FDA.reportPublic FDA data

Application 022418

Type
NDA
Sponsor
ATHENA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FIBRICORFENOFIBRIC ACIDTABLET;ORAL35MGYesNo
002FIBRICORFENOFIBRIC ACIDTABLET;ORAL105MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13310-101FIBRICORFenofibric AcidAR Scientific, Inc.NDACurrent
13310-102FIBRICORFenofibric AcidAR Scientific, Inc.NDACurrent
49708-101FIBRICORFenofibric AcidCaraco Pharma, Inc.NDACurrent
49708-102FIBRICORFenofibric AcidCaraco Pharma, Inc.NDACurrent
53489-677Fenofibric AcidFenofibric AcidMutual Pharmaceutical Company, Inc.NDA AUTHORIZED GENERICCurrent
53489-678Fenofibric AcidFenofibric AcidMutual Pharmaceutical Company, Inc.NDA AUTHORIZED GENERICCurrent
68134-601Fenofibric AcidFenofibric AcidPalmetto Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
68134-602Fenofibric AcidFenofibric AcidPalmetto Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
69916-035FIBRICORFenofibric AcidTribute Pharmaceuticals US, Inc.NDACurrent
69916-105FIBRICORFenofibric AcidTribute Pharmaceuticals US, Inc.NDACurrent
69973-035Fenofibric AcidFenofibric AcidHalton LaboratoriesNDACurrent
69973-105Fenofibric AcidFenofibric AcidHalton LaboratoriesNDACurrent
70347-035FIBRICORFenofibric AcidAralez Pharmaceuticals US Inc.NDACurrent
70347-105FIBRICORFenofibric AcidAralez Pharmaceuticals US Inc.NDACurrent
71511-501FIBRICORFenofibric AcidAthena Bioscience, LLCNDACurrent
71511-501FIBRICORFenofibric AcidAthena Bioscience, LLCNDACurrent
71511-501FIBRICORFenofibric AcidAthena Bioscience, LLCNDACurrent
71511-501FIBRICORFenofibric AcidAthena Bioscience, LLCNDACurrent
71511-502FIBRICORFenofibric AcidAthena Bioscience, LLCNDACurrent
71511-502FIBRICORFenofibric AcidAthena Bioscience, LLCNDACurrent
71511-502FIBRICORFenofibric AcidAthena Bioscience, LLCNDACurrent
71511-502FIBRICORFenofibric AcidAthena Bioscience, LLCNDACurrent
72834-035Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-035Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-035Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-035Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-035Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-105Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-105Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-105Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-105Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent
72834-105Fenofibric AcidFenofibric AcidSarras Health, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82511SUPPL 2025-06-09
82491SUPPL 2025-06-09
67714SUPPL2021-06-07
67706SUPPL2021-06-04
60181SUPPL2019-10-01
60174SUPPL2019-10-01
58759SUPPL2019-05-16
54320SUPPL2018-05-24
54281SUPPL2018-05-21
38685SUPPL2014-01-07
7362SUPPL2014-01-07
29706SUPPL2013-03-19
38684SUPPL2013-03-11
7361SUPPL2012-12-19
7360SUPPL2012-12-19
38683SUPPL2012-12-13
17566SUPPL2012-12-13
29705SUPPL2012-03-19
38682SUPPL2012-03-16
7359SUPPL2012-01-17
38681SUPPL2012-01-06
44750ORIG2010-01-05
42518ORIG2010-01-05
17565ORIG2009-10-01
7358ORIG2009-08-21