FDA.reportPublic FDA data

Application 022224

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRILIPIXCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 45MG FENOFIBRIC ACIDYesNo
002TRILIPIXCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 135MG FENOFIBRIC ACIDYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3161TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3161TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3161TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3161TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3161TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3161TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3161TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3162TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3162TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3162TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3162TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3162TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3162TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-3162TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-9189TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-9189TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-9642TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0074-9642TrilipixFenofibric AcidAbbVie Inc.NDACurrent
0115-1554Fenofibric AcidFenofibric AcidImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1554Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1554Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1554Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1554Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1554Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1555Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1555Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1555Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1555Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1555Fenofibric AcidFenofibric AcidAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1555Fenofibric AcidFenofibric AcidImpax GenericsNDA AUTHORIZED GENERICCurrent
50090-4561Fenofibric AcidFenofibric AcidA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4561Fenofibric AcidFenofibric AcidA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
68382-232Fenofibric AcidFenofibric AcidZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-232Fenofibric AcidFenofibric AcidZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-232Fenofibric AcidFenofibric AcidZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-232Fenofibric AcidFenofibric AcidZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-233Fenofibric AcidFenofibric AcidZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-233Fenofibric AcidFenofibric AcidZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-233Fenofibric AcidFenofibric AcidZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-233Fenofibric AcidFenofibric AcidZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82503SUPPL 2025-06-09
82487SUPPL 2025-06-09
67726SUPPL2021-06-07
67715SUPPL2021-06-07
67708SUPPL2021-06-04
67707SUPPL2021-06-04
58187SUPPL2019-04-02
58140SUPPL2019-03-29
56461SUPPL2018-11-15
56385SUPPL2018-11-08
54302SUPPL2018-05-22
54270SUPPL2018-05-21
7072SUPPL2015-04-28
38409SUPPL2015-04-27
29428SUPPL2012-09-14
7071SUPPL2012-09-14
38408SUPPL2012-09-06
17104SUPPL2012-09-06
29427SUPPL2011-10-03
7070SUPPL2011-10-03
38407SUPPL2011-09-30
17103SUPPL2011-09-30
29426SUPPL2011-03-16
38406SUPPL2010-09-20
29425SUPPL2010-09-16
24262ORIG2009-05-28
21963ORIG2009-05-28
38405ORIG2009-01-02
7069ORIG2008-12-19