FDA.reportPublic FDA data

Application 022118

Type
NDA
Sponsor
SALIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOGLIDEFENOFIBRATETABLET;ORAL40MGYesNo
002FENOGLIDEFENOFIBRATETABLET;ORAL120MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1522FenofibrateFenofibrateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1522FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1522FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1522FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1522FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1522FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1522FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1523FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1523FenofibrateFenofibrateImpax GenericsNDA AUTHORIZED GENERICCurrent
0115-1523FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1523FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1523FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1523FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
0115-1523FenofibrateFenofibrateAmneal Pharmaceuticals of New York LLCNDA AUTHORIZED GENERICCurrent
52725-490FenoglidefenofibrateShore Therapeutics, IncNDACurrent
52725-495FenoglidefenofibrateShore Therapeutics, IncNDACurrent
68012-490FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-490FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-490FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-490FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-490FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-490FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-495FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-495FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-495FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-495FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-495FenoglidefenofibrateSantarus, Inc.NDACurrent
68012-495FenoglidefenofibrateSantarus, Inc.NDACurrent
68682-490FenofibratefenofibrateOceanside PharmaceuticalsNDACurrent
68682-490FenofibratefenofibrateOceanside PharmaceuticalsNDACurrent
68682-490FenofibratefenofibrateOceanside PharmaceuticalsNDACurrent
68682-490FenofibratefenofibrateOceanside PharmaceuticalsNDACurrent
68682-495FenofibratefenofibrateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-495FenofibratefenofibrateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-495FenofibratefenofibrateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-495FenofibratefenofibrateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82504SUPPL 2025-06-09
82490SUPPL 2025-06-09
67718SUPPL2021-06-07
67705SUPPL2021-06-04
58760SUPPL2019-05-16
58748SUPPL2019-05-16
58262SUPPL2019-04-09
57995SUPPL2019-03-14
54296SUPPL2018-05-22
54273SUPPL2018-05-21
16986SUPPL2012-11-06
6936SUPPL2012-11-06
6935SUPPL2012-03-14
42422ORIG2008-10-30
38284SUPPL2008-03-05
6934SUPPL2008-03-05
38283ORIG2007-08-14
29289ORIG2007-08-14