FDA.reportPublic FDA data

Application 021073

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACTOSPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 15MG BASEYesNo
002ACTOSPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 30MG BASEYesNo
003ACTOSPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 45MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-147Actospioglitazone hydrochlorideRebel Distributors Corp.NDACurrent
21695-148Actospioglitazone hydrochlorideRebel Distributors Corp.NDACurrent
54458-884PioglitazonePioglitazoneInternational Laboratories, LLCNDA AUTHORIZED GENERICCurrent
54458-885PioglitazonePioglitazoneInternational Laboratories, LLCNDA AUTHORIZED GENERICCurrent
63304-311PioglitazonepioglitazoneRanbaxy Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
63304-312PioglitazonepioglitazoneRanbaxy Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
63304-313PioglitazonepioglitazoneRanbaxy Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
64764-151ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-151ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-151ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-151ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-301ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-301ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-301ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-301ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-451ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-451ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-451ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
64764-451ActospioglitazoneTakeda Pharmaceuticals America, Inc.NDACurrent
66116-504PioglitazonepioglitazoneMedVantx, Inc.NDA AUTHORIZED GENERICCurrent
68071-1621PioglitazonepioglitazoneNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-1621PioglitazonepioglitazoneNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-1621PioglitazonepioglitazoneNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68151-3792PioglitazonepioglitazoneCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-3798PioglitazonepioglitazoneCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68258-3034Actospioglitazone hydrochlorideDispensing Solutions, Inc.NDACurrent
68258-5230Actospioglitazone hydrochlorideDispensing Solutions, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50915SUPPL2017-12-27
50864SUPPL2017-12-26
50863SUPPL2017-12-26
46170SUPPL2016-12-15
46137SUPPL2016-12-13
36020SUPPL2013-11-14
4217SUPPL2013-11-14
26646SUPPL2012-05-22
26645SUPPL2011-08-05
4216SUPPL2011-08-05
14292SUPPL2011-08-04
14291SUPPL2011-08-04
14289SUPPL2011-02-09
4215SUPPL2010-07-30
4214SUPPL2009-10-26
14290SUPPL2009-09-18
36019SUPPL2009-01-02
26644SUPPL2008-12-18
41929SUPPL2008-07-31
41928SUPPL2008-07-31
43567SUPPL2008-06-12
4213SUPPL2008-05-09
41926SUPPL2008-02-19
21414SUPPL2008-02-19
21411SUPPL2008-02-19
21410SUPPL2008-02-19
21408SUPPL2008-02-19
21416SUPPL2007-11-19
21415SUPPL2007-11-19
41924SUPPL2007-09-13
41923SUPPL2007-09-13
21409SUPPL2007-09-13
21407SUPPL2007-09-13
26643SUPPL2007-09-11
14288SUPPL2007-09-11
4212SUPPL2007-08-17
36018SUPPL2007-08-15
41925SUPPL2007-07-27
21412SUPPL2007-07-27
21413SUPPL2007-07-09
41927SUPPL2007-07-06
36015SUPPL2007-03-07
26641SUPPL2007-03-06
4211SUPPL2006-11-07
36017SUPPL2006-11-06
26642SUPPL2006-10-02
4210SUPPL2006-09-18
36016SUPPL2006-09-01
14286SUPPL2004-08-05
4208SUPPL2004-08-05
14287SUPPL2004-07-21
4209SUPPL2004-07-21
36014SUPPL2003-12-08
4207SUPPL2003-12-04
26640SUPPL2003-06-22
14285SUPPL2003-06-22
26639SUPPL2003-01-17
4206SUPPL2002-12-03
36013SUPPL2002-07-12
4204SUPPL2002-07-12
4205SUPPL2002-01-07
41922ORIG2000-06-30
26638ORIG1999-07-15
14284ORIG1999-07-15