FLUDEOXYGLUCOSE F-18 | N021870 | FEINSTEIN INSTITUTE MEDICAL RESEARCH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
ABT Molecular Imaging, Inc. - Citizen Petition FDA-2012-P-0387 · 3 docket documents ABT Molecular Imaging, Inc. filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Fludeoxyglucose F18 Injection suitable for consideration in an ANDA with a reduced strength range of 1–20 mCi/mL End of Synthesis, compared | Other | 2012-05-02 | Granted | — |
Feinstein Institute for Medical Reseach, North Shore-LIJ Health System - Citi... FDA-2012-P-0103 · 5 docket documents Thomas Chaly, Ph.D., representing The Feinstein Institute for Medical Research/North Shore-LIJ Health System, submitted this citizen petition under section 505(j)(2)C of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare a proposed generic drug product suitable for consideratio | Other | 2012-02-03 | Granted | — |
Mayo Clinic - Citizen Petition FDA-2010-P-0444 · 3 docket documents Mayo Clinic, represented by Joseph C. Hung, filed this petition under Section 505(j)(2)(C) requesting permission to file an abbreviated new drug application for Fludeoxyglucose F-18 Injection by seeking amendment of the reference listed drug's highest strength from 300 mCi/mL to 500 mCi/mL at the en | Other | 2010-08-25 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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