Manufacturing Establishments7
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ultragenyx Pharmaceutical Inc.
Ultragenyx Pharmaceutical Inc.
962892019
Haupt Pharma Wolfratshausen GmbH
Ultragenyx Pharmaceutical Inc.
314715889
GBA Pharma GMbH
Ultragenyx Pharmaceutical Inc.
342374604
Labor LS SE & CO. KG.
Ultragenyx Pharmaceutical Inc.
314929072
Integrated Commercialization Solutions, LLC
Ultragenyx Pharmaceutical Inc.
832820588
IOI Oleo GmbH & Co. KG
Ultragenyx Pharmaceutical Inc.
342589974
AndersonBrecon Inc. (PCI Pharma Services) USA
Ultragenyx Pharmaceutical Inc.
053217022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DOJOLVI
Product Details
NDC Product Code
69794-050Application Number
NDA213687Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 19, 2023TriheptanoinActive
Code: 2P6O7CFW5KClass: ACTIBQuantity: 0.96 g in 1 mL