FDA.reportPublic FDA data

Application 021350

Type
NDA
Sponsor
SKYEPHARMA AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIGLIDEFENOFIBRATETABLET;ORAL50MGNoNo
002TRIGLIDEFENOFIBRATETABLET;ORAL160MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59630-485TRIGLIDEFENOFIBRATEShionogi Inc.NDACurrent
69597-346FENOFIBRATEFENOFIBRATEBasiemNDACurrent
70199-013TRIGLIDEFENOFIBRATECasper Pharma LLCNDACurrent
70199-013TRIGLIDEFENOFIBRATECasper Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78507SUPPL 2024-05-20
78477SUPPL 2024-05-15
67746SUPPL2021-06-08
67721SUPPL2021-06-07
58761SUPPL2019-05-16
54297SUPPL2018-05-22
54272SUPPL2018-05-21
5128SUPPL2015-11-16
27563SUPPL2015-04-17
36730SUPPL2015-04-16
36729SUPPL2013-01-22
5127SUPPL2013-01-17
5126SUPPL2012-04-23
36728SUPPL2012-04-20
15256SUPPL2008-11-19
27562SUPPL2008-11-18
15255SUPPL2008-01-18
5125SUPPL2008-01-18
42115ORIG2007-09-10
27561SUPPL2006-07-13
36727SUPPL2006-07-05
15254ORIG2005-05-17
5124ORIG2005-05-17