Stem definition | Drug id | CAS RN |
---|---|---|
5399 | 620-67-7 |
None
Property | Value | Reference |
---|---|---|
S (Water solubility) | 0.00 mg/mL | Bocci G, Oprea TI, Benet LZ |
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Date | Agency | Company | Orphan |
---|---|---|---|
June 30, 2020 | FDA | ULTRAGENYX PHARM INC |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Rhabdomyolysis | 61.44 | 57.59 | 13 | 55 | 43938 | 63445016 |
None
None
None
Source | Code | Description |
---|---|---|
ATC | A16AX17 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Various alimentary tract and metabolism products |
FDA CS | M0021969 | Triglycerides |
FDA EPC | N0000194023 | Medium-chain Triglyceride |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Disorder of fatty acid metabolism | indication | 39929009 | |
Long-chain fatty acid transport deficiency | indication | 426387005 |
None
None
None
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
100% w/w | DOJOLVI | ULTRAGENYX PHARM INC | N213687 | June 30, 2020 | RX | LIQUID | ORAL | June 30, 2025 | NEW CHEMICAL ENTITY |
100% w/w | DOJOLVI | ULTRAGENYX PHARM INC | N213687 | June 30, 2020 | RX | LIQUID | ORAL | June 30, 2027 | INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS FOR THE TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH MOLECULARLY CONFIRMED LONG-CHAIN FATTY ACID OXIDATION DISORDERS (LC-FAOD) |
None
ID | Source |
---|---|
D11465 | KEGG_DRUG |
2P6O7CFW5K | UNII |
C2604598 | UMLSCUI |
CHEMBL4297585 | ChEMBL_ID |
69286 | PUBCHEM_CID |
DB11677 | DRUGBANK_ID |
11431 | IUPHAR_LIGAND_ID |
018432 | NDDF |
926370002 | SNOMEDCT_US |
926378009 | SNOMEDCT_US |
4039553 | VANDF |
1313234 | RXNORM |
336029 | MMSL |
38592 | MMSL |
d09588 | MMSL |
C531010 | MESH_SUPPLEMENTAL_RECORD_UI |
10893 | INN_ID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
DOJOLVI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69794-050 | LIQUID | 0.96 g | ORAL | NDA | 25 sections |
DOJOLVI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69794-050 | LIQUID | 0.96 g | ORAL | NDA | 25 sections |
DOJOLVI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69794-050 | LIQUID | 0.96 g | ORAL | NDA | 25 sections |