Minitec

NDA 17339, held by Bracco. Technetium Tc-99m Sodium Pertechnetate Generator.

As of Nov 13, 2026, NDA 17339 (Minitec), held by Bracco, was first approved by FDA on Jun 3, 1974, with 20 approved supplements and 0 published complete response letters.

First approved: Jun 3, 1974
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
May 27, 1983	Supplement 18Efficacy (new indication or use)	Approved	None posted
Jun 3, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Minitec0.22-2.22 CI/GENERATOR · solution;injection, oral	Technetium Tc-99m Sodium Pertechnetate Generator	Discontinued

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 26Labeling	Approved	None posted
Mar 13, 2009	Supplement 20Labeling	Approved	None posted
Mar 13, 2009	Supplement 14Labeling	Approved	None posted
Sep 30, 1985	Supplement 29Manufacturing · Standard review	Approved	None posted
May 30, 1985	Supplement 28Manufacturing · Standard review	Approved	None posted
May 27, 1983	Supplement 18Efficacy (new indication or use)	Approved	None posted
Nov 18, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 22, 1981	Supplement 22Manufacturing · Standard review	Approved	None posted
May 5, 1981	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 8, 1980	Supplement 23Labeling	Approved	None posted
Oct 11, 1979	Supplement 19Manufacturing · Standard review	Approved	None posted
May 18, 1979	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 5, 1979	Supplement 17Labeling	Approved	None posted
Mar 20, 1978	Supplement 13Labeling	Approved	None posted
Jun 15, 1977	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 11, 1977	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 21, 1976	Supplement 10Labeling	Approved	None posted
Feb 5, 1976	Supplement 9Labeling	Approved	None posted
Dec 22, 1975	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 2, 1975	Supplement 7Labeling	Approved	None posted
Jun 3, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17339
Drugs@FDA: Overview at FDA
Company: Bracco

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