Amerscan Mdp Kit

NDA 18335, held by Ge Healthcare. Technetium Tc-99m Medronate Kit.

As of Nov 13, 2026, NDA 18335 (Amerscan Mdp Kit), held by Ge Healthcare, was first approved by FDA on Aug 5, 1982, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 5, 1982
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 5, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Aug 24, 1988	Supplement 2Labeling · Standard review	Approved	None posted
Sep 18, 1986	Supplement 1Labeling · Standard review	Approved	None posted
Aug 5, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18335
Drugs@FDA: Overview at FDA
Company: GE Healthcare

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