FDA.reportPublic FDA data

Application 021925

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUETACTGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL2MG;30MGYesYes
002DUETACTGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL4MG;30MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64764-302Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-302Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-302Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-302Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-304Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-304Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-304Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
64764-304Duetactpioglitazone and glimepirideTakeda Pharmaceuticals America, Inc.NDACurrent
66993-821pioglitazone and glimepiridepioglitazone and glimepiridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-821pioglitazone and glimepiridepioglitazone and glimepiridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-822pioglitazone and glimepiridepioglitazone and glimepiridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-822pioglitazone and glimepiridepioglitazone and glimepiridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50917SUPPL2017-12-27
50860SUPPL2017-12-26
50859SUPPL2017-12-26
46140SUPPL2016-12-13
37889SUPPL2015-03-19
28857SUPPL2015-03-17
28856SUPPL2013-11-14
28854SUPPL2013-11-14
16582SUPPL2013-11-14
16580SUPPL2013-11-14
6466SUPPL2012-05-22
37888SUPPL2011-08-04
28855SUPPL2011-08-04
16581SUPPL2011-08-04
6465SUPPL2011-08-04
37887SUPPL2010-09-29
6464SUPPL2010-09-28
6463SUPPL2009-10-26
28853SUPPL2009-01-06
16579SUPPL2009-01-06
21872ORIG2008-09-04
28852SUPPL2007-10-04
28851SUPPL2007-10-04
16578SUPPL2007-10-04
37886SUPPL2007-09-26
28850SUPPL2007-09-11
16577SUPPL2007-09-07
23684ORIG2007-08-15
37885SUPPL2007-02-23
6462SUPPL2007-02-12
37884ORIG2006-08-04
28849ORIG2006-08-04