Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
HAS Healthcare Advanced Synthesis SA
Horizon Therapeutics USA, Inc.
481296960
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ravicti
Product Details
NDC Product Code
75987-050Application Number
NDA203284Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 13, 2021Glycerol phenylbutyrateActive
Code: ZH6F1VCV7BClass: ACTIBQuantity: 1.1 g in 1 mL