FDA.reportPublic FDA data

Application 206164

Type
ANDA
Sponsor
TOLMAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADAPALENE AND BENZOYL PEROXIDEADAPALENE; BENZOYL PEROXIDEGEL;TOPICAL0.1%;2.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-7182Adapalene and Benzoyl PeroxideAdapalene and Benzoyl PeroxideSandoz Inc.ANDACurrent
0781-7182Adapalene and Benzoyl PeroxideAdapalene and Benzoyl PeroxideSandoz Inc.ANDACurrent