Fenofibrate
These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS FENOFIBRATE tablets for oral use Initial U.S. Approval: 1993
Approved
Approval ID
edace25a-3296-9ca7-dcb8-d0698f65840d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2019
Manufacturers
FDA
AustarPharma LLC
DUNS: 362785011
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35561-343
Application NumberANDA207803
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2019
FDA Product Classification
INGREDIENTS (1)
FENOFIBRATEActive
Quantity: 54 mg in 1 1
Code: U202363UOS
Classification: ACTIB
Fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35561-344
Application NumberANDA207803
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2019
FDA Product Classification
INGREDIENTS (1)
FENOFIBRATEActive
Quantity: 160 mg in 1 1
Code: U202363UOS
Classification: ACTIB