FDA.reportPublic FDA data

Application 202211

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYTROL FOR WOMENOXYBUTYNINFILM, EXTENDED RELEASE;TRANSDERMAL3.9MG/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-9637Oxytrol for WomenOxybutyninAllergan, Inc.NDACurrent
0023-9637Oxytrol for WomenOxybutyninAllergan, Inc.NDACurrent
0023-9637Oxytrol for WomenOxybutyninAllergan, Inc.NDACurrent
0023-9637Oxytrol for WomenOxybutyninAllergan, Inc.NDACurrent
52544-166Oxytrol For WomenoxybutyninActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40139SUPPL2016-03-04
32206SUPPL2016-03-04
19296ORIG2013-11-12
24410ORIG2013-11-05
22878ORIG2013-11-05
32205ORIG2013-01-30