Technetium Tc-99m Medronate Kit

NDA 18107, held by Cardinal Health 414. Technetium Tc-99m Medronate Kit.

As of Nov 14, 2026, NDA 18107 (Technetium Tc-99m Medronate Kit), held by Cardinal Health 414, was first approved by FDA on Feb 17, 1981, with 14 approved supplements and 0 published complete response letters.

First approved: Feb 17, 1981
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Technetium Tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Feb 17, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Technetium Tc-99m Medronate KitN/A · injectable;injection	Technetium Tc-99m Medronate Kit	Rx

All 15 submissions, including labeling and manufacturing supplements


May 22, 2025	Supplement 17Labeling · Standard review	Approved	Label Letter
Nov 13, 2020	Supplement 15Labeling · Standard review	Approved	Letter
Sep 10, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 21, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 26, 2008	Supplement 11Manufacturing · Standard review	Approved	Letter
Nov 23, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 4, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 21, 1994	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 24, 1993	Supplement 6Labeling	Approved	None posted
Mar 24, 1993	Supplement 3Labeling	Approved	None posted
Sep 30, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 30, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 12, 1982	Supplement 2Labeling	Approved	None posted
Apr 13, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 17, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18107
Drugs@FDA: Overview at FDA
Company: Cardinal Health 414

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