FDA.reportPublic FDA data

Application 213291

Type
ANDA
Sponsor
ALEOR DERMACEUTICALS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBETASOL PROPIONATECLOBETASOL PROPIONATECREAM;TOPICAL0.05%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62332-547CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals, Inc.ANDACurrent
62332-547CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals, Inc.ANDACurrent
62332-547CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAlembic Pharmaceuticals, Inc.ANDACurrent
71589-006CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAleor Dermaceuticals LimitedANDACurrent
71589-006CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAleor Dermaceuticals LimitedANDACurrent
71589-006CLOBETASOL PROPIONATECLOBETASOL PROPIONATEAleor Dermaceuticals LimitedANDACurrent