Is Technetium tc 99m pentetate kit approved by the US FDA?

Drugs@FDA lists 5 application product lines for Technetium tc 99m pentetate kit, including DRAXIMAGE DTPA (Prescription); TECHNETIUM TC-99M PENTETATE KIT (Prescription); TECHNETIUM TC-99M PENTETATE KIT (Discontinued); MPI DTPA KIT - CHELATE (Discontinued); AN-DTPA (Discontinued).

Are there safety signals or safety updates for Technetium tc 99m pentetate kit?

US FDA: 2 entries (latest 2023-06-07).

Active substance

Technetium tc 99m pentetate kit

US FDA 5
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DRAXIMAGE DTPA	N/A	injectable · injection	JUBILANT	Prescription	29 Dec 1989
TECHNETIUM TC-99M PENTETATE KIT	N/A	injectable · injection	CURIUM	Prescription	26 Mar 2025
TECHNETIUM TC-99M PENTETATE KIT	N/A	injectable · injection	GE HEALTHCARE	Discontinued	14 Feb 1974
MPI DTPA KIT - CHELATE	N/A	injectable · injection	GE HEALTHCARE	Discontinued	15 Apr 1976
AN-DTPA	N/A	injectable · injection	JUBILANT DRAXIMAGE	Discontinued	16 Nov 1976

Safety signals and safety-related labeling changes

US FDA 7 Jun 2023 DRAXIMAGE DTPA — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 26 Dec 2017 DTPA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for technetium tc 99m pentetate kit →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.