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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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment I - From: "Young, Johnny"<Johnny.Young@fda.hhs.gov> "Suitability P... FDA-2010-P-0630 Heyltex Corporation, on behalf of HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG, filed Suitability Petition 2009-P-0258 requesting FDA approval regarding Pentetate Zinc Trisodium Injection, a chelation agent used in nuclear medicine for treating certain types of heavy metal poisoning and intern	Suitability	2010-12-20	Open	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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#001 — EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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