FDA.reportPublic FDA data

Application 209148

Type
ANDA
Sponsor
TARO

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
51672-1384Adapalene and Benzoyl PeroxideADAPALENE and BENZOYL PEROXIDETaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1384Adapalene and Benzoyl PeroxideADAPALENE and BENZOYL PEROXIDETaro Pharmaceuticals U.S.A., Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49690ORIG2018-11-15