RELYVRIO
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 09/2022
Approved
Approval ID
126747c4-39f3-4e20-8f3c-7b8596d8ba7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2024
Manufacturers
FDA
Amylyx Pharmaceuticals Inc
DUNS: 080954012
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium phenylbutyrate/taurursodiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73063-035
Application NumberNDA216660
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium phenylbutyrate/taurursodiol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (11)
SODIUM PHENYLBUTYRATEActive
Quantity: 3 g in 1 1
Code: NT6K61736T
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TAURURSODIOL DIHYDRATEActive
Quantity: 1 g in 1 1
Code: U7XRV7RZ1I
Classification: ACTIM