company: Bracco

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