Glofil-125

For renal disease. NDA 17279, held by Isotex. Iothalamate Sodium I-125.

As of Nov 13, 2026, NDA 17279 (Glofil-125), held by Isotex, was first approved by FDA on Feb 12, 1974, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 12, 1974
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 12, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Glofil-125250-300uCi/ML · injectable;injection	Iothalamate Sodium I-125	Rx

All 6 submissions, including labeling and manufacturing supplements


Jan 22, 2002	Supplement 8Labeling · Standard review	Approved	Letter
Mar 27, 1997	Supplement 7Labeling · Standard review	Approved	None posted
Aug 8, 1994	Supplement 5Labeling	Approved	None posted
Jan 16, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 4, 1976	Supplement 2Labeling	Approved	None posted
Feb 12, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17279
Drugs@FDA: Overview at FDA
Company: Isotex

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