Sodium Iodide I 131

NDA 17315, held by Sun Pharm Inds Inc. Sodium Iodide I-131.

As of Nov 15, 2026, NDA 17315 (Sodium Iodide I 131), held by Sun Pharm Inds Inc, was first approved by FDA on Nov 16, 1976, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 16, 1976
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 16, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Iodide I 13150mCi/ML · solution;oral	Sodium Iodide I-131	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 5, 1985	Supplement 3Labeling	Approved	None posted
Dec 5, 1979	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 16, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17315
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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