FDA.reportPublic FDA data

Application 021695

Type
NDA
Sponsor
LUPIN ATLANTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANTARA (MICRONIZED)FENOFIBRATECAPSULE;ORAL43MGYesNo
002ANTARA (MICRONIZED)FENOFIBRATECAPSULE;ORAL87MGNoNo
003ANTARA (MICRONIZED)FENOFIBRATECAPSULE;ORAL130MGYesYes
004ANTARA (MICRONIZED)FENOFIBRATECAPSULE;ORAL30MGYesNo
005ANTARA (MICRONIZED)FENOFIBRATECAPSULE;ORAL90MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27437-107AntarafenofibrateLupin Pharmaceuticals, Inc.NDACurrent
27437-107AntarafenofibrateLupin Pharmaceuticals, Inc.NDACurrent
27437-107AntarafenofibrateLupin Pharmaceuticals, Inc.NDACurrent
27437-108AntarafenofibrateLupin Pharmaceuticals, Inc.NDACurrent
27437-108AntarafenofibrateLupin Pharmaceuticals, Inc.NDACurrent
27437-108AntarafenofibrateLupin Pharmaceuticals, Inc.NDACurrent
27437-109ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.NDACurrent
27437-109ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.NDACurrent
27437-109ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.NDACurrent
27437-109ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.NDACurrent
27437-110ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.NDACurrent
27437-110ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.NDACurrent
27437-110ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.NDACurrent
27437-110ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.NDACurrent
68180-130FenofibratefenofibrateLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-130FenofibratefenofibrateLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-130FenofibratefenofibrateLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-131FenofibratefenofibrateLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-131FenofibratefenofibrateLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-131FenofibratefenofibrateLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-745FENOFIBRATEFENOFIBRATELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-745FENOFIBRATEFENOFIBRATELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-745FENOFIBRATEFENOFIBRATELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-745FENOFIBRATEFENOFIBRATELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-746FENOFIBRATEFENOFIBRATELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-746FENOFIBRATEFENOFIBRATELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-746FENOFIBRATEFENOFIBRATELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-746FENOFIBRATEFENOFIBRATELupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83640SUPPL 2025-10-03
83632SUPPL 2025-10-02
79274SUPPL 2024-08-02
79260SUPPL 2024-07-31
67719SUPPL2021-06-07
67704SUPPL2021-06-04
58762SUPPL2019-05-16
58747SUPPL2019-05-16
57819SUPPL2019-02-27
57531SUPPL2019-02-13
56458SUPPL2018-11-15
56402SUPPL2018-11-09
54332SUPPL2018-05-24
54305SUPPL2018-05-22
49757SUPPL2017-09-15
49719SUPPL2017-09-12
16007SUPPL2015-09-04
28396SUPPL2013-10-22
16005SUPPL2013-10-22
6004SUPPL2012-12-26
16006SUPPL2012-12-21
37472SUPPL2012-03-06
28395SUPPL2012-03-05
16004SUPPL2008-06-19
28394SUPPL2008-06-06
6003SUPPL2007-01-23
21781ORIG2006-06-08
28393ORIG2004-12-06
16003ORIG2004-12-03