FDA — authorised 19 August 1994
- Application: NDA020306
- Marketing authorisation holder: DOWNSTATE CLINCL
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Fludeoxyglucose F18 in United States
FDA authorised Fludeoxyglucose F18 on 19 August 1994
Marketing authorisations
FDA — authorised 5 August 2004
- Application: NDA021768
- Marketing authorisation holder: WEILL MEDCL COLL
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 August 2005
- Application: NDA021870
- Marketing authorisation holder: FEINSTEIN
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 14 February 2013
- Application: ANDA203665
- Marketing authorisation holder: SOFIE
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 June 2013
- Application: ANDA203811
- Marketing authorisation holder: UCLA BIOMEDICAL
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 5 August 2013
- Application: ANDA203612
- Marketing authorisation holder: MCPRF
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 December 2013
- Application: ANDA203709
- Marketing authorisation holder: WISCONSIN
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 13 January 2014
- Application: ANDA203246
- Marketing authorisation holder: UNIV TX MD ANDERSON
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 February 2014
- Application: ANDA203664
- Marketing authorisation holder: PHARMALOGIC HLDGS
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 5 February 2014
- Application: ANDA203946
- Marketing authorisation holder: ESSENTIAL ISOTOPES
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 5 February 2014
- Application: ANDA203935
- Marketing authorisation holder: WUSM CYCLOTRON
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 May 2014
- Application: ANDA203902
- Marketing authorisation holder: UCSF RODIOPHARM
- Status: approved
FDA — authorised 6 August 2014
- Application: ANDA203990
- Marketing authorisation holder: UIHC PET IMAGING
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 25 September 2014
- Application: ANDA204333
- Marketing authorisation holder: MA GENERAL HOSP
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 21 October 2014
- Application: ANDA204463
- Marketing authorisation holder: SOFIE
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 29 October 2014
- Application: ANDA203801
- Marketing authorisation holder: TRUSTEES UNIV PA
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 29 October 2014
- Application: ANDA204385
- Marketing authorisation holder: CHILDRENS HOSP MI
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 29 October 2014
- Application: ANDA204525
- Marketing authorisation holder: ISOLOGIC INNOVATIVE
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 30 October 2014
- Application: ANDA203816
- Marketing authorisation holder: BRIGHAM WOMENS
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 30 October 2014
- Application: ANDA203937
- Marketing authorisation holder: HOT SHOTS NM LLC
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 January 2015
- Application: ANDA204512
- Marketing authorisation holder: NCM USA BRONX LLC
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 February 2015
- Application: ANDA203994
- Marketing authorisation holder: NORTHLAND
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 April 2015
- Application: ANDA204546
- Marketing authorisation holder: PRECISION NUCLEAR
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 22 April 2015
- Application: ANDA203911
- Marketing authorisation holder: NUKEMED
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 April 2015
- Application: ANDA203904
- Marketing authorisation holder: METHODIST HOSP RES
- Status: approved
FDA — authorised 1 May 2015
- Application: ANDA203710
- Marketing authorisation holder: BIOMEDCL RES FDN
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 1 May 2015
- Application: ANDA203837
- Marketing authorisation holder: BIOMEDCL RES FDN
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 June 2015
- Application: ANDA203920
- Marketing authorisation holder: JUBILANT DRAXIMAGE
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 June 2015
- Application: ANDA204498
- Marketing authorisation holder: UNIV UTAH CYCLOTRON
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 July 2015
- Application: ANDA204531
- Marketing authorisation holder: UNIV MICHIGAN
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 31 August 2015
- Application: ANDA203771
- Marketing authorisation holder: QUEEN HAMAMATSU PET
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 31 August 2015
- Application: ANDA203591
- Marketing authorisation holder: SOFIE
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 11 September 2015
- Application: ANDA204472
- Marketing authorisation holder: MIPS CRF
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 October 2015
- Application: ANDA204759
- Marketing authorisation holder: KETTERING MEDCTR
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 30 October 2015
- Application: ANDA203778
- Marketing authorisation holder: 3D IMAGING DRUG
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 13 November 2015
- Application: ANDA203603
- Marketing authorisation holder: CARDINAL HEALTH 414
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 November 2015
- Application: ANDA203736
- Marketing authorisation holder: MIDWEST MEDCL
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 11 April 2016
- Application: ANDA203942
- Marketing authorisation holder: KREITCHMAN PET CTR
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 8 December 2016
- Application: ANDA208679
- Marketing authorisation holder: MEM SLOAN-KETTERING
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 December 2020
- Application: ANDA209341
- Marketing authorisation holder: UNIV SOUTHERN CA
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 11 March 2025
- Application: ANDA216125
- Marketing authorisation holder: BAMF
- Local brand name: FLUDEOXYGLUCOSE F18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Frequently asked questions
Is Fludeoxyglucose F18 approved in United States?
Yes. FDA authorised it on 19 August 1994; FDA authorised it on 5 August 2004; FDA authorised it on 19 August 2005.
Who is the marketing authorisation holder for Fludeoxyglucose F18 in United States?
DOWNSTATE CLINCL holds the US marketing authorisation.