FENOFIBRATE
FENOFIBRATE TABLETS, 54 mg and 160 mg
Approved
Approval ID
07913d99-c2d8-4078-9f1f-acad2a83b3d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 14, 2019
Manufacturers
FDA
Lake Erie Medical DBA Quality Care Products LLC
DUNS: 831276758
Products 1
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 Code35356-916
Application NumberANDA076509
Product Classification
M
Marketing Category
C73584
G
Generic Name
FENOFIBRATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2019
FDA Product Classification
INGREDIENTS (12)
FENOFIBRATEActive
Quantity: 160 mg in 1 1
Code: U202363UOS
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT