FDA — authorised 24 February 1972
- Application: NDA017042
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: FLUORINE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 SODIUM FLUORIDE F 18 in United States
FDA authorised SODIUM FLUORIDE F 18 on 24 February 1972
Marketing authorisations
FDA — authorised 26 January 2011
- Application: NDA022494
- Marketing authorisation holder: NIH NCI DCTD
- Local brand name: SODIUM FLUORIDE F 18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 June 2013
- Application: ANDA203605
- Marketing authorisation holder: MCPRF
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 December 2013
- Application: ANDA203247
- Marketing authorisation holder: UNIV TX MD ANDERSON
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 13 March 2014
- Application: ANDA204437
- Marketing authorisation holder: UCSF RODIOPHARM
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 21 October 2014
- Application: ANDA204464
- Marketing authorisation holder: DECATUR
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 29 October 2014
- Application: ANDA204541
- Marketing authorisation holder: ESSENTIAL ISOTOPES
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 November 2014
- Application: ANDA204328
- Marketing authorisation holder: THE FEINSTEIN INST
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 November 2014
- Application: ANDA204513
- Marketing authorisation holder: NCM USA BRONX LLC
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 January 2015
- Application: ANDA204351
- Marketing authorisation holder: BIOMEDCL RES FDN
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 February 2015
- Application: ANDA204542
- Marketing authorisation holder: PRECISION NUCLEAR
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 20 April 2015
- Application: ANDA204497
- Marketing authorisation holder: UNIV UTAH CYCLOTRON
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 22 April 2015
- Application: ANDA203912
- Marketing authorisation holder: NUKEMED
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 21 July 2015
- Application: ANDA204517
- Marketing authorisation holder: MIPS CRF
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 29 July 2015
- Application: ANDA204530
- Marketing authorisation holder: HOT SHOTS NM LLC
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 30 July 2015
- Application: ANDA203780
- Marketing authorisation holder: CARDINAL HEALTH 414
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 18 August 2015
- Application: ANDA203592
- Marketing authorisation holder: SOFIE
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 September 2015
- Application: ANDA203890
- Marketing authorisation holder: PETNET
- Status: approved
FDA — authorised 19 October 2015
- Application: ANDA203777
- Marketing authorisation holder: 3D IMAGING DRUG
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 October 2015
- Application: ANDA203968
- Marketing authorisation holder: JUBILANT DRAXIMAGE
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 November 2015
- Application: ANDA204462
- Marketing authorisation holder: UIHC PET IMAGING
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 November 2015
- Application: ANDA204440
- Marketing authorisation holder: MIDWEST MEDCL
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 May 2016
- Application: ANDA203936
- Marketing authorisation holder: KREITCHMAN PET CTR
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 6 December 2022
- Application: ANDA216126
- Marketing authorisation holder: BAMF
- Local brand name: SODIUM FLUORIDE F-18
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
SODIUM FLUORIDE F 18 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is SODIUM FLUORIDE F 18 approved in United States?
Yes. FDA authorised it on 24 February 1972; FDA authorised it on 26 January 2011; FDA authorised it on 28 June 2013.
Who is the marketing authorisation holder for SODIUM FLUORIDE F 18 in United States?
GE HEALTHCARE holds the US marketing authorisation.