Jeanatope

BLA 17836, held by Iso Tex. Albumin Iodinated I-125 Serum.

As of Nov 13, 2026, BLA 17836 (Jeanatope), held by Iso Tex, was first approved by FDA on Feb 23, 1976, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 23, 1976
Review: Priority
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 23, 1976	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Jeanatope500uCi/0.5ML · injectable;injection	Albumin Iodinated I-125 Serum	Rx
Jeanatope1,000uCi/ML · injectable;injection	Albumin Iodinated I-125 Serum	Rx
Jeanatope100uCi/10ML (10uCi/ML) · injectable;injection	Albumin Iodinated I-125 Serum	Rx

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 12, 2023	Supplement 9Labeling · Standard review	Approved	Label Letter
Jun 8, 2004	Supplement 8Manufacturing · Priority review	Approved	Letter
May 21, 1996	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 3, 1977	Supplement 2Labeling	Approved	None posted
Feb 3, 1977	Supplement 3Labeling	Approved	None posted
Feb 3, 1977	Supplement 4Labeling	Approved	None posted
Oct 8, 1976	Supplement 1Labeling	Approved	None posted
Feb 23, 1976	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: BLA 17836
Drugs@FDA: Overview at FDA
Company: Iso-Tex Diagnostics

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters