Technescan Hdp

NDA 18321, held by Curium. Technetium Tc-99m Oxidronate Kit.

As of Nov 14, 2026, NDA 18321 (Technescan Hdp), held by Curium, was first approved by FDA on Feb 18, 1981, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 18, 1981
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in adult and pediatric patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Apr 28, 1989	Supplement 8Efficacy (new indication or use)	Approved	None posted
Feb 18, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Technescan HdpN/A · injectable;injection	Technetium Tc-99m Oxidronate Kit	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Nov 24, 2025	Supplement 25Labeling · Standard review	Approved	Letter Label
May 22, 2025	Supplement 26Labeling · Standard review	Approved	Label Letter
Mar 31, 2017	Supplement 22Labeling · Standard review	Approved	Label Letter
Jun 17, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 14, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 8, 1998	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 29, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 14, 1994	Supplement 15Labeling · Standard review	Approved	None posted
Apr 28, 1989	Supplement 8Efficacy (new indication or use)	Approved	None posted
Sep 30, 1988	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 5, 1987	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 10, 1986	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 3, 1983	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 18, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18321
Drugs@FDA: Overview at FDA
Company: Curium

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