FDA.reportPublic FDA data

Application 207917

Type
NDA
Sponsor
GALDERMA LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIDUO FORTEADAPALENE; BENZOYL PEROXIDEGEL;TOPICAL0.3%;2.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-6303adapalene and benzoyl peroxideadapalene and benzoyl peroxideTEVA PHARMACEUTICALS USA, INCNDA AUTHORIZED GENERICCurrent
0093-6303adapalene and benzoyl peroxideadapalene and benzoyl peroxideTEVA PHARMACEUTICALS USA, INCNDA AUTHORIZED GENERICCurrent
0299-5906epiduo forteadapalene and benzoyl peroxideGalderma Laboratories, L.P.NDACurrent
0299-5906epiduo forteadapalene and benzoyl peroxideGalderma Laboratories, L.P.NDACurrent
0299-5906epiduo forteadapalene and benzoyl peroxideGalderma Laboratories, L.P.NDACurrent
0299-5906epiduo forteadapalene and benzoyl peroxideGalderma Laboratories, L.P.NDACurrent
68308-662adapalene and benzoyl peroxideadapalene and benzoyl peroxideMayne Pharma Inc.NDA AUTHORIZED GENERICCurrent
68308-662adapalene and benzoyl peroxideadapalene and benzoyl peroxideMayne Pharma Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70859SUPPL2022-04-29
70858SUPPL2022-04-29
70845SUPPL2022-04-28
70844SUPPL2022-04-28
51451ORIG2018-01-01
43536ORIG2016-05-25
10625ORIG2015-07-20
40594ORIG2015-07-16
51449ORIG1900-01-01
51443ORIG1900-01-01