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CARDIOLITE

NDA

TECHNETIUM TC-99M SESTAMIBI KIT | N019785 | 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
Dec 5, 2019	SUPPL -22	View Letter (PDF)
Jun 18, 2008	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — N/A

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 21, 1990

No patent or exclusivity listings for this strength.

#003 — N/A

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 23, 1997