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FLUDEOXYGLUCOSE F18

NDA

FLUDEOXYGLUCOSE F-18 | N021870 | FEINSTEIN INSTITUTE MEDICAL RESEARCH

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

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

INSTITUTE CLINICAL PETInactiveFLUDEOXYGLUCOSE F-18 INJECTION

DMF 90571991

GENERAL ELECTRIC MEDICAL SYSTEMSInactiveFLUDEOXYGLUCOSE F-18 INJECTION

DMF 132681998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Aug 19, 2005

No patent or exclusivity listings for this strength.

#002 — 20-400mCi/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Nov 21, 2008