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PENTETATE ZINC TRISODIUM

NDA

PENTETATE ZINC TRISODIUM | N021751 | HAMELN PHARMA PLUS GMBH

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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Heyltex Corporation, HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG - Cit... FDA-2010-P-0630 · 11 docket documents HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG filed this citizen petition requesting that the FDA Commissioner determine whether Pentetate Zinc Trisodium covered by NDA 21-751, voluntarily withdrawn from the U.S. market by Hameln Pharms, was withdrawn for reasons other than safety or effectiven	505(q)	2010-12-20	Granted	—
HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG - Citizen Petition FDA-2009-P-0258 · 3 docket documents HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Pentetate Zinc Trisodium (Zn-DTPA) injection solution at a strength of 1055 mg/5 mL suitable for submission of an Abbrevi	Other	2009-06-09	Open	—

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

Clinical Trials

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of IV-Administered Ca-DTPA and Zn-DTPA To Treat Patients With Gadolinium Deposition Disease NCT02947022	Phase 1/2	Terminated	University of North Carolina, Chapel Hill	1	2016-10 → 2017-01-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 22, 2013	SUPPL -8	View Letter (PDF)
Aug 8, 2005	SUPPL -2	View Letter (PDF)
Aug 11, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INHALATION, INTRAVENOUS | Approved: Aug 11, 2004

No patent or exclusivity listings for this strength.