fluorodopa (18F) 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4550 92812-82-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluorodopa F-18
  • fluorodopa (18F)
  • fluorodopa F 18
  • Molecular weight: 214.18
  • Formula: C9H10FNO4
  • CLOGP: -2.29
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 4
  • TPSA: 103.78
  • ALOGS: -1.95
  • ROTB: 3

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Oct. 10, 2019 FDA FEINSTEIN

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V09IX05 VARIOUS
DIAGNOSTIC RADIOPHARMACEUTICALS
TUMOUR DETECTION
Other diagnostic radiopharmaceuticals for tumour detection

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Positron emission tomography indication 82918005




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.15 acidic
pKa2 9.68 acidic
pKa3 12.96 acidic
pKa4 8.91 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.42-8.33mCi/ML FLUORODOPA F18 FEINSTEIN N200655 Oct. 10, 2019 RX SOLUTION INTRAVENOUS Oct. 10, 2024 EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
0.42-8.33mCi/ML FLUORODOPA F18 FEINSTEIN N200655 Oct. 10, 2019 RX SOLUTION INTRAVENOUS Oct. 10, 2024 NEW CHEMICAL ENTITY

Bioactivity Summary:

None

External reference:

IDSource
D04220 KEGG_DRUG
CHEBI:49166 CHEBI
CHEMBL3400972 ChEMBL_ID
C043437 MESH_SUPPLEMENTAL_RECORD_UI
DB13848 DRUGBANK_ID
2C598205QX UNII
56494 PUBCHEM_CID
2571853 RXNORM
018176 NDDF
5811000122108 SNOMEDCT_US
C0244672 UMLSCUI
6692 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
FluorodopaF18 HUMAN PRESCRIPTION DRUG LABEL 1 13267-345 INJECTION 8.33 mCi INTRAVENOUS NDA 15 sections
FluorodopaF18 HUMAN PRESCRIPTION DRUG LABEL 1 13267-346 INJECTION 40 mCi INTRAVENOUS NDA 15 sections