FDA.reportPublic FDA data

Application 021656

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRICORFENOFIBRATETABLET;ORAL48MGYesNo
002TRICORFENOFIBRATETABLET;ORAL145MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3173TricorFenofibrateAbbVie Inc.NDACurrent
0074-3173TricorFenofibrateAbbVie Inc.NDACurrent
0074-3173TricorFenofibrateAbbVie Inc.NDACurrent
0074-3173TricorFenofibrateAbbVie Inc.NDACurrent
0074-3173TricorFenofibrateAbbVie Inc.NDACurrent
0074-3189TricorFenofibrateAbbVie Inc.NDACurrent
0074-3189TricorFenofibrateAbbVie Inc.NDACurrent
0074-3189TricorFenofibrateAbbVie Inc.NDACurrent
0074-3189TricorFenofibrateAbbVie Inc.NDACurrent
0074-3189TricorFenofibrateAbbVie Inc.NDACurrent
0093-7755FenofibrateFenofibrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-7755FenofibrateFenofibrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-7756FenofibrateFenofibrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-7756FenofibrateFenofibrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
43353-032TricorFenofibrateAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-272TricorFenofibrateAphena Pharma Solutions - Tennessee, LLCNDACurrent
50090-2857FenofibrateFenofibrateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2899TricorFenofibrateA-S Medication SolutionsNDACurrent
50090-2899TricorFenofibrateA-S Medication SolutionsNDACurrent
51655-010FenofibrateFenofibrateNorthwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent
51655-902FENOFIBRATEFENOFIBRATENORTHWIND PHARMACEUTICALSNDA AUTHORIZED GENERICCurrent
55700-319FenofibrateFenofibrateLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
63187-940FenofibrateFenofibrateProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-940FenofibrateFenofibrateProficient Rx LPNDA AUTHORIZED GENERICCurrent
63629-6459FenofibrateFenofibrateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7213FenofibrateFenofibrateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7213FenofibrateFenofibrateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7213FenofibrateFenofibrateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7316FenofibrateFenofibrateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7316FenofibrateFenofibrateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
68071-2042FenofibrateFenofibrateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-2115FenofibrateFenofibrateNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68151-4717FenofibrateFenofibrateCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-4718FenofibrateFenofibrateCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68382-269FenofibrateFenofibrateZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-269FenofibrateFenofibrateZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-269FenofibrateFenofibrateZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-269FenofibrateFenofibrateZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-270FenofibrateFenofibrateZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-270FenofibrateFenofibrateZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-270FenofibrateFenofibrateZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-270FenofibrateFenofibrateZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82502SUPPL 2025-06-09
82488SUPPL 2025-06-09
67756SUPPL2021-06-10
67717SUPPL2021-06-07
67716SUPPL2021-06-07
58190SUPPL2019-06-07
58139SUPPL2019-03-29
56495SUPPL2018-11-16
56386SUPPL2018-11-08
54295SUPPL2018-05-22
54275SUPPL2018-05-21
28322SUPPL2013-02-07
15933SUPPL2013-02-06
28321SUPPL2011-09-26
37408SUPPL2011-09-23
15932SUPPL2011-09-23
5931SUPPL2010-10-25
15931SUPPL2010-10-21
5930SUPPL2008-04-16
5929SUPPL2007-09-25
42255ORIG2006-04-21
28320ORIG2004-11-08
15930ORIG2004-11-08