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AN-DTPA

NDA

TECHNETIUM TC-99M PENTETATE KIT | N017714 | JUBILANT DRAXIMAGE INC

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 Foley & Lardner LLP FDA-2017-P-3201 · 4 docket documents Foley & Lardner LLP filed this citizen petition requesting that the FDA designate two Technetium Tc-99m Pentetate Kit products (NDA 17714 by Jubilant Draximage, Inc. and NDA 18511 by Draximage, Inc.) as reference listed drugs in the Orange Book so that abbreviated new drug applications can be filed	505(q)	2017-05-19	Withdrawn	Foley & Lardner LLP

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
Mar 20, 2002	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — N/A

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.