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MPI DMSA KIDNEY REAGENT

NDA

TECHNETIUM TC-99M SUCCIMER KIT | N017944 | GE HEALTHCARE

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps, & McNamara P.C. FDA-2021-P-0959 · 5 docket documents Hyman, Phelps & McNamara P.C. filed this petition under FDC Act sections 505(j) and 505(w) requesting that FDA determine whether MPI DMSA KIDNEY REAGENT (technetium Tc-99m succimer injection), approved under NDA 017944 and held by GE Healthcare, was withdrawn for safety or effectiveness reasons, to	505(q)	2021-09-01	Denied	Hyman, Phelps, & McNamara P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 25, 2003	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — N/A **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 18, 1982

No patent or exclusivity listings for this strength.