FDA.reportPublic FDA data

Application 022204

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GELNIQUEOXYBUTYNIN CHLORIDEGEL;TRANSDERMAL10% (100MG/PACKET)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5812GELNIQUEoxybutynin chlorideAllergan, Inc.NDACurrent
0023-5812GELNIQUEoxybutynin chlorideAllergan, Inc.NDACurrent
0023-5861GELNIQUEoxybutynin chlorideAllergan, Inc.NDACurrent
0023-5861GELNIQUEoxybutynin chlorideAllergan, Inc.NDACurrent
0023-5861GELNIQUEoxybutynin chlorideAllergan, Inc.NDACurrent
52544-084GELNIQUEoxybutynin chlorideActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50230SUPPL2017-10-30
50196SUPPL2017-10-26
38383SUPPL2015-07-13
7046SUPPL2015-07-13
38382SUPPL2012-10-12
29405SUPPL2012-10-12
29404SUPPL2011-02-04
38381SUPPL2011-01-31
44701ORIG2010-05-13
42449ORIG2010-05-13
17082ORIG2009-02-04
7045ORIG2009-02-03