Fenofibrate
Fenofibrate Capsules, USP (MICRONIZED)
Approved
Approval ID
a5bc232c-ff27-f8b6-e053-2995a90ad399
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2023
Manufacturers
FDA
Austarpharma, LLC
DUNS: 362785011
Products 3
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 Code35561-346
Application NumberANDA207805
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENOFIBRATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2021
FDA Product Classification
INGREDIENTS (1)
FENOFIBRATEActive
Quantity: 134 mg in 1 1
Code: U202363UOS
Classification: ACTIB
FENOFIBRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35561-347
Application NumberANDA207805
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENOFIBRATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2021
FDA Product Classification
INGREDIENTS (1)
FENOFIBRATEActive
Quantity: 200 mg in 1 1
Code: U202363UOS
Classification: ACTIB
FENOFIBRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35561-345
Application NumberANDA207805
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENOFIBRATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2021
FDA Product Classification
INGREDIENTS (1)
FENOFIBRATEActive
Quantity: 67 mg in 1 1
Code: U202363UOS
Classification: ACTIB