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NDA

TECHNETIUM TC-99M TETROFOSMIN KIT | N020372 | MEDI-PHYSICS INC DBA GE HEALTHCARE

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

Today

9549999

Mar. 10, 2030

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Dec 7, 2022	SUPPL -33	View Letter (PDF)
Mar 10, 2022	SUPPL -31	View Letter (PDF)
Apr 18, 2017	SUPPL -28	View Letter (PDF)
Mar 5, 2009	SUPPL -22	View Letter (PDF)
Jul 15, 2005	SUPPL -19	View Letter (PDF)
Nov 26, 2003	SUPPL -15	View Letter (PDF)
Mar 10, 2003	SUPPL -13	View Letter (PDF)
May 22, 2002	SUPPL -11	View Letter (PDF)
Nov 3, 2001	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — N/A

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 9, 1996

No patent or exclusivity listings for this strength.

#002 — N/A

RLD

1 patent0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 7, 2005