Application 212464

Type
ANDA
Sponsor
PERRIGO UK FINCO LTD PARTNERSHIP

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
45802-853ADAPALENE AND BENZOYL PEROXIDEadapalene and benzoyl peroxidePadagis Israel Pharmaceuticals LtdANDACurrent
63629-9322ADAPALENE AND BENZOYL PEROXIDEadapalene and benzoyl peroxideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61151ORIG2019-12-04