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TECHNELITE

NDA

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | N017771 | SHINE SPECT USA LLC

2 strengths0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 23, 2023	SUPPL -44	View Letter (PDF)
Feb 13, 2014	SUPPL -35	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 0.0083-2.7 CI/GENERATOR

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 1-20 CI/GENERATOR

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 12, 2014