FDA.reportPublic FDA data

Application 022352

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLCRYSCOLCHICINETABLET;ORAL0.6MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0254-2008ColchicineColchicinePar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
0254-2008ColchicineColchicinePar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
0254-2008ColchicineColchicinePar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
13310-119ColcrysColchicineAR Scientific Inc.NDACurrent
43353-854ColcrysColchicineAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-854ColcrysColchicineAphena Pharma Solutions - Tennessee, LLCNDACurrent
60687-389ColchicineColchicineAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-389ColchicineColchicineAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-389ColchicineColchicineAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
63187-292ColcrysColchicineProficient Rx LPNDACurrent
63187-292ColcrysColchicineProficient Rx LPNDACurrent
63187-292ColcrysColchicineProficient Rx LPNDACurrent
63629-2166ColchicineColchicineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2166ColchicineColchicineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2166ColchicineColchicineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2167ColchicineColchicineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2167ColchicineColchicineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2167ColchicineColchicineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
64764-119ColcrysColchicineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-119ColcrysColchicineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-119ColcrysColchicineTakeda Pharmaceuticals America, Inc.NDACurrent
64764-119ColcrysColchicineTakeda Pharmaceuticals America, Inc.NDACurrent
66993-165ColchicineColchicinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
67296-1708ColchicineColchicineRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent
67296-1708ColchicineColchicineRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent
71205-310ColchicineColchicineProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-310ColchicineColchicineProficient Rx LPNDA AUTHORIZED GENERICCurrent
71335-1802ColchicineColchicineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1802ColchicineColchicineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
72189-249COLCHICINECOLCHICINEdirect rxNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63078SUPPL2020-05-18
63077SUPPL2020-05-18
63025SUPPL2020-05-15
46116SUPPL2016-12-09
17287SUPPL2015-12-31
7286SUPPL2015-12-18
38615SUPPL2014-08-15
29641SUPPL2014-08-15
38614SUPPL2011-07-25
29640SUPPL2011-07-25
17286SUPPL2011-07-25
7285SUPPL2011-07-25
17285SUPPL2010-05-07
29639SUPPL2010-05-06
44742ORIG2010-02-17
42498ORIG2010-02-17
29638ORIG2009-08-06
38613ORIG2009-07-30