FDA.reportPublic FDA data

Application 022320

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIDUOADAPALENE; BENZOYL PEROXIDEGEL;TOPICAL0.1%;2.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-5908EPIDUOadapalene and benzoyl peroxideGalderma Laboratories, L.P.NDACurrent
66993-869Adapalene and Benzoyl Peroxideadapalene and benzoyl peroxidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57670SUPPL2019-02-15
38572SUPPL2013-02-06
7231SUPPL2013-02-04
38571SUPPL2011-12-20
7230SUPPL2011-12-20
38570SUPPL2011-02-24
29589SUPPL2011-02-24
42491ORIG2010-01-13
24282ORIG2010-01-13
38569ORIG2009-01-02
7229ORIG2008-12-19
68901ORIG1900-01-01
68900ORIG1900-01-01
68899ORIG1900-01-01
51442SUPPL1900-01-01
51441SUPPL1900-01-01
51440SUPPL1900-01-01