FDA.reportPublic FDA data

Application 021368

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIALISTADALAFILTABLET;ORAL5MGYesNo
002CIALISTADALAFILTABLET;ORAL10MGYesNo
003CIALISTADALAFILTABLET;ORAL20MGYesYes
004CIALISTADALAFILTABLET;ORAL2.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-4462CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4462CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4462CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4462CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4463CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4463CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4463CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4463CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4464CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4464CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4464CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4464CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4465CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4465CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4465CialisTadalafilEli Lilly and CompanyNDACurrent
0002-4465CialisTadalafilEli Lilly and CompanyNDACurrent
21695-028CialisTadalafilRebel Distributors Corp.NDACurrent
21695-029CialisTadalafilRebel Distributors Corp.NDACurrent
43063-236CialisTadalafilPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-236CialisTadalafilPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-236CialisTadalafilPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-236CialisTadalafilPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-236CialisTadalafilPD-Rx Pharmaceuticals, Inc.NDACurrent
43353-044CialisTadalafilAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-044CialisTadalafilAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-857CialisTadalafilAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-857CialisTadalafilAphena Pharma Solutions - Tennessee, LLCNDACurrent
50436-4462CialisTadalafilUnit Dose ServicesNDACurrent
50436-4463CialisTadalafilUnit Dose ServicesNDACurrent
50436-4464CialisTadalafilUnit Dose ServicesNDACurrent
50436-4465CialisTadalafilUnit Dose ServicesNDACurrent
50436-7001TadalafilTadalafilUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
50436-7010TadalafilTadalafilUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
55154-1830CialisTadalafilCardinal HealthNDACurrent
55154-1832CialisTadalafilCardinal HealthNDACurrent
63629-4601CialisTadalafilBryant Ranch PrepackNDACurrent
63629-4601CialisTadalafilBryant Ranch PrepackNDACurrent
63629-6367CialisTadalafilBryant Ranch PrepackNDACurrent
63629-6367CialisTadalafilBryant Ranch PrepackNDACurrent
63629-6769CialisTadalafilBryant Ranch PrepackNDACurrent
63629-6769CialisTadalafilBryant Ranch PrepackNDACurrent
63629-6769CialisTadalafilBryant Ranch PrepackNDACurrent
63629-7145CialisTadalafilBryant Ranch PrepackNDACurrent
63629-7145CialisTadalafilBryant Ranch PrepackNDACurrent
63629-7145CialisTadalafilBryant Ranch PrepackNDACurrent
66336-566CialisTadalafilDispensing Solutions, Inc.NDACurrent
66993-700TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-700TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-700TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-700TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-701TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-701TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-701TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-701TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-702TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-702TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-702TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-702TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-702TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-703TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-703TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-703TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-703TadalafilTadalafilPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
71610-213TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
71610-214TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52707SUPPL2018-02-23
52660SUPPL2018-02-16
52351ORIG2017-11-16
52350ORIG2017-11-16
52349ORIG2017-11-16
52348ORIG2017-11-16
48306SUPPL2017-05-09
48269SUPPL2017-05-08
36788SUPPL2016-04-29
5211SUPPL2016-04-26
15333SUPPL2015-09-23
5210SUPPL2015-09-17
15332SUPPL2014-05-02
27623SUPPL2014-04-30
21624SUPPL2014-01-17
36787SUPPL2013-10-17
5209SUPPL2013-10-11
27622SUPPL2011-10-12
5208SUPPL2011-10-12
36786SUPPL2011-10-07
15331SUPPL2011-10-07
15330SUPPL2010-02-16
5207SUPPL2010-02-16
5206SUPPL2008-08-13
5204SUPPL2008-01-09
15328SUPPL2008-01-08
5205SUPPL2007-10-22
15329SUPPL2007-10-18
27619SUPPL2007-01-25
15324SUPPL2007-01-24
27621SUPPL2006-10-26
5203SUPPL2006-10-26
15327SUPPL2006-10-25
15326SUPPL2006-10-25
27620SUPPL2006-03-23
15325SUPPL2006-03-10
44119ORIG2005-07-28
5202SUPPL2005-07-15
15323SUPPL2005-07-08
27618SUPPL2005-04-06
15322SUPPL2005-04-06
15321SUPPL2005-04-06
5201SUPPL2005-04-06
42124ORIG2004-03-08
43569ORIG2003-11-21
36785ORIG2003-11-21
5200ORIG2003-11-21
54084SUPPL1900-01-01
54083SUPPL1900-01-01
53531ORIG1900-01-01