Draximage Mdp-10, Draximage Mdp-25

NDA 18035, held by Jubilant. Technetium Tc-99m Medronate.

As of Nov 13, 2026, NDA 18035 (Draximage Mdp-10, Draximage Mdp-25), held by Jubilant, was first approved by FDA on Nov 28, 1978, with 16 approved supplements and 0 published complete response letters.

First approved: Nov 28, 1978
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE MDP-25 (Kit for the Preparation of 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 17 submissions below

Date	Submission	Status	Documents
Nov 28, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Draximage Mdp-10N/A · injectable;injection	Technetium Tc-99m Medronate	Discontinued
Draximage Mdp-25N/A · injectable;injection	Technetium Tc-99m Medronate	RxReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 22, 2025	Supplement 43Labeling · Standard review	Approved	Label Letter
Sep 23, 2011	Supplement 32Labeling · Standard review	Approved	Label Letter
Oct 22, 2010	Supplement 29Labeling	Approved	Letter Label
Jul 8, 2009	Supplement 24Manufacturing · Standard review	Approved	Letter Label
Feb 27, 2004	Supplement 18Manufacturing · Standard review	Approved	Letter
Jul 3, 2002	Supplement 17Manufacturing · Standard review	Approved	Letter
Apr 2, 1999	Supplement 16Labeling · Standard review	Approved	None posted
Apr 2, 1999	Supplement 15Labeling · Standard review	Approved	None posted
Aug 23, 1996	Supplement 14Labeling · Standard review	Approved	None posted
Dec 30, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 8, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 31, 1988	Supplement 12Labeling	Approved	None posted
May 30, 1980	Supplement 1Labeling	Approved	None posted
May 29, 1980	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 15, 1979	Supplement 4Labeling	Approved	None posted
Apr 26, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 28, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Identifiers

Application: NDA 18035
Drugs@FDA: Overview at FDA
Company: Jubilant

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