Cis-Pyro

NDA 19039, held by Sun Pharm Inds Inc. Technetium Tc-99m Pyrophosphate Kit.

As of Nov 13, 2026, NDA 19039 (Cis-Pyro), held by Sun Pharm Inds Inc, was first approved by FDA on Jun 30, 1987, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1987
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 30, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


May 22, 2025	Supplement 22Labeling · Standard review	Approved	Label Letter
Nov 24, 2014	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 12, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 27, 2002	Supplement 2Labeling · Standard review	Approved	Letter
May 27, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 30, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19039
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