Chromalbin

BLA 17835, held by Iso Tex. Albumin Chromated Cr-51 Serum.

As of Nov 13, 2026, BLA 17835 (Chromalbin), 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
Chromalbin100uCi/VIAL · injectable;injection	Albumin Chromated Cr-51 Serum	Discontinued
Chromalbin250uCi/VIAL · injectable;injection	Albumin Chromated Cr-51 Serum	Discontinued
Chromalbin500uCi/VIAL · injectable;injection	Albumin Chromated Cr-51 Serum	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 17, 1986	Supplement 8Manufacturing · Priority review	Approved	None posted
Jul 29, 1981	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 8, 1979	Supplement 5Labeling	Approved	None posted
Mar 8, 1979	Supplement 6Labeling	Approved	None posted
Feb 28, 1978	Supplement 2Labeling	Approved	None posted
Feb 28, 1978	Supplement 4Labeling	Approved	None posted
Jul 16, 1976	Supplement 1Manufacturing · Priority review	Approved	None posted
Feb 23, 1976	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: BLA 17835
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