Chenodal
Chenodal
Approved
Approval ID
769e0a3b-826d-4faf-9129-5eeb7ebe0b67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2023
Manufacturers
FDA
Travere Therapeutics
DUNS: 965454502
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chenodiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68974-876
Application NumberANDA091019
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chenodiol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2023
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLCELLULOSE (100 MPA.S)Inactive
Code: 4GFU244C4J
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CHENODIOLActive
Quantity: 250 mg in 1 1
Code: 0GEI24LG0J
Classification: ACTIB