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PENTETATE CALCIUM TRISODIUM

NDA

PENTETATE CALCIUM TRISODIUM | N021749 | HAMELN PHARMA 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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Heyltex Corporation, Heyl Chemisch-Pharmazeutische Fabrik GnbH & Co. KG - Cit... FDA-2010-P-0628 · 10 docket documents Heyl Chemisch-pharmazeutische Fabrik GmbH & Co. KG filed this petition requesting that the FDA Commissioner determine whether Hameln Pharms' voluntary withdrawal of Pentetate Calcium Trisodium from sale, the subject of NDA 21-749, was for reasons other than safety or effectiveness. The petitioner su	505(q)	2010-12-20	Denied	—

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#001 — EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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