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SODIUM PERTECHNETATE TC 99M

NDA

TECHNETIUM TC-99M SODIUM PERTECHNETATE | N017471 | GE HEALTHCARE

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
Spectron mrc, LLC - Citizen Petition FDA-2013-P-1516 · 4 docket documents Spectron mrc, LLC filed this citizen petition requesting that the FDA issue a notice determining that Sodium Pertechnetate Tc-99m (technetium Tc-99m sodium pertechnetate) injection, oral, was not withdrawn from sale for reasons of safety or effectiveness, thereby allowing the agency to approve abbre	505(q)	2013-12-13	Granted	—

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

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer NCT03120624	Phase 1	Active	Mayo Clinic	34	2017-09-15 → 2028-01-01

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

Products (1)

#001 — 2-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INJECTION, ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.