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FDA Orange Book · active-ingredient family

Fludeoxyglucose f-18

Fludeoxyglucose f-18 is approved as 3 brand and 41 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FLUDEOXYGLUCOSE F18 · NDA 021870

3

Brand (NDA)

41

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
FLUDEOXYGLUCOSE F18RLD×2FEINSTEINNDA 021870—Aug 19, 2005
FLUDEOXYGLUCOSE F18RLDWEILL MEDCL COLLNDA 021768—Aug 05, 2004
FLUDEOXYGLUCOSE F18RLD×2DOWNSTATE CLINCLNDA 020306—Aug 19, 1994

Generic (ANDA) products (41)

ProductApplicantApplicationTEApproved
FLUDEOXYGLUCOSE F18BAMFANDA 216125APMar 11, 2025
FLUDEOXYGLUCOSE F18UNIV SOUTHERN CAANDA 209341APDec 16, 2020
FLUDEOXYGLUCOSE F18UNIV TX SW MEDCTRANDA 210265—Feb 06, 2020
FLUDEOXYGLUCOSE F18MEM SLOAN-KETTERINGANDA 208679—Dec 08, 2016
FLUDEOXYGLUCOSE F18KREITCHMAN PET CTRANDA 203942APApr 11, 2016
FLUDEOXYGLUCOSE F18MIDWEST MEDCLANDA 203736—Nov 19, 2015
FLUDEOXYGLUCOSE F18×2CARDINAL HEALTH 414ANDA 203603APNov 13, 2015
FLUDEOXYGLUCOSE F183D IMAGING DRUGANDA 203778APOct 30, 2015
FLUDEOXYGLUCOSE F18KETTERING MEDCTRANDA 204759APOct 27, 2015
FLUDEOXYGLUCOSE F18MIPS CRFANDA 204472APSep 11, 2015
FLUDEOXYGLUCOSE F18QUEEN HAMAMATSU PETANDA 203771APAug 31, 2015
FLUDEOXYGLUCOSE F18SOFIEANDA 203591APAug 31, 2015
FLUDEOXYGLUCOSE F18UNIV MICHIGANANDA 204531APJul 17, 2015
FLUDEOXYGLUCOSE F18JUBILANT DRAXIMAGEANDA 203920APJun 23, 2015
FLUDEOXYGLUCOSE F18UNIV UTAH CYCLOTRONANDA 204498APJun 23, 2015
FLUDEOXYGLUCOSE F18BIOMEDCL RES FDNANDA 203710APMay 01, 2015
FLUDEOXYGLUCOSE F18BIOMEDCL RES FDNANDA 203837APMay 01, 2015
FLUDEOXYGLUCOSE F18METHODIST HOSP RESANDA 203904APApr 23, 2015
FLUDEOXYGLUCOSE F18NUKEMEDANDA 203911—Apr 22, 2015
FLUDEOXYGLUCOSE F18PRECISION NUCLEARANDA 204546APApr 07, 2015
FLUDEOXYGLUCOSE F18NORTHLANDANDA 203994—Feb 04, 2015
FLUDEOXYGLUCOSE F18NCM USA BRONX LLCANDA 204512APJan 07, 2015
FLUDEOXYGLUCOSE F18PHARMALOGICANDA 204264APDec 18, 2014
FLUDEOXYGLUCOSE F18BRIGHAM WOMENSANDA 203816APOct 30, 2014
FLUDEOXYGLUCOSE F18HOT SHOTS NM LLCANDA 203937—Oct 30, 2014
FLUDEOXYGLUCOSE F18CHILDRENS HOSP MIANDA 204385APOct 29, 2014
FLUDEOXYGLUCOSE F18ISOLOGIC INNOVATIVEANDA 204525APOct 29, 2014
FLUDEOXYGLUCOSE F18TRUSTEES UNIV PAANDA 203801APOct 29, 2014
FLUDEOXYGLUCOSE F18SOFIEANDA 204463APOct 21, 2014
FLUDEOXYGLUCOSE F18MA GENERAL HOSPANDA 204333APSep 25, 2014
FLUDEOXYGLUCOSE F18UIHC PET IMAGINGANDA 203990APAug 06, 2014
FLUDEOXYGLUCOSE F18UCSF RODIOPHARMANDA 203902APMay 09, 2014
FLUDEOXYGLUCOSE F18ESSENTIAL ISOTOPESANDA 203946—Feb 05, 2014
FLUDEOXYGLUCOSE F18WUSM CYCLOTRONANDA 203935APFeb 05, 2014
FLUDEOXYGLUCOSE F18PHARMALOGIC HLDGSANDA 203664APFeb 04, 2014
FLUDEOXYGLUCOSE F18×2UNIV TX MD ANDERSONANDA 203246—Jan 13, 2014
FLUDEOXYGLUCOSE F18WISCONSINANDA 203709—Oct 23, 2013
FLUDEOXYGLUCOSE F18MCPRFANDA 203612APAug 05, 2013
FLUDEOXYGLUCOSE F18UCLA BIOMEDICALANDA 203811APJun 27, 2013
FLUDEOXYGLUCOSE F18SOFIEANDA 203665—Feb 14, 2013
FLUDEOXYGLUCOSE F18PETNETANDA 079086APFeb 25, 2011

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Fludeoxyglucose f-18 — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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