fluorodopa (18F) 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4550 | 92812-82-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Positron emission tomography | indication | 82918005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| ID | Source |
|---|---|
| D04220 | KEGG_DRUG |
| CHEBI:49166 | CHEBI |
| CHEMBL3400972 | ChEMBL_ID |
| C043437 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB13848 | DRUGBANK_ID |
| 2571853 | RXNORM |
| 018176 | NDDF |
| 5811000122108 | SNOMEDCT_US |
| C0244672 | UMLSCUI |
| 6692 | INN_ID |
| 56494 | PUBCHEM_CID |
| 2C598205QX | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |