Macrotec

BLA 17833, held by Bracco. Technetium Tc-99m Albumin Aggregated Kit.

As of Nov 13, 2026, BLA 17833 (Macrotec), held by Bracco, was first approved by FDA on Feb 23, 1976, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 23, 1976
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Feb 23, 1976	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
MacrotecN/A · injectable;injection	Technetium Tc-99m Albumin Aggregated Kit	Discontinued

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 1, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 21, 1994	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 6, 1989	Supplement 10Labeling	Approved	None posted
Sep 30, 1985	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 6, 1984	Supplement 7Labeling	Approved	None posted
Jun 12, 1978	Supplement 4Labeling	Approved	None posted
Jul 13, 1977	Supplement 3Labeling	Approved	None posted
Jul 13, 1977	Supplement 1Labeling	Approved	None posted
Apr 25, 1977	Supplement 2Labeling	Approved	None posted
Feb 23, 1976	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: BLA 17833
Drugs@FDA: Overview at FDA
Company: Bracco

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