Pyrolite

NDA 17684, held by Pharmalucence. Technetium Tc-99m Pyro/Trimeta Phosphates Kit.

As of Nov 13, 2026, NDA 17684 (Pyrolite), held by Pharmalucence, was first approved by FDA on Nov 19, 1976, with 13 approved supplements and 0 published complete response letters.

First approved: Nov 19, 1976
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 10, 1986	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 2, 1983	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 19, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
PyroliteN/A · injectable;injection	Technetium Tc-99m Pyro/Trimeta Phosphates Kit	Discontinued

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 2, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 7, 2000	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 17, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 23, 1998	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 13, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 26, 1989	Supplement 14Labeling · Standard review	Approved	None posted
May 2, 1989	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 10, 1986	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 17, 1983	Supplement 8Manufacturing · Standard review	Approved	None posted
May 31, 1983	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 2, 1983	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Feb 4, 1982	Supplement 6Labeling · Standard review	Approved	None posted
Aug 11, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 19, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17684
Drugs@FDA: Overview at FDA
Company: Pharmalucence

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