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FLUORODOPA F18

NDA

FLUORODOPA F-18 | N200655 | FEINSTEIN INSTITUTE MEDICAL RESEARCH

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Natural History of Familial Carcinoid Tumor NCT00646022	—	Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1,600	2008-08-25
Amino Acid PET to Assess the Efficacy of IDH Inhibitor Treatments for IDH Mutated Gliomas NCT07017790	—	Completed	Central Hospital, Nancy, France	22	2025-06-30 → 2025-08-30
Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin NCT02856347	N/A	Completed	Institut Claudius Regaud	24	2017-03-22 → 2020-12-20

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 11, 2020	SUPPL -1	View Letter (PDF)
Oct 11, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1-40mCi/ML

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 10, 2019

No patent or exclusivity listings for this strength.