FIBRICOR
These highlights do not include all the information needed to use FIBRICOR (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
31c80f84-0169-4659-b9cf-8f897ed319eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2018
Manufacturers
FDA
Aralez Pharmaceuticals US Inc.
DUNS: 046550531
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fenofibric Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70347-035
Application NumberNDA022418
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2017
FDA Product Classification
INGREDIENTS (5)
Fenofibric AcidActive
Quantity: 35 mg in 1 1
Code: BGF9MN2HU1
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
crospovidoneInactive
Code: 2S7830E561
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Fenofibric Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70347-105
Application NumberNDA022418
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2017
FDA Product Classification
INGREDIENTS (5)
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
Fenofibric AcidActive
Quantity: 105 mg in 1 1
Code: BGF9MN2HU1
Classification: ACTIB
crospovidoneInactive
Code: 2S7830E561
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT