FDA.reportPublic FDA data

Application 021644

Type
NDA
Sponsor
GALDERMA LABS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-3847Clobexclobetasol propionateGalderma Laboratories, L.P.NDACurrent
0299-3847Clobexclobetasol propionateGalderma Laboratories, L.P.NDACurrent
0781-7137clobetasol propionateclobetasol propionateSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-7137clobetasol propionateclobetasol propionateSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-7137clobetasol propionateclobetasol propionateSandoz Inc.NDA AUTHORIZED GENERICCurrent
66993-939clobetasol propionateclobetasol propionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
15917SUPPL2014-01-14
5905SUPPL2012-12-03
37390SUPPL2012-08-20
28305SUPPL2012-08-20
42249ORIG2004-12-07
15916ORIG2004-03-03
28304ORIG2004-02-27