FDA.reportPublic FDA data

Application 021835

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBEXCLOBETASOL PROPIONATESPRAY;TOPICAL0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-3849CLOBEXclobetasol propionateGalderma Laboratories, L.P.NDACurrent
0591-4039CLOBETASOL PROPIONATECLOBETASOL PROPIONATEActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57086SUPPL2018-12-31
57016SUPPL2018-12-26
16433SUPPL2012-09-11
28677SUPPL2012-09-10
28678SUPPL2012-08-20
16434SUPPL2012-08-20
37736SUPPL2011-01-14
37735SUPPL2011-01-14
28676SUPPL2011-01-14
6277SUPPL2011-01-14
21838ORIG2007-07-03
28675ORIG2005-11-01
16432ORIG2005-11-01