FDA.reportPublic FDA data

Application 021612

Type
NDA
Sponsor
CIPHER PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIPOFENFENOFIBRATECAPSULE;ORAL50MGYesNo
002LIPOFENFENOFIBRATECAPSULE;ORAL100MGNoNo
003LIPOFENFENOFIBRATECAPSULE;ORAL150MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61269-210FenofibratefenofibrateH2-Pharma, LLCNDACurrent
61269-212FenofibratefenofibrateH2-Pharma, LLCNDACurrent
62559-305LipofenfenofibrateANI Pharmaceuticals, Inc.NDACurrent
62559-306LipofenfenofibrateANI Pharmaceuticals, Inc.NDACurrent
62559-460FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-460FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-460FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-460FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-461FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-461FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-461FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-461FenofibratefenofibrateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
66869-137LIPOFENfenofibrateKowa Pharmaceuticals America Inc.NDACurrent
66869-137LIPOFENfenofibrateKowa Pharmaceuticals America Inc.NDACurrent
66869-137LIPOFENfenofibrateKowa Pharmaceuticals America, Inc.NDACurrent
66869-137LIPOFENfenofibrateKowa Pharmaceuticals America, Inc.NDACurrent
66869-147LIPOFENfenofibrateKowa Pharmaceuticals America Inc.NDACurrent
66869-147LIPOFENfenofibrateKowa Pharmaceuticals America Inc.NDACurrent
66869-147LIPOFENfenofibrateKowa Pharmaceuticals America, Inc.NDACurrent
66869-147LIPOFENfenofibrateKowa Pharmaceuticals America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82500SUPPL 2025-06-09
82489SUPPL 2025-06-09
67720SUPPL2021-06-07
67703SUPPL2021-06-04
58758SUPPL2019-05-16
58746SUPPL2019-05-16
56457SUPPL2018-11-15
56384SUPPL2018-11-08
54280SUPPL2018-05-21
54279SUPPL2018-05-21
37338SUPPL2013-01-23
28246SUPPL2013-01-23
15876SUPPL2013-01-23
5856SUPPL2013-01-23
5855SUPPL2011-11-02
15875SUPPL2011-10-31
28245SUPPL2008-12-19
5854SUPPL2008-12-19
42233ORIG2008-11-17
15874ORIG2006-01-24
5853ORIG2006-01-24