FDA.reportPublic FDA data

Application 021513

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENABLEXDARIFENACIN HYDROBROMIDETABLET, EXTENDED RELEASE;ORALEQ 7.5MG BASEYesNo
002ENABLEXDARIFENACIN HYDROBROMIDETABLET, EXTENDED RELEASE;ORALEQ 15MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0430-0170EnablexdarifenacinAllergan, Inc.NDACurrent
0430-0170EnablexdarifenacinAllergan, Inc.NDACurrent
0430-0170EnablexdarifenacinAllergan, Inc.NDACurrent
0430-0170EnablexdarifenacinAllergan, Inc.NDACurrent
0430-0171EnablexdarifenacinAllergan, Inc.NDACurrent
0430-0171EnablexdarifenacinAllergan, Inc.NDACurrent
0430-0171EnablexdarifenacinAllergan, Inc.NDACurrent
0430-0171EnablexdarifenacinAllergan, Inc.NDACurrent
0591-4375DarifenacindarifenacinActavis Pharma, Inc.NDACurrent
0591-4375DarifenacindarifenacinActavis Pharma, Inc.NDACurrent
0591-4380DarifenacindarifenacinActavis Pharma, Inc.NDACurrent
0591-4380DarifenacindarifenacinActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68106SUPPL2021-07-16
68092SUPPL2021-07-15
5591SUPPL2012-03-19
15644SUPPL2012-03-16
15643SUPPL2012-01-26
27984SUPPL2012-01-18
27983SUPPL2011-04-20
15642SUPPL2011-04-18
27982SUPPL2010-10-25
37111SUPPL2010-10-19
37110SUPPL2009-01-02
5590SUPPL2008-12-19
15641SUPPL2008-06-05
5589SUPPL2008-04-22
15640SUPPL2005-10-25
5588SUPPL2005-10-25
21707ORIG2005-02-08
15639ORIG2004-12-29
5587ORIG2004-12-29