Cis-Mdp

NDA 18124, held by Sun Pharm Inds Inc. Technetium Tc-99m Medronate Kit.

As of Nov 13, 2026, NDA 18124 (Cis-Mdp), held by Sun Pharm Inds Inc, was first approved by FDA on Aug 29, 1979, with 15 approved supplements and 0 published complete response letters.

First approved: Aug 29, 1979
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Technetium Tc 99m Medronate Injection 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 16 submissions below

Date	Submission	Status	Documents
Aug 29, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 22, 2025	Supplement 32Labeling · Standard review	Approved	Label Letter
May 17, 2016	Supplement 27Manufacturing · Standard review	Approved	None posted
May 26, 2015	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 21, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 18, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 19, 2005	Supplement 13Manufacturing · Standard review	Approved	Letter Label
May 27, 1997	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 28, 1989	Supplement 11Labeling	Approved	None posted
Aug 18, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 2, 1986	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 27, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 2, 1985	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 29, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 27, 1984	Supplement 2Labeling	Approved	None posted
Mar 27, 1984	Supplement 3Labeling	Approved	None posted
Aug 29, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18124
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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