DOJOLVI
These highlights do not include all the information needed to use DOJOLVI safely and effectively. See full prescribing information for DOJOLVI. DOJOLVI (triheptanoin) oral liquid Initial U.S. Approval: 2020
Approved
Approval ID
4cfeb8bd-143e-4dd7-bc34-b0bcda02460d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 19, 2023
Manufacturers
FDA
Ultragenyx Pharmaceutical Inc.
DUNS: 962892019
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Triheptanoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69794-050
Application NumberNDA213687
Product Classification
M
Marketing Category
C73594
G
Generic Name
Triheptanoin
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2023
FDA Product Classification
INGREDIENTS (1)
TRIHEPTANOINActive
Quantity: 0.96 g in 1 mL
Code: 2P6O7CFW5K
Classification: ACTIB