FDA.reportPublic FDA data

Application 208108

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

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
68462-301adapalene and benzoyl peroxideadapalene and benzoyl peroxideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-301adapalene and benzoyl peroxideadapalene and benzoyl peroxideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-301adapalene and benzoyl peroxideadapalene and benzoyl peroxideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-301adapalene and benzoyl peroxideadapalene and benzoyl peroxideGlenmark Pharmaceuticals Inc., USAANDACurrent