FDA.reportPublic FDA data

Application 213508

Type
ANDA
Sponsor
ALEOR DERMACEUTICALS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADAPALENEADAPALENEGEL;TOPICAL0.3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62332-549ADAPALENEADAPALENEAlembic Pharmaceuticals, Inc.ANDACurrent
62332-549ADAPALENEADAPALENEAlembic Pharmaceuticals, Inc.ANDACurrent
62332-549ADAPALENEADAPALENEAlembic Pharmaceuticals, Inc.ANDACurrent
71589-008ADAPALENEADAPALENEAleor Dermaceuticals LimitedANDACurrent
71589-008ADAPALENEADAPALENEAleor Dermaceuticals LimitedANDACurrent