FDA.reportPublic FDA data

Application 214553

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

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
70771-1716Adapalene and benzoyl peroxideAdapalene and benzoyl peroxideZydus Lifesciences LimitedANDACurrent
72578-119Adapalene and benzoyl peroxideAdapalene and benzoyl peroxideViona Pharmaceuticals IncANDACurrent
72578-119Adapalene and benzoyl peroxideAdapalene and benzoyl peroxideViona Pharmaceuticals IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69664ORIG2021-12-20