FDA.reportPublic FDA data

Application 214185

Type
ANDA
Sponsor
ALEOR DERMACEUTICALS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADAPALENE AND BENZOYL PEROXIDEADAPALENE; BENZOYL PEROXIDEGEL;TOPICAL0.3%;2.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62332-662ADAPALENE AND BENZOYL PEROXIDEadapalene and benzoyl peroxide topicalAlembic Pharmaceuticals, Inc.ANDACurrent
62332-662ADAPALENE AND BENZOYL PEROXIDEadapalene and benzoyl peroxide topicalAlembic Pharmaceuticals, Inc.ANDACurrent