FDA.reportPublic FDA data

Application 021518

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VESICARESOLIFENACIN SUCCINATETABLET;ORAL5MGYesNo
002VESICARESOLIFENACIN SUCCINATETABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0972VESIcaresolifenacin succinateA-S Medication SolutionsNDACurrent
51248-150VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-150VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-150VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-150VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-150VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-150VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-151VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-151VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-151VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-151VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-151VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
51248-151VESIcaresolifenacin succinateAstellas Pharma US, Inc.NDACurrent
55154-3875VESIcaresolifenacin succinateCardinal HealthNDACurrent
55154-3876VESIcaresolifenacin succinateCardinal HealthNDACurrent
55154-3877VESIcaresolifenacin succinateCardinal HealthNDACurrent
55154-3877VESIcaresolifenacin succinateCardinal HealthNDACurrent
55154-3878VESIcaresolifenacin succinateCardinal HealthNDACurrent
55154-3878VESIcaresolifenacin succinateCardinal HealthNDACurrent
66993-397Solifenacin Succinatesolifenacin succinatePrascoNDA AUTHORIZED GENERICCurrent
66993-398Solifenacin Succinatesolifenacin succinatePrascoNDA AUTHORIZED GENERICCurrent
68151-5406VESIcaresolifenacin succinateCarilion Materials ManagementNDACurrent
70518-1866VESIcaresolifenacin succinateREMEDYREPACK INC.NDACurrent
70518-1866VESIcaresolifenacin succinateREMEDYREPACK INC.NDACurrent
70518-1866VESIcaresolifenacin succinateREMEDYREPACK INC.NDACurrent
70518-2094VESIcaresolifenacin succinateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63325SUPPL2020-05-28
63304SUPPL2020-05-27
58516SUPPL2019-05-02
58502SUPPL2019-05-01
52346ORIG2017-07-20
52345ORIG2017-07-20
52344ORIG2017-07-20
52343ORIG2017-07-20
51594ORIG2017-07-20
51593ORIG2017-07-20
51592ORIG2017-07-20
37132SUPPL2013-10-17
5609SUPPL2013-10-11
37131SUPPL2013-04-01
5608SUPPL2013-04-01
37130SUPPL2012-08-06
5607SUPPL2012-08-06
37129SUPPL2012-07-25
5606SUPPL2012-07-17
28009SUPPL2012-06-12
37127SUPPL2012-06-11
37128SUPPL2012-01-23
28010SUPPL2012-01-19
5605SUPPL2011-03-14
37126SUPPL2011-03-11
5604SUPPL2010-07-14
15663SUPPL2010-07-01
5603SUPPL2008-11-21
37125SUPPL2008-11-19
28008SUPPL2008-10-30
28007SUPPL2008-02-14
15662SUPPL2008-02-14
5602SUPPL2007-07-24
15661SUPPL2007-07-16
42199ORIG2005-02-08
15660ORIG2004-12-03
28006ORIG2004-12-02
68846SUPPL1900-01-01
68845SUPPL1900-01-01